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Original Article Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials
Katsuyoshi Matsuoka1orcid, Stefan Schreiber2orcid, Erina Hata3orcid, Toshihiko Kaise3orcid, Toshifumi Hibi4orcid

DOI: https://doi.org/10.5217/ir.2025.00219
Published online: March 4, 2026

1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan

2Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany

3Gilead Sciences K.K., Tokyo, Japan

4Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan

Correspondence to Katsuyoshi Matsuoka, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura 285-8741, Japan. E-mail: matsuoka@fk2.so-net.ne.jp
This study was presented at the 20th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 19-22, 2025, Berlin, Germany.
• Received: September 9, 2025   • Revised: November 23, 2025   • Accepted: December 7, 2025

© 2026 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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  • Background/Aims
    This post hoc analysis of the phase 2b/3 SELECTION (NCT02914522) study and its long-term extension (SELECTIONLTE; NCT02914535) evaluated the impact of filgotinib 200 mg (FIL200) on health-related quality of life (HRQoL) and work productivity in Japanese patients with ulcerative colitis over 3 years.
  • Methods
    Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1–3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).
  • Results
    Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1–3.
  • Conclusions
    FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.
  • Keywords: Janus kinase inhibitors; Quality of life; Japan; Ulcerative colitis; Productivity
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease of the colonic mucosa [1]. Common signs and symptoms of UC, such as bloody diarrhea, abdominal pain, fecal urgency, tenesmus, anemia, and fatigue, can negatively affect the health-related quality of life (HRQoL) of patients [2-6]. These symptoms affect various aspects of life, including mental, physical, social, and sexual functioning [2-6]. Moreover, reduced HRQoL and fatigue have been identified as the strongest determinants for work productivity loss among employed individuals with UC [7]. When evaluating options for managing UC, patients place significant importance on how well a therapy can enhance their HRQoL [8]. Consequently, in addition to the induction of clinical remission, endoscopic mucosal healing and symptom relief, the aims of UC treatment now include the improvement or normalization of HRQoL [9].
Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved in Europe, the UK, Japan, South Korea, Taiwan, and Singapore for the treatment of UC [10-15]. The efficacy and safety of filgotinib in adults with moderately to severely active UC were evaluated in the phase 2b/3 SELECTION study (NCT02914522) [16]. In SELECTION, filgotinib 200 mg (FIL200) was effective at inducing and maintaining clinical remission compared with placebo (PBO) over 58 weeks of treatment [16], enabled corticosteroid-free remission regardless of baseline characteristics [17], and provided rapid and sustained improvements in UC symptoms [18]. In addition, FIL200 improved HRQoL and work productivity according to multiple patient-reported outcome (PRO) measures (Inflammatory Bowel Disease Questionnaire [IBDQ], EQ 5-dimension [EQ-5D], 36-item Short Form Health Survey [SF-36], and Work Productivity and Activity Impairment [WPAI] questionnaires) [19].
A post hoc analysis conducted in Japanese patients with UC who participated in the SELECTION trial indicated an efficacy and safety profile for FIL200 that was generally consistent with that of the overall SELECTION population [20]. Further analyses of data from SELECTION and its long-term extension study (SELECTIONLTE; NCT02914535) have demonstrated long-term improvements in UC disease control and HRQoL in patients receiving FIL200. In patients who responded to 10 weeks of FIL200 induction therapy and completed 47 weeks of maintenance therapy, improvements in UC symptoms, HRQoL (determined using the IBDQ, EQ visual analog scale [EQ VAS], and SF-36), and work productivity were maintained for up to approximately 3 years of FIL200 treatment [21]. Furthermore, in patients who did not initially respond to 10 weeks of FIL200 induction therapy, but who continued taking FIL200 treatment, UC symptoms, HRQoL, and work productivity improved over time [21]. The long-term efficacy and safety of FIL200 have been demonstrated in Japanese patients with UC [22]. However, the effects of FIL200 on measures of HRQoL and work productivity have not been assessed in Japanese patients with UC. Given the distinct lifestyle and work culture in Japan, which includes long working hours and low rates of leave [23], Japanese patients may experience and report HRQoL and productivity outcomes differently from Western populations, underscoring the need for population-specific data.
This post hoc analysis of SELECTION and SELECTIONLTE data assessed the impact of FIL200 treatment on PRO measures of generic HRQoL (determined using the EQ-5D and SF-36), disease-specific HRQoL (determined using the IBDQ), and work productivity (determined using the WPAI) over 3 years in Japanese patients. A Plain Language Summary and a Visual Plain Language Summary for this analysis are available (see Supplementary Materials 1, 2).
1. Study Design and Patients
SELECTION was a phase 2b/3 double-blind, randomized, placebo-controlled trial comprising 2 induction studies (induction study A [biologic-naive patients] or induction study B [biologic-experienced patients]) and a maintenance study. Details of the study design have been previously reported [16]. Briefly, eligible patients who were 18–75 years of age with moderately to severely active UC were randomized 2:2:1 to receive FIL200, filgotinib 100 mg (FIL100), or PBO orally once daily for 11 weeks. Patients who were in clinical remission or had a Mayo Clinic Score response at week 10 (responders) were re-randomized 2:1 at week 11 to continue their assigned filgotinib regimen or receive PBO in the 47-week maintenance study. PBO responders continued to receive PBO. Clinical remission was defined as a Mayo endoscopic subscore of 0 or 1, a rectal bleeding subscore of 0, and a stool frequency subscore of 0 or 1 (with a decrease of at least 1 point from induction baseline). Mayo Clinic Score response was defined as a decrease in Mayo Clinic Score of at least 3 points and 30% or more from baseline, with a decrease in rectal bleeding subscore of 1 point or more, or an absolute rectal bleeding subscore of 0 or 1. Patients who did not respond to filgotinib at week 10 (non-responders) were excluded from the maintenance study but could enter the ongoing long-term extension study, SELECTIONLTE, and receive open-label FIL200. Patients who completed the SELECTION induction and maintenance studies (completers) could also enter SELECTIONLTE and continue double-blinded dosing of their assigned treatment in SELECTION until the unblinding of the SELECTION trial on May 6, 2020; after this date, patients who were receiving filgotinib continued treatment with open-label filgotinib at their assigned doses, and patients who were receiving PBO were discontinued.
