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Review Efficacy and safety of filgotinib in the treatment of ulcerative colitis with a focus on rapid and sustained efficacy: a narrative review
Tadakazu Hisamatsu1orcid, Toshihiko Kaise2orcid, Chisa Nagakura2orcid, Makoto Kamiya2orcid, Shu-Chen Wei3orcid

DOI: https://doi.org/10.5217/ir.2025.00155
Published online: November 19, 2025

1Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan

2Gilead Sciences K.K., Tokyo, Japan

3Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

Correspondence to Toshihiko Kaise, Gilead Sciences K.K., 1-9-2 Marunouchi, Chiyoda-ku, Tokyo 100-6616, Japan. E-mail: toshihiko.kaise@gilead.com
• Received: July 25, 2025   • Revised: September 23, 2025   • Accepted: September 28, 2025

© 2025 Korean Association for the Study of Intestinal Diseases.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • The rising incidence of ulcerative colitis (UC) globally highlights the necessity for treatment strategies that extend beyond symptom control to include inducing and maintaining remission, achieving biochemical and endoscopic remission, and restoring quality of life. Janus kinase inhibitors, such as filgotinib (FIL), show promise in treating UC. This review consolidates evidence on FIL in treating UC from the SELECTION and SELECTIONLTE trials, and real-world studies. Overall, FIL demonstrated rapid symptom relief (e.g., improved rectal bleeding and stool frequency) within 7 days and durable efficacy (e.g., clinical remission, Mayo Clinic Score response) up to 4 years. Improvements in health-related quality of life (HRQoL) and reduced corticosteroid dependency were also observed. The 200 mg dose generally elicited greater efficacy responses than the 100 mg dose, and hence may potentially be a more suitable choice for optimizing treatment outcomes. Although FIL may be an effective long-term treatment option regardless of prior biologic experience, biologic-naive patients may experience greater sustained clinical improvements. Safety outcomes indicated that FIL was well tolerated with no unexpected safety signals in SELECTION and SELECTIONLTE. These findings support FIL’s potential as a robust therapeutic option for UC, due to its acceptable safety profile and benefits across clinical and HRQoL outcomes.
  • Keywords: Ulcerative colitis; Inflammatory bowel diseases; Janus kinase inhibitors; Efficacy; Safety
Ulcerative colitis (UC) is a chronic relapsing and remitting inflammatory bowel disease (IBD), which causes continuous mucosal inflammation extending from the rectum to the proximal colon [1]. Common clinical symptoms include bloody diarrhea, rectal urgency, heightened stool frequency, general malaise, fatigue, and varying degrees of abdomen pain that is often relieved by defecation [1,2]. UC is associated with significant morbidity, and has a major impact on patients’ quality of life (QoL) and their ability to work [2].
The burden of UC may vary considerably across different countries/regions–globally, the estimated annual incidence and prevalence of UC ranges 1.2–20.3 and 7.6–245 cases per 100,000 persons, respectively [1]. In Asian countries such as Japan, Malaysia, South Korea, and Taiwan, the incidence/prevalence of UC have increased by 1.5–20 times over the last four decades, thereby contributing to rising healthcare costs and resource use [3]. Due to disparities in healthcare systems and funding, Asian countries may face unique challenges in the management of UC, which include optimizing resource utilization and making informed decisions when selecting from a growing number of emerging treatment options [3].
In terms of treatment goals for UC, the primary aim of clinical management involves the induction and maintenance of remission [4]. Long-term treatment goals also include preventing disability, colectomy, and colorectal cancer, as well as minimizing the risks associated with corticosteroid exposure [4]. Although treatment strategies traditionally targeted symptom control, the focus has broadened to include achieving biochemical and endoscopic remission, as well as restoring QoL [2].
Patients with mild-to-moderate UC are primarily treated with aminosalicylates, while refractory patients are prescribed systemic therapies (e.g., corticosteroids, biological therapies, small molecules) [2]. Advanced therapies targeting pivotal molecules or pathways in UC have also emerged, encompassing biologics such as anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin-12/23 antibodies, and sphingosine 1-phosphate receptor modulators [2,5]. Despite the development of advanced therapies, a substantial proportion of patients do not respond to treatment, lose response over time, or experience adverse events (AEs) [2,5]. Therefore, novel therapeutic options are important for optimizing treatment and uplifting healthcare outcomes among patients with UC.
As an emerging targeted therapy, Janus kinase (JAK) inhibitors have demonstrated efficacy in treating inflammatory conditions by disrupting intracellular signaling from pro-inflammatory cytokines [2,6]. These cytokines bind to cell surface receptors, activating the JAK-signal transducers and activators of transcription (STAT) pathway, which involves JAK family members (JAK1, JAK2, JAK3, TYK2) crucial for cytokine signal transduction [2]. The JAK-STAT signaling pathway, which prompts gene expression of various inflammatory responses, is therefore a promising target for UC treatment due to its role in disease-related cytokine activity [2]. Unlike biologics, JAK inhibitors can be administered orally, have no risk of immunogenicity, and demonstrate reduced pharmacokinetic variability compared with biologics [6].
Filgotinib (FIL), an oral, once-daily, JAK1 preferential inhibitor, has been approved for the treatment of moderately to severely active UC in the European Union, Japan, South Korea, Singapore, Taiwan, and the United Kingdom, based on results of the phase 2b/3 SELECTION trial [7-13]. Compared with other JAK inhibitors with broader activity across multiple JAK isoforms, FIL is highly selective for JAK1 pathways [14-16]. This targeted approach appears sufficient to achieve clinical efficacy comparable to other JAK inhibitors, suggesting JAK1 inhibition is a critical driver of their overall effectiveness [16]. In real-world clinical practice, FIL appears to be associated with a reduced incidence of AEs compared to other JAK inhibitors for UC. A registry study, for instance, reported that AEs occurred less frequently in patients receiving FIL compared to those on tofacitinib and upadacitinib [17]. Further supporting this, a multicenter cohort study specifically comparing FIL to upadacitinib for UC, also noted a lower frequency of AEs with FIL [18].
Currently, there are several studies in the literature which report on efficacy and safety outcomes from SELECTION and/or its open-label long-term extension, SELECTIONLTE. However, no published articles have comprehensively reviewed and consolidated the data from these studies–such synthesized information could help support healthcare professionals in making informed clinical decisions on prescribing FIL as a treatment option in patients with UC. This narrative review therefore aims to provide a summary of the latest evidence on FIL, particularly on its rapid and durable efficacy and safety, in the treatment of UC based on results from SELECTION and SELECTIONLTE, as well as relate these results with real-world evidence (RWE) studies.
1. Publications Included in This Narrative Review
Overall, 23 articles/abstracts published in 2021–2025 were included in this narrative review [5,6,18-38], including 17 publications reporting data from the SELECTION and SELECTIONLTE trials (Table 1 and Supplementary Table 1) [5,6,20-23,26-31,33-37], and 6 RWE studies (Table 2 and Supplementary Table 2) [18,19,24,25,32,38].
2. SELECTION and SELECTIONLTE Study Designs
The study designs of SELECTION and SELECTIONLTE, including detailed definitions and inclusion/exclusion criteria, have been described previously [5,6,37]. Briefly, SELECTION (NCT02914522) was a phase 2b/3, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of FIL among patients with moderately to severely active UC [5]. Eligible patients were aged 18–75 years at screening and had a UC diagnosis, with evidence of UC ≥ 6 months before enrolment. Patients (n=1,348) were randomized 2:2:1 to receive once-daily FIL 200 mg, FIL 100 mg, or placebo in: (1) induction study A, consisting of biologic-naive patients (n=659), or (2) induction study B, consisting of biologic-experienced patients (n=689) [5]. Efficacy in the induction studies was assessed at Week 10. At Week 11, patients in clinical remission or with a Mayo Clinic Score (MCS) response were re-randomized 2:1 to continue their induction FIL regimen or receive placebo to Week 58 (maintenance study). The primary endpoint of the SELECTION induction and maintenance studies was clinical remission, defined as Mayo endoscopic (subscore: 0), rectal bleeding (subscore: 0), and stool frequency (subscore: ≤ 1; ≥ 1 point decrease from induction baseline) scores [5].
SELECTIONLTE (NCT02914535) is an ongoing phase 3 trial assessing the long-term safety of FIL [37]. The following eligible patients from SELECTION enrolled into its ongoing open-label extension, SELECTIONLTE [37]: (1) completers who achieved clinical remission or an MCS response at Week 10 and completed SELECTION to Week 58; (2) non-responders who did not achieve clinical remission or an MCS response and discontinued SELECTION; or (3) patients who experienced protocol-specified disease worsening (PSDW) in the maintenance study.
Completers continued the same dosing until SELECTION was unblinded, after which they received open-label FIL at the same dose, and patients receiving placebo discontinued the study [6,37]. Non-responders and patients who experienced PSDW during maintenance were generally assigned to open-label FIL 200 mg [6,37].
3. Baseline Characteristics in SELECTION and SELECTIONLTE
The baseline demographics and characteristics of patients enrolled in SELECTION and SELECTIONLTE are reported in Table 3.
4. Efficacy of FIL

1) Clinical Response and Remission Outcomes: Primary and Secondary Endpoints

Feagan et al. [5] was a pivotal study which reported on the preplanned primary and secondary endpoints of SELECTION. According to Feagan et al., FIL 200 mg significantly improved clinical remission rates (primary endpoint; defined in section above) at Week 10 versus placebo (biologic-naive patients: 26.1% vs. 15.3% [P=0.02]; biologic-experienced patients: 11.5% vs. 4.2% [P=0.01]), and at Week 58 versus placebo (37.2% vs. 11.2% [P<0.0001]). In the FIL 100 mg group, clinical remission was not significantly different compared with placebo at Week 10, but was significant by Week 58 (23.8% vs. 13.5%; P=0.04). The treatment effect of FIL 200 mg on clinical remission relative to placebo at Week 58 was consistent across prespecified subgroups (by biologic-naive/experienced, TNF antagonist failure, vedolizumab failure, TNF antagonist + vedolizumab failure statuses).
Pre-planned secondary endpoints, including MCS remission (total MCS score: ≤2, no single subscore of >1), endoscopic remission (Mayo endoscopic subscore: 0), and histologic remission (based on the Geboes score; no/mild increase in chronic inflammatory infiltrate in lamina propria, no neutrophils in the lamina propria/epithelium, and no erosion/ulceration/granulation tissue) were also met at Week 10 in biologic-naive patients treated with FIL 200 mg and Week 58 in FIL 200 mg-treated patients (i.e., significantly greater proportions achieving remission versus placebo), but these endpoints were not met in biologic-experienced patients at Week 10 and the FIL 100 mg group at Week 58 [5].

2) Rapid Symptom Relief and Achievement of pMCS Remission

Two post hoc analyses of the SELECTION trial reported on rapid symptom relief and achievement of partial MCS (pMCS) remission among FIL-treated patients [20,33]. In a post hoc analysis which assessed rapid symptom relief and pMCS remission (pMCS ≤ 2 and no rectal bleeding, stool frequency, or physician’s global assessment subscore >1) among FIL-treated patients with UC [20], FIL 200 mg significantly improved rectal bleeding and stool frequency within 7 days compared with placebo (P<0.05). Specifically, the treatment effect of FIL 200 mg versus placebo in achieving a combined improvement in rectal bleeding and stool frequency was observed by Day 9 in biologic-naive patients (18.8% vs. 9.5%; P=0.01) and Day 7 in biologic-experienced patients (10.7% vs. 4.2%; P=0.02). By Day 3, improvements in stool frequency alone were already observed in biologic-naive patients treated with FIL 200 mg versus placebo (29.0% vs. 19.0%; P=0.03).
By Week 2, greater proportions of FIL 200 mg-treated patients versus placebo achieved pMCS remission (biologic-naive: 15.1% vs. 8.0% [P=0.04]; biologic-experienced: 10.3% vs. 4.2% [P=0.03]), with similar treatment effects observed at Week 58 (P<0.0001) [20]. Day 7 rectal bleeding and stool frequency subscores were associated with MCS response at Weeks 10 and 58. Patients in pMCS remission at Weeks 10 and 58 also had greater improvements in IBD Questionnaire (IBDQ) scores than those not in pMCS remission, demonstrating that symptomatic relief were associated with both short-term and long-term improvements in health-related QoL (HRQoL).
As a supplement to the above study, Saruta et al. [33] assessed rapid symptom relief based on baseline disease severity (moderate: pMCS <7; severe: pMCS ≥7). The study found that Day 2 improvements in rectal bleeding and stool frequency with FIL 200 mg treatment were significantly higher in patients with baseline pMCS <7 versus pMCS ≥7 (biologic-naive: 8.4% vs. 1.1% [P=0.009]; biologic-experienced: 8.8% vs. 0.7% [P=0.004]). From Day 2–15, symptomatic remission rates increased regardless of prior exposure to biologics, and these rates generally continued to be significantly higher in those with baseline pMCS <7 versus pMCS ≥7. By Week 10, however, symptomatic remission rates with FIL 200 mg treatment were no longer significantly different between those with baseline pMCS <7 and pMCS ≥7. Hence, although symptomatic response to FIL 200 mg occurred more rapidly in patients with lower UC severity than those with higher severity, converging response rates over 10 weeks of treatment led to symptomatic remission regardless of baseline disease severity.

