FDA approves Xeljanz, first JAK inhibitor for polyarticular course JIA
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The FDA has approved Xeljanz in tablet and oral formulations for the treatment of polyarticular course juvenile idiopathic arthritis in patients aged 2 years and older, according to a press release from Pfizer.
Previously approved in the United States for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis and ulcerative colitis who had previously failed other therapies, Xeljanz (tofacitinib) is the first JAK inhibitor approved for JIA.
“Polyarticular course juvenile idiopathic arthritis — or pcJIA — is debilitating as it can cause significant joint pain and limit participation in child-appropriate activities,” Hermine I. Brunner, MD, MSc, MBA, director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and scientific director of the Pediatric Rheumatology Collaborative Study Group, said in a press release. “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 based its approval on results from a two-part phase 3 trial — including an 18-week open-label, run-in phase (n=225), followed by a 26-week double-blind, placebo-controlled, randomized, withdrawal phase (n=173) — examining the safety and efficacy of Xeljanz taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily.
According to the study results, among patients with pcJIA who achieved a JIA American College of Rheumatology (ACR) 30 response at the conclusion of the run-in phase, the incidence of disease flare in patients who received tofacitinib (31%) was statistically significantly (P=0.0007) lower than patients who received placebo (55%) at week 44.
According to the press release, the observed safety profile of tofacitinib in pcJIA was consistent with that found in patients with RA, with common serious adverse events including upper respiratory tract infection, nasopharyngitis, diarrhea, headache and hypertension.
“Many children and adolescents living with polyarticular course juvenile idiopathic arthritis are in need of advanced oral treatment options, so we are proud to now offer Xeljanz to this patient community,” Michael Corbo, PhD, chief development officer, Inflammation and Immunology, Global Product Development, at Pfizer, said in the release. “This approval, which is the fourth indication for Xeljanz, reinforces its utility in the treatment of immune-mediated inflammatory conditions and further demonstrates our expertise in JAK science.”
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