OCTAVE Open Trial Tests Tofacitinib in Maintenance of Remission in UC

Approximately half of all patients with moderate to severe ulcerative colitis (UC) who participated in the open-label, multicenter, phase 3 OCTAVE Open trial of tofacitinib 5 mg twice daily maintained remission after 36 months of treatment, researchers found.

Patients eligible to enroll in OCTAVE Open had completed the pivotal OCTAVE Sustain phase 3 study, which investigated the efficacy of twice-daily tofacitinib 5 mg in inducing and maintaining remission of moderate to severe UC over 52 weeks.

The researchers analyzed data from 142 participants who were in remission at the conclusion of OCTAVE Sustain, who then continued to receive treatment with tofacitinib 5 mg twice daily during OCTAVE Open. Safety data, efficacy—including remission of UC according to total Mayo score—endoscopic improvement, clinical response, and partial Mayo score were assessed up to month 36.

Following 12 months of tofacitinib 5 mg twice daily, 68.3% of patients in the OCTAVE Open trial remained in remission, 73.9% showed endoscopic improvement, and 77.5% evidenced a clinical response. After 36 months of therapy with tofacitinib 5 mg twice daily, 50.4% of the participants had sustained remission, while 55.3% demonstrated endoscopic improvement and 56.0% showed a clinical response. The researchers did not identify any new safety risks associated with long-term use of the therapy.

“Efficacy endpoints were maintained for up to 36 months, regardless of prior tofacitinib dose, including patients who reduced from tofacitinib 10 mg to 5 mg twice daily upon OCTAVE Open entry,” the researchers concluded.

—Rebecca Mashaw

Reference:FULL LENGTH ARTICLE

Colombel JF, Osterman MT, Thorpe AJ, et al. Maintenance of remission with tofacitinib therapy in patients with ulcerative colitis. Clin Gastroenterol Hepatol. Published online October 8, 2020.

doi: https://doi.org/10.1016/j.cgh.2020.10.004