3) Durable and Long-term Efficacy

Three analyses reported on the durable and long-term efficacy of FIL (Feagan et al. [4-year interim data], Laharie et al., and Feagan et al. [5-year interim data]) [6,23,27].
When evaluating the durable action of FIL, an interim analysis of SELECTIONLTE [6] reported that among FIL-treated patients who achieved clinical remission at Week 10, 79.3% (FIL 200 mg) and 63.0% (FIL 100 mg) were in clinical remission or had an MCS response at Week 58; these rates were numerically greater than patients re-randomized at Week 11 to placebo (FIL 200 mg-placebo: 44.4%; FIL 100 mg-placebo: 41.7%).
When the long-term efficacy of FIL was evaluated in Feagan et al. [6], the proportions of FIL 200 mg-treated patients achieving pMCS (score: ≤ 1), IBDQ (score: ≥ 170), and fecal calprotectin (FCP; ≤250 μg/g) remission were maintained over time from long-term extension baseline to Week 144 among SELECTION Week 10 responders (80.0%, 86.4%, and 86.0%, respectively); among Week 10 non-responders, these proportions increased over time from long-term extension baseline to Week 192 (62.1%, 76.7%, and 59.3%, respectively). These responses were similarly maintained up to 5 years, where 85.0% and 84.8% of Week 10 responders achieved pMCS and IBDQ remission, respectively; among Week 10 non-responders, 66.7% and 77.8% achieved pMCS and IBDQ remission, respectively [23]. Generally, differences between patients treated with FIL 200 mg and 100 mg were minimal, and the FIL induction dose did not influence efficacy outcomes among FIL 200 mg-treated patients in SELECTIONLTE [6]. Even among initial non-responders, gradual improvements and maintenance of efficacy measures were observed upon continued FIL treatment in SELECTIONLTE. Furthermore, improvements up to 4 years with FIL treatment in both Week 10 responders and non-responders were accompanied by low corticosteroid use, and high proportions of patients in corticosteroid-free pMCS remission [6].
Laharie et al. [27], a post hoc analysis of SELECTION assessing the prolonged benefit (i.e., sustained response) of FIL, demonstrated that continuous FIL 200 mg treatment significantly reduced the risk of PSDW compared with patients who were re-randomized from FIL 200 mg to placebo (FIL 200 mg-placebo: hazard ratio [HR], 0.26; P<0.0001). Among patients who were in clinical remission or had an MCS response at Week 10, 66.8% treated with continuous FIL 200 mg had a prolonged benefit at Week 58, compared with 32.7% in the FIL 200 mg-placebo arm. Additionally, in the continuous FIL 200 mg arm, 82.0% of patients with prolonged benefit at Week 58 had IBDQ remission at Week 58, demonstrating that prolonged benefit was associated with improvements in HRQoL.

4) Predictive Markers of Efficacy

Seven analyses included in this review identified patient factors associated with greater efficacy responses to FIL treatment or beneficial long-term response trajectories [21,22,29-31,34,36].
In a pre-planned exploratory analysis which identified circulating biomarkers of UC [30], FIL 100 mg and 200 mg significantly lowered levels of almost all circulating biomarkers associated with UC pathology at Weeks 4 and 10 versus placebo, especially at the 200 mg dose. Notably, there was a consistent decrease in almost all systemic inflammatory biomarkers, neutrophil activation biomarkers, T helper (Th)17- and Th2-related factors, and immunoglobulin M levels, with similar effects observed in biologic-naive and biologic-experienced patients. Therefore, changes in certain biomarker levels at Week 4 may be early mediators of FIL treatment effects at Week 10.
Across 6 post hoc analyses [21,22,29,31,34,36], factors such as biologic-naive status, smoking, female sex (vs. male), recent UC diagnosis (<1 year), FIL 200 mg treatment (vs.100 mg), and Week 10 assessments including stool frequency improvements (subscore: ≤1), FCP concentration (<250 μg/g), low endosopic inflammatory activity (subscore: ≤ 1), Geboes histologic remission, and HRQoL improvements (IBDQ total score: >170) were identified as predictive markers of sustained clinical remission to approximately 1 year. Aside from biologic-naive status, female sex, and lower baseline C-reactive protein (CRP) levels, Feagan et al. [22], also found that rapid symptom relief (i.e., improved rectal bleeding and stool frequency) on Day 7 predicted MCS response/remission at Week 10.
In addition to analyzing predictive factors, Schreiber et al. [34] identified distinct patient subgroups of response to FIL based on pMCS trajectories over time. In this study, beneficial trajectory groups generally had higher proportions of patients who were recently diagnosed (<1 year; 4%–9% vs. 4%–5%), receiving FIL 200 mg (43%–65% vs. 36%–46%), and biologic-naive (54%–70% vs. 35%–58%) compared with relapsing trajectory groups. Furthermore, 55.4% of patients had sustained beneficial trajectories, with ≥43% having low baseline endoscopic subscores (subscore: 2) and ≥61% having strong Week 10 FCP responses (>50% decrease in FCP from baseline). Sustained beneficial trajectory groups also had a higher probability of achieving comprehensive disease control (CDC) at Week 58 than other groups (31%–32% vs. 0%–7%).
When the efficacy of FIL based on prior biologic failure was analyzed post hoc, Dotan et al. [21] showed that FIL 200 mg induced and maintained benefits relative to placebo in terms of achieving Week 10 clinical remission (biologic-naive, OR: 1.98; had prior biologic failure, OR: 3.91) and reducing the risk of PSDW at Week 58 (biologic-naive, HR: 0.22; had prior biologic failure, HR: 0.22), with the estimated therapeutic benefit being higher in biologic-naive patients than patients with prior biologic failure. Furthermore, among patients with prior biologic failure, the likelihood of PSDW at Week 58 generally increased with increasing numbers of prior biologics.

5) Health-Related Quality of Life

Schreiber et al. [35] reported on pre-planned exploratory analyses of SELECTION data, evaluating the effect of FIL on generic HRQoL (measured by 36-Item Short-Form Survey [SF-36] and EuroQol 5-dimension [EQ-5D] scores) and disease-specific HRQoL (measured by IBDQ score). At Weeks 10 and 58, patients who received FIL 200 mg had greater least-squares mean increases from induction and maintenance baseline, respectively, in SF-36, EQ-5D, and IBDQ scores than those who had received placebo (P<0.05); generally, these treatment differences were numerically larger among biologic-experienced than biologic-naive patients. Overall, treatment with FIL 200 mg improved generic and disease-specific HRQoL in the short term (10 weeks) among both biologic-naive and biologic-experienced patients, with improvements maintained during long-term treatment (58 weeks).

6) CDC: A Multi-Component Endpoint

Two studies assessed a multi-component endpoint, CDC, defined as achievement of pMCS remission, endoscopic improvement (subscore: ≤1), inflammatory biomarker remission (FCP <150 μg/g), and IBDQ remission (score: ≥ 170) assessed at individual patient level [6,35].
In a post hoc SELECTION analysis [35], a greater proportion of patients treated with FIL 200 mg achieved CDC than placebo at Week 10 (10.9% vs. 2.9%; P<0.001) and Week 58 (22.1% vs. 7.1%; P=0.002), and this trend was more pronounced in biologic-naive than biologic-experienced patients. CDC was also associated with clinically important improvements in HRQoL (e.g., SF-36, EQ-5D scores) and histological remission over both periods (all P<0.05). This suggests that CDC achievement may be associated with HRQoL restoration and controlled disease at the cellular level.
Similarly, according to an interim analysis of SELECTIONLTE [6], achieving CDC with FIL 200 mg at Week 58 of SELECTION was associated with improved efficacy, improved HRQoL, and reduced corticosteroid use during 3 years of follow-up, as shown by the significantly higher proportions of Week 58 CDC achievers than non-achievers who reached pMCS remission (pMCS ≤1), IBDQ remission (IBDQ score: ≥170), and corticosteroid-free pMCS remission (pMCS ≤ 1; not taking corticosteroids on the day of study visit) up to long-term extension Week 96 (all P<0.05). Generally, higher proportions of CDC achievers at Week 58 reached remission outcomes in SELECTIONLTE than those achieving individual components of CDC, suggesting that this multi-component endpoint may provide more rigorous assessment of treatment efficacy compared with individual endpoints.

7) Corticosteroid-Sparing Effects

Three studies included in this review investigated the corticosteroid-sparing effects of FIL, based on data from the SELECTION/SELECTIONLTE trials [5,26,28].
Briefly, in the pivotal SELECTION study [5], a significantly greater proportion of patients treated with FIL 200 mg versus placebo had 6-month corticosteroid-free remission at Week 58 (27.2% vs. 6.4%; P=0.01).
A post hoc analysis of SELECTION assessing the corticosteroid-sparing effects of FIL 200 mg at Week 58 by Loftus et al. [28] also found that among patients receiving corticosteroids at maintenance baseline, 30.4%, 29.3%, 27.2%, and 21.7% had been in corticosteroid-free remission for ≥1, ≥3, ≥6, or ≥8 months, respectively, versus 6.4% receiving placebo across all thresholds (P<0.05).
In addition, 6-month corticosteroid-free remission based on baseline characteristics were assessed by Kobayashi et al. [26], which observed that a lower baseline MCS endoscopic subscore (2 vs. 3) was associated with increased odds of corticosteroid-free remission in patients treated with FIL 200 mg and 100 mg, while female sex, smoking, and biologic-naive status was associated with increased odds of corticosteroid-free remission in those treated with FIL 200 mg versus 100 mg. These results indicated that although steroid tapering can be achieved in patients with UC receiving FIL 200 mg independently of baseline characteristics (e.g., clinical activity, illness duration), the likelihood of achieving corticosteroid-free remission may be higher among patients who are biologic-naive, smokers, had low endoscopic inflammatory burden, and females.
Overall, based on the above findings, FIL 200 mg demonstrated corticosteroid-sparing effects and maintained corticosteroid-free clinical remission in patients with UC.

