The FDA ( Food and Drug Administration ) has approved Xeljanz ( Tofacitinib ) to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to, or who are intolerant of, Methotrexate.

Rheumatoid arthritis is an autoimmune disease, in which the body's immune system mistakenly attacks healthy tissue leading to inflammation of the joints and surrounding tissues.
According to the Centers for Disease Control and Prevention ( CDC ), rheumatoid arthritis affects an estimated 1.5 million Americans.

Xeljanz, a pill taken twice daily, works by blocking molecules called Janus kinases, which are important in the joint inflammation of rheumatoid arthritis.

The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active rheumatoid arthritis. In all of the trials, patients treated with Xeljanz experienced improvement in clinical response and physical functioning compared to patients treated with placebo.

The use of Xeljanz was associated with an increased risk of serious infections, including opportunistic infections ( infections that occur primarily when the immune system is suppressed ), tuberculosis, cancers and lymphoma.
Xeljanz carries a Boxed Warning regarding these safety risks. Xeljanz treatment is also associated with increases in cholesterol and liver enzyme tests and decreases in blood counts.

The FDA approved Xeljanz with a Risk Evaluation and Mitigation Strategy ( REMS ), which consists of a Medication Guide advising patients about important safety information and a communication plan to inform health care providers about the serious risks associated with Xeljanz.

To study the long-term effects of Xeljanz on heart disease, cancer, and serious infections, the FDA has required a postmarketing study that will evaluate two doses of Xeljanz and include a group of patients on another approved treatment to serve as a comparison.

The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the pharynx.

Source: FDA, 2012

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