This post hoc analysis assessed HRQoL and work productivity at week 10 in Japanese patients who received FIL200 or PBO in SELECTION, and at week 10 and years 1, 2, and 3 in Japanese completers and non-responders who received FIL200 in SELECTION and SELECTIONLTE. Both the SELECTION and the SELECTIONLTE studies were performed in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol and amendments were approved by local review boards or ethics committees (Toho University Sakura Medical Center Institutional Review Board and others). Informed written consent was obtained from all patients.
2. HRQoL and Work Productivity Outcomes
The proportions of patients with minimal clinically important differences (MCIDs) in the direction of improvement compared with induction baseline in IBDQ total score (≥ 16-point increase), EQ-5D values (≥0.076 increase), EQ VAS scores (≥10-point increase), SF-36 mental component summary (MCS) and physical component summary (PCS) scores (≥ 5-point increase), and WPAI activity impairment (≥7% absolute decrease) were assessed at week 10 in patients who received FIL200 or PBO at induction baseline, and at week 10 and years 1, 2, and 3 in completers and non-responders (PRO primary analysis) (Supplementary Fig. 1) [19]. WPAI absenteeism, presenteeism, and work productivity loss scores were assessed only in patients who were employed at the time the WPAI was completed [19]. Mean (standard deviation [SD]) changes from induction baseline were calculated for the HRQoL measures and their domains and for the WPAI measures at week 10 in patients who received FIL200 or PBO, and at week 10 and years 1, 2, and 3 in completers and non-responders (PRO secondary analysis).
3. Statistical Analysis
Patient demographics and baseline characteristics were analyzed using descriptive statistics. Binary variables are presented as proportions (%) and 95% confidence intervals (CIs). Continuous variables are reported as mean±SD.
The MCID rates were calculated at week 10 in Japanese patients who received FIL200 or PBO in SELECTION (at induction baseline), and at week 10 and years 1, 2, and 3 for completers and non-responders, using observed data (without imputation). Imputation analyses, where missing values were imputed as non-response (non-responder imputation [NRI]), were also conducted if differences in drop-out/outcome-reporting rates between FIL200 and PBO treatment groups were deemed likely to skew comparisons. Analyses using observed data included participants with available data at both baseline and week 10. For NRI analyses, missing week-10 data due to patient discontinuation, or due to lack of outcome reporting for participants who remained enrolled, were imputed as not achieving an MCID. Patients with data available at week 10 but not at baseline were excluded from week-10 questionnaire response rate calculations and from NRI analyses. Owing to the small sample size, statistical testing of the differences between groups or time points was not performed.
1. Baseline Patient Characteristics and Questionnaire Response Rates
Baseline characteristics were generally well balanced between the induction FIL200 and induction PBO groups, and between completers and non-responders (Table 1). Exceptions were a lower proportion of women, lower mean fecal calprotectin levels, and lower mean WPAI absenteeism scores at baseline in non-responders compared with completers, and differing patterns of concomitant UC treatment (systemic corticosteroids, immunomodulators, and 5-aminosalicylic acid) between these groups.
By week 10 of the induction study, 5 patients had discontinued treatment (FIL200: 1/44 [2%]; PBO: 4/20 [20%]), 4 patients because of an adverse event (FIL200: 1/44 [2%]; PBO: 3/20 [15%]). Of patients who entered the SELECTIONLTE study, 3 patients discontinued prematurely (completer: 2/15 [13%]; non-responder: 1/14 [7%]), 1 patient because of an adverse event (1/15 [7%] completers).
At week 10, EQ-5D, EQ VAS, IBDQ, and SF-36 questionnaire response rates were lower (due to study discontinuation or lack of outcome reporting) in patients who received induction PBO (13/18–14/18 [72%–78%]) than in those who received induction FIL200 (43/44 [98%]). At week 10, WPAI activity impairment questionnaire response rates were lower in patients who received induction PBO (13/18 [72%]) than in those who received induction FIL200 (43/44 [98%]), as were WPAI absenteeism, work productivity loss, and presenteeism questionnaire response rates in employed individuals (PBO: 11/13–11/14 [79%–85%]; FIL200: 26/26 [100%]).
To account for the notably lower questionnaire response rates in the induction PBO group compared with the FIL200 groups at week 10, MCID rates for the FIL200 versus PBO comparison were calculated using both observed data and NRI.
2. HRQoL and Work Productivity at Week 10: FIL200 versus PBO
As observed proportions of patients with MCIDs at week 10 were higher in patients receiving FIL200 than in those receiving PBO for IBDQ total score (77% vs. 54%), SF-36 MCS (58% vs. 21%), and SF-36 PCS (54% vs. 36%) (Fig. 1). As observed proportions of patients receiving FIL200 and PBO who had MCIDs at week 10 were similar for EQ-5D values (49% vs. 43%) and EQ VAS scores (47% vs. 57%) (Fig. 1), and for all WPAI items (WPAI absenteeism: 15% vs. 18%; WPAI activity impairment: 70% vs 69%; WPAI productivity loss: 54% vs. 55%; WPAI presenteeism: 54% vs. 55%) (Fig. 2). Results from the questionnaire NRI analysis generally mirrored those of the observed analysis, showing slightly more consistent trends in favor of FIL200 compared with PBO (Figs. 1, 2). Mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO were observed for all HRQoL measures, except for WPAI absenteeism (Supplementary Figs. 2, 3).
