P3638 - Characterization of Hospitalized Patients With Ulcerative Colitis Treated With Tofacitinib in the OCTAVE Clinical Program for up to 7.8 Years

Carlos Taxonera, ¹, Christina Ha, MD², Maria del Pilar Fortes, ³, Sean Gardiner, ³, Rajiv Mundayat, ³, Subrata Ghosh, ⁴, Susan J. Connor, ^5
1Inflammatory Bowel Disease Unit, Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos, Madrid, Madrid, Spain; ²Mayo Clinic Arizona, Scottsdale, AZ; ³Pfizer Inc., New York, NY; ⁴APC Microbiome Ireland, College of Medicine and Health, University College, Cork, Cork, Ireland; ⁵Liverpool Hospital, University of New South Wales Sydney, Ingham Institute of Applied Medical Research, Sydney, New South Wales, Australia

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.

Methods: 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.

Results: 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). In OCTAVE Induction 1&2, OCTAVE Sustain, and OCTAVE Open, 2.1%, 1.0%, and 6.6% of pts, respectively, had UC-related 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). The most frequent cause of UC-related hospitalizations in tofacitinib- and placebo-treated pts was non surgical UC-related events (ie UC flares; Table).

Discussion: 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.

References
1. Sandborn et al. N Engl J Med 2017;376:1723–36
2. Sandborn et al. Aliment Pharmacol Ther 2022;55:464–78
3. Bressler et al. J Crohns Colitis 2021;15:1694–1706


Disclosures:


Carlos Taxonera, ¹, Christina Ha, MD², Maria del Pilar Fortes, ³, Sean Gardiner, ³, Rajiv Mundayat, ³, Subrata Ghosh, ⁴, Susan J. Connor, ⁵. P3638 - Characterization of Hospitalized Patients With Ulcerative Colitis Treated With Tofacitinib in the OCTAVE Clinical Program for up to 7.8 Years, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.