Tu1722 – Darvadstrocel Treatment Outcomes in Crohn's Disease Patients with Complex Perianal Fistulas: the Role of Tnfi Co-Treatment in Admire Cd

Background: Tofacitinib is an oral, small molecule JAK inhibitor approved in several countries, including the US, for the treatment of ulcerative colitis (UC).Here, we present data from the Phase 3 OCTAVE Sustain (NCT01458574) study, 1 comparing the 52-week maintenance efficacy of tofacitinib in patients with UC who achieved baseline remission (ie remitters), to that of those who achieved clinical response but not remission (ie non-remitters) after 8 weeks of induction therapy.Methods: Patients who had achieved clinical response (≥3point and ≥30% decrease from induction study baseline total Mayo score, plus a ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding subscore ≤1) after 8 weeks of therapy in OCTAVE Induction 1 or 2 (NCT01465763; NCT01458951) were rerandomized at baseline to receive placebo, tofacitinib 5 or 10 mg twice daily (BID) in the double-blind, parallel-group, multicenter OCTAVE Sustain study.The proportion of patients in remission (total Mayo score ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0), and the proportion of patients with mucosal healing (Mayo endoscopic subscore ≤1) at Week 52, were analyzed in baseline remitters (N=165) vs non-remitters (N=358), excluding patients treated with placebo who achieved clinical response at baseline.This analysis was also performed for prior tumor necrosis factor inhibitor (TNFi) failures (N=234) and non-failures (N=283), although the six patients who did not meet clinical response criteria at baseline of OCTAVE Sustain were also excluded.Results: A numerically higher proportion of tofacitinib-treated patients who were baseline remitters achieved remission at Week 52 vs non-remitters, regardless of tofacitinib dose received or TNFi failure status.Similar findings were also observed for mucosal healing at Week 52.The relative increase in the observed treatment effect of tofacitinib 10 over 5 mg BID was generally similar between baseline remitters and non-remitters.Furthermore, the greater dose-related relative increase in efficacy in the TNFi failure vs the TNFi non-failure subpopulation was evident regardless of the maintenance baseline remission status (Table ).Conclusion: A numerically higher proportion of baseline remitters vs non-remitters treated with tofacitinib achieved remission or mucosal healing at Week 52 in OCTAVE Sustain, although a large proportion of non-remitters and prior TNFi failures still achieved remission or mucosal healing at Week 52.