Trends towards improvements with FIL200 treatment compared with PBO, in terms of the mean change from baseline in item scores per domain at week 10, were observed for all domains of IBDQ (systemic symptoms: +1.12; bowel symptoms: +1.03; social function: +0.99; emotional health: +0.70), SF-36 PCS (role physical: +6.3; general health: +4.8; bodily pain: +2.4; physical functioning: +1.9), and SF-36 MCS (vitality: +8.6; role emotional: +7.6; social functioning: +5.3; mental health: +4.1) (Supplementary Fig. 4).
3. HRQoL and Work Productivity over 3 Years with FIL200: Completers versus Non-Responders
In SELECTION completers, MCID rates at week 10 for each measure were generally maintained over 3 years of treatment with FIL200 (Figs. 3, 4). In non-responders, MCID rates increased notably from week 10 to year 1 for all measures except WPAI absenteeism and EQ-5D values and were generally maintained over 3 years of FIL200 treatment (Figs. 3, 4). MCID rates over time were driven predominantly by numbers of patients achieving MCIDs (numerator), rather than changes in the number of patients with available data (denominator).
Trends toward improvements from week 10 to year 1, in terms of the mean change from baseline in item scores per domain, were observed in non-responders for all domains of IBDQ (bowel symptoms: +1.03; systemic symptoms: +0.92; emotional health: +0.89; social function: +0.79), SF-36 PCS (general health: +6.1; bodily pain: +4.3; physical functioning: +2.5; role physical: +2.1), and SF-36 MCS (social functioning: +8.6; vitality: +5.3; role emotional: +2.0; mental health: +1.8) (Supplementary Fig. 5). For all 3 of these measures, mean domain item score changes from baseline at years 1–3 were generally similar between non-responders and completers, with some exceptions. Mean domain item score changes from baseline through years 1–3 were notably lower for social functioning domains in non-responders versus completers for the IBDQ (0.83–0.98 vs. 1.88–2.05) and SF-36 MCS (8.9–11.6 vs. 14.4–17.0), and notably higher for the general health domain in non-responders versus completers for the SF-36 PCS (8.6–11.5 vs. 4.9–6.4) (Supplementary Fig. 5).
In this post hoc analysis of SELECTION and SELECTIONLTE data, improved HRQoL was associated with FIL200 treatment for up to 3 years in Japanese patients with UC who responded to 10 weeks of FIL200 induction therapy, and from 1 to 3 years in those who did not respond to 10 weeks of FIL200 induction therapy. Importantly, these HRQoL improvements occurred across multiple domains, including physical, social, emotional, and mental health measures, and bowel- and systemic-related symptoms. Compared with PBO, FIL200 treatment was associated with marked improvements at week 10 in the vitality and role emotional domains of the SF-36. Although conclusions from this descriptive analysis are limited by the small sample sizes, the results are consistent with those reported for the overall SELECTION and SELECTIONLTE trial populations, in which symptom and HRQoL improvements over time persisted in completers and increased in non-responders [21].
Compared with patients from the overall SELECTION population who received induction FIL200, the subgroup of Japanese patients from SELECTION who received induction FIL200 had numerically better baseline HRQoL scores for the EQ VAS (overall: 48–54; Japanese: 60), EQ-5D value (overall: 0.6–0.7; Japanese: 0.8), IBDQ total score (overall: 112–119; Japanese: 138), and SF-36 PCS (overall: 41–42; Japanese: 45), and better baseline work productivity scores for WPAI absenteeism (overall: 18–25; Japanese: 6), WPAI presenteeism (overall: 45; Japanese: 41), and WPAI work productivity loss (overall: 52–54; Japanese: 44) despite having similar mean Mayo Clinic Scores (overall: 8.6–9.2; Japanese: 8.5) (Supplementary Table 1) [19]. Only baseline SF-36 MCS (overall: 38–40; Japanese: 39) and WPAI activity impairment (overall: 50–57; Japanese: 53) scores overlapped between the overall SELECTION population and the Japanese SELECTION population [19]. It is unclear what may be driving these differences, although cultural factors may be one explanation. For example, the lower baseline WPAI absenteeism scores observed in Japanese patients compared with the overall SELECTION population, despite comparable baseline SF-36 MCS scores, may reflect differences in work behavior compared with other cultures, whereby individuals may be less inclined to take time off work even if experiencing health challenges.
Mean changes from baseline at week 10 in HRQoL and work productivity measures were consistently greater (except for WPAI absenteeism) in Japanese patients with UC treated with FIL200 than in those treated with PBO. As it may be difficult to directly relate changes in scores for the HRQoL and WPAI measures (and their domains) to tangible improvements in clinical or real-life settings, the primary outcomes in this study were based on MCID rates for the various measures. For some measures, namely IBDQ, SF-36 MCS, and SF-36 PCS, the improvements from baseline in scores at week 10 did translate to increased MCID rates in patients treated with FIL200 compared with PBO. However, the increases in scores for the HRQoL and WPAI measures did not translate into increased proportions of patients with MCIDs for all measures, with no notable differences observed between FIL200 and PBO at week 10 for EQ-5D, EQ VAS, or WPAI measures, in contrast to findings for the overall SELECTION population [19]. Several factors should be considered in relation to this finding. First, the questionnaire response rate in Japanese patients was notably lower in those taking PBO (65%–70%) than in those taking FIL200 (98%), which may have biased toward an overestimation of MCID rates with PBO. Indeed, when the questionnaire NRI analysis was applied instead of the “as observed” analysis, differences in MCID rates were slightly more consistent in terms of favoring improvement with FIL200 compared with PBO. Second, the FIL200 group at week 10 included both responders and non-responders to treatment. Given that MCID rates for HRQoL measures showed consistent improvements in non-responders after 10 weeks (to levels comparable with those in completers), peak benefits of FIL200 in terms of improved HRQoL would likely not have occurred until after 10 weeks. Third, as noted above, baseline HRQoL and work productivity measures in Japanese patients from SELECTION were numerically better than for the overall SELECTION population, potentially leaving less scope for improvement with FIL200 treatment. Finally, our findings must be evaluated in the context of the small patient numbers available (especially for the WPAI questionnaire items) for this post hoc analysis, which is a limitation of our study that increases the susceptibility of our data to random variation, especially for binary (MCID) versus continuous (mean change) outcomes.
