US-based pharmaceutical company Pfizer has reported positive top-line results from the Phase III oral clinical trials for tofacitinib in ulcerative colitis (OCTAVE) Sustain trial of XELJANZ, to treat moderately to severely active ulcerative colitis (UC).
XELJANZ (tofacitinib citrate) is a prescription medicine inhibiting Janus kinase (JAK), an enzyme generating cytokine-mediated signals through the JAK-STAT pathway.
The randomised, double-blind, placebo-controlled, parallel group, multi-centre Phase III OCTAVE Sustain trial has been designed to evaluate the safety and efficacy of orally administered tofacitinib as a maintenance therapy to treat adult patients with moderately to severely active UC.
The trial involved 593 patients who were randomised to be administered with tofacitinib in 5mg and 10mg dosage and placebo all in a twice daily (BID) regimen.
The OCTAVE Sustain study had achieved its primary efficacy endpoint as results displayed that the patients being treated with tofacitinib experienced better remission after 52 weeks of the study compared to placebo.
Pfizer inflammation and immunology chief development officer Michael Corbo said: “Ulcerative colitis is a chronic, often debilitating inflammatory condition that can be difficult to treat.
“There are a limited number of therapies available and patients need additional treatment options.
"These findings, along with the previously released positive induction data from the OCTAVE studies, are encouraging and provide evidence that tofacitinib, if approved, has the potential to be an effective new oral treatment option that both induces and maintains remission.”
Pfizer is currently conducting an OCTAVE, open-label extension study to evaluate the safety and tolerability of tofacitinib in patients who have either completed, had a treatment failure during OCTAVE Sustain or did not respond after undergoing Pfizer’s OCTAVE Induction I and OCTAVE Induction II trials.