FDA Approves New Oral Treatment for Ulcerative Colitis

Last updated: September 2020

On May 30th, 2018, the United States Food and Drug Administration (FDA) announced that it had expanded its approval of Xeljanz (tofacitinib) to include treating adults with moderate to severe active ulcerative colitis. Currently, all other medications that treat long-term moderate to severe ulcerative colitis are either given through an IV or an injection under the skin. Xeljanz is the first oral medication approved for this use.

The FDA recognizes that there are currently almost a million people in the United States who are affected by ulcerative colitis and that many of these people fall in the moderate to severe category. While there is currently no cure for ulcerative colitis, there is also a need for new, effective medications, especially for patients who have problems tolerating the presently limited options for moderate to severe disease.


Xeljanz was tested in patients with moderate to severe ulcerative colitis in three different studies. The first looked at patients who were experiencing active disease symptoms. Over eight weeks, patients were either given Xeljanz 10 mg or a placebo twice daily. By week eight, almost 20% of patients taking Xeljanz were in remission.

The next study looked at patients who had responded to Xlejanz (had relief of their symptoms, but not complete remission). For a year, these patients were either given 5 mg or 10 mg of Xeljanz twice daily. 34% of patients taking 5 mg of Xeljanz twice daily had remission after a year of therapy, and 41% of patients taking 10 mg of Xelajanz twice daily achieved remission after a year of therapy.

The last study looked at the patients who were in remission after taking the medication for eight weeks. These patients continued to take either 5mg or 10 mg of Xeljanz twice daily for a year. 35% of those taking the 5 mg dose and 47% of those taking the 10 mg dose had corticosteroid-free remission after one year.

Side effects

Like all medications, Xeljanz is not without side effects. The most common symptoms experienced by ulcerative colitis patients are:

  • Diarrhea
  • elevated cholesterol levels
  • Headache
  • Shingles
  • Increased blood creatine
  • Common cold
  • Rash
  • Upper respiratory tract infection

Xeljanz has some serious side effects that carry a boxed warning. These include the risk of cancers (such as lymphomas or other cancers) and serious infections known as opportunistic infections. These serious side effects may require you to be hospitalized or they can lead to death. It is not recommended that you take Xeljanz if you are on immunosuppressant medications like cyclosporine or azathioprine, or if you are already taking an injectable biological therapy.

Xeljanz is a step forward in providing treatment options for patients with moderate to severe ulcerative colitis and paves the way for other innovative therapies for patients who have limited medication choices.

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