In our study, there appeared to be no substantial impact of FIL200 on absenteeism in terms of either mean changes from baseline or MCID rates compared with PBO, and this was also the only work productivity measure that did not notably increase over time from week 10 in non-responders. This finding is consistent with data for the overall SELECTION trial population, which also showed no differences in MCID WPAI absenteeism rates between FIL200 and PBO groups [19]. Of note, baseline mean WPAI absenteeism scores were substantially lower (18–25) compared with other WPAI domains (44–60) in the overall SELECTION population, and in Japanese patients in the current analysis (4–15 vs. 37–57) [19]. These findings are consistent with those of a recent meta-analysis (16 vs. 36–46) [24], and with data from a cross-sectional study that found that only severe inflammatory bowel disease (IBD) symptoms impaired WPAI absenteeism, whereas mild–moderate symptoms were sufficient to impair other WPAI items [25]. The limited effects of FIL200 on WPAI absenteeism may thus be due, at least in part, to lower baseline impairment of this measure versus other WPAI domains in patients with IBD, limiting the scope for further improvement upon FIL200 treatment in this study. Additionally, specific cultural factors may also play a role in the low baseline impairment of absenteeism in Japanese patients. Rates of absenteeism among Japanese patients with UC are estimated to be approximately 6%, compared with up to 12% in patients with UC in the United States [26,27]. In Japan, the concept of “ganbaru,” or “working hard,” features prominently in workplace culture, where rather than placing the emphasis predominantly on results and productivity, the focus is more on the act of exerting effort and time itself [23]. This culture of hard work, as well as the resulting pressure to conform to the norm of overworking and difficulties around taking sick leave, often leads to long working hours and a tendency for workers to attend work even when unwell, contributing to lower absenteeism rates than in other countries.
Examination of specific HRQoL domains in our analysis revealed that mean item scores for social functioning (IBDQ and SF-36 MCS) in non-responders did not recover over time to the same degree as observed for other HRQoL domains. This may indicate that impaired social functioning is more challenging to address in non-responders than other aspects of HRQoL, even with prolonged FIL200 treatment. This finding, if replicated elsewhere, could be due to residual IBD symptoms or comorbid (non-IBD) symptoms that disproportionately affect social functioning. Not all UC symptoms known to impact social functioning in Japanese patients have been investigated in terms of filgotinib efficacy. For example, bowel urgency, which was one of the most distressing symptoms reported in Japanese patients with UC in a global, survey-based study (CONFIDE) [28], was not evaluated in the SELECTION trial [18]. It is noteworthy that a recent European, real-world study reported MCID rates with filgotinib treatment in patients with moderately and severely active UC, respectively, that were higher for the Short IBDQ (75% and 68%) and Functional Assessment of Chronic Illness Therapy-Fatigue (76% and 59%) scores than for Urgency Numerical Rating Scale scores (35% and 42%) [29]. However, potential variation in the stringency of MCID calculations across PRO measures precludes any firm conclusions from these data. With regard to the potential impact of comorbid symptoms on social functioning, anxiety is often associated with IBD flares and may also persist during periods of remission [30]. Indeed, anxiety and depression are more common in patients with IBD than in the general population [31], and anxiety has been associated with more aggressive IBD [32], which may be more difficult to treat and thus overrepresented in non-responders. It would be interesting to determine whether these findings in Japanese patients are also observed in the overall SELECTION trial population.
In this post hoc analysis, limitations include that the conclusions are limited by the small sample sizes and a lack of formal statistical analyses. Furthermore, it should be noted that in the extension part of the study, the comparison between the completers and non-responders was between 2 non-randomized groups with different characteristics, so statistical testing may not have been appropriate in this scenario. Analyses were performed using the MCID of binary counts rather than changes in scores in order to better reflect tangible, clinically validated improvements, but because of the small sample size, the use of MCID rates may have limited the ability to detect differences between the FIL200 and PBO groups. Additionally, a lack of validated MCID thresholds for specific HRQoL domains meant that, in several instances, only mean domain item changes (rather than MCID rates) could be calculated. Furthermore, the SELECTIONLTE lacked a PBO arm, so long-term changes in HRQoL could only be compared between non-responders and completers. Despite these limitations (most notably the small sample size) clear and consistent results were observed in this dedicated analysis of Japanese patients that are representative of findings from the overall SELECTION and SELECTIONLTE populations. These findings provide valuable insights into the long-term effects of FIL200 on HRQoL in Japanese patients with UC, highlighting the potential benefits of continued treatment even in non-responders.
In conclusion, this post hoc analysis demonstrated that FIL200 treatment was associated with sustained improvements in HRQoL across multiple domains over 3 years in Japanese patients with UC, in both responders and non-responders to induction therapy. Although the study is limited by small sample sizes, the findings suggest that HRQoL outcomes for Japanese patients are consistent with those observed in the overall SELECTION and SELECTIONLTE trial populations, while also highlighting key regional trends in HRQoL, particularly at baseline. Overall, these results provide clinically relevant information for the use of filgotinib in Japan, underscoring the potential benefits of long-term FIL200 treatment in managing UC and improving patients’ HRQoL.

