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

Taxonera, C.(1)*;Ha, C.(2);del Pilar Fortes, M.(3);Gardiner, S.(3);Mundayat, R.(3);Ghosh, S.(4);Connor, S.J.(5);

(1)Inflammatory Bowel Disease- Unit Gastroenterology Department, Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos, Madrid, Spain;(2)-, Division of Gastroenterology and Hepatology- Mayo Clinic, Scottsdale- Arizona, United States;(3)-, Pfizer Inc, New York- NY, United States;(4)APC Microbiome Ireland, College of Medicine and Health- University College Cork, Cork, Ireland;(5)-, Liverpool Hospital- University of New South Wales- Ingham Institute of Applied Medical Research, Sydney, Australia;


Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib were demonstrated in the OCTAVE clinical programme.1,2 Here, we present an analysis of the number and causes of UC-related hospitalisations during the OCTAVE clinical programme.


This descriptive analysis comprised patients (pts) hospitalised 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; it includes data from pts with ≤7.8 years of tofacitinib exposure. We examined the demographic and clinical characteristics, proportions, causes and other aspects of UC-related hospitalisations in pts treated with placebo or tofacitinib in the OCTAVE clinical programme.


Overall, 1139 pts with UC were included in this analysis. Demographic and disease characteristics of pts with UC-related hospitalisations were generally similar across treatment groups in each study; most pts were <40 years old, had pancolitis, a mean total Mayo score >8, prior treatment with oral corticosteroids and immunosuppressants (Table 1). Ninety-five pts had UC-related hospitalisations; of whom 92 had one UC-related hospitalisation and 3 pts were hospitalised twice (Table 2). In OCTAVE Induction 1&2, OCTAVE Sustain and OCTAVE Open, 2.1%, 1.0% and 6.6% of pts, respectively, had UC-related hospitalisations 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 hospitalisations did not lead to temporary treatment discontinuations in most pts (Table 2). The most frequent cause of UC-related hospitalisations in tofacitinib- and placebo-treated pts was non-surgical UC-related events (ie, UC flares; Table 2).


UC-related hospitalisations were infrequent in the OCTAVE clinical programme, and rates were generally lower than those reported in a real-world assessment of pts with UC treated with biological therapies.3 Most hospitalised pts were aged <40 years with severe disease and prior corticosteroid and immunosuppressant exposure. The most common cause of hospitalisation was non-surgical UC-related events.


1.     Sandborn WJ et al. N Engl J Med 2017;376:1723-1736.
2.     Sandborn WJ et al. Aliment Pharmacol Ther 2022;55:464-478.
3.     Bressler B et al. J Crohn’s Colitis 2021;15:1694-1706.