FDA Approves New Treatment Option for Ulcerative Colitis
Xeljanz (tofacitinib; Pfizer) has been approved by the Food and Drug Administration (FDA) to treat adults with moderate to severely active ulcerative colitis (UC), making it the first oral medication for chronic use for this indication.
The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study. In the 2 induction studies, 17 to 18% of patients treated with tofacitinib 10mg twice daily were found to be in remission by week 8. In the maintenance study, patients who achieved clinical response in the induction trials were randomized to receive tofacitinib 5mg or 10mg twice daily or placebo for 52 weeks. Compared with placebo, a greater proportion of patients in the Xeljanz arms achieved clinical remission by week 52 (34% for Xeljanz 5mg twice daily, 41% for Xeljanz 10mg twice daily vs 11% for placebo).
The most common adverse events noted in the UC trials were diarrhea, elevated cholesterol levels, headache, herpes zoster, increased blood creatine phosphokinase, nasopharyngitis, rash, and upper respiratory tract infection.
The use of Xeljanz in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Xeljanz, a Janus kinase (JAK) inhibitor, is already approved to treat adults with moderately to severely active rheumatoid arthritis and adults with active psoriatic arthritis. It is available in 5mg and 10mg strength tablets in 28-, 60-, and 180-count bottles.
For more information call (800) 438-1985 or visit Xeljanz.com.