Tofacitinib is an oral JAK inhibitor, that has shown efficacy and a favourable safety profile for the treatment of UC in three phase 3 trials (OCTAVE Induction 1 and 2: NCT01465763; NCT01458951, OCTAVE Sustain: NCT01458574). The current study aimed to assess the long-term efficacy of tofacitinib in a sub-population, including 163 patients with moderately to severely active UC that were in remission at week 52 of the OCTAVE Sustain trial1.
Included patients received 5 mg tofacitinib twice daily at baseline of the open-label extension study. They were able to dose escalate to 10 mg twice daily after 2 months. The median treatment duration was 1,529 days. Dr Walter Reinisch (Medical University of Vienna, Austria) presented the results. Patients that did not discontinue the open-label extension study showed a maintained efficacy at 36 months.
The sustained endoscopic improvement, clinical remission, and clinical response was irrespective of the dose that patients had received in the OCTAVE Sustain trial (5 mg or 10 mg). However, 48% of the patients that entered the open-label extension study discontinued. The main reasons for discontinuing the study were adverse events and insufficient clinical response, causing respectively 12.3% and 11.7% of patients to discontinue. The safety profile of tofacitinib users in this study was consistent with the previous OCTAVE trials.