Tofacitinib: Results from the OCTAVE open-label studies

The ongoing, open-label, long-term extension (OLE) OCTAVE Open evaluates the efficacy and safety of tofacitinib in ulcerative colitis patients [1]. Participants have shown clinical response but not remission after 52 weeks of maintenance therapy in the OCTAVE Sustain study, and subsequently received tofacitinib 10 mg twice daily. Over 50% of patients who completed OCTAVE Sustain as clinical responders improved to remission within 2 months. Efficacy was observed regardless of prior anti-TNF failure status.

Of 82 patients, 38 (46.3%) had prior anti-TNF failure. Clinical response at 24 months was maintained by 69.5% of patients overall, and by 65.4% and 72.7% of patients with and without prior anti-TNF failure, respectively. By month 2, the proportion of patients who had improved to remission was 58.5%, 60.5%, and 56.8%, respectively. Remission rates at month 2 were 77.8% (n=14/18) for patients who had received placebo in OCTAVE Sustain, 57.1% (n=16/28) for patients who had received 5 mg twice daily, and 50.0% (n=18/36) for patients who had received 10 mg twice daily. No new safety concerns associated with tofacitinib emerged in the overall study population.

Also presented was an update of previous analyses of delayed responders to 16 weeks of tofacitinib 10 mg twice daily (8 weeks induction + 8 weeks OLE) [2]. Of 295 induction non-responders, 50.7% achieved clinical response. Of these 'delayed responders', 72.2%, 61.3%, and 54.3% showed clinical response at 12, 24, and 36 months, respectively. Mucosal healing was seen in 56.8%, 52.7%, and 51.4%, respectively. About 45% of patients were in remission at each time point after month 2. Treatment effects were generally similar regardless of prior anti-TNF failure status. Proportions of delayed responders who achieved clinical response, mucosal healing, and remission at 12 months were similar to responders to 8 weeks of treatment. Proportions of delayed responders with adverse and safety events of special interest were similar to 8-week clinical responders.

1. Chiorean M, et al. ECCO 2019, DOP41.
2. Rubin DT, et al. ECCO 2019, DOP43.



Posted on 9 May 20199 April 2024