Xeljanz (tofacitinib) is currently approved by the U. S. Food and Drug Administration (FDA), for use in the treatment of rheumatoid arthritis. Xeljanz is also being studied in numerous other inflammatory conditions including ankylosing spondylitis, psoriatic arthritis and ulcerative colitis (UC), a form of inflammatory bowel disease.
UC is an inflammatory bowel disorder (IBD) as is Crohn’s disease. Although both manifest as chronic immune-mediated inflammation of the gastrointestinal system and thus cause similar symptoms, they are managed differently. Also, UC affects only the colon, or large intestine, whereas Crohn’s can affect any part of the gastrointestinal system. In ulcerative colitis, the lining of the colon becomes inflamed and develops tiny, open sores (ulcers) that produce pus and mucous. The combination of inflammation and ulceration can cause abdominal discomfort, frequent bowel movements, and infection.
The NEJM has reported the results of 3 clinical trials (OCTAVE) evaluating Xeljanz therapy compared to a placebo in adults with ulcerative colitis.
- In OCTAVE 1, the induction trial, remission at 8 weeks was the primary endpoint that was achieved in 18.5% of Xeljanz treated patients compared to 8.2% of those on placebo.
- In the OCTAVE Induction 2 trial, remission occurred in 16.6% of Xeljanz treated patients compared to 3.6% with placebo.
- In the OCTAVE Sustain trial patients responding to treatment with Xeljanz were re-randomized to treatment with one of two doses of Xeljanz or placebo and directly compared. Remission was seen in 34.3%, 40.6% and 11.1% of those treated with Xeljanz 5 mg, Xeljanz 10 mg or placebo group.
As seen in the experience with rheumatoid arthritis, Xeljanz was well tolerated with minimal side effects. Taken together, these clinical trials suggest that Xeljanz may become an effective treatment option for patients with ulcerative colitis.
Sandborn W, Su C, Sands B, et al. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2017; 376:1723-1736.