FDA Approves Tildrakizumab for Adults With Active Psoriatic Arthritis
Key Takeaways
- The FDA has approved ILUMYA (tildrakizumab-asmn) for adults with active psoriatic arthritis, expanding its indication beyond moderate-to-severe plaque psoriasis.
- The approval is supported by the phase 3 INSPIRE-1 and INSPIRE-2 trials, which evaluated the efficacy and safety of tildrakizumab 100 mg in adults with active psoriatic arthritis.
- ILUMYA is administered by a healthcare professional. According to Sun Pharma, no new safety signals were identified in the two phase 3 studies.
The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (ILUMYA; Sun Pharmaceutical Industries) for the treatment of adults with active psoriatic arthritis (PsA), according to an announcement from the company.
The approval expands the use of the IL-23 inhibitor, which was initially approved in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is administered exclusively by a healthcare professional.
Phase 3 INSPIRE Trials Support Approval
The approval was supported by INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531), two global, multicenter, randomized, double-blind, placebo-controlled phase 3 trials evaluating tildrakizumab 100 mg in adults with active PsA.
Both studies evaluated efficacy and safety at week 24 following two doses, with study periods extending to 52 weeks. According to Sun Pharma, the safety findings were consistent with the established safety profile of tildrakizumab, with no new safety signals identified. The announcement did not provide numerical efficacy results or comparative response rates.
Tildrakizumab may increase the risk of infections, and patients should be evaluated for tuberculosis before treatment initiation. The company identified upper respiratory tract infections and COVID-19 among the most common adverse reactions reported in the PsA studies.
“Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient’s symptoms and treatment goals,” said Philip Mease, MD, director of rheumatology research at Swedish Medical Center and Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine in Seattle.