8) RWE on Effectiveness

Although randomized clinical trials represent the optimal approach for evaluating efficacy and safety, RWE studies serve as a valuable complement to the SELECTION trials, by providing insights into FIL’s effect among broader, more diverse populations. Moreover, RWE studies can capture data on treatment outcomes of emerging importance (e.g., fecal urgency) that were not evaluated in the SELECTION trials, along with key treatment parameters such as drug persistence. The ongoing GALOCEAN study, for example, assesses both urgency and persistence [39]. Here, we report the results from several RWE studies [18,19,24,25,32,38].
Gros et al. [24] was the first cohort study to report data on real-world outcomes of FIL in patients with UC (n=91), which comprised a substantial proportion (67%) of biologic/small molecule-naive patients. Based on this retrospective analysis conducted in Scotland, pMCS (<2), biochemical (CRP ≤5 mg/L), and fecal biomarker (FCP <250 μg/g) remission outcomes were achieved in over 70% of patients at Week 12, and these improvements were maintained through Week 24. At Week 12, there were significant reductions in median pMCS, CRP levels, and FCP levels (all P<0.0001), whereas no significant changes were observed in total cholesterol and alanine transaminase levels. An exploratory analysis was performed to identify factors associated with clinical remission at Week 12, but no factors were identified. At the end of median follow-up of 42 weeks, 82.4% of patients remained on FIL and median time to FIL discontinuation was 13 weeks. The primary reason for drug discontinuation was primary non-response (9.9%), followed by secondary loss of response (2.2%). It was found that decreased albumin levels (<36 g/L) at baseline were associated with worse drug persistence (P=0.011). Consistent with analyses of SELECTION data, these real-world findings demonstrated that FIL effectively induced and maintained remission in patients with UC, with favorable outcomes persisting up to 6 months.
Similarly, Nogami et al. [18] was the first multicenter cohort study to assess outcomes in FIL-treated patients with UC (n=98). This retrospective observational analysis conducted in Japan demonstrated Week 8 clinical response and remission rates of 55.1% and 46.9%, respectively, with similar rates being observed regardless of previous exposure to tofacitinib (tofacitinib-naive: 54.9% and 48.8%; tofacitinib-exposed: 56.3% and 37.5%). Over a median follow-up of 191 days, 52.0% of patients treated with FIL discontinued treatment. Plachta-Danielzik et al. [32] reported the results from a prospective, multicenter observational FilgoColitis study, which investigated the clinical effectiveness of newly introduced FIL therapy in patients with active UC. At the 6-month interim analysis (n=164), treatment persistence was 87.2%, and clinical response and remission rates were 59.2% and 41.7%, respectively. Notably, no significant difference in clinical remission rates was observed between biologic-naive (41.7%) and biologic-experienced (41.4%) patients. For those who responded by Week 10, the effectiveness was even more pronounced at 6 months, with response and remission rates of 85.0% and 58.8% respectively. Additionally, patients experienced significant improvements in HRQoL, as evidenced by an increase in mean Short IBDQ (sIBDQ) scores, from 42.0 to 56.0 (P<0.001) [32].
Further real-world insights emerge from the interim analysis of the prospective, observational, multicenter GALOCEAN study [25], which investigated FIL’s effectiveness with and without concomitant UC therapies (CT) in patients with UC. At the time of analysis, 223 patients had available baseline data, of which 62.3% and 37.2% completed 10 and 24 weeks of treatment, respectively; the remainder of the patients may have discontinued before these timepoints or may not have reached these timepoints at data cutoff. At Week 24, MCS remission was achieved by 30% of patients (FIL-CT: 29%; FIL+CT: 31%), while pMCS remission rates were 47% across both groups. Minimal clinically important differences (MCIDs) in sIBDQ scores were achieved by 66% of the overall cohort (FIL-CT: 75%; FIL+CT: 58%), and 43% (FIL-CT: 50%; FIL+CT: 36%) for the Urgency Numerical Rating Scale (NRS) score. This analysis underscores FIL’s overall effectiveness in a real-world cohort over 24 weeks, demonstrating comparable benefits whether used as monotherapy or with concomitant treatments [25].
A post hoc analysis of the early real-world outcomes from the same GALOCEAN study specifically examined FIL’s effectiveness in patients stratified by baseline disease activity (moderately vs. severely active UC). At the time of analysis, 219 patients had available baseline data, of which 62.6% and 37.4% completed 10 and 24 weeks of treatment, respectively; the remainder of the patients may have discontinued before these timepoints or may not have reached these timepoints at data cutoff. In this interim analysis, MCS remission rates at Week 24 were 33% in patients with moderately active UC compared to 25% in those with severely active UC. Similarly, pMCS remission rates were 56% and 43% for moderately and severely active patients, respectively. Clinically meaningful improvements in patient-reported outcomes were also observed, with MCID in the sIBDQ score achieved by 75% of moderately active UC patients and 68% of severely active UC patients, and MCID in the Urgency NRS score achieved by 35% and 42%, respectively. These findings indicate that FIL generally leads to improved UC symptoms and reduced disease activity over 24 weeks in real-world settings, with numerically greater proportions of patients with moderately active UC achieving remission and clinically meaningful sIBDQ score improvements [38].
Akiyama et al. [19], a real-world multicenter retrospective study, identified FIL-treated patients with UC (n=238), across 12 institutions in Japan. In this study, clinical remission rates based on per-protocol analysis at 10, 26, and 58 weeks were 47%, 55.8%, and 64.6%, respectively. At a median follow-up of 28 weeks, the rates of clinical remission, clinical response, corticosteroid-free remission, and endoscopic improvement were 39.9%, 54.7%, and 36.5%, and 43.5%, respectively. Notably, these rates were comparable between biologic/JAK inhibitor-naive and -experienced patients. At this median follow-up, the discontinuation rate of FIL was 39%. The majority of patients discontinued due to lack of efficacy (83%), followed by intolerance (14%). Most discontinuations occurred within 10 weeks of induction. The discontinuation rate was significantly higher among biologic/JAK inhibitor-experienced patients compared to biologic/JAK inhibitor-naive patients (47% vs. 30%; P=0.011). Multivariate analysis from this study showed clinical remission with FIL at the most recent follow-up was inversely related to baseline platelet count and number of prior biologics/JAK inhibitors (odds ratio [OR]=0.953; P=0.0102 and OR=0.768; P=0.0433, respectively). Furthermore, baseline platelet count and partial Mayo score were significantly associated with the risk of FIL discontinuation (OR=1.045; P=0.0178 and OR=1.196; P=0.0255, respectively), suggesting that patients with higher disease activity are more likely to discontinue FIL. Meanwhile, discontinuation was inversely related to concomitant use of immunomodulators (OR=0.485; P=0.0499). These findings suggest that platelet count could serve as a unique biomarker for both predicting efficacy and monitoring disease activity in FIL-treated patients, although further investigations are warranted to clarify the molecular links between platelet counts and JAK1 signaling inhibition in UC [19].
Future RWE studies involving longer follow-up durations and identifying predictive factors of effectiveness could help strengthen the evidence supporting FIL treatment in UC therapy.

9) Overall Efficacy Findings

In summary, the publications included in this review demonstrated the rapid and durable efficacy of FIL in treating UC, in terms of achieving clinical remission, improving HRQoL, reducing biomarker levels, symptomatic relief, reducing corticosteroid dependency, and multidimensional disease control. The SELECTION trial and its post hoc analyses demonstrated significant efficacy improvements with FIL as early as 7 days (e.g., improved rectal bleeding and stool frequency) [5,20,33]. Long-term data from the SELECTIONLTE extension studies (4-year and 5-year interim analyses), along with a post hoc analysis of SELECTION assessing sustained response, showed responses extending up to approximately 5 years (e.g., clinical remission, MCS response, improvements in IBDQ), even in patients who did not initially respond after 10 weeks of treatment [6,23,27]. RWE consistently supports FIL’s effectiveness in improving UC symptoms, reducing disease activity, and improving HRQoL. The overall effectiveness of FIL in real-world cohorts appears comparable whether used as monotherapy or with concomitant treatments, and effectiveness is similar across various patient populations, including those with prior biologic experience [18,19,24,25,32,38].
Achieving these efficacy outcomes is vital for enhancing patients’ QoL and alleviating disease burden. Specifically, rapid symptom relief leads to swift improvements in discomfort and pain, thereby mitigating the emotional and physical stress associated with undesirable symptoms [35]. Such rapid benefits can enhance treatment adherence, increase patient satisfaction, and improve long-term health outcomes. Additionally, durable efficacy outcomes in clinical remission and HRQoL improvements facilitate sustained symptom relief and long-term disease management, minimizing the need for frequent therapy adjustments. Prolonged periods of UC remission also decrease patients’ anxiety concerning disease flares, and reduce reliance on additional medications (e.g., corticosteroids) which may have harmful side effects [20,40]. This stability conferred by durable efficacy outcomes enables patients to maintain their daily activities and productivity, while lowering the long-term health risks associated with untreated or poorly managed UC.
When considering efficacy outcomes by patient subgroups, these findings suggest the potential of FIL as a robust long-term treatment option in patients with UC, including those with prior biologic experience. However, those with lower (vs. higher) disease severity may experience more rapid symptomatic remission, and biologic-naive patients (vs. patients with prior biologic experience/failure) and those who use corticosteroids sparingly (vs. high corticosteroid use) may experience greater sustained clinical improvements on FIL treatment [20,33].
Furthermore, these findings support the utility of FIL in reducing corticosteroid dependency, which is crucial for patient safety and long-term disease management. The results also indicated a potential dose-response relationship, with the 200 mg dose generally eliciting greater efficacy responses than the 100 mg dose, and FIL 100 mg demonstrating greater efficacy than placebo in terms of clinical remission only in the maintenance study [5,26,28]. It is important to note that for moderate to severe UC, Japan’s Pharmaceuticals and Medical Devices Agency only indicates FIL 100 mg for maintenance therapy or for patients with severe or moderate kidney impairment. For all other instances where existing, conventional treatments are insufficient in effectiveness, FIL 200 mg is indicated [11]. Conversely, FIL 200 mg is indicated for both induction and maintenance therapy in the EU, UK, Singapore, and South Korea. FIL 100 mg is only indicated for maintenance therapy in elderly patients (i.e., ≥ 65 years of age) or adults at higher risk of venous thromboembolic event (VTE), major adverse cardiovascular events (MACE), and malignancy, or patients with severe or moderate kidney impairment [7-10].
As evidenced from various post hoc analyses, it is also important to consider factors including baseline assessment of serum biomarkers, clinical symptoms, patient demographics, and rigorous multi-component endpoints for optimizing UC management, as these predictive markers may facilitate the development of personalized and holistic management strategies in treating UC. Lastly, these findings support the possibility of using biomarkers and symptom monitoring as proxies for invasive mucosal assessments (e.g., endoscopy) at early timepoints of UC management [21,22,29-31,34,36].
5. Safety Profile of FIL

1) Safety Outcomes in SELECTION and SELECTIONLTE

Table 4 summarizes the safety outcomes of 3 papers reporting on SELECTION and/or SELECTIONLTE data, at Week 58 and up to Week 202 [5,6,37]. Across the 3 safety analyses that report on overlapping patient groups enrolled in SELECTION and SELECTIONLTE, there were low/moderate occurrences of serious treatment-emergent AEs (TEAEs; 0.0%–18.1%) and TEAEs leading to study discontinuation (2.0%–25.6%), and very low occurrences of death (0%–0.8%) among FIL-treated patients, with comparable rates observed in the placebo group (Table 4) [5,6,37]. Regarding AEs of interests, infections were slightly higher in patients treated with FIL 200 mg (25.3%–52.7%) versus 100 mg (25.7%–33.8%), while serious infections (0%–5.8%) and herpes zoster infections remained low (0%–3.6%) across all treatment arms and studies [5,6,37]. Similar rates of AE occurrences were observed in FIL-treated patients compared with the placebo group [5,37].
Feagan et al. [5] was the first publication to assess safety outcomes at induction (Week 10) and maintenance (Week 58) of SELECTION. Across the induction and maintenance studies, the incidences of serious AEs, AEs of interest (including infections), and treatment discontinuation due to AEs were similar between FIL and placebo groups; FIL was generally well tolerated at both 100 mg and 200 mg, and most AEs were mild or moderate in severity. Similarly, occurrences of serious infections and herpes zoster infections (n=6; none were serious/complicated or resulted in study discontinuation) were low in all treatment groups. Frequently observed AEs included nasopharyngitis, headache, worsening of UC, and arthralgia. One VTE (pulmonary embolism) was reported among FIL 200 mg-treated patients at induction, and 2 VTEs occurred among placebo-treated patients at maintenance. Malignancies and non-melanoma skin cancers each occurred in 3 FIL-treated patients. Two deaths were reported in the FIL 200 mg group during the maintenance study; neither were related to treatment.
Feagan et al. [6], reported the long-term safety outcomes (up to 3.9 years) of FIL in SELECTIONLTE as a primary endpoint. In this study, FIL’s long-term safety profile was generally consistent with the results of SELECTION trial and the previous data cutoff for SELECTIONLTE [5,37]. Occurrence of AEs was similar between patients treated with FIL 200 mg and 100 mg. Generally, the occurrence of TEAEs were low, with FIL 200 mg and 100 mg groups reporting overall TEAE incidences of 111.5 exposure-adjusted incidence rate per 100 censored patient-years of exposure (EAIR/100 cPYE) and 103.4 EAIR/100 cPYE, respectively. Serious TEAEs and TEAEs of grade 3 or higher were also uncommon (<10.0 EAIR/100 cPYE). Six deaths occurred during SELECTIONLTE in the FIL 200 mg group, deemed unrelated to the study drug, and mostly related to coronavirus disease 2019 (COVID-19) infections and/or related complications. The most frequent AEs were worsening of UC (FIL 200 mg: 16.5%; FIL 100 mg: 23.1%), COVID-19 infection (FIL 200 mg: 4.4%; FIL 100 mg: 1.3%), and anemia (FIL 200 mg: 3.8%; FIL 100 mg: 1.3%). Herpes zoster infections were rare (n=34; FIL 200 mg: 1.5 EAIR/100 cPYE; FIL 100 mg: 1.0 EAIR/100 cPYE) and mostly mild (all grade 2 or lower except for one grade 3 case), but incidence rates were somewhat higher in the Asian population compared with other ethnicities. There were also no increased risks of opportunistic infections, malignancies, MACE, or VTE associated with continuous FIL treatment.
In an integrated interim analysis of SELECTION and SELECTIONLTE representing a total of 3,326.2 patient-years of exposure (PYE) [37], the safety of FIL was compared in different patient subpopulations (e.g., by age, previous biologic exposure). Consistent with Feagan et al. [5], FIL was well tolerated with no unexpected safety signals in this integrated interim analysis; FIL also had an acceptable safety profile pertaining to infection risk, regardless of previous biologic exposure or age. Incidences of serious infection, thromboembolic events, and MACE were consistently low across treatment groups, with the majority of patients with MACE having cardiovascular risk factors. The incidence (measured by EAIR/cPYE) of herpes zoster infections was numerically higher for FIL 200 mg (1.44) and FIL 100 mg (0.69) than for placebo (0.26), and incidence of all infections was numerically higher in biologic-experienced (FIL 200 mg: 45.3; placebo: 72.9) than biologic-naive patients (FIL 200 mg: 28.9; placebo: 25.3). In line with previous reports of age as a risk factor for AEs such as malignancy, incidences of AEs including infections (e.g., herpes zoster), MACE, and malignancies were higher in patients aged ≥ 65 years than those < 65 years. Four deaths occurred, including 3 cardiovascular deaths, none of which were considered related to FIL.
An integrated post hoc analysis, pooling safety data from all phase 2 and 3 trials of FIL 100 mg and 200 mg in both rheumatoid arthritis and UC, aimed to evaluate the long-term safety of FIL. Particularly, the risks for MACE, VTE, and malignancies were assessed. Specifically for UC, the analysis included data from the SELECTION and SELECTIONLTE trials, representing over 2,800 PYE [41].
Among individuals with UC, MACE incidence was slightly higher in older (≥65 years) versus younger (<65 years) patients (EAIR: 1.7/100 PYE vs. 0.2/100 PYE), indicating an age-related increase in risk. No cases of VTE were reported in UC patients aged ≥65 years. Across both MACE and VTE, the EAIRs in patients with UC were generally similar between FIL 200 mg and FIL 100 mg, suggesting no consistent dose-related effect for these events. Malignancy rates generally followed a similar age-related trend, with a slightly higher incidence among older patients receiving FIL 200 mg compared to younger patients (EAIR: 2.3 PYE vs. 0.4/100 PYE, respectively) [41].
Overall, the safety data of FIL are consistent with previous overall safety analyses, demonstrating overall low rates of AEs of interest (AEI). Numerically higher rates of AEI occurred in patients aged ≥ 65 year, and there was no consistent FIL dose effect on AEI, suggesting that the occurrence of these AEI is predominantly influenced by the patients’ advancing age and underlying inflammatory disease, rather than a direct drug effect, thereby supporting dose adjustments for older patients [41].
Beyond overall incidence rates, the integrated post hoc analysis also explored baseline characteristics associated with the occurrence of specific AEI in patients with UC. While no formal statistical analysis was performed, certain patterns of association were observed irrespective of FIL dose. For MACE events in UC, there was a higher proportion of male patients, patients aged ≥65 years, and those who had a history of hypertension or dyslipidemia. A higher mean body mass index (BMI) was also noted in UC patients who experienced MACE compared to those who did not. UC patients who had malignancy events (excluding non-melanoma skin cancer [NMSC]), were more likely to be aged ≥ 65 years or have a history of hypertension, irrespective of FIL dose. Additionally, patients with UC were more likely to have a higher mean FCP level or a history of diabetes mellitus, though the interpretation of these associations is limited by the small number of events. Similarly, UC patients who developed NMSC were more likely to be aged ≥ 65 years or have a history of hypertension or dyslipidemia at baseline. These exploratory findings collectively suggest that older age and pre-existing cardiovascular risk factors (e.g., hypertension, dyslipidemia, higher BMI), along with indicators of higher disease activity or comorbidities, may be associated with an increased likelihood of MACE and malignancies in UC patients treated with FIL, irrespective of the specific FIL dose [41].

