Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) for the Treatment of Ulcerative Colitis

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

July 28, 2016

Pfizer Inc. has announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of XELJANZ® (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52-week study evaluating oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies.

OCTAVE Sustain study’s top-line results revealed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 and 10 mg BID groups compared to placebo. In the study, no new or unexpected safety findings for tofacitinib were observed.

Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer, Inc., 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. We are proud to advance our clinical development program for tofacitinib as we work to bring a potential new treatment option to patients living with ulcerative colitis.”


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