Rheumatoid arthritis (RA) is an autoimmune disease, in which the body's healthy tissue is under attack by the immune system. This leads to inflammation of the joints and surrounding tissues. RA affects about 1.5 million Americans according to the Centers for Disease Control and Prevention.
Xeljanz is a pill taken twice a day that functions by inhibiting molecules known as "Janus kinases", crucial to the joint inflammation that characterizes RA.
"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.
Xeljanz is approved before the product's prescription drug user fee goal date of November 21, 2012.
The effectiveness and safety of Xeljanz were tested during seven clinical trails that included adult patients with moderate to severe RA. Trial participants were given Xeljanz or a placebo.
Those treated with Xeljanz exhibited improvement in physical mobility and clinical response compared with those who received the placebo.
A risk documented explains that with the use of Xeljanz, there is an elevated risk of serious infections, like opportunistic infections, tuberculosis, cancers, and lymphoma. It also carries a warning against increases in cholesterol, increases in liver enzyme tests, and reductions in blood counts.
Xeljanz was approved with a Risk Evaluation and Mitigation Strategy (REMS). This includes a Medication Guide specifying crucial directions and safety information for patients, in addition to content for healthcare providers about the side effects associated with the drug.
The FDA is now requiring a post-marketing study in order to examine the long-term outcomes of Xeljanz on heart disease, serious infections and cancer. They recommend a comparison with a group of patients on another approved treatment to view any differences.
During the clinical trials, investigators saw upper respiratory tract infections, diarrhea, inflammation of the nasal passage and upper part of the pharynx, and headaches as the most frequent side effects.
What is Rheumatoid Arthritis?Rheumatoid arthritis, also known as rheumatoid disease, is an autoimmune disease which is characterized by chronic joint inflammation. It may also involve inflammation of the eyes, heart, lungs and other tissues.
Rheumatoid arthritis is known as a "systemic illness", i.e. it can affect many parts of the body.
Although rheumatoid arthritis is a long-term (chronic) disease, patients may go through long spells with no symptoms at all.
With rheumatoid arthritis, the synovium (synovium) is attacked by the immune system, resulting in inflammation and pain. Untreated patients risk deformity.
The disease is considerably more common in females than males and usually strikes when the person is between 40 and 60 years old. However, people of all ages, including children can be affected.