2) RWE on Safety

To complement the results of clinical trials, a RWE study of patients with UC in Scotland reported a 16.5% occurrence of AEs during the overall study period (July 2022–May 2023) [24]. These included mild AEs (5.5%; e.g., headache, fatigue, mild nausea, joint pain) and moderate AEs leading to temporary discontinuation of FIL (8.8%; mostly respiratory tract infections). Serious AEs leading to definitive drug discontinuation or death occurred in 2 patients.
Similarly, in Nogami et al. [18], the occurrence of AEs was reported in 24.5% of FIL-treated patients with UC in Japan during the overall study period (March 2022–February 2024). Serious AEs occurred in only 1 patient and resolved after drug discontinuation, while AEs leading to drug discontinuation occurred in 6.1% of patients. The occurrence of infections was 11.2%, with 3.1% developing herpes zoster infection. None of the patients experienced MACE, thrombosis, or malignancies.

3) Overall Safety Findings

FIL 100 mg and 200 mg were generally well tolerated with no unexpected safety signals in SELECTION and SELECTIONLTE, and had an acceptable short-term (Week 10) and long-term (up to 4 years) benefit-risk profile; a similar safety profile of FIL was observed in real-world studies. Incidence of AEs were comparable between FIL-treated patients and the placebo group, as well as between patients treated with FIL 100 mg and 200 mg. Across all safety analyses, the occurrences of serious AEs, serious infections, and herpes zoster infections were low. Additionally, the occurrence of infections was numerically higher in biologic-experienced (versus biologic-naive) patients and older (versus younger) patients. MACE and malignancy rates, although low overall, increased with advancing age in UC patients. Exploratory analysis of baseline characteristics further indicated that older age and pre-existing comorbidities (including hypertension and dyslipidemia) were associated with a higher likelihood of these AEs, irrespective of FIL dose [41]. Nevertheless, FIL was shown to have an acceptable safety profile regardless of the FIL dose received, previous biologic exposure, age, or corticosteroid use.
In conclusion, FIL demonstrated robust efficacy in both the short-term induction and long-term maintenance of clinical remission and other efficacy outcomes for patients with moderately to severely active UC. Notably, FIL provided rapid symptom relief within 7 days and shows sustainable efficacy up to 4 years, with significant improvements in clinical remission, HRQoL, and reduced corticosteroid use. FIL 200 mg dose generally elicited greater efficacy responses than the 100 mg dose, and hence may potentially be a more suitable choice for optimizing treatment outcomes; however, the selection of the appropriate dose should be guided by the approved dosing recommendations within each country and tailored to the individual patient’s characteristics [7-11].
In clinical practice, FIL could be particularly beneficial for biologic-naive patients who may experience greater sustained clinical benefits compared with biologic-experienced patients. Monitoring clinical predictors such as baseline serum biomarkers, clinical symptoms, and HRQoL is crucial for optimizing UC management through the development of personalized and holistic treatment strategies. Furthermore, vigilance for AEs is essential, particularly in older and biologic-experienced patients who may have a higher incidence of infections. Overall, the safety profile of FIL remains acceptable, supporting its use as a long-term therapeutic option for UC management.

Funding Source

This study was sponsored by Gilead Sciences K.K. (Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan), and EA Pharma Co., Ltd. (Tokyo, Japan). Support for third-party writing assistance for this article, provided by Olivia Seow, Costello Medical, Singapore, was funded by Gilead Sciences K.K. (Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan), and EA Pharma Co., Ltd. (Tokyo, Japan) in accordance with Good Publication Practice (GPP 2022) guidelines (https://www.ismpp.org/gpp-2022).

Conflict of Interest

Hisamatsu T has received grant support from Mitsubishi Tanabe Pharma Corporation, EA Pharma Co., Ltd., AbbVie GK, JIMRO Co., Ltd., Zeria Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., Mochida Pharmaceutical Co., Ltd., Boston Scientific Corporation, Kissei Pharmaceutical Co., Ltd.; consulting for Mitsubishi Tanabe Pharma Corporation, EA Pharma Co., Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer Inc., Nichi-Iko Pharmaceutical Co., Ltd., Eli Lilly, Gilead Sciences, Bristol Myers Squibb; lecture fee from Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., Kissei Pharmaceutical Co., Ltd., Kaise T, Nagakura C, and Kamiya M are employees of Gilead Sciences K.K. and shareholders of Gilead Sciences, Inc. Wei SC serves as a board member/advisor for AbbVie, Bristol Myers Squibb, Celltrion, Everest Medicine, Ferring Pharmaceuticals Inc., Janssen, Pfizer, Sanofi, and Takeda; speaker fees from AbbVie, Bristol Myers Squibb, Celltrion, CornerStones, Excelsior, Ferring Pharmaceuticals Inc., Janssen, Pfizer, Takeda, and ThermoFisher. And she is also an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Data Availability Statement

This narrative review is based on publicly available information and literature. No new data was generated or analyzed during the review, and therefore, data sharing is not applicable.

Author Contributions

Conceptualization: all authors. Data curation: all authors. Data interpretation: all authors. Formal analysis: all authors. Writing–original draft: all authors. Writing–review & editing: all authors. Approval of final manuscript: all authors.

Additional Contributions

The authors acknowledge Yoshie Takatori, Gilead Sciences K.K., Tokyo, Japan for her contribution to the study conception. The authors would also like to thank Costello Medical for editorial assistance and publication coordination, on behalf of Gilead, and acknowledge Olivia Seow, Costello Medical, Singapore for medical writing and editorial assistance based on authors’ input and direction.

Supplementary materials are available at the Intestinal Research website (https://www.irjournal.org).

Supplementary Table 1.

Summary of Original Research Publications (n=17) Included in This Narrative Review Which Reported on SELECTION and/or SELECTIONLTE, Including Their Efficacy Outcomes
ir-2025-00155-Supplementary-Table-1.pdf

Supplementary Table 2.

Summary of Real-World Evidence Publications (n=6) Included in This Narrative Review
ir-2025-00155-Supplementary-Table-2.pdf
ir-2025-00155f1.jpg
Table 1.
Summary of Original Research Publications (n=17) Included in This Narrative Review Which Reported on SELECTION and/or SELECTIONLTE, Including Their Efficacy Outcomes
Author (year) Population and treatment Key efficacy results Conclusion
Feagan (2021) [5] Population: Adults aged 18–75 with moderately to severely active UC Induction study Aa: At Week 10, FIL 200 mg: 26.1% clinical remission vs. placebo: 15.3% (P=0.0157) FIL 200 mg was effective and well tolerated for inducing and maintaining clinical remission in UC
SELECTION (Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Induction study Ba: At Week 10, FIL 200 mg: 11.5% clinical remission vs. placebo: 4.2% (P=0.0103)
Maintenance studya: At Week 58, FIL 200 mg: 37.2% clinical remission vs. placebo: 11.2% (P<0.0001)
Feagan (2024) [6] Population: SELECTION trial completers, non-responders, and those who experienced PSDW during maintenanceb Maintenance studya: Patients treated with FIL 200 mg maintained high pMCS, IBDQ, and FCP remission, with low AE occurrences over 202 weeks FIL induced and maintained symptomatic remission and improved HRQoL over 4 years.
SELECTIONLTEb (interim analysis; Ph 3 [LTE]) Treatment: FIL 200 mg, FIL 100 mg Safety results showed a proven long-term benefit-risk profile
Schreiber (2023) [37] Population: Adults with moderately to severely active UC Efficacy results not reported, as this publication only reported on safety outcomes (see Table 4) FIL 200 mg and 100 mg were well tolerated with no unexpected safety signals, regardless of previous biologic exposure or age
SELECTION and SELECTIONLTEb (integrated interim analysis; Ph 2b/3 + 3 [LTE]) Treatment: FIL 200 mg, FIL 100 mg, placebo
Nakase (2024) [30] Population: Patients with moderately to severely active UC in the induction studies of the SELECTION trial Induction Study A and Ba: FIL significantly lowered almost all circulating biomarker levels associated with UC pathobiology at Weeks 4 and 10 vs. placebo, especially at the 200 mg dose FIL significantly impacted circulating biomarkers related to UC pathology, suggesting they may be early mediators and predictors of clinical response to FIL treatment
SELECTION (pre-planned exploratory analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo
Schreiber (2023) [35] Population: Adults with moderately to severely active UC Induction study Aa: FIL 200 mg showed significantly greater HRQoL improvements vs. placebo at Week 10; FIL 200 mg: 17.6% achieved CDC at Week 10 vs. placebo: 4.4% (P<0.001) FIL 200 mg resulted in both short- and long-term improvements in HRQoL for patients with UC
SELECTION (pre-planned exploratory and post hoc analyses; Ph 2b/3) Treatment: FIL 200 mg, placebo Induction study Ba: Greater improvements in HRQoL measures in FIL 200 mg group vs. placebo at Week 10; FIL 200 mg: 4.6% achieved CDC at Week 10 vs. placebo: 1.4% (P=0.167) Achievement of CDC is associated with improved HRQoL and may indicate meaningful disease control
Maintenance studya: Improvements in HRQoL measures sustained with FIL 200 mg at Week 58 vs. placebo; FIL 200 mg: 22.1% achieved CDC at Week 58 vs. placebo: 7.1% (P=0.002)
Danese (2023) [20] Population: Patients with moderately to severely active UC Induction study Aa: FIL 200 mg: Significant combined improvement in rectal bleeding and stool frequency vs. placebo by Day 9 FIL 200 mg is effective for rapid and sustained relief of UC symptoms and HRQoL
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Induction study Ba: FIL 200 mg: Significant combined improvement in rectal bleeding and stool frequency vs. placebo by Day 7
Maintenance studya: FIL 200 mg resulted in sustained pMCS remission and response
Saruta (2025) [33],c Population: Patients with UC in the induction study Induction study Aa: Higher remission rates in patients with baseline pMCS < 7 vs. pMCS ≥ 7 (biologic-naive: 8.4% vs. 1.1%; P=0.009) Rapid symptom relief was more common in patients with less severe disease; long-term rates converge across severity groups
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo Induction study Ba: Higher remission rates in patients with baseline pMCS <7 vs. pMCS ≥7 (biologic-experienced: 8.8% vs. 0.7%; P=0.004)
Laharie (2023) [27],c Population: Patients with moderately to severely active UC Continuous FIL 200 mg versus placebo significantly reduced risk of PSDW (HR: 0.26; P<0.0001) Most patients who were in clinical remission or had MCS response at Week 10 had prolonged benefit after a year of FIL 200 mg treatment
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Two-thirds of patients who were in clinical remission or had MCS response at Week 10, and approximately 80% who were in clinical remission at Week 10 had prolonged benefit after a year of FIL 200 mg treatment
Loftus (2023) [28] Population: Patients with moderately to severely active UC Among patients receiving corticosteroids at baseline of the maintenance study, 30.4%, 29.3%, 27.2%, and 21.7% had been in corticosteroid-free remission for ≥ 1, ≥ 3, ≥ 6, or ≥ 8 months, respectively, vs. 6.4% receiving placebo (P<0.05) FIL 200 mg demonstrated significant corticosteroid-sparing effects
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo
Kobayashi (2024) [26] Population: Patients with UC receiving corticosteroids at maintenance baseline Maintenance studya: 27.2% on FIL 200 mg achieved 6 months corticosteroid-free remission Corticosteroid-free remission can be achieved independently of baseline characteristics but is more likely in biologic-naive patients, current smokers, females, and those with lower endoscopic burden
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg
Dotan (2023) [21] Population: Patients with moderately to severely active UC At Week 10, patients treated with FIL 200 mg were more likely to achieve clinical remission than placebo, with OR of 1.98 in the biologic-naive group and 3.91 in the biologic-failed group. FIL 200 mg induced and maintained benefits relative to placebo regardless of previous biologic use; however, the estimated therapeutic benefit was greatest in biologic-naive patients
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo At Week 58, FIL 200 mg-treated patients had reduced risk of PSDW in the biologic-naive (HR: 0.22) and biologic-failed (HR: 0.22) groups, and in all biologic-failed subgroups (except > 1 TNF antagonist failure)
Schreiber (2024) [34] Population: Patients with moderately to severely active UC Beneficial trajectory groups generally had higher proportions of patients who were recently diagnosed (< 1 year), were receiving FIL 200 mg (vs. 100 mg), and were biologic-naive vs. the relapsing trajectory groups (4%–9% vs. 4%–5%; 43%–65% vs. 36%–46%; 54%–70% vs. 35%–58%, respectively) Beneficial long-term response trajectories were associated with being biologic-naive and having less severe disease at baseline
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg 55.4% of patients had sustained beneficial trajectories, with low baseline endoscopic subscores (subscore of 2: ≥ 43% of patients) and strong Week 10 FCP responses (> 50% decrease in FCP from baseline: ≥ 61% of patients)
Sustained beneficial trajectory groups had a higher probability of achieving CDC at Week 58 than other groups (31%–32% vs. 0%–7%)
Schreiber (2022) [36],c Population: Patients with moderately to severely active UC Higher proportion of biologic-naive patients in the fast/sustained (70%) and slow/sustained improvement groups (59%) than in the other groups (i.e., slow rebound, fast rebound, gradual improvement). At Week 58, sustained improvement was seen in higher proportions of biologic-naive, female patients with a lower endoscopic inflammatory burden and a strong FCP response at Week 10
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg Better performing groups also contained higher proportions of patients with low endoscopic and stool frequency subscores at baseline than the slow and fast rebound groups
Fast/sustained (91%) and slow/sustained improvement (75%) had high proportions of patients with a > 50% change in FCP level between baseline and Week 10
Peyrin-Biroulet (2023) [31],c Population: Patients with moderately to severely active UC Previous use of ≥ 1 biologic therapy or a TNF antagonist/vedolizumab, and Week 10 MCS subscores ≤ 1 were associated with higher pMCS over time than their respective reference categories (P<0.0001) History of previous biologic therapy, and Week 10 assessments (endoscopic, clinical, biomarker and PRO) were among the factors influencing pMCS over the course of 1 year of FIL treatment
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg Week 10 endoscopic score ≤ 1, Geboes histologic remission, and IBDQ total score > 170 were associated with lower pMCS over time than their respective reference categories (P≤0.0001)
Change from baseline in pMCS and FCP levels at Week 10 were positively associated with pMCS over time (P<0.0001)
PRO measures at Week 10 were negatively associated with pMCS over time (P≤0.0001)
Louis (2022) [29],c Population: Patients with moderately to severely active UC FCP<250 μg/g at Week 10 was associated with an MCS response at Week 10 (yes: n = 340 [PPV: 75.9%]; no: n = 454 [NPV: 61.5%]) FCP concentration following induction with FIL 200 mg is associated with a short-term response. The combination of FCP<250 µg/g and pMCS remission at Week 10 may be a good, noninvasive prognostic marker of clinical remission at Week 58
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg Combining FCP<250 μg/g with pMCS remission improved both the PPV (79.8%) and NPV (73.5%) for MCS response at Week 10 Low disease burden measured by CRP and rapid treatment response were good predictors for Week 10 response and remission; factors such as sex, current smoking, and biologic-naive status are likely disease-related
Feagan (2022) [22],c Population: Patients with moderately to severely active UC Multivariate analysis of FIL 200 mg showed that sex, biologic-naive status, lower CRP levels, and rectal bleeding = 0 with stool frequency ≤ 1 on Day 7 were predictors for MCS response/remission at Week 10 Low disease burden measured by CRP and rapid treatment response were good predictors for Week 10 response and remission; factors such as sex, current smoking, and biologic-naive status are likely disease-related
SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Being a current smoker and biologic-naive status was associated with clinical remission at Week 58 in all treatment groups, while stool frequency ≤ 1 (but not rectal bleeding = 0) at Week 10 was associated with clinical remission at Week 58 only among patients receiving FIL 200 mg
Feagan (2024) [23],c Population: SELECTION trial completers and non-responders Maintenance studya: Patients treated with FIL 200 mg maintained high pMCS and IBDQ remission, with no new safety signals over 192 weeks in completers and 240 weeks in induction non-responders FIL 200 mg was effective in maintaining symptomatic remission and HRQoL for up to 5 years
SELECTIONLTE interim analysisb (Ph 3 [LTE]) Treatment: FIL 200 mg

