FDA Approves Xeljanz for RA

Xeljanz for rheumatoid arthritis has been approved for adults with moderate to severe disease activity

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) When the standard drug treatment for rheumatoid arthritis is not working for a patient, it may be time to move on to another treatment. Now there is a new drug option for patients who need to make that switch.

The US Food and Drug Administration (FDA) has approved Xeljanz (tofacitinib) to treat adults with moderate to severe rheumatoid arthritis who did not respond well to methotrexate - one of the most commonly used drugs for the treatment of arthritis and other rheumatic diseases.

"Ask your rheumatologist about your drug options."

Rheumatoid arthritis is an autoimmune disease, which means that body's immune system mistakenly attacks healthy tissues. This autoimmune attack leads to inflammation and pain in the joints.

Xeljanz is a pill taken twice a day that blocks specific molecules that play a large role in the joint inflammation of rheumatoid arthritis.

The drug is marketed by Pfizer Inc.

"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of rheumatoid arthritis who have had a poor response to methotrexate," said Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA was scheduled to complete their review of the Xeljanz by November 21, 2012. Instead, the drug has been approved ahead of schedule.

To test its safety and effectiveness, Xeljanz went through seven clinical trials in adults with moderately to severely active rheumatoid arthritis. In every trial, patients who took Xeljanz had better physical function and improved clinical response compared to patients who took placebo.

Even though Xeljanz led to improvements in rheumatoid arthritis, the drug is not without side effects. Trials showed that the drug may increase the risk of:

  • serious infections such as opportunistic infections - infections that happen mainly when the immune system is suppressed
  • tuberculosis
  • cancer
  • lymphoma

During the clinical trials, the most common harmful reactions to Xeljanz were:

  • upper respiratory tract infection
  • headache
  • diarrhea
  • inflammation of the nasal passage and the upper part of the pharynx (part of the throat immediately below the mouth and nasal cavity)

Xeljanz was also linked to increases in cholesterol and liver enzyme tests (a sign of liver damage) and decreases in blood counts (a measure of patients' overall health).

To notify patients and consumers of these risks, Xeljanz comes with a Boxed Warning.

Even though Xeljanz has been approved, the FDA has required a postmarking study to examine the long-term effects of Xeljanz on heart disease, cancer and serious infections. The study will compare two doses of Xeljanz to another approved treatment for rheumatoid arthritis.

According to an article on the Forbes website, Pfizer said Xeljanz will cost $2,055.13 for a 30-day supply, or about $24,666 per year. This price is slightly cheaper than competing rheumatoid arthritis drugs such as Humira or Enbrel.

Reviewed by: 
Review Date: 
November 7, 2012
Last Updated:
November 8, 2012