FDA expands Tofacitinib indication for ulcerative colitis: 5 notes

The FDA expanded the indication for tofacitinib (Xeljanz) to include adults with moderate to severe active ulcerative colitis, Medscape reports.

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Here are five things to know:

1. The selective oral Janus kinase inhibitor was approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.

2. Tofacitinib is the first oral medication approved for long-term use in ulcerative colitis; other FDA-approved long-term treatments must be delivered through intravenous infusion or subcutaneous injection.

3. Two eight-week placebo-controlled trials demonstrated that 10 milligrams of tofacitinib given twice daily induces remission in 17 to 18 percent of patients by week eight.

4. A placebo-controlled trial involving patients who achieved a clinical response by eight weeks and were given at a dose of 5 or 10 milligrams twice daily induced remission by 52 weeks in 34 and 41 percent of patients, respectively.

5. The FDA does not recommend tofacitinib be used in combination with biological therapies for ulcerative colitis or with potent immunosuppressants such as azathioprine and cyclosporine.

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