a Patients in the SELECTION trial (NCT02914522) were enrolled into 1 of 2 induction studies: induction study A which included biologic-naive patients, and induction study B which included biologic-experienced patients. Those who achieved either clinical remission or a total MCS response at Week 10 were re-randomized 2:1 at Week 11 to continue their induction FIL regimen or receive placebo in the maintenance study through Week 58 [5].

b Eligible patients from SELECTION could enroll in SELECTIONLTE (NCT02914535). Patients eligible for enrolment into SELECTIONLTE included: those who achieved clinical remission or an MCS response at Week 10 and completed SELECTION to Week 58 (completers), and those who did not achieve clinical remission or an MCS response at Week 10 and discontinued SELECTION (non-responders); and those who experienced PSDW during maintenance (defined as an increase in pMCS of ≥3 points from the Week 10 value on 2 consecutive visits to achieve a score of >5 or an increase in pMCS on 2 consecutive visits to achieve a score of 9 if the Week 10 value was >6). Of those eligible for enrolment in SELECTIONLTE, only completers and non-responders were evaluated in the interim analysis [6,23].

c Abstracts presented at congresses (n=7); the rest of the rows are manuscripts published in academic journals (n=10).

Ph, phase; UC, ulcerative colitis; FIL, filgotinib; SELECTIONLTE, SELECTION long-term extension; LTE, long-term extension; pMCS, partial Mayo Clinic Score; FCP, fecal calprotectin; IBDQ, Inflammatory Bowel Disease Questionnaire; AEs, adverse events; HRQoL, health-related quality of life; CDC, comprehensive disease control; PSDW, prolonged symptomatic disease worsening; MCS, Mayo Clinic Score; OR, odds ratio; HR, hazard ratio; TNF, tumor necrosis factor; PRO, patient-reported outcome; PPV, positive predictive value; NPV, negative predictive value; CRP, C-reactive protein.

Table 2.
Summary of Real-World Evidence Publications (n=6) Included in This Narrative Review
Author (year) Population and FIL dosage Results Conclusion
Gros (2023) [24] Population: Patients aged > 18 years with active UC who received FIL in NHS Lothian, Scotland Efficacy: FIL achieved clinical remission (pMCS < 2) in 71.9% of patients at Week 12 and 76.4% at Week 24; biochemical remission (CRP≤5 mg/L) in 87.3% at Week 12 and 88.9% at Week 24 FIL is an effective and low-risk treatment option for patients with UC
Retrospective, observational, cohort study FIL dosage: 200 mg in 98% of patients; other dosages not specified Persistence: At the end of follow-up (median 42 weeks), 82.4% of patients remained on FIL
Safety: Severe AEs leading to discontinuation occurred in 2.2% of patients; moderate AEs required temporary discontinuation in 8.8%
Nogami (2024) [18],a Population: Patients aged ≥ 18 years with active UC who received FIL at 3 specialist centers in Japan Efficacy: At Week 8, FIL achieved clinical response and remissionb in 55.1% and 46.9% of patients, respectively FIL is a suitable option for patients with UC, particularly when safety is a concern
Retrospective, observational, multicenter cohort study Persistence: Over median follow-up time of 191 days, treatment was discontinued in 52.0% of patients
FIL dosage: 200 mg continuously or reduced to 100 mg if necessary Safety: AEs occurred in 24.5% of FIL-treated patients; AEs led to discontinuation in 6.1% of patients
Plachta-Danielzik (2025) [32] Population: Patients with active UC and newly introduced FIL therapy Efficacy: Clinical response and remission ratesc were 59.2% and 41.7%, respectively. No significant difference in clinical remission rates between biologic-naive (41.7%) and biologic-experienced (41.4%) patients. For those who responded by Week 10, response and remission rates were 85.0% and 58.8% respectively. Mean sIBDQ scores increased from 42.0 to 56.0 (P<0.001) This real-world study demonstrated a further improvement with FIL at 6 months, compared to the induction phase
Prospective, multicenter, non-interventional, observational study FIL dosage: No dosage was specified in the abstract Persistence: Treatment persistence at month 6 was 87.2%
Safety: AEs were not reported in this abstract
Høivik (2025) [25] Population: Patients aged ≥ 18 years with moderately or severely active UC and starting FIL treatment [39] Efficacy: Remission was achieved by 30% of patients for the MCS, 47% for the pMCS, and 50% for the PRO2 score. MCIDs were achieved by 66% of patients for the sIBDQ score, 64% for the FACIT-Fatigue score, and 43% for the Urgency NRS score This study highlights the overall effectiveness and safety profile of FIL up to 24 weeks in a real-world cohort, both when used alone or with concomitant therapy
Interim analysis of the multicenter, prospective, observational GALOCEAN study FIL dosage: No dosage was specified in the abstract Persistence: A total of 223 patients had available baseline data; 139 and 83 patients completed 10 and 24 weeks of FIL treatment, respectively
Safety: 30% of patients had ≥ 1 TEAE and 6% (6% in each subgroup) had ≥ 1 AESI
Seenan (2025) [38] Population: Patients aged ≥ 18 years with moderately or severely active UC and starting FIL treatment [39] Efficacy: Moderately and severely active UC: MCS remission was achieved by 33% and 25% of patients; pMCS remission by 56% and 43% of patients; PRO2 remission by 57% and 44% of patients; MCID in the sIBDQ score was achieved by 75% and 68% of patients; MCID in FACIT-Fatigue score by 76% and 59%, and MCID in the Urgency NRS score by 35% and 42% of patients, respectively Patients receiving FIL had improved UC symptoms and reduced disease activity over 24 weeks. Numerically greater proportions of patients with moderately active UC achieved remission and clinically meaningful improvements in PROs than those with severely active UC
Interim analysis of data from the multicenter, prospective, observational GALOCEAN study FIL dosage: No dosage was specified in the abstract Persistence: A total of 219 patients had available baseline pMCS score; 137 and 82 patients com-pleted weeks 10 and 24 of FIL treatment, respectively
Safety: 30% of patients in each group had ≥ 1 TEAE, and 6% (moderately active UC) and 7% (severely active UC) had ≥ 1 AESI
Akiyama (2024) [19] Population: Patients with UC that started FIL at 12 participating institutions in Japan, between March 2022 and September 2023 Efficacy: Clinical remission ratesd at 10, 26, and 58 weeks were 47.0%, 55.8%, and 64.6%, respectively; at median follow-up of 28 weeks, clinical remission, clinical response,d CS-free remission, and endoscopic improvement rates were 39.9%, 54.7%, 36.5%, and 43.5%, respectively Real-world data demonstrate favorable clinical and safety outcomes of FIL for UC
Real-world multicenter retrospective study FIL dosage: 200 mg of daily FIL in 97.5% of patients; other dosages not specified Persistence: At median follow-up of 28 weeks, FIL was discontinued in 39% of patients. Most patients discontinued due to lack of efficacy (83%), followed by intolerance (14%) and unknown causes (3.2%). The majority of FIL discontinuations occurred within the 10 weeks after induction
Safety: 1.3% of patients developed herpes zoster infections. No cases of thrombosis or death were reported

a Nogami et al. [18] also reported on results of upadacitinib in treating UC; however, these results are not included in this narrative review study which focused on FIL treatment in UC.

b Clinical response is defined as pMCS reduction by ≥2 points and 30% from baseline, RB subscore reduction of ≥1, and clinical remission is defined as pMCS≤2, stool frequency≤1, physician’s global assessment subscore ≤1, RB=0 [18].

c Clinical response is defined as reduction of pMCS by ≥3 points from baseline to month 6, along with either a ≥30% reduction or remission at month 6, and clinical remission is defined as pMCS ≤1 plus a bleeding subscore=0 [32].

d Clinical remission is defined as pMCS≤1 with a rectal bleeding score of 0 or SCCAI ≤2 with a blood-in-stool score of 0, and clinical response is defined as ≥2-point reduction from the baseline pMCS or a ≥3-point reduction from the baseline SCCAI [19].

FIL, filgotinib; UC, ulcerative colitis; NHS, National Health Service; pMCS, partial Mayo Clinic Score; CRP, C-reactive protein; AEs, adverse events; sIBDQ, Short Inflammatory Bowel Disease Questionnaire; MCS, Mayo clinical score; PRO2, 2-item patient reported outcomes; MCID, minimal clinically important difference; NRS, Numerical Rating Scale; TEAEs, treatment-emergent adverse events; AESI, adverse event of special interest; FACITFatigue, Functional Assessment of Chronic Illness Therapy Fatigue scale; CS, corticosteroid; RB, rectal bleeding; SCCAI, Simple Clinical Colitis Activity Index.

