Efficacy and Safety of Tofacitinib Re-Treatment for Ulcerative Colitis

Ulcerative Colitis
Ulcerative Colitis
Investigators examined the safety and efficacy of tofacitinib re-treatment in patients with ulcerative colitis who underwent treatment interruption.

Following treatment interruption, the efficacy of tofacitinib can be safely and successfully recaptured with re-treatment in patients with ulcerative colitis (UC), according to a study published in the Journal of Crohn’s and Colitis.

It is important that physicians managing patients with UC understand the possible clinical consequences of temporarily discontinuing pharmacological therapy due to various situations (eg, pregnancy, surgery, illness). Therefore, researchers evaluated the efficacy and safety of tofacitinib re-treatment following treatment interruption in patients with UC.

Patients with a clinical response to tofacitinib 10 mg twice daily induction therapy were randomized to receive placebo in OCTAVE Sustain (ClinicalTrials.gov identifier: NCT01458574). Those experiencing treatment failure after week 8 of OCTAVE Sustain entered OCTAVE Open (ClinicalTrials.gov identifier: NCT01470612) and reinitiated tofacitinib 10 mg twice daily [retreatment subpopulation].

By month 36 of OCTAVE Open, the median time to treatment failure following interruption was 169 and 123 days for induction remitters and induction responders but nonremitters, respectively. Following retreatment with tofacitinib, rates of clinical response, remission, and endoscopic improvement were 74.0%, 39.0%, and 55.0% at month 2, and 48.5%, 37.4%, and 42.4% at month 36, respectively.

Among induction remitters and induction responders but nonremitters, clinical response rates at month 36 were 60.6% and 42.4%, respectively. Efficacy was recaptured regardless of prior tumor necrosis factor inhibitor failure status. The safety profile of tofacitinib 10mg twice daily re-treatment was consistent with the overall cohort and no new safety risks were associated with exposure up to 36 months.

“These analyses suggest that while efficacy can be safely and successfully recaptured with tofacitinib 10 mg b.d. retreatment following treatment interruption in a substantial proportion of patients with UC, many patients failed to recapture efficacy,” concluded the authors. “Therefore, although therapy with tofacitinib 10 mg b.d. can be temporarily stopped to accommodate scenarios such as pregnancy, surgery, illness, adverse events, or a change in patients’ insurance, treatment interruption without cause in patients with response to tofacitinib therapy is not generally recommended,” the authors added.

Disclosure: This research was supported by Pfizer Inc. Please see the original reference for a full list of disclosures.


Panés J, Vermeire S, Dubinsky MC, et al. Efficacy and safety of tofacitinib retreatment for ulcerative colitis after treatment interruption: results from the OCTAVE clinical trials. J Crohn’s Colitis. Published online April 22, 2021. doi: 10.1093/ecco-jcc/jjab065