Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis.
The Food and Drug Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs.
Xeljanz/Xeljanz XR is the first and only Janus kinase inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis and active psoriatic arthritis.
“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” said Angela Hwang, global president, inflammation and immunology, Pfizer. “The approval of Xeljanz is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”
‘Psoriatic arthritis is a form of arthritis that affects some people who have psoriasis — a condition that features red patches of skin topped with silvery scales. Most people develop psoriasis first and are later diagnosed with psoriatic arthritis, but the joint problems can sometimes begin before skin lesions appear.’ — Mayo Clinic
The recommended dose of Xeljanz/Xeljanz XR is in combination with nonbiologic disease-modifying antirheumatic drugs, and use in combination with biologic disease-modifying antirheumatic drugs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
The FDA approval of Xeljanz for the treatment of adult patients with active psoriatic arthritis was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.
Both pivotal studies met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score at three months in patients receiving Xeljanz 5 mg BID treatment in combination with a nonbiologic disease-modifying antirheumatic drugs, compared to those treated with placebo.
In OPAL Broaden, 50 percent of patients taking Xeljanz 5 mg BID achieved an ACR20 response, compared to 33 percent of patients taking placebo (p≤0.05), at three months. In OPAL Beyond, 50 percent of patients achieved an ACR20 response with Xeljanz 5 mg BID, compared to 24 percent of patients taking placebo (p≤0.05), at three months.
In both studies, statistically significant improvements in ACR20 response was also seen with Xeljanz 5 mg BID compared to placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22 percent and 6 percent [p=0.0003], respectively; OPAL Beyond: 27 percent and 13 percent [p=0.0046], respectively).
The safety profile observed in patients with active psoriatic arthritis treated with Xeljanz was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events observed occurring in greater than 3 percent of patients on Xeljanz 5 mg BID were nasopharyngitis, upper respiratory tract infection, headache and diarrhea.
(Source: Pfizer Inc.)
Filed Under: Drug Discovery
