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SELECTION study on filgotinib in ulcerative colitis is published in The Lancet. Galapagos NV.

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Last updated:24th Sep 2021
Published:5th Jun 2021
Galapagos NV announced that primary and secondary endpoint results from the phase III SELECTION induction and maintenance study (NCT02914522) were published in The Lancet. The study, sponsored by Gilead Sciences, Inc., was designed to assess the efficacy and safety of the once-daily, oral preferential JAK1 inhibitor, filgotinib, under investigation in patients with moderately to severely active ulcerative colitis (UC).

 In addition to the primary and secondary endpoints, which have been reported at the United European Gastroenterology congress in October 2020 and can be found on the Galapagos website, www.glpg.com/press-releases, the publication also reports data from a post-hoc analysis by induction cohort of filgotinib 200mg versus placebo during the maintenance study on multiple efficacy endpoints. These include sustained clinical remission, 6-month corticosteroid free remission, Mayo Clinic Score (MCS), endoscopic and histologic remission, MCS response and endoscopic improvement. Across all these endpoints, numerically greater differences in favor of filgotinib 200 mg compared to placebo were shown. This is reported independent of previous biologic treatment status (biologic-naïve and biologic-experienced) with an overall larger numerical effect among biologic-naïve patients. A further post-hoc analysis in the publication reports mucosal healing, a composite endpoint defined as endoscopic improvement (Mayo endoscopy score 0-1) and histological remission in the same patient. The proportion of patients achieving mucosal healing after 10 weeks of induction treatment with filgotinib 200 mg was numerically greater compared with placebo (23.3% vs 10.9% in biologic-naïve and 9.9% vs 4.2% in biologic-experienced) and at week 58 in the overall study population (32.7% vs 10.2%). See-"Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial." Prof Brian G Feagan, MD ,Silvio Danese, MD, Edward V Loftus Jr, MD et al. Published:June 03, 2021DOI:https://doi.org/10.1016/S0140-6736(21)00666-8. The incidence of adverse events (AEs), serious adverse events (SAEs) and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study. .

Condition: Ulcerative Colitis
Type: drug