The New Drug XELJANZ For Treatment Of Psoriatic Arthritis Is Recently Approved By FDA
Psoriatic arthritis is a chronic autoimmune inflammatory disease that can affect peripheral joints, tendons, ligaments or the skin. Symptoms of PsA may include such things as joint stiffness and pain, swollen toes and / or fingers, reduced range of motion, etc., causing great inconvenience to the patient's life and the emergence of new drugs that will improve their condition.
XELJANZ, developed by Pfizer, is a new drug for the treatment of this condition. It is a novel oral JAK inhibitor designed to suppress the JAK signaling pathway in cells whereas the JAK pathway is thought to play an important role in the inflammatory response of PsA. By inhibiting these JAK pathways, XELJANZ inhibits cell signaling, gene expression and activation, thereby ameliorating the condition.
The decision of the FDA to approve XELJANZ for adult patients with active PsA is based on the results of the Oral Psoriatic Arthritis Trial, Phase 3, which includes two key trials, OPAL Broaden and OPAL Beyond. Both of these pivotal studies have achieved two major endpoints of efficacy: patients treated with a combination of XELJANZ 5 mg BID and abiotic DMARD at 3 months at the American College of Rheumatology 20 (ACR20) compared with placebo, , And the Health Assessment Questionnaire-Disability Index (HAQ-DI) showed statistically significant improvements. In OPAL Broaden, 50% of patients receiving XELJANZ 5mg BID achieved ACR20 relief at 3 months, compared with 33% of patients receiving placebo (p <0.05). In OPAL Beyond, 50% of patients receiving XELJANZ 5mg BID achieved ACR20 remission at 3 months compared with 24% of patients receiving placebo (p <0.05). It is worth mentioning that in both studies, a significant increase in ACR20 remission in the drug-treated group was observed in the second week relative to the control group, reaching the secondary endpoint of the study (OPAL Broaden: 22% vs .6% in the control group [p = 0.0003]; OPAL Beyond: 27% in the drug group vs. 13% in the control group [p = 0.0046]).
Sincerely hope it can bring improvement to the lives of the majority of patients.