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Clin Gastroenterol Hepatol. 2022;20(3):591–601.e8

Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE

Efficacy and safety of tofacitinib in ulcerative colitis based on prior tumor necrosis factor inhibitor failure status

Background and aims: Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis. The authors summarize the efficacy and safety data of tofacitinib 5 or 10 mg twice daily in the ulcerative colitis clinical program, stratified by prior tumor necrosis factor inhibitor (TNFi) failure status.
Methods: Efficacy was assessed in the pooled phase 3 OCTAVE Induction 1 and 2 studies (n = 1139), the phase 3 OCTAVE Sustain maintenance study (n = 593), and the dose-escalation subpopulation of the open-label, long-term extension OCTAVE Open study (n = 59). Safety was assessed in OCTAVE Sustain, the dose-escalation subpopulation, and the Overall Cohort, which included patients from OCTAVE Induction 1 and 2, OCTAVE Sustain, and OCTAVE Open (n = 1124; no prior TNFi failure, n = 541; prior TNFi failure, n = 583; phase 2 data were excluded when stratified by prior TNFi failure status). The dose-escalation subpopulation received tofacitinib 10 mg twice daily in OCTAVE Induction 1 and 2, tofacitinib 5 mg twice daily in OCTAVE Sustain, and tofacitinib 10 mg twice daily in OCTAVE Open.
Results: Tofacitinib had greater efficacy than placebo, regardless of prior TNFi failure status. In OCTAVE Sustain and the Overall Cohort, herpes zoster (non-serious and serious) rates were numerically higher in tofacitinib-treated patients with versus without prior TNFi failure. Dose escalation to tofacitinib 10 mg twice daily generally recaptured clinical response for most patients. Herpes zoster (non-serious and serious) rates were numerically higher in the dose-escalation subpopulation versus the Overall Cohort.

Conclusions: Tofacitinib was efficacious in patients with ulcerative colitis regardless of prior tumor necrosis factor inhibitor (TNFi) failure status. Herpes zoster (non-serious and serious) rates were numerically higher in patients who had previously failed TNFi.

W.J. Sandborn, M.D., Professor of Medicine, Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA,
E-Mail: wsandborn@health.ucsd.edu

DOI: DOI: 10.1016/j.cgh.2021.02.043

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