Funding Source

This post hoc analysis was funded by Gilead Sciences K.K., Eisai Co., Ltd and EA Pharma Co., Ltd. The SELECTION trial was sponsored by Gilead Sciences, Inc. (Foster City, CA, USA). Galapagos NV (Mechelen, Belgium) was a collaborator for the SELECTION trial. The SELECTIONLTE trial was sponsored by Galapagos NV (Mechelen, Belgium).

Conflict of Interest

Matsuoka K reports personal fees from AbbVie, Bristol Myers Squibb, Celltrion, EA Pharma Co. Ltd., Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, JIMRO Co., Ltd., Kissei Pharmaceutical, Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Pfizer, Takeda, and Zeria Pharmaceutical Co., Ltd.; and research grants from AbbVie, EA Pharma Co., Ltd., JIMRO Co., Ltd., Kissei Pharmaceutical, Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., and Takeda. Schreiber S reports personal fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos/Gilead Sciences, I-Mab, Janssen Pharmaceuticals, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Sandoz/Hexal, Takeda, Theravance Biopharma, and UCB. Hata E and Kaise T are employees of Gilead Sciences K.K. and shareholders of Gilead Sciences, Inc. Hibi T reports lecture fees from Aspen Japan K.K., Janssen Pharmaceuticals, JIMRO Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Pfizer, and Takeda; research grants from AbbVie GK, Activaid, Alfresa Pharma, Bristol Myers Squibb, Eli Lilly Japan K.K., Ferring Pharmaceuticals, Gilead Sciences, Inc., Janssen Pharmaceuticals K.K., JMDC Inc., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Japan Inc., and Takeda; scholarship contributions from Mitsubishi Tanabe Pharma Corporation, Nippon Kayaku Co., Ltd., and Zeria Pharmaceutical Co., Ltd.; and study group sponsorship from AbbVie GK, EA Pharma Co., Ltd., JIMRO Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Otsuka Holdings, and Zeria Pharmaceutical Co., Ltd.

Matsuoka K and Hibi T are editorial board members of the journal but were 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

Gilead Sciences shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curricula vitae and reflecting non-conflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Sciences’ discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com.

Author Contributions

Conceptualization: Matsuoka K, Hata E, Kaise T. Data curation: Matsuoka K, Hata E, Kaise T. Formal analysis: Hata E, Kaise T. Funding acquisition: Hata E, Kaise T. Investigation: Matsuoka K, Schreiber S. Methodology: all authors. Project administration: Hata E. Resources: Matsuoka K, Schreiber S, Hibi T. Supervision: Kaise T, Hibi T. Visualization: Matsuoka K, Hata E. Writing–original draft: all authors. Writing–review & editing: all authors. Approval of final manuscript: all authors.

Additional Contributions

The authors thank all the patients who kindly participated in this study. Medical writing support was provided by Michael Molloy-Bland PhD and Tamsyn Stanborough PhD of Oxford PharmaGenesis, Melbourne, Australia, and funded by Gilead Sciences K.K., Eisai Co., Ltd., and EA Pharma Co., Ltd., in accordance with Good Publication Practice 2022 (GPP 2022) guidelines (https://www.ismpp.org/gpp-2022).

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

Supplementary Material 1.

Plain Language Summary
ir-2025-00219-Supplementary-Material-1.pdf

Supplementary Material 2.

Visual Plain Language Summary
ir-2025-00219-Supplementary-Material-2.pdf

Supplementary Table 1.

Comparison of HRQoL Measures at Baseline between the Japanese Patient Subgroup and the Overall SELECTION/SELECTIONLTE Patient Population
ir-2025-00219-Supplementary-Table-1.pdf

Supplementary Fig. 1.

Study design of SELECTION and SELECTION trials, and the timing of evaluations in this post hoc analysis. aIncluded induction studies A (biologic-naive patients) and B (biologic-experienced patients); bResponders in SELECTION were patients who achieved clinical remission (defined as a Mayo endoscopic subscore of 0 or 1, a rectal bleeding subscore of 0, and a stool frequency subscore of 0 or 1 [with a decrease of at least 1 point from induction baseline]) or a Mayo Clinic Score response (defined as a decrease in Mayo Clinic Score of at least 3 points and 30% or more from baseline, with a decrease in rectal bleeding subscore of 1 point or more, or an absolute rectal bleeding subscore of 0 or 1) at week 10. Mayo Clinic Score was defined as the sum of endoscopic, rectal bleeding, stool frequency, and Physician’s Global Assessment subscores, with the total score ranging from 0 to 12; cNon-responders were patients who did not respond to induction treatment at SELECTION week 10; dCompleters were induction responders who also completed the SELECTION maintenance phase to week 58. BL, baseline; FIL100, filgotinib 100 mg; FIL200, filgotinib 200 mg; HRQoL, health-related quality of life; LTE, long-term extension; WPAI, Work Productivity and Activity Impairment. Reproduced from Feagan BG, et al. Aliment Pharmacol Ther 2024;60:563-584, with permission of John Wiley & Sons Ltd [2].
ir-2025-00219-Supplementary-Fig-1.pdf

Supplementary Fig. 2.

Mean changes from induction baseline at week 10 in Japanese patients receiving FIL200 or PBO for IBDQ total score (A), EQ-5D value (B), EQ VAS score (C), SF-36 MCS score (D), and SF-36 PCS score (E) in the SELECTION study. IBDQ, Inflammatory Bowel Disease Questionnaire; SD, standard deviation; FIL200, filgotinib 200 mg; PBO, placebo; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary.
ir-2025-00219-Supplementary-Fig-2.pdf

Supplementary Fig. 3.

Mean changes from induction baseline at week 10 in Japanese patients receiving FIL200 or PBO for WPAI absenteeism (A), activity impairment (B), work productivity loss (C), and presenteeism (D) items at week 10 in the SELECTION study. aData are from patients who were in employment at the time when the WPAI was completed. WPAI, Work Productivity and Activity Impairment questionnaire; FIL200, filgotinib 200 mg; PBO, placebo; SD, standard deviation.
ir-2025-00219-Supplementary-Fig-3.pdf

Supplementary Fig. 4.