Table 3.
Baseline Demographics and Characteristics of Patients in SELECTION and SELECTIONLTE
Variable SELECTION (Feagan et al. 2021) [5]
 SELECTIONLTE (Feagan et al. 2024) [6]
Induction study Aa (biologic-naive patients)
 Induction study Ba (biologic-naive patients)
 Maintenance studya
 Completersb
 Non-respondersb
Placebo (n = 137) FIL100 (n = 277) FIL200 (n = 245) Placebo (n = 142) FIL100 (n = 285) FIL200 (n = 262) Placebo-placebo (n = 93) FIL100-placebo (n = 91) FIL100-FIL100 (n = 179) FIL200-placebo (n = 99) FIL200-FIL200 (n = 202) FIL200-FIL200-FIL200 (n=148) FIL100-FIL100-FIL100 (n=102) FIL200-FIL200 (n = 160) FIL100-FIL200 (n = 212)
Age (yr) 41.0 ± 12.9 42.0 ± 13.3 42.0 ± 13.1 44.0 ± 14.9 43.0 ± 14.3 43.0 ± 14.2 43.0 ± 13.0 43.0 ± 15.1 42.0 ± 12.6 42.0 ± 13.0 43.0 ± 13.8 44.3 ± 13.4 43.1 ± 11.9 43.2 ± 13.9 43.2 ± 13.5
Female sex 50 (36.5) 120 (43.3) 122 (49.8) 56 (39.4) 99 (34.7) 114 (43.5) 44 (47.3) 42 (46.2) 78 (43.6) 51 (51.5) 107 (53.0) 83 (56.1) 47 (46.1) 55 (34.4) 74 (34.9)
Duration of UC (yr) 6.4 ± 7.4 6.7 ± 7.4 7.2 ± 6.9 10.2 ± 8.2 9.7 ± 7.2 9.8 ± 7.6 7.0 ± 6.8 7.5 ± 7.5 8.9 ± 8.4 8.9 ± 7.6 8.4 ± 7.4 8.7 ± 7.7 8.7 ± 8.9 8.6 ± 7.5 8.2 ± 7.0
Induction study A 67 (72.0) 54 (59.3) 107 (59.8) 54 (54.5) 109 (54.0) 87 (58.8) 70 (68.6) 70 (43.8) 75 (35.4)
Induction study B 26 (28.0) 37 (40.7) 72 (40.2) 45 (45.5) 93 (46.0) 61 (41.2) 32 (31.4) 90 (56.3) 137 (64.6)
CRP (mg/L) 5.8 ± 7.6 7.8 ± 17.4 8.6 ± 16.3 14.0 ± 24.3 11.7 ± 18.0 12.2 ± 14.9 3.3 ± 5.3 3.5 ± 5.4 3.0 ± 5.7 2.7 ± 4.4 3.7 ± 10.1 8.7 ± 18.6 6.8 ± 14.8 12.1 ± 14.2 10.5 ± 16.6
FCP (μg/g) 2,231 ± 2,917 2,001 ± 3,448 2,059 ± 2,639 2,479 ± 3,571 2,236 ± 3,095 2,845 ± 4,077 1,043 ± 1,546 760 ± 1,475 662 ± 1,291 934 ± 2,622 627 ± 945 2,713 ± 3,447 1,715 ± 3,163 2,067 ± 3,093 2,402 ± 3,654
Concomitant/prior use of systemic corticosteroidsc 34 (24.8) 67 (24.2) 54 (22.0) 51 (35.9) 103 (36.1) 94 (35.9) 25 (26.9) 28 (30.8) 62 (34.6) 31 (31.3) 61 (30.2) 105 (70.9) 84 (81.6) 123 (76.9) 153 (72.2)
Concomitant/prior use of immunosuppressantsc 33 (24.1) 63 (22.7) 53 (21.6) 21 (14.8) 34 (11.9) 34 (13.0) 23 (24.7) 15 (16.5) 27 (15.1) 18 (18.2) 35 (17.3) 82 (55.4) 50 (48.5) 116 (72.5) 143 (67.5)
Concomitant/prior use of systemic corticosteroids and immunosuppressantsc 8 (5.8) 19 (6.9) 20 (8.2) 11 (7.7) 28 (9.8) 28 (10.7) 7 (7.5) 9 (9.9) 17 (9.5) 9 (9.1) 19 (9.4)
Prednisone-equivalent dose (mg/day) 20.0 (15.0–30.0) 15.0 (10.0–25.0) 20.0 (10.0–25.0) 20.0 (10.0–20.0) 20.0 (10.0–20.0) 15.0 (10.0–20.0) 22.5 (20.0–30.0) 20.0 (10.0–20.0) 20.0 (10.0–25.0) 20.0 (10.0–30.0) 20.0 (10.0–20.0)
No. of prior biologic agents
 0 137 (100.0) 275 (99.3) 245 (100.0) 3 (2.1) 2 (0.7) 3 (1.1) 68 (73.1) 56 (61.5) 106 (59.2) 55 (55.6) 110 (54.5)
 1 0 1 (0.4) 0 46 (32.4) 98 (34.4) 80 (30.5) 12 (12.9) 9 (9.9) 32 (17.9) 16 (16.2) 36 (17.8)
 2 0 1 (0.4) 0 45 (31.7) 109 (38.2) 90 (34.4) 4 (4.3) 15 (16.5) 22 (12.3) 10 (10.1) 31 (15.3)
 ≥3 0 0 0 48 (33.8) 76 (26.7) 89 (34.0) 9 (9.7) 11 (12.1) 19 (10.6) 18 (18.2) 25 (12.4)
Prior therapeutic use
 ≥ 1 anti-TNF agent 0 2 (0.7) 0 130 (91.5) 266 (93.3) 242 (92.4) 21 (22.6) 32 (35.2) 68 (38.0) 43 (43.4) 84 (41.6) 55 (37.2) 30 (29.1) 83 (51.9) 131 (61.8)
 Vedolizumab 0 1 (0.4) 0 85 (59.9) 145 (50.9) 164 (62.6) 15 (16.1) 16 (17.6) 32 (17.9) 24 (24.2) 49 (24.3) 30 (20.3) 12 (11.7) 69 (43.1) 84 (39.6)
 ≥ 1 anti-TNF agent and vedolizumab 0 1 (0.4) 0 76 (53.5) 128 (44.9) 147 (56.1) 11 (11.8) 13 (14.3) 27 (15.1) 23 (23.2) 41 (20.3) 24 (16.2) 9 (8.7) 63 (39.4) 78 (36.8)

Values are presented as mean±standard deviation, number (%), or median (interquartile range). Empty cells represent information that was either not applicable to the patient subgroup, or not detailed in the publication.

a Patients in the SELECTION trial (NCT02914522) were enrolled into 1 of 2 induction studies: induction study A which included biologic-naive patients, and induction study B which included biologic-experienced patients. Those who achieved either clinical remission or a total MCS response at Week 10 were re-randomized 2:1 at Week 11 to continue their induction FIL regimen or receive placebo in the maintenance study through Week 58 [5].

b In SELECTIONLTE (NCT02914535), completers were defined as patients who achieved clinical remission or an MCS response at Week 10 and completed SELECTION to Week 58; non-responders were defined as patients who did not achieve clinical remission or an MCS response at Week 10 and discontinued SELECTION [6].

c Feagan et al. [5] reported values for concomitant systemic corticosteroid and/or immunosuppressant use; Feagan et al. [6] reported values for prior systemic corticosteroid and/or immunosuppressant use.

SELECTIONLTE, SELECTION long-term extension; FIL, filgotinib; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; UC, ulcerative colitis; CRP, C-reactive protein; FCP, fecal calprotectin; TNF, tumor necrosis factor; MCS, Mayo Clinic Score.

Table 4.
Summary of Safety Outcomes Reported for SELECTION and/or SELECTIONLTE
Variable Feagan et al. (2021) [5] (SELECTION; Week 58)
 Feagan et al. (2024)[6] (SELECTIONLTE; Week 202)
 Schreiber et al. (2023)[37] (integrated interim analysis; total PYE: 3,326.2)
Placebo-placebo (n=93; total PWE: 38.1) FIL100-placebo (n=91; total PWE: 29.2) FIL100-FIL100 (n=179; total PWE: 34.5) FIL200-placebo (n=99; total PWE: 28.8) FIL200-FIL 200 (n=202; total PWE: 39.4) FIL100 (n=160; total PYE: 308.0) FIL200 (n=873; total PYE: 2,055.5) Placebo (n=469; total PYE: 387.8) FIL100 (n=583; total PYE: 585.9) FIL200 (n=971; total PYE: 2,352.5)
TEAEs, No. (%)
 Overall AE 57 (61.3) 60 (65.9) 108 (60.3) 59 (59.6) 135 (66.8) 128 (80.0) 724 (82.9) 306 (65.2) 388 (66.6) 817 (84.1)
 Serious AEs 4 (4.3) 7 (7.7) 8 (4.5) 0 9 (4.5) 15 (9.4) 146 (16.7) 34 (7.2) 53 (9.1) 176 (18.1)
 AEs leading to study drug discontinuation 3 (3.2) 4 (4.4) 10 (5.6) 2 (2.0) 7 (3.5) 41 (25.6) 181 (20.7) 41 (8.7) 71 (12.2) 210 (21.6)
 Deaths 0 0 0 0 2 (1.0) 0 6 (0.7) 0 0 8 (0.8)
AEs of interest, No (%)
 All infections 21 (22.6) 27 (29.7) 46 (25.7) 25 (25.3) 71 (35.1) 54 (33.8) 449 (51.4) 118 (25.2) 150 (25.7) 512 (52.7)
 Serious infections 1 (1.1) 2 (2.2) 3 (1.7) 0 2 (1.0) 3 (1.9) 51 (5.8) 8 (1.7) 14 (2.4) 56 (5.8)
 Herpes zoster 0 1 (1.1) 0 0 1 (0.5) 3 (1.9) 31 (3.6) 1 (0.2) 4 (0.7) 33 (3.4)

SELECTIONLTE, SELECTION long-term extension; PWE, patient-weeks of exposure; PYE, patient-years of exposure; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; TEAEs, treatment-emergent adverse events; AEs, adverse events.

