Abstract
The OCTAVE clinical program included Phase 3 induction (OCTAVE Induction 1&2, NCT01465763 and NCT01458951) and maintenance (OCTAVE Sustain, NCT01458574) studies, and an open-label, long-term extension study (OCTAVE Open, NCT01470612).1,2 Stool frequency (SF) and rectal bleeding (RB) are important patient (pt)-reported outcomes (PROs) in measuring UC disease activity and treatment effect. OCTAVE Open data are from the final analyses (Aug 2020). a.Pts were eligible to enroll in OCTAVE Sustain if they had achieved clinical response upon completion of OCTAVE Induction 1 or 2; these pts were re-randomized to receive PBO, tofacitinib 5 mg BID, or tofacitinib 10 mg BID (with a 1:1:1 allocation ratio) in OCTAVE Sustain; b.Pts in remission (total Mayo score ≤ 2, no individual subscore > 1, RBS of 0) at Wk52 of OCTAVE Sustain (central read) received tofacitinib 5 mg BID per protocol in OCTAVE Open; c.Data from OCTAVE Open are reported up to M48, as follow-up data were limited (≤ 40 pts) at M60 and beyond. BID, twice daily; FAS, full analysis set; M, Month; N, number of randomized pts in the total population; n, number of pts with the specified response within the given category; PBO, placebo; pts, patients; RBS, Mayo rectal bleeding subscore; SFS, Mayo stool frequency subscore; UC, ulcerative colitis; Wk/wk, Week/week [Figure omitted.