Drug cleared to treat moderately to severely active ulcerative colitis

It is the first oral medication to be approved for chronic use in this population.


The FDA has expanded the approval of tofacitinib (Xeljanz) to treat adults with moderately to severely active ulcerative colitis, the agency announced on May 30. The drug is the first oral medication to be approved for chronic use in this population.

In placebo-controlled trials, 10 mg of tofacitinib given twice daily induced remission in 17% to 18% of patients at eight weeks. In a trial of patients who achieved a clinical response by week eight, the drug was effective in inducing remission after 52 weeks in 34% of those who received 5 mg twice daily and 41% of those who received 10 mg twice daily. Among patients who achieved remission after eight weeks of treatment, 5-mg and 10-mg doses led to sustained corticosteroid-free remission in 35% and 47%, respectively.

The most common adverse events associated with the drug were diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase levels, nasopharyngitis, rash, and upper respiratory tract infection. A boxed warning notes the potential for malignancy and serious infections (e.g., opportunistic infections). The drug was approved in 2012 to treat rheumatoid arthritis and in 2017 to treat psoriatic arthritis.