Dataset Information

Efficacy and Safety of Tofacitinib Retreatment for Ulcerative Colitis After Treatment Interruption: Results From the OCTAVE Clinical Trials.

ABSTRACT:

Background and aims

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib retreatment following treatment interruption in patients with ulcerative colitis.

Methods

Here, patients with clinical response to tofacitinib 10mg b.d. induction therapy were randomised to receive placebo in OCTAVE Sustain. Those experiencing treatment failure after Week 8 of OCTAVE Sustain entered OCTAVE Open and reinitiated tofacitinib 10mg b.d. [retreatment subpopulation]; efficacy and safety data are presented up to Month 36 of OCTAVE Open.

Results

Median time to treatment failure following interruption was 169 [95% CI, 94.0-179.0] and 123 [95% CI, 91.0-168.0] days for induction remitters and induction responders but nonremitters, respectively. Following retreatment with tofacitinib, rates (non-responder imputation after a patient discontinued; last observation carried forward imputation after a patient advanced to a subsequent study [NRI-LOCF]) 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 non-remitters, clinical response rates at Month 36 were 60.6% and 42.4% [NRI-LOCF], respectively. Efficacy was recaptured regardless of prior tumour necrosis factor inhibitor failure status. The safety profile of tofacitinib 10mg b.d. retreatment was consistent with the overall cohort and demonstrated no new safety risks associated with exposure ≤36 months.

Conclusions

Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters. Following treatment interruption, efficacy was safely and successfully recaptured with tofacitinib 10mg b.d. retreatment in a substantial proportion of patients. ClinicalTrials.gov:NCT01458574;NCT01470612.

SUBMITTER: Panes J

PROVIDER: S-EPMC8575053 | biostudies-literature |

REPOSITORIES: biostudies-literature

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