P781 Treatment outcome of tofacitinib dose reduction to 5 mg BID vs remaining on 10 mg BID in patients with Ulcerative Colitis who were in stable remission on 10 mg BID: Updated 30-month data from the double-blind, randomised RIVETING study

Abstract Background Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. The long-term, Phase 3b/4 RIVETING study (NCT03281304) assessed efficacy and safety tofacitinib dose reduction from 10 mg twice daily (BID) maintenance therapy to 5 BID in patients (pts) stable remission.1 We present a final analysis after ≥30 months treatment. Methods was double-blind, randomised, parallel-group with 42-month (M) duration. Eligible pts had received ≥2 consecutive years open-label, long-term extension (NCT01470612), been remission ≥6 corticosteroid-free ≥4 weeks prior baseline. primary endpoint at M6 based on modified Mayo (mMayo) score (endoscopic stool frequency subscores ≤1 rectal bleeding subscore 0).1 terminated (primary objective met) when all passed M30 (or discontinued); some already completed visits up M42. Here, we assess throughout. Results Overall, 140 were randomised (1:1) or BID; 50.0% 62.9% mMayo groups, respectively, consistent findings observed other secondary endpoints (Table 1). At M30, differences between generally greater subgroup baseline endoscopic 1 vs 0 without tumour necrosis factor (TNFi) failure percentage who experienced loss by as estimated Kaplan-Meier curves, numerically higher group (28.1%; 95% confidence interval [CI], 17.68–39.49 21.7%; CI, 12.21–32.95, respectively). Table 2 shows adverse events special interest, group. One death occurred due fatal coronavirus disease 2019 pneumonia (10 BID). Conclusion These data showed that most maintained through BID. Dose difference M6.1 Differences groups subgroups TNFi failure. tofacitinib’s known profile; incidence serious infections herpes zoster 1. Vermeire S et al. J Crohns Colitis 2021;15:1130-41.