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      Efficacy and safety of filgotinib in the treatment of ulcerative colitis with a focus on rapid and sustained efficacy: a narrative review
      Author (year) Population and treatment Key efficacy results Conclusion
      Feagan (2021) [5] Population: Adults aged 18–75 with moderately to severely active UC Induction study Aa: At Week 10, FIL 200 mg: 26.1% clinical remission vs. placebo: 15.3% (P=0.0157) FIL 200 mg was effective and well tolerated for inducing and maintaining clinical remission in UC
      SELECTION (Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Induction study Ba: At Week 10, FIL 200 mg: 11.5% clinical remission vs. placebo: 4.2% (P=0.0103)
      Maintenance studya: At Week 58, FIL 200 mg: 37.2% clinical remission vs. placebo: 11.2% (P<0.0001)
      Feagan (2024) [6] Population: SELECTION trial completers, non-responders, and those who experienced PSDW during maintenanceb Maintenance studya: Patients treated with FIL 200 mg maintained high pMCS, IBDQ, and FCP remission, with low AE occurrences over 202 weeks FIL induced and maintained symptomatic remission and improved HRQoL over 4 years.
      SELECTIONLTEb (interim analysis; Ph 3 [LTE]) Treatment: FIL 200 mg, FIL 100 mg Safety results showed a proven long-term benefit-risk profile
      Schreiber (2023) [37] Population: Adults with moderately to severely active UC Efficacy results not reported, as this publication only reported on safety outcomes (see Table 4) FIL 200 mg and 100 mg were well tolerated with no unexpected safety signals, regardless of previous biologic exposure or age
      SELECTION and SELECTIONLTEb (integrated interim analysis; Ph 2b/3 + 3 [LTE]) Treatment: FIL 200 mg, FIL 100 mg, placebo
      Nakase (2024) [30] Population: Patients with moderately to severely active UC in the induction studies of the SELECTION trial Induction Study A and Ba: FIL significantly lowered almost all circulating biomarker levels associated with UC pathobiology at Weeks 4 and 10 vs. placebo, especially at the 200 mg dose FIL significantly impacted circulating biomarkers related to UC pathology, suggesting they may be early mediators and predictors of clinical response to FIL treatment
      SELECTION (pre-planned exploratory analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo
      Schreiber (2023) [35] Population: Adults with moderately to severely active UC Induction study Aa: FIL 200 mg showed significantly greater HRQoL improvements vs. placebo at Week 10; FIL 200 mg: 17.6% achieved CDC at Week 10 vs. placebo: 4.4% (P<0.001) FIL 200 mg resulted in both short- and long-term improvements in HRQoL for patients with UC
      SELECTION (pre-planned exploratory and post hoc analyses; Ph 2b/3) Treatment: FIL 200 mg, placebo Induction study Ba: Greater improvements in HRQoL measures in FIL 200 mg group vs. placebo at Week 10; FIL 200 mg: 4.6% achieved CDC at Week 10 vs. placebo: 1.4% (P=0.167) Achievement of CDC is associated with improved HRQoL and may indicate meaningful disease control
      Maintenance studya: Improvements in HRQoL measures sustained with FIL 200 mg at Week 58 vs. placebo; FIL 200 mg: 22.1% achieved CDC at Week 58 vs. placebo: 7.1% (P=0.002)
      Danese (2023) [20] Population: Patients with moderately to severely active UC Induction study Aa: FIL 200 mg: Significant combined improvement in rectal bleeding and stool frequency vs. placebo by Day 9 FIL 200 mg is effective for rapid and sustained relief of UC symptoms and HRQoL
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Induction study Ba: FIL 200 mg: Significant combined improvement in rectal bleeding and stool frequency vs. placebo by Day 7
      Maintenance studya: FIL 200 mg resulted in sustained pMCS remission and response
      Saruta (2025) [33],c Population: Patients with UC in the induction study Induction study Aa: Higher remission rates in patients with baseline pMCS < 7 vs. pMCS ≥ 7 (biologic-naive: 8.4% vs. 1.1%; P=0.009) Rapid symptom relief was more common in patients with less severe disease; long-term rates converge across severity groups
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo Induction study Ba: Higher remission rates in patients with baseline pMCS <7 vs. pMCS ≥7 (biologic-experienced: 8.8% vs. 0.7%; P=0.004)
      Laharie (2023) [27],c Population: Patients with moderately to severely active UC Continuous FIL 200 mg versus placebo significantly reduced risk of PSDW (HR: 0.26; P<0.0001) Most patients who were in clinical remission or had MCS response at Week 10 had prolonged benefit after a year of FIL 200 mg treatment
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Two-thirds of patients who were in clinical remission or had MCS response at Week 10, and approximately 80% who were in clinical remission at Week 10 had prolonged benefit after a year of FIL 200 mg treatment
      Loftus (2023) [28] Population: Patients with moderately to severely active UC Among patients receiving corticosteroids at baseline of the maintenance study, 30.4%, 29.3%, 27.2%, and 21.7% had been in corticosteroid-free remission for ≥ 1, ≥ 3, ≥ 6, or ≥ 8 months, respectively, vs. 6.4% receiving placebo (P<0.05) FIL 200 mg demonstrated significant corticosteroid-sparing effects
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo
      Kobayashi (2024) [26] Population: Patients with UC receiving corticosteroids at maintenance baseline Maintenance studya: 27.2% on FIL 200 mg achieved 6 months corticosteroid-free remission Corticosteroid-free remission can be achieved independently of baseline characteristics but is more likely in biologic-naive patients, current smokers, females, and those with lower endoscopic burden
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg
      Dotan (2023) [21] Population: Patients with moderately to severely active UC At Week 10, patients treated with FIL 200 mg were more likely to achieve clinical remission than placebo, with OR of 1.98 in the biologic-naive group and 3.91 in the biologic-failed group. FIL 200 mg induced and maintained benefits relative to placebo regardless of previous biologic use; however, the estimated therapeutic benefit was greatest in biologic-naive patients
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, placebo At Week 58, FIL 200 mg-treated patients had reduced risk of PSDW in the biologic-naive (HR: 0.22) and biologic-failed (HR: 0.22) groups, and in all biologic-failed subgroups (except > 1 TNF antagonist failure)
      Schreiber (2024) [34] Population: Patients with moderately to severely active UC Beneficial trajectory groups generally had higher proportions of patients who were recently diagnosed (< 1 year), were receiving FIL 200 mg (vs. 100 mg), and were biologic-naive vs. the relapsing trajectory groups (4%–9% vs. 4%–5%; 43%–65% vs. 36%–46%; 54%–70% vs. 35%–58%, respectively) Beneficial long-term response trajectories were associated with being biologic-naive and having less severe disease at baseline
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg 55.4% of patients had sustained beneficial trajectories, with low baseline endoscopic subscores (subscore of 2: ≥ 43% of patients) and strong Week 10 FCP responses (> 50% decrease in FCP from baseline: ≥ 61% of patients)
      Sustained beneficial trajectory groups had a higher probability of achieving CDC at Week 58 than other groups (31%–32% vs. 0%–7%)
      Schreiber (2022) [36],c Population: Patients with moderately to severely active UC Higher proportion of biologic-naive patients in the fast/sustained (70%) and slow/sustained improvement groups (59%) than in the other groups (i.e., slow rebound, fast rebound, gradual improvement). At Week 58, sustained improvement was seen in higher proportions of biologic-naive, female patients with a lower endoscopic inflammatory burden and a strong FCP response at Week 10
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg Better performing groups also contained higher proportions of patients with low endoscopic and stool frequency subscores at baseline than the slow and fast rebound groups
      Fast/sustained (91%) and slow/sustained improvement (75%) had high proportions of patients with a > 50% change in FCP level between baseline and Week 10
      Peyrin-Biroulet (2023) [31],c Population: Patients with moderately to severely active UC Previous use of ≥ 1 biologic therapy or a TNF antagonist/vedolizumab, and Week 10 MCS subscores ≤ 1 were associated with higher pMCS over time than their respective reference categories (P<0.0001) History of previous biologic therapy, and Week 10 assessments (endoscopic, clinical, biomarker and PRO) were among the factors influencing pMCS over the course of 1 year of FIL treatment
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg Week 10 endoscopic score ≤ 1, Geboes histologic remission, and IBDQ total score > 170 were associated with lower pMCS over time than their respective reference categories (P≤0.0001)
      Change from baseline in pMCS and FCP levels at Week 10 were positively associated with pMCS over time (P<0.0001)
      PRO measures at Week 10 were negatively associated with pMCS over time (P≤0.0001)
      Louis (2022) [29],c Population: Patients with moderately to severely active UC FCP<250 μg/g at Week 10 was associated with an MCS response at Week 10 (yes: n = 340 [PPV: 75.9%]; no: n = 454 [NPV: 61.5%]) FCP concentration following induction with FIL 200 mg is associated with a short-term response. The combination of FCP<250 µg/g and pMCS remission at Week 10 may be a good, noninvasive prognostic marker of clinical remission at Week 58
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg Combining FCP<250 μg/g with pMCS remission improved both the PPV (79.8%) and NPV (73.5%) for MCS response at Week 10 Low disease burden measured by CRP and rapid treatment response were good predictors for Week 10 response and remission; factors such as sex, current smoking, and biologic-naive status are likely disease-related
      Feagan (2022) [22],c Population: Patients with moderately to severely active UC Multivariate analysis of FIL 200 mg showed that sex, biologic-naive status, lower CRP levels, and rectal bleeding = 0 with stool frequency ≤ 1 on Day 7 were predictors for MCS response/remission at Week 10 Low disease burden measured by CRP and rapid treatment response were good predictors for Week 10 response and remission; factors such as sex, current smoking, and biologic-naive status are likely disease-related
      SELECTION (post hoc analysis; Ph 2b/3) Treatment: FIL 200 mg, FIL 100 mg, placebo Being a current smoker and biologic-naive status was associated with clinical remission at Week 58 in all treatment groups, while stool frequency ≤ 1 (but not rectal bleeding = 0) at Week 10 was associated with clinical remission at Week 58 only among patients receiving FIL 200 mg
      Feagan (2024) [23],c Population: SELECTION trial completers and non-responders Maintenance studya: Patients treated with FIL 200 mg maintained high pMCS and IBDQ remission, with no new safety signals over 192 weeks in completers and 240 weeks in induction non-responders FIL 200 mg was effective in maintaining symptomatic remission and HRQoL for up to 5 years
      SELECTIONLTE interim analysisb (Ph 3 [LTE]) Treatment: FIL 200 mg
      Author (year) Population and FIL dosage Results Conclusion
      Gros (2023) [24] Population: Patients aged > 18 years with active UC who received FIL in NHS Lothian, Scotland Efficacy: FIL achieved clinical remission (pMCS < 2) in 71.9% of patients at Week 12 and 76.4% at Week 24; biochemical remission (CRP≤5 mg/L) in 87.3% at Week 12 and 88.9% at Week 24 FIL is an effective and low-risk treatment option for patients with UC
      Retrospective, observational, cohort study FIL dosage: 200 mg in 98% of patients; other dosages not specified Persistence: At the end of follow-up (median 42 weeks), 82.4% of patients remained on FIL
      Safety: Severe AEs leading to discontinuation occurred in 2.2% of patients; moderate AEs required temporary discontinuation in 8.8%
      Nogami (2024) [18],a Population: Patients aged ≥ 18 years with active UC who received FIL at 3 specialist centers in Japan Efficacy: At Week 8, FIL achieved clinical response and remissionb in 55.1% and 46.9% of patients, respectively FIL is a suitable option for patients with UC, particularly when safety is a concern
      Retrospective, observational, multicenter cohort study Persistence: Over median follow-up time of 191 days, treatment was discontinued in 52.0% of patients
      FIL dosage: 200 mg continuously or reduced to 100 mg if necessary Safety: AEs occurred in 24.5% of FIL-treated patients; AEs led to discontinuation in 6.1% of patients
      Plachta-Danielzik (2025) [32] Population: Patients with active UC and newly introduced FIL therapy Efficacy: Clinical response and remission ratesc were 59.2% and 41.7%, respectively. No significant difference in clinical remission rates between biologic-naive (41.7%) and biologic-experienced (41.4%) patients. For those who responded by Week 10, response and remission rates were 85.0% and 58.8% respectively. Mean sIBDQ scores increased from 42.0 to 56.0 (P<0.001) This real-world study demonstrated a further improvement with FIL at 6 months, compared to the induction phase
      Prospective, multicenter, non-interventional, observational study FIL dosage: No dosage was specified in the abstract Persistence: Treatment persistence at month 6 was 87.2%
      Safety: AEs were not reported in this abstract
      Høivik (2025) [25] Population: Patients aged ≥ 18 years with moderately or severely active UC and starting FIL treatment [39] Efficacy: Remission was achieved by 30% of patients for the MCS, 47% for the pMCS, and 50% for the PRO2 score. MCIDs were achieved by 66% of patients for the sIBDQ score, 64% for the FACIT-Fatigue score, and 43% for the Urgency NRS score This study highlights the overall effectiveness and safety profile of FIL up to 24 weeks in a real-world cohort, both when used alone or with concomitant therapy
      Interim analysis of the multicenter, prospective, observational GALOCEAN study FIL dosage: No dosage was specified in the abstract Persistence: A total of 223 patients had available baseline data; 139 and 83 patients completed 10 and 24 weeks of FIL treatment, respectively
      Safety: 30% of patients had ≥ 1 TEAE and 6% (6% in each subgroup) had ≥ 1 AESI
      Seenan (2025) [38] Population: Patients aged ≥ 18 years with moderately or severely active UC and starting FIL treatment [39] Efficacy: Moderately and severely active UC: MCS remission was achieved by 33% and 25% of patients; pMCS remission by 56% and 43% of patients; PRO2 remission by 57% and 44% of patients; MCID in the sIBDQ score was achieved by 75% and 68% of patients; MCID in FACIT-Fatigue score by 76% and 59%, and MCID in the Urgency NRS score by 35% and 42% of patients, respectively Patients receiving FIL had improved UC symptoms and reduced disease activity over 24 weeks. Numerically greater proportions of patients with moderately active UC achieved remission and clinically meaningful improvements in PROs than those with severely active UC
      Interim analysis of data from the multicenter, prospective, observational GALOCEAN study FIL dosage: No dosage was specified in the abstract Persistence: A total of 219 patients had available baseline pMCS score; 137 and 82 patients com-pleted weeks 10 and 24 of FIL treatment, respectively
      Safety: 30% of patients in each group had ≥ 1 TEAE, and 6% (moderately active UC) and 7% (severely active UC) had ≥ 1 AESI
      Akiyama (2024) [19] Population: Patients with UC that started FIL at 12 participating institutions in Japan, between March 2022 and September 2023 Efficacy: Clinical remission ratesd at 10, 26, and 58 weeks were 47.0%, 55.8%, and 64.6%, respectively; at median follow-up of 28 weeks, clinical remission, clinical response,d CS-free remission, and endoscopic improvement rates were 39.9%, 54.7%, 36.5%, and 43.5%, respectively Real-world data demonstrate favorable clinical and safety outcomes of FIL for UC
      Real-world multicenter retrospective study FIL dosage: 200 mg of daily FIL in 97.5% of patients; other dosages not specified Persistence: At median follow-up of 28 weeks, FIL was discontinued in 39% of patients. Most patients discontinued due to lack of efficacy (83%), followed by intolerance (14%) and unknown causes (3.2%). The majority of FIL discontinuations occurred within the 10 weeks after induction
      Safety: 1.3% of patients developed herpes zoster infections. No cases of thrombosis or death were reported
      Variable SELECTION (Feagan et al. 2021) [5]
      		 SELECTIONLTE (Feagan et al. 2024) [6]
      Induction study Aa (biologic-naive patients)
      		 Induction study Ba (biologic-naive patients)
      		 Maintenance studya
      		 Completersb
      		 Non-respondersb
      Placebo (n = 137) FIL100 (n = 277) FIL200 (n = 245) Placebo (n = 142) FIL100 (n = 285) FIL200 (n = 262) Placebo-placebo (n = 93) FIL100-placebo (n = 91) FIL100-FIL100 (n = 179) FIL200-placebo (n = 99) FIL200-FIL200 (n = 202) FIL200-FIL200-FIL200 (n=148) FIL100-FIL100-FIL100 (n=102) FIL200-FIL200 (n = 160) FIL100-FIL200 (n = 212)
      Age (yr) 41.0 ± 12.9 42.0 ± 13.3 42.0 ± 13.1 44.0 ± 14.9 43.0 ± 14.3 43.0 ± 14.2 43.0 ± 13.0 43.0 ± 15.1 42.0 ± 12.6 42.0 ± 13.0 43.0 ± 13.8 44.3 ± 13.4 43.1 ± 11.9 43.2 ± 13.9 43.2 ± 13.5
      Female sex 50 (36.5) 120 (43.3) 122 (49.8) 56 (39.4) 99 (34.7) 114 (43.5) 44 (47.3) 42 (46.2) 78 (43.6) 51 (51.5) 107 (53.0) 83 (56.1) 47 (46.1) 55 (34.4) 74 (34.9)
      Duration of UC (yr) 6.4 ± 7.4 6.7 ± 7.4 7.2 ± 6.9 10.2 ± 8.2 9.7 ± 7.2 9.8 ± 7.6 7.0 ± 6.8 7.5 ± 7.5 8.9 ± 8.4 8.9 ± 7.6 8.4 ± 7.4 8.7 ± 7.7 8.7 ± 8.9 8.6 ± 7.5 8.2 ± 7.0
      Induction study A 67 (72.0) 54 (59.3) 107 (59.8) 54 (54.5) 109 (54.0) 87 (58.8) 70 (68.6) 70 (43.8) 75 (35.4)
      Induction study B 26 (28.0) 37 (40.7) 72 (40.2) 45 (45.5) 93 (46.0) 61 (41.2) 32 (31.4) 90 (56.3) 137 (64.6)
      CRP (mg/L) 5.8 ± 7.6 7.8 ± 17.4 8.6 ± 16.3 14.0 ± 24.3 11.7 ± 18.0 12.2 ± 14.9 3.3 ± 5.3 3.5 ± 5.4 3.0 ± 5.7 2.7 ± 4.4 3.7 ± 10.1 8.7 ± 18.6 6.8 ± 14.8 12.1 ± 14.2 10.5 ± 16.6
      FCP (μg/g) 2,231 ± 2,917 2,001 ± 3,448 2,059 ± 2,639 2,479 ± 3,571 2,236 ± 3,095 2,845 ± 4,077 1,043 ± 1,546 760 ± 1,475 662 ± 1,291 934 ± 2,622 627 ± 945 2,713 ± 3,447 1,715 ± 3,163 2,067 ± 3,093 2,402 ± 3,654
      Concomitant/prior use of systemic corticosteroidsc 34 (24.8) 67 (24.2) 54 (22.0) 51 (35.9) 103 (36.1) 94 (35.9) 25 (26.9) 28 (30.8) 62 (34.6) 31 (31.3) 61 (30.2) 105 (70.9) 84 (81.6) 123 (76.9) 153 (72.2)
      Concomitant/prior use of immunosuppressantsc 33 (24.1) 63 (22.7) 53 (21.6) 21 (14.8) 34 (11.9) 34 (13.0) 23 (24.7) 15 (16.5) 27 (15.1) 18 (18.2) 35 (17.3) 82 (55.4) 50 (48.5) 116 (72.5) 143 (67.5)
      Concomitant/prior use of systemic corticosteroids and immunosuppressantsc 8 (5.8) 19 (6.9) 20 (8.2) 11 (7.7) 28 (9.8) 28 (10.7) 7 (7.5) 9 (9.9) 17 (9.5) 9 (9.1) 19 (9.4)
      Prednisone-equivalent dose (mg/day) 20.0 (15.0–30.0) 15.0 (10.0–25.0) 20.0 (10.0–25.0) 20.0 (10.0–20.0) 20.0 (10.0–20.0) 15.0 (10.0–20.0) 22.5 (20.0–30.0) 20.0 (10.0–20.0) 20.0 (10.0–25.0) 20.0 (10.0–30.0) 20.0 (10.0–20.0)
      No. of prior biologic agents
       0 137 (100.0) 275 (99.3) 245 (100.0) 3 (2.1) 2 (0.7) 3 (1.1) 68 (73.1) 56 (61.5) 106 (59.2) 55 (55.6) 110 (54.5)
       1 0 1 (0.4) 0 46 (32.4) 98 (34.4) 80 (30.5) 12 (12.9) 9 (9.9) 32 (17.9) 16 (16.2) 36 (17.8)
       2 0 1 (0.4) 0 45 (31.7) 109 (38.2) 90 (34.4) 4 (4.3) 15 (16.5) 22 (12.3) 10 (10.1) 31 (15.3)
       ≥3 0 0 0 48 (33.8) 76 (26.7) 89 (34.0) 9 (9.7) 11 (12.1) 19 (10.6) 18 (18.2) 25 (12.4)
      Prior therapeutic use
       ≥ 1 anti-TNF agent 0 2 (0.7) 0 130 (91.5) 266 (93.3) 242 (92.4) 21 (22.6) 32 (35.2) 68 (38.0) 43 (43.4) 84 (41.6) 55 (37.2) 30 (29.1) 83 (51.9) 131 (61.8)
       Vedolizumab 0 1 (0.4) 0 85 (59.9) 145 (50.9) 164 (62.6) 15 (16.1) 16 (17.6) 32 (17.9) 24 (24.2) 49 (24.3) 30 (20.3) 12 (11.7) 69 (43.1) 84 (39.6)
       ≥ 1 anti-TNF agent and vedolizumab 0 1 (0.4) 0 76 (53.5) 128 (44.9) 147 (56.1) 11 (11.8) 13 (14.3) 27 (15.1) 23 (23.2) 41 (20.3) 24 (16.2) 9 (8.7) 63 (39.4) 78 (36.8)
      Variable Feagan et al. (2021) [5] (SELECTION; Week 58)
      		 Feagan et al. (2024)[6] (SELECTIONLTE; Week 202)
      		 Schreiber et al. (2023)[37] (integrated interim analysis; total PYE: 3,326.2)
      Placebo-placebo (n=93; total PWE: 38.1) FIL100-placebo (n=91; total PWE: 29.2) FIL100-FIL100 (n=179; total PWE: 34.5) FIL200-placebo (n=99; total PWE: 28.8) FIL200-FIL 200 (n=202; total PWE: 39.4) FIL100 (n=160; total PYE: 308.0) FIL200 (n=873; total PYE: 2,055.5) Placebo (n=469; total PYE: 387.8) FIL100 (n=583; total PYE: 585.9) FIL200 (n=971; total PYE: 2,352.5)
      TEAEs, No. (%)
       Overall AE 57 (61.3) 60 (65.9) 108 (60.3) 59 (59.6) 135 (66.8) 128 (80.0) 724 (82.9) 306 (65.2) 388 (66.6) 817 (84.1)
       Serious AEs 4 (4.3) 7 (7.7) 8 (4.5) 0 9 (4.5) 15 (9.4) 146 (16.7) 34 (7.2) 53 (9.1) 176 (18.1)
       AEs leading to study drug discontinuation 3 (3.2) 4 (4.4) 10 (5.6) 2 (2.0) 7 (3.5) 41 (25.6) 181 (20.7) 41 (8.7) 71 (12.2) 210 (21.6)
       Deaths 0 0 0 0 2 (1.0) 0 6 (0.7) 0 0 8 (0.8)
      AEs of interest, No (%)
       All infections 21 (22.6) 27 (29.7) 46 (25.7) 25 (25.3) 71 (35.1) 54 (33.8) 449 (51.4) 118 (25.2) 150 (25.7) 512 (52.7)
       Serious infections 1 (1.1) 2 (2.2) 3 (1.7) 0 2 (1.0) 3 (1.9) 51 (5.8) 8 (1.7) 14 (2.4) 56 (5.8)
       Herpes zoster 0 1 (1.1) 0 0 1 (0.5) 3 (1.9) 31 (3.6) 1 (0.2) 4 (0.7) 33 (3.4)
      Table 1. Summary of Original Research Publications (n=17) Included in This Narrative Review Which Reported on SELECTION and/or SELECTIONLTE, Including Their Efficacy Outcomes

