Sun Pharmaceutical Industries Ltd has announced encouraging top-line results from two Phase 3 clinical trials—INSPIRE-1 and INSPIRE-2—evaluating tildrakizumab 100 mg (marketed as ILUMYA®) for the treatment of active psoriatic arthritis (PsA).
In both studies, ILUMYA demonstrated significantly greater improvements in the signs and symptoms of PsA at Week 24 compared to placebo. The primary endpoint was met in both trials, with a higher proportion of patients achieving ACR20 responses (a standard measure of improvement in arthritis symptoms) at the 24-week mark (p < 0.05).
“We are pleased to announce that both INSPIRE-1 and INSPIRE-2 successfully met their primary endpoints,” said Dr. Marek Honczarenko, Senior Vice President and Head of Global Specialty Development at Sun Pharma. “These promising results highlight the potential of ILUMYA as a treatment for active psoriatic arthritis. We thank the patients, investigators, and study teams for their invaluable contributions and look forward to sharing the full clinical findings soon.”
The safety results from both trials were consistent with ILUMYA’s established safety profile, which has already been approved for treating adults with moderate-to-severe plaque psoriasis. No new safety concerns were observed in the PsA studies.