Mean changes from induction baseline at week 10 in domain item scores for the IBDQ (A), SF-36 PCS (B), and SF-36 MCS (C). IBDQ, Inflammatory Bowel Disease Questionnaire; FIL200, filgotinib 200 mg; PBO, placebo; SF-36, 36-item Short Form Health Survey; PCS, physical component summary; MCS, mental component summary.
ir-2025-00219-Supplementary-Fig-4.pdf

Supplementary Fig. 5.

Mean changes from induction baseline in completers and non-responders in domain item scores for the IBDQ (A, B), SF-36 PCS (C, D) and SF-36 MCS (E, F) from week 10 through years 1–3 of FIL200 (filgotinib 200 mg) treatment in SELECTION and SELECTIONLTE. IBDQ, Inflammatory Bowel Disease Questionnaire; W, week; LTE, long-term extension; BL, baseline; SF-36, 36-item Short Form Health Survey; PCS, physical component summary; MCS, mental component summary.
ir-2025-00219-Supplementary-Fig-5.pdf
Fig. 1.
Proportions (observeda and based on questionnaire NRIb) of Japanese patients receiving FIL200 or PBO who experienced MCIDs in IBDQ total score (A), EQ-5D value (B), EQ VAS score (C), SF-36 MCS score (D), and SF-36 PCS score (E) at week 10 in the SELECTION study. Error bars show 95% confidence intervals. aObserved values were calculated using only data from patients who responded to the questionnaire at both baseline and week 10; bNRI values were calculated using data from patients who had missing week-10 data due to patient discontinuation or those who remained enrolled but did not provide responses to the questionnaire at week 10. Patients with data available at week 10 but not at baseline were excluded from NRI analyses. IBDQ, Inflammatory Bowel Disease Questionnaire; MCID, minimally clinically important difference; FIL200, filgotinib 200 mg; PBO, placebo; NRI, non-response imputation; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary.
ir-2025-00219f1.jpg
Fig. 2.
Proportions (observeda and based on questionnaire NRIb) of Japanese patients receiving FIL200 or PBO who experienced MCIDs in WPAI absenteeism (A), activity impairment (B), productivity loss (C), and presenteeism (D) items at week 10 in the SELECTION study. Error bars show 95% confidence intervals. aObserved values were calculated using only data from patients who responded to the questionnaire at both baseline and week 10; bNRI values were calculated using data from patients who had missing week-10 data due to patient discontinuation or those who remained enrolled but did not provide responses to the questionnaire at week 10. Patients with data available at week 10 but not at baseline were excluded from NRI analyses; cData are from patients who were in employment at the time when the WPAI was completed. WPAI, Work Productivity and Activity Impairment; MCID, minimally clinically important difference; FIL200, filgotinib 200 mg; PBO, placebo; NRI, non-response imputation.
ir-2025-00219f2.jpg
Fig. 3.
Proportions of Japanese patients who experienced MCIDs in IBDQ total score, EQ-5D value, EQ VAS score, SF-36 MCS score, and SF-36 PCS score in completers (A-E) and non-responders (F-J) from week 10 through years 1–3 of FIL200 treatment in SELECTION and SELECTIONLTE. LTE BL (completers) and LTE W48 (non-responders) both correspond to 1 year after SELECTION induction. Therefore, the second, third, and fourth bars in each panel show data at years 1, 2, and 3, respectively, after SELECTION induction. The dashed vertical lines show the entry time points into the LTE for completers (defined as patients from SELECTION who were in clinical remission or had a Mayo Clinic Score response at week 10 and completed the 11-week induction and 47-week maintenance studies) and non-responders (defined as patients who were discontinued from SELECTION after week 10 because they were not in clinical remission or did not have a Mayo Clinic Score response at week 10). Error bars show 95% confidence intervals. “N” numbers are the numbers of patients who completed the questionnaire at each time point. IBDQ, Inflammatory Bowel Disease Questionnaire; MCID, minimally clinically important difference; LTE, long-term extension; BL, baseline; W, week; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary; FIL200, filgotinib 200 mg.
ir-2025-00219f3.jpg
Fig. 4.
Proportions of Japanese patients who experienced MCIDs in WPAI absenteeism, activity impairment, work productivity loss, and presenteeism items in completers (A-D) and non-responders (E-H) from week 10 through years 1–3 of FIL200 treatment in SELECTION and SELECTIONLTE. LTE BL (completers) and LTE W48 (non-responders) both correspond to 1 year after SELECTION induction. Therefore, the second, third, and fourth bars in each panel show data at years 1, 2, and 3, respectively, after SELECTION induction. The dashed vertical lines show the entry time points into the LTE for completers (defined as patients from SELECTION who were in clinical remission or had a Mayo Clinic Score response at week 10 and completed the 11-week induction and 47-week maintenance studies) and non-responders (defined as patients who were discontinued from SELECTION after week 10 because they were not in clinical remission or did not have a Mayo Clinic Score response at week 10). Error bars show 95% confidence intervals. “N” numbers are the numbers of patients who completed the questionnaire at each time point. aData are from patients who were in employment at induction baseline. WPAI, Work Productivity and Activity Impairment; MCID, minimally clinically important difference; LTE, long-term extension; BL, baseline; W, week; FIL200, filgotinib 200 mg.
ir-2025-00219f4.jpg
ir-2025-00219f5.jpg
Table 1.
Baseline Patient Characteristics
Variable Induction FIL200 (n=44) Induction PBO (n=20) Completers (n=15) Non-responders (n=14)
Age (yr), mean±SD 47.7±15.6 48.9±14.4 50.7±13.5 45.5±16.4
Female sex, No. (%) 18 (40.9) 6 (30.0) 8 (53.3) 4 (28.6)
BMI (kg/m2), median (IQR) 21.7 (20.4–23.0) 21.2 (20.1–22.7) 21.8 (19.3–22.8) 21.7 (20.7–23.1)
Duration of UC (yr), mean±SD 8.5±7.3 10.2±10.0 8.1±7.0 8.9±7.9
Total Mayo Clinic Score, mean±SD 8.5±1.3 8.8±1.6 8.5±1.3 8.1±1.2
MES of 3, No. (%) 35 (79.5) 18 (90.0) 11 (73.3) 12 (85.7)
C-reactive protein (mg/L), mean±SD 6.0±9.7 4.2±6.4 6.9±14.0 5.8 ±6.1
Fecal calprotectin (µg/g), mean±SD 2,734±2,802 3,180±4,981 4,381±3,405 1,967±2,240
Concomitant UC treatments
Systemic corticosteroids, No. (%) 12 (27.3) 6 (30.0) 6 (40.0) 2 (14.3)
Immunomodulators, No. (%) 11 (25.0) 5 (25.0) 2 (13.3) 5 (35.7)
Systemic corticosteroids and immunomodulators, No. (%) 6 (13.6) 3 (15.0) 1 (6.7) 3 (21.4)
5-ASAs, No. (%) 36 (81.8) 16 (80.0) 11 (73.3) 14 (100.0)
Previous UC treatments, No. (%)
 TNFα inhibitors 29 (65.9) 13 (65.0) 9 (60.0) 10 (71.4)
 Vedolizumab 3 (6.8) 4 (20.0) 0 2 (14.3)
 TNFα inhibitors and vedolizumab 3 (6.8) 3 (15.0) 0 2 (14.3)
Previously failed UC treatments, No. (%)
 TNFα inhibitors 25 (56.8) 13 (65.0) 8 (53.3) 9 (64.3)
 Vedolizumab 1 (2.3) 1 (5.0) 0 1 (7.1)
IBDQ total score, mean±SD 138.3±31.9 142.4±30.5 133.5±30.8 143.3±36.9
EQ-5D score, mean±SD
 EQ-5D value 0.8±0.2 0.8±0.2 0.8±0.2 0.8±0.2
 EQ VAS score 59.8±19.1 50.0±22.3 57.6±21.5 59.4±17.3
SF-36 score, mean±SD
 MCS 39.2±11.1 42.9±8.9 38.7±12.5 40.9±12.1
 PCS 44.6±6.9 44.6±7.7 44.2±6.5 44.6±7.4
WPAI %, mean±SD
 Absenteeism score 6.0±12.8 14.5±30.7 12.1±20.1 3.7±6.8
 Activity impairment 52.7±25.6 48.9±31.2 57.3±28.9 50.0±22.9
 Productivity loss 44.0±28.0 43.1±32.4 48.1±36.7 49.3±18.2
 Presenteeism 41.2±26.4 36.9±27.2 42.5±33.7 48.0±16.9

