According to a story from PR Newswire, the U.S. Food and Drug Administration (FDA) recently approved the expansion of the indication for tofacitinib (marketed as Xeljanz), which will now include treatment for adults with moderate to severe active ulcerative colitis. Xeljanz represents an attractive treatment option for these patients. Other drugs approved for the same indication must either be infused or injected, but Xeljanz can simply be taken orally. This route of administration should significantly improve the quality of life of patients.
Ulcerative colitis is a long-term type of inflammatory bowel disease. It causes to colon and rectum to become inflamed and results in the formation of ulcers. Research has yet to discover a direct cause of ulcerative colitis, with most theories suggesting genetic and environmental origins. Symptoms of ulcerative colitis include bloody diarrhea and abdominal pain, weight loss, fever, and anemia. It has the potential to cause many complications, such as colon cancer, megacolon, and inflammation of other parts of the body. Symptoms tend to appear slowly and can vary significantly in severity. Symptoms tend to appear as periodic “flare-ups” that are followed by periods of no symptoms. A combination of medications and surgical procedures are used to managed ulcerative colitis. Removal of the rectum and colon can cure the disease. To learn more about ulcerative colitis, click here.
The approval comes after the result of a recent trial that demonstrated that a 10mg dose caused remission at 8 weeks in 18 percent of patients and 41 percent after 52 weeks of use. Of the 18 percent that saw remission at 8 weeks, 47 percent were able to sustain long term remission without the use of other drugs.
Common side effects after 52 weeks include a greater vulnerability to infection, diarrhea, headache, and elevated cholesterol levels. Xeljanz is marketed with a box warning for serious infections. In the past Xeljanz was approved for treating rheumatoid and psoriatic arthritis in 2012 and 2017, respectively. The drug is not recommended for use in combination with other treatments such as immunosuppressants.
This historic approval gives ulcerative colitis patients a new and more convenient option for treating their condition, which will allow them greater quality of life and help reduce flare ups.