Sun Pharma’s phase 3 clinical studies evaluating ILUMYA in active psoriatic arthritis met their primary endpoint

Sun Pharmaceutical Industries announced top-line results from two Phase 3 clinical studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) administered over 24 weeks for the treatment of active psoriatic arthritis.

Treatment with tildrakizumab 100 mg (ILUMYA) resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo. Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05).

Safety data in the studies were consistent with the well-documented safety profile of ILUMYA, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.

Findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of tildrakizumab 100 mg (ILUMYA) in psoriatic arthritis is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.