FIL200, filgotinib 200 mg; PBO, placebo; SD, standard deviation; BMI, body mass index; IQR, interquartile range; UC, ulcerative colitis; MES, Mayo endoscopic subscore; 5-ASAs, 5-aminosalicylates; TNFα, tumor necrosis factor alpha; IBDQ, Inflammatory Bowel Disease Questionnaire; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary; WPAI, Work Productivity and Activity Impairment.

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      Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials
      Image Image Image Image Image
      Fig. 1. Proportions (observeda and based on questionnaire NRIb) of Japanese patients receiving FIL200 or PBO who experienced MCIDs in IBDQ total score (A), EQ-5D value (B), EQ VAS score (C), SF-36 MCS score (D), and SF-36 PCS score (E) at week 10 in the SELECTION study. Error bars show 95% confidence intervals. aObserved values were calculated using only data from patients who responded to the questionnaire at both baseline and week 10; bNRI values were calculated using data from patients who had missing week-10 data due to patient discontinuation or those who remained enrolled but did not provide responses to the questionnaire at week 10. Patients with data available at week 10 but not at baseline were excluded from NRI analyses. IBDQ, Inflammatory Bowel Disease Questionnaire; MCID, minimally clinically important difference; FIL200, filgotinib 200 mg; PBO, placebo; NRI, non-response imputation; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary.
      Fig. 2. Proportions (observeda and based on questionnaire NRIb) of Japanese patients receiving FIL200 or PBO who experienced MCIDs in WPAI absenteeism (A), activity impairment (B), productivity loss (C), and presenteeism (D) items at week 10 in the SELECTION study. Error bars show 95% confidence intervals. aObserved values were calculated using only data from patients who responded to the questionnaire at both baseline and week 10; bNRI values were calculated using data from patients who had missing week-10 data due to patient discontinuation or those who remained enrolled but did not provide responses to the questionnaire at week 10. Patients with data available at week 10 but not at baseline were excluded from NRI analyses; cData are from patients who were in employment at the time when the WPAI was completed. WPAI, Work Productivity and Activity Impairment; MCID, minimally clinically important difference; FIL200, filgotinib 200 mg; PBO, placebo; NRI, non-response imputation.
      Fig. 3. Proportions of Japanese patients who experienced MCIDs in IBDQ total score, EQ-5D value, EQ VAS score, SF-36 MCS score, and SF-36 PCS score in completers (A-E) and non-responders (F-J) from week 10 through years 1–3 of FIL200 treatment in SELECTION and SELECTIONLTE. LTE BL (completers) and LTE W48 (non-responders) both correspond to 1 year after SELECTION induction. Therefore, the second, third, and fourth bars in each panel show data at years 1, 2, and 3, respectively, after SELECTION induction. The dashed vertical lines show the entry time points into the LTE for completers (defined as patients from SELECTION who were in clinical remission or had a Mayo Clinic Score response at week 10 and completed the 11-week induction and 47-week maintenance studies) and non-responders (defined as patients who were discontinued from SELECTION after week 10 because they were not in clinical remission or did not have a Mayo Clinic Score response at week 10). Error bars show 95% confidence intervals. “N” numbers are the numbers of patients who completed the questionnaire at each time point. IBDQ, Inflammatory Bowel Disease Questionnaire; MCID, minimally clinically important difference; LTE, long-term extension; BL, baseline; W, week; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary; FIL200, filgotinib 200 mg.
      Fig. 4. Proportions of Japanese patients who experienced MCIDs in WPAI absenteeism, activity impairment, work productivity loss, and presenteeism items in completers (A-D) and non-responders (E-H) from week 10 through years 1–3 of FIL200 treatment in SELECTION and SELECTIONLTE. LTE BL (completers) and LTE W48 (non-responders) both correspond to 1 year after SELECTION induction. Therefore, the second, third, and fourth bars in each panel show data at years 1, 2, and 3, respectively, after SELECTION induction. The dashed vertical lines show the entry time points into the LTE for completers (defined as patients from SELECTION who were in clinical remission or had a Mayo Clinic Score response at week 10 and completed the 11-week induction and 47-week maintenance studies) and non-responders (defined as patients who were discontinued from SELECTION after week 10 because they were not in clinical remission or did not have a Mayo Clinic Score response at week 10). Error bars show 95% confidence intervals. “N” numbers are the numbers of patients who completed the questionnaire at each time point. aData are from patients who were in employment at induction baseline. WPAI, Work Productivity and Activity Impairment; MCID, minimally clinically important difference; LTE, long-term extension; BL, baseline; W, week; FIL200, filgotinib 200 mg.
      Graphical abstract

