The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (Ilumya) for adults with active psoriatic arthritis, expanding the interleukin-23 (IL-23) inhibitor's use beyond moderate-to-severe plaque psoriasis. The subcutaneous biologic is administered by a health care professional, providing an additional treatment option for patients with active psoriatic arthritis.
Sun Pharmaceutical Industries announced the approval of the supplemental Biologics License Application in a company press release on October 30. Tildrakizumab-asmn, which selectively targets the p19 subunit of IL-23, was initially approved in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The expanded indication is supported by INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531), 2 global, multicenter, randomized, double-blind, placebo-controlled phase 3 trials evaluating tildrakizumab 100 mg in adults with active psoriatic arthritis. The studies included patients with and without prior tumor necrosis factor (TNF) inhibitor exposure and assessed efficacy at week 24, following 2 doses.
In a pooled analysis of 806 participants, the primary end point of at least 20% improvement according to American College of Rheumatology criteria (ACR20) was achieved by 38.8% of patients receiving tildrakizumab versus 24.4% receiving placebo at week 24.
ACR50 responses occurred in 21.5% versus 12.5%, while ACR70 responses occurred in 8.6% versus 3.5%. Among participants with at least 3% body surface area affected by psoriasis, 41.0% versus 10.9% achieved at least 75% improvement in Psoriasis Area and Severity Index scores. The between-group difference in Health Assessment Questionnaire–Disability Index scores was not statistically significant.
According to Sun Pharma, safety findings were consistent with the established profile of tildrakizumab, with no new safety signals identified. The most common adverse reactions reported in patients with psoriatic arthritis, occurring in at least 3%, were upper respiratory tract infections and COVID-19.
Tildrakizumab-asmn is contraindicated in patients with a history of serious hypersensitivity to the drug or its excipients. Clinicians should evaluate patients for tuberculosis before treatment, treat latent infection before initiation, and avoid administration in patients with active tuberculosis or other clinically important active infections, Sun Pharma suggests. They also advise that live vaccines should be avoided during treatment.
Therapy is administered subcutaneously by a health care professional. Prescribing information also advises monitoring for clinically important infections and considering treatment discontinuation until serious infections resolve.