      Patients in the SELECTION trial (NCT02914522) were enrolled into 1 of 2 induction studies: induction study A which included biologic-naive patients, and induction study B which included biologic-experienced patients. Those who achieved either clinical remission or a total MCS response at Week 10 were re-randomized 2:1 at Week 11 to continue their induction FIL regimen or receive placebo in the maintenance study through Week 58 [5].

      Eligible patients from SELECTION could enroll in SELECTIONLTE (NCT02914535). Patients eligible for enrolment into SELECTIONLTE included: those who achieved clinical remission or an MCS response at Week 10 and completed SELECTION to Week 58 (completers), and those who did not achieve clinical remission or an MCS response at Week 10 and discontinued SELECTION (non-responders); and those who experienced PSDW during maintenance (defined as an increase in pMCS of ≥3 points from the Week 10 value on 2 consecutive visits to achieve a score of >5 or an increase in pMCS on 2 consecutive visits to achieve a score of 9 if the Week 10 value was >6). Of those eligible for enrolment in SELECTIONLTE, only completers and non-responders were evaluated in the interim analysis [6,23].

      Abstracts presented at congresses (n=7); the rest of the rows are manuscripts published in academic journals (n=10).

      Ph, phase; UC, ulcerative colitis; FIL, filgotinib; SELECTIONLTE, SELECTION long-term extension; LTE, long-term extension; pMCS, partial Mayo Clinic Score; FCP, fecal calprotectin; IBDQ, Inflammatory Bowel Disease Questionnaire; AEs, adverse events; HRQoL, health-related quality of life; CDC, comprehensive disease control; PSDW, prolonged symptomatic disease worsening; MCS, Mayo Clinic Score; OR, odds ratio; HR, hazard ratio; TNF, tumor necrosis factor; PRO, patient-reported outcome; PPV, positive predictive value; NPV, negative predictive value; CRP, C-reactive protein.

      Table 2. Summary of Real-World Evidence Publications (n=6) Included in This Narrative Review

      Nogami et al. [18] also reported on results of upadacitinib in treating UC; however, these results are not included in this narrative review study which focused on FIL treatment in UC.

      Clinical response is defined as pMCS reduction by ≥2 points and 30% from baseline, RB subscore reduction of ≥1, and clinical remission is defined as pMCS≤2, stool frequency≤1, physician’s global assessment subscore ≤1, RB=0 [18].

      Clinical response is defined as reduction of pMCS by ≥3 points from baseline to month 6, along with either a ≥30% reduction or remission at month 6, and clinical remission is defined as pMCS ≤1 plus a bleeding subscore=0 [32].

      Clinical remission is defined as pMCS≤1 with a rectal bleeding score of 0 or SCCAI ≤2 with a blood-in-stool score of 0, and clinical response is defined as ≥2-point reduction from the baseline pMCS or a ≥3-point reduction from the baseline SCCAI [19].

      FIL, filgotinib; UC, ulcerative colitis; NHS, National Health Service; pMCS, partial Mayo Clinic Score; CRP, C-reactive protein; AEs, adverse events; sIBDQ, Short Inflammatory Bowel Disease Questionnaire; MCS, Mayo clinical score; PRO2, 2-item patient reported outcomes; MCID, minimal clinically important difference; NRS, Numerical Rating Scale; TEAEs, treatment-emergent adverse events; AESI, adverse event of special interest; FACITFatigue, Functional Assessment of Chronic Illness Therapy Fatigue scale; CS, corticosteroid; RB, rectal bleeding; SCCAI, Simple Clinical Colitis Activity Index.

      Table 3. Baseline Demographics and Characteristics of Patients in SELECTION and SELECTIONLTE

      Values are presented as mean±standard deviation, number (%), or median (interquartile range). Empty cells represent information that was either not applicable to the patient subgroup, or not detailed in the publication.

      Patients in the SELECTION trial (NCT02914522) were enrolled into 1 of 2 induction studies: induction study A which included biologic-naive patients, and induction study B which included biologic-experienced patients. Those who achieved either clinical remission or a total MCS response at Week 10 were re-randomized 2:1 at Week 11 to continue their induction FIL regimen or receive placebo in the maintenance study through Week 58 [5].

      In SELECTIONLTE (NCT02914535), completers were defined as patients who achieved clinical remission or an MCS response at Week 10 and completed SELECTION to Week 58; non-responders were defined as patients who did not achieve clinical remission or an MCS response at Week 10 and discontinued SELECTION [6].

      Feagan et al. [5] reported values for concomitant systemic corticosteroid and/or immunosuppressant use; Feagan et al. [6] reported values for prior systemic corticosteroid and/or immunosuppressant use.

      SELECTIONLTE, SELECTION long-term extension; FIL, filgotinib; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; UC, ulcerative colitis; CRP, C-reactive protein; FCP, fecal calprotectin; TNF, tumor necrosis factor; MCS, Mayo Clinic Score.

      Table 4. Summary of Safety Outcomes Reported for SELECTION and/or SELECTIONLTE

      SELECTIONLTE, SELECTION long-term extension; PWE, patient-weeks of exposure; PYE, patient-years of exposure; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; TEAEs, treatment-emergent adverse events; AEs, adverse events.

      Table 1.

      Table 2.

      Table 3.

      Table 4.

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