OREANDA-NEWS. Pfizer Inc. announced today top-line results from two Phase 3 induction trials of tofacitinib 10 mg twice daily (BID) tablets in the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) global clinical development program for the treatment of adults with moderate to severe ulcerative colitis (UC): OCTAVE Induction 1 (A3921094) and OCTAVE Induction 2 (A3921095). Both studies met their primary endpoints as measured by the proportion of patients receiving tofacitinib in remission at Week 8 compared to patients receiving placebo.

“We are encouraged by the results of the OCTAVE induction studies as ulcerative colitis is a chronic, and at times debilitating, disease that can be difficult to treat” said Rory O’Connor, MD, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. “Pfizer remains committed to advancing the science of Janus kinase inhibition and enhancing understanding of tofacitinib, the first in this new class of medications being investigated for ulcerative colitis. We look forward to sharing the results of our ongoing Phase 3 maintenance study OCTAVE Sustain, when available, which will provide further information on tofacitinib in ulcerative colitis.”

No new or unexpected safety findings for tofacitinib were observed in the studies. Serious adverse events observed were similar to those seen in other clinical development programs for tofacitinib. Detailed analyses of OCTAVE Induction 1 and OCTAVE Induction 2, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.

OCTAVE Induction 1 and OCTAVE Induction 2 are two identical Phase 3 placebo-controlled studies evaluating induction of remission by oral tofacitinib 10 mg BID in adult patients with moderate to severe UC. A total of 598 patients in OCTAVE Induction 1 and 541 patients in OCTAVE Induction 2 were randomized to tofacitinib 10 mg BID or placebo treatment groups.

The OCTAVE global clinical development program includes three Phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain (A3921096), as well as a long-term extension trial, OCTAVE Open (A3921139). Results for OCTAVE Sustain are anticipated by the end of 2016. These four studies will form the potential submission package to regulatory authorities for a potential UC indication.

About Ulcerative Colitis

UC is a chronic, often debilitating inflammatory bowel disease that affects millions of people worldwide.1,2,3 It is believed that UC is the result of complex interactions between multiple factors that include the environment, genetic predisposition, immune response, and the gut microbiome in the colon or intestines.4 It can cause abdominal pain, fever, weight loss and chronic, bloody diarrhea. UC can have an effect on work, family and social activities.5 In up to one-third of patients with UC, treatment is not completely successful or complications arise. Under these circumstances, surgery to remove the colon (colectomy) may be considered. Even after surgery, certain symptoms of UC may still persist. 6,7,8

About Tofacitinib

Tofacitinib (brand name XELJANZ®) is a prescription medicine called a Janus Kinase (JAK) Inhibitor.

XELJANZ is the first and only JAK inhibitor approved in over 40 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The benefit:risk profile of XELJANZ in RA has been studied in approximately 6,200 patients in the global clinical development program for XELJANZ in moderate to severe RA. A new drug application (NDA) for XELJANZ 11 mg once-daily modified release for the treatment of moderate to severe RA is under review with the U.S. Food & Drug Administration (FDA). In the United States, XELJANZ has a boxed warning for serious infections and malignancies.

Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program in a range of immune-mediated inflammatory conditions in the areas of rheumatology, dermatology and gastroenterology.