The U.S. Food and Drug Administration (FDA) recently approved Pfizer’s drug XELJANZ (tofacitinib) for treatment of polyarticular course juvenile idiopathic arthritis (pcJIA).
The cause of pcJIA, which is a chronic inflammatory disease occurring in children 16 years or younger for at least six weeks, is unknown according to Pfizer. The approval is for use on patients two years and older and includes two forms of prescription, oral and tablets. They are administered based on weight.
“Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant joint pain and limit participation in child appropriate activities,” said Dr. Hermine Brunner, Director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and Scientific Director of the Pediatric Rheumatology Collaborative Study Group, in a press release by Pfizer. “Although there are already several advanced treatments available, tofacitinib will be an appealing new option given it does not require injections or infusions. These can be quite burdensome to both children with pcJIA and their caretakers. The FDA approval of XELJANZ for pcJIA is positive news for this community as it provides a new advanced treatment option in an oral formulation.”
The drug inhibits Janus kinase (JAK), an enzyme involved in immune cell signaling, and is the only approved drug of its kind to treat pcJIA currently. XELJANZ is already used to treat adults, mostly with rheumatoid arthritis, and has been prescribed to approximately 208,000 people over the last seven years.
Data from a 44-week study to determine the efficacy of the drug taken in either the oral or tablet dose was evaluated for FDA approval.
A long-term extension study was performed on patients with ulcerative colitis and found an increase in observed malignancies including solid cancers and lymphomas in patients taking the 10 mg twice daily dosing XELJANZ .
All patients using the drug increase their risk of serious and sometimes life-threatening infections, including invasive fungal infections, pneumonia, cellulitis, herpes zoster, urinary tract infections and appendicitis, according to Pfizer.
Alerts Sign-up