Background/Aims Surgery remains a crucial treatment option for Crohn’s disease (CD), even with the introduction of biological agents. This nationwide cohort study in Taiwan investigates surgery trends and the impacts of biologics in a region with a low prevalence of CD.
Methods This retrospective population-based cohort study used Taiwan’s National Health Insurance Database from 2003 to 2018. The cohort included 725 CD patients. Patient characteristics, surgery outcomes, and impact of the biologic era on surgical risk were analyzed.
Results During the study period, 292 CD patients (40.3%) underwent surgery, with 125 in the pre-biologic era and 167 in the post-biologic era. The incidences of intestinal surgery (IS) and perianal surgery (PS) have significantly decreased. The cumulative probabilities of IS were 20%, 35%, and 44% after 1, 5, and 10 years, respectively; the PS incidences were 3%, 5%, and 7%, respectively. The cumulative incidence of IS was significantly lower in the post-biologic era compared to the pre-biologic era (P= 0.049). CD patients had high second IS incidences of 31% at 5 years after the first IS.
Conclusions Our study demonstrates the surgical incidences have decreased in the biologic era but remained relatively high in a region with low disease prevalence. This suggests the need for further improvements in CD management.
Background/Aims Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
Methods In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.
Results A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).
Conclusions VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.
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Background/Aims Ustekinumab is effective in active Crohn’s disease. In a retrospective study we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes.
Methods Forty-one patients with mild to severe active Crohn’s disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn’s Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed.
Results The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies.
Conclusions Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.
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Background/Aims It remains uncertain which patients with stricturing-type Crohn’s disease (CD) require early small bowel surgery after the initial diagnosis. We aimed to clarify clinical characteristics associated with the intervention in such condition of CD.
Methods We retrospectively evaluated the clinical course of 53 patients with CD and small bowel strictures who were initially treated with medications after the initial diagnosis. We investigated possible associations between small bowel surgery and the following: clinical factors and radiologic findings at initial diagnosis and the types of medications administered during follow-up.
Results Twenty-eight patients (53%) required small bowel resection during a median follow-up period of 5.0 years (range, 0.5–14.3 years). The cumulative incidence rates of small bowel surgery at 2, 5, and 10 years were 26.4%, 41.0%, and 63.2%, respectively. Univariate analysis indicated that obstructive symptoms (P=0.036), long-segment stricture (P<0.0001), and prestenotic dilation (P<0.0001) on radiography were associated with small bowel surgery, and immunomodulatory (P=0.037) and biological therapy (P=0.008) were significant factors during follow-up. Multivariate analysis revealed that long-segment stricture (hazard ratio [HR], 4.25; 95% confidence interval [CI], 1.78–10.53; P=0.001) and prestenotic dilation (HR, 3.41; 95% CI, 1.24–9.62; P=0.018) on radiography showed a positive correlation with small bowel surgery, and biological therapy (HR, 0.40; 95% CI, 0.15–0.99; P=0.048) showed a negative correlation.
Conclusions CD patients with long-segment stricture and prestenotic dilation on radiography seem to be at a higher risk of needing small bowel surgery. For such patients, early surgical intervention might be appropriate, even at initial diagnosis.
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