P550 Characterisation of hospitalised patients with ulcerative colitis treated with tofacitinib in the OCTAVE clinical programme for up to 7.8 years

Abstract Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety tofacitinib were demonstrated in OCTAVE clinical programme.1,2 Here, we present analysis number causes UC-related hospitalisations during programme. Methods This descriptive comprised patients (pts) hospitalised UC who received placebo or 10 mg twice daily (BID) Induction 1&2 (NCT01465763; NCT01458951)1, pts placebo, 5 BID Sustain (NCT01458574)1, ≥1 dose Open (NCT01470612)2; it includes data from with ≤7.8 years exposure. We examined demographic characteristics, proportions, other aspects treated Results Overall, 1139 included this analysis. Demographic disease characteristics generally similar across groups each study; most <40 old, had pancolitis, a mean total Mayo score >8, prior oral corticosteroids immunosuppressants (Table 1). Ninety-five hospitalisations; whom 92 one hospitalisation 3 2). In 1&2, Open, 2.1%, 1.0% 6.6% pts, respectively, vs 2.9% receiving 3.4% 4.0% Sustain, respectively. did not lead to temporary discontinuations The frequent cause tofacitinib- placebo-treated was non-surgical events (ie, flares; Table Conclusion infrequent programme, rates lower than those reported real-world assessment biological therapies.3 Most aged severe corticosteroid immunosuppressant common events. References: 1. Sandborn WJ et al. N Engl J Med 2017;376:1723-1736. 2. Aliment Pharmacol Ther 2022;55:464-478. 3. Bressler B Crohn’s Colitis 2021;15:1694-1706.