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Xeljanz may help rheumatoid sufferers not helped by methotrexate

Robin Wulffson MD's picture
rheumatoid arthritis, Xeljanz, tofacitinib, FDA approval, side-effects, infectio

On November 6, the US Food and Drug Administration (FDA) announced that it had approved Xeljanz (tofacitinib), manufactured by Pfizer, Inc. for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to, or who are intolerant of, methotrexate. According to the Centers for Disease Control and Prevention (CDC), RA affects an estimated 1.5 million Americans.

Rheumatoid Arthritis is an autoimmune disease, in which the body's immune system attacks healthy tissue, which results in inflammation of the joints and surrounding tissues. Xeljanz is an oral medication, which is taken twice daily; it works by blocking molecules called “Janus kinases,” which are important in the joint inflammation of rheumatoid arthritis. “Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate,” noted Badrul Chowdhury, MD, PhD., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

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The FDA notes that Xeljanz is being approved ahead of the product’s prescription drug user fee goal date of November 21, 2012, the date the agency was scheduled to complete review of the drug application. The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active RA. In all of the trials, compared to patients who received a placebo, patients treated with Xeljanz experienced improvement in clinical response and physical functioning.

As with many potent pharmaceuticals, the medication was found to have a risk of major side-effects. The studies found that 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 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

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. The FDA is requiring Pfizer to conduct a postmarketing study of the drug. The studies will assess the long-term effects of Xeljanz on heart disease, cancer, and serious infections. Two doses of Xeljanz will be studied on one group of patients. Another group will receive another approved treatment for RA to serve as a comparison.

Reference: FDA