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

Abstract

Introduction: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in the OCTAVE clinical program.1,2 Here, we present an analysis of the number and causes of UC-related hospitalizations during the OCTAVE clinical program including up to 7.8 years' tofacitinib exposure. Method(s): This descriptive analysis comprised patients (pts) hospitalized for UC who received placebo or tofacitinib 10 mg twice daily (BID) in OCTAVE Induction 1&2 (NCT01465763; NCT01458951),1 and pts who received placebo, or tofacitinib 5 or 10 mg BID, in OCTAVE Sustain (NCT01458574),1 or >= 1 dose of tofacitinib in OCTAVE Open (NCT01470612).2 Demographic and clinical characteristics, proportions, causes, and other aspects of UC-related hospitalizations were evaluated. Result(s): Overall, 1,139 pts with UC were included in this analysis. Demographic and disease characteristics of pts with UC-related hospitalizations were generally similar across treatment groups in each study; most pts were < 40 years of age, had pancolitis, a mean total Mayo score > 8, and prior treatment with oral corticosteroids (CS) and immunosuppressants. Ninety-five pts had UC-related hospitalizations, of whom 92 had one UC-related hospitalization and 3 were hospitalized twice (Table 1). In OCTAVE Induction 1&2, OCTAVE Sustain, and OCTAVE Open, 2.1%, 1.0%, and 6.6% of pts, respectively, had UCrelated hospitalizations with tofacitinib 10 mg BID vs 1.0% and 2.9% of pts receiving tofacitinib 5 mg BID in OCTAVE Sustain and OCTAVE Open, and 3.4% and 4.0% of pts receiving placebo in OCTAVE Induction 1&2 and OCTAVE Sustain, respectively. UC-related hospitalizations did not lead to temporary treatment discontinuations in most pts (Table 1). The most frequent cause of UC-related hospitalizations in tofacitinib- and placebo-treated pts was non surgical UC-related events (ie UC flares; Table 1). Conclusion(s): UC-related hospitalizations were infrequent in the OCTAVE clinical program, and rates were generally lower than those reported in pts with UC treated with biologic therapies.3 Most hospitalized pts were < 40 years of age with severe disease and prior CS and immunosuppressant exposure. The most common cause of hospitalization was non-surgical UC-related events. (Table Presented).