Sun Pharma’s ILUMYA Achieves Primary Endpoints In Phase 3 Psoriatic Arthritis Trials

Sun Pharmaceutical Industries Ltd. has reported positive top-line results from two Phase 3 clinical trials — INSPIRE-1 and INSPIRE-2 — evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA®) for the treatment of active psoriatic arthritis (PsA). Over a 24-week treatment period, patients receiving ILUMYA showed significantly greater improvement in PsA signs and symptoms compared to those given a placebo.

"We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Speciality Development at Sun Pharma.

Both studies successfully met their primary endpoints, demonstrating that a higher proportion of patients treated with ILUMYA achieved ACR20 responses at Week 24 versus placebo, with statistical significance (p < 0.05). These outcomes suggest ILUMYA’s potential in managing active PsA, adding to its existing approval for moderate-to-severe plaque psoriasis.

The safety profile seen in the PsA studies was congruent with the established track record of ILUMYA with no new adverse events reported. Although the results of these Phase 3 trials have not yet led to access to ILUMYA in psoriatic arthritis, the investigational medicine will be discussed at upcoming scientific events and filed as an article in peer-reviewed journals.