Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): A phase 2b/3 double-blind, randomised, placebo-controlled trial
The Lancet 2021;397:2372–2384 doi: 10.1016/S0140-6736(21)00666-8
Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.
Feagan et al presented data from the Phase 2b/3 SELECTION trial on the safety and efficacy of filgotinib for the onset and maintenance of remission in patients with moderate to severe active UC. Patients were identified as either biologic-naïve or biologic-experienced in an induction study period and randomised to receive either FIL 200 mg, FIL 100 mg, or placebo. Patients were re-randomised at Week 10 and reassessed at Week 58.