Xeljanz (tofacitinib) garnered a lot of interest back in 2012 when it was developed and approved for the treatment of rheumatoid arthritis. Then, in 2017, studies found that this oral medication also treated psoriatic arthritis and FDA approval was added for that indication.
Last week, yet another FDA approval for Xeljanz came: this medication now has an expanded FDA approval for adults with moderately to severely active ulcerative colitis. This makes Xeljanz the first oral prescription option for ulcerative colitis. In other words, this is big news and a potential game changer for the nearly one million Americans with this form of inflammatory bowel disease. All of the other FDA-approved treatments for chronic ulcerative colitis involve either intravenous infusion or subcutaneous injection. So, clearly, an oral alternative is welcome news to many patients.
This latest FDA approval was spurred after results from three clinical trials in patients with ulcerative colitis showed remission for patients on Xeljanz in up to 47% of patients taking the medication long term. Safety data was collected, with the more common adverse effects being diarrhea, elevated cholesterol levels, and headache. Although there are some less common adverse effects that led to Xeljanz coming with a box warning for serious infections and malignancy. Xeljanz cannot be used at the same time as biological therapies or with potent immunosuppressants (e.g., azathioprine and cyclosporine).
Inflammatory bowel diseases, which include both ulcerative colitis and Crohn’s disease, are chronic inflammatory diseases of the bowel. They can develop as a result of genetic or environmental factors (e.g., smoking, diet, or any alteration of the normal human gut flora) that trigger an immune response, which in turn creates mucosal damage to the GI tract.
Symptoms of inflammatory bowel disease range from diarrhea, abdominal pain, and perianal fistulas to fatigue, weight loss, and/or bowel obstruction. While ulcerative colitis is more closely associated with changes to the inner lining of the colon, Crohn’s disease can affect any segment of the gastrointestinal tract: all the way from mouth to anus.
The BioPlus Specialty Pharmacy team is ready to help patients and their health care providers access Xeljanz for ulcerative colitis.
Press release. FDA approves new treatment for moderately to severely active ulcerative colitis. FDA May 30, 2018.