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      Fig. 2.

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      Graphical abstract

      Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials
      Variable Induction FIL200 (n=44) Induction PBO (n=20) Completers (n=15) Non-responders (n=14)
      Age (yr), mean±SD 47.7±15.6 48.9±14.4 50.7±13.5 45.5±16.4
      Female sex, No. (%) 18 (40.9) 6 (30.0) 8 (53.3) 4 (28.6)
      BMI (kg/m2), median (IQR) 21.7 (20.4–23.0) 21.2 (20.1–22.7) 21.8 (19.3–22.8) 21.7 (20.7–23.1)
      Duration of UC (yr), mean±SD 8.5±7.3 10.2±10.0 8.1±7.0 8.9±7.9
      Total Mayo Clinic Score, mean±SD 8.5±1.3 8.8±1.6 8.5±1.3 8.1±1.2
      MES of 3, No. (%) 35 (79.5) 18 (90.0) 11 (73.3) 12 (85.7)
      C-reactive protein (mg/L), mean±SD 6.0±9.7 4.2±6.4 6.9±14.0 5.8 ±6.1
      Fecal calprotectin (µg/g), mean±SD 2,734±2,802 3,180±4,981 4,381±3,405 1,967±2,240
      Concomitant UC treatments
      Systemic corticosteroids, No. (%) 12 (27.3) 6 (30.0) 6 (40.0) 2 (14.3)
      Immunomodulators, No. (%) 11 (25.0) 5 (25.0) 2 (13.3) 5 (35.7)
      Systemic corticosteroids and immunomodulators, No. (%) 6 (13.6) 3 (15.0) 1 (6.7) 3 (21.4)
      5-ASAs, No. (%) 36 (81.8) 16 (80.0) 11 (73.3) 14 (100.0)
      Previous UC treatments, No. (%)
       TNFα inhibitors 29 (65.9) 13 (65.0) 9 (60.0) 10 (71.4)
       Vedolizumab 3 (6.8) 4 (20.0) 0 2 (14.3)
       TNFα inhibitors and vedolizumab 3 (6.8) 3 (15.0) 0 2 (14.3)
      Previously failed UC treatments, No. (%)
       TNFα inhibitors 25 (56.8) 13 (65.0) 8 (53.3) 9 (64.3)
       Vedolizumab 1 (2.3) 1 (5.0) 0 1 (7.1)
      IBDQ total score, mean±SD 138.3±31.9 142.4±30.5 133.5±30.8 143.3±36.9
      EQ-5D score, mean±SD
       EQ-5D value 0.8±0.2 0.8±0.2 0.8±0.2 0.8±0.2
       EQ VAS score 59.8±19.1 50.0±22.3 57.6±21.5 59.4±17.3
      SF-36 score, mean±SD
       MCS 39.2±11.1 42.9±8.9 38.7±12.5 40.9±12.1
       PCS 44.6±6.9 44.6±7.7 44.2±6.5 44.6±7.4
      WPAI %, mean±SD
       Absenteeism score 6.0±12.8 14.5±30.7 12.1±20.1 3.7±6.8
       Activity impairment 52.7±25.6 48.9±31.2 57.3±28.9 50.0±22.9
       Productivity loss 44.0±28.0 43.1±32.4 48.1±36.7 49.3±18.2
       Presenteeism 41.2±26.4 36.9±27.2 42.5±33.7 48.0±16.9
      Table 1. Baseline Patient Characteristics

      FIL200, filgotinib 200 mg; PBO, placebo; SD, standard deviation; BMI, body mass index; IQR, interquartile range; UC, ulcerative colitis; MES, Mayo endoscopic subscore; 5-ASAs, 5-aminosalicylates; TNFα, tumor necrosis factor alpha; IBDQ, Inflammatory Bowel Disease Questionnaire; EQ-5D, EQ 5-dimension; EQ VAS, EQ visual analog scale; SF-36, 36-item Short Form Health Survey; MCS, mental component summary; PCS, physical component summary; WPAI, Work Productivity and Activity Impairment.

      Table 1.

      Intest Res : Intestinal Research
      © Korean Association for the Study of Intestinal Diseases.
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