FDA Approves Tofacitinib for Moderately to Severely Active Ulcerative Colitis


Tofacitinib is the first and only Janus kinase inhibitor approved by the FDA for this patient population.

Officials with the FDA have approved tofacitinib (Xeljanz, Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), making it the first Janus kinase (JAK) inhibitor for this patient population, according to a Pfizer press release.

For treatment of UC, patients may take tofacitinib 10 mg twice-daily (BID) for at least 8 weeks, followed by tofacitinib 5 mg BID or 10 mg BID.

The approval is based on data from three phase 3 studies: OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain, as well as OCTAVE Open, which is an ongoing trial. All 3 studies met their primary endpoints, showing statistically significant, greater proportion of patients in remission after 8 weeks in the induction studies, and in remission after 52 weeks in the maintenance study, compared with placebo.

Tofacitinib is also approved for the treatment of moderately to severely active rheumatoid arthritis and active psoriatic arthritis. According to the press release, tofacitinib is not recommended for use in combination with biological therapies for UC or with potent immunosuppressants, such as azathioprine and cyclosporine.

Dose-dependent adverse effects observed in patients treated with 10 mg BID, in comparison to 5 mg BID, include herpes zosters infections, serious infections, and nonmelanoma skin cancer (NMSC). Risks associated with use in the United States clinical program include serious infection, malignancies, gastrointestinal perforation, and laboratory abnormalities.

“Ulcerative colitis is a chronic inflammatory bowel disease that can significantly impact the lives of patients and has limited therapeutic options available,” Michael Goettler, Global President of Inflammation and Immunology, Pfizer, said in the press release. “With the FDA approval of tofacitinib, adults living with moderately to severely active UC now have an oral option that may help achieve and maintain steroid-free remission.”


  • Pfizer announces US FDA approves Xeljanz (tofacitinib) for the treatment of moderately to severely active ulcerative colitis [news release]. Pfizer’s website. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_u_s_fda_approves_xeljanz_tofacitinib_for_the_treatment_of_moderately_to_severely_active_ulcerative_colitis. Accessed May 30, 2018.

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