Trial reportJournal of Crohn's & colitis2025
Re-evaluating Methods for Assessing Differences in Response in Ileal vs Colonic Crohn's Disease: A Post-hoc Analysis of the FITZROY Trial.
Trial report in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02048618 (Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration), which is not on this map. Not yet cited in PubMed.
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Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration
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11 authors.
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Abstract
BACKGROUND AND
aimsThe ileum is the most commonly affected segment of the gastrointestinal tract in Crohn's disease [CD]. We aimed to determine whether disease location affects response to filgotinib, a Janus kinase [JAK] inhibitor, in patients with moderately-to-severely active Crohn's disease [CD] and applying appropriate methods to account for differences in measuring disease activity in the ileum compared with the colon.
methodsThis post-hoc analysis of data from the FITZROY phase 2 trial [NCT02048618] compared changes in the Crohn's Disease Activity Index [CDAI] and Simple Endoscopic Score for Crohn's Disease [SES-CD] among patients with ileal-dominant and isolated colonic CD treated with 10 weeks of filgotinib 200 mg daily or placebo. A mixed effects model for repeated measures was used to test whether ileal disease responded differently when compared with colonic disease, by evaluating for effect modification using the interaction term of treatment assignment-by-disease location.
resultsNumerically greater proportions of patients with isolated colonic disease compared to ileal-dominant CD achieved clinical remission [CDAI < 150, 75.9% vs 41.6%] and endoscopic response [SES-CD reduction by 50%, 52.5% vs 15.5%] at Week 10. However, after adjusting for baseline disease activity by disease location and within-patient clustering effects, there was no significant difference in treatment response by disease location [mean difference in ΔCDAI between ileal-dominant vs isolated colonic disease + 9.24 [95% CI: -87.19, +105.67], p = 0.85; mean difference in ΔSES-CD -1.93 [95% CI: -7.03, +3.44], p = 0.48.
conclusionsFilgotinib demonstrated similar efficacy in ileal-dominant and isolated colonic CD when controlling for baseline disease activity and clustering effects.
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