Sun Pharma has announced 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) in patients with active psoriatic arthritis. The studies, which enrolled over 800 patients, met their primary endpoint, demonstrating significant improvements in psoriatic arthritis signs and symptoms compared to placebo after 24 weeks of treatment.
Tildrakizumab, a high-affinity humanized immunoglobulin antibody, targets the p19 subunit of IL-23 and has been previously approved for the treatment of plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. The INSPIRE-1 and INSPIRE-2 studies were designed to assess the efficacy and safety of tildrakizumab in patients with active psoriatic arthritis, with patients randomized to receive either tildrakizumab 100 mg or placebo.
The primary endpoint of the studies was the proportion of participants achieving an American College of Rheumatology 20% response criteria (ACR20) at Week 24, which was met in both INSPIRE-1 and INSPIRE-2. Secondary efficacy endpoints at 24 weeks included ACR50, ACR70, and Psoriasis Area Severity Index (PASI) 75. The safety data observed in the studies aligns with the well-documented safety profile of tildrakizumab for moderate-to-severe plaque psoriasis.
According to Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, “These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis.” The company plans to present the full results at upcoming conferences and publish them in a peer-reviewed medical journal.
The findings support the potential regulatory submission of Ilumya for the treatment of active psoriatic arthritis in the US. Tildrakizumab is also being evaluated for the treatment of stable nonsegmental vitiligo. The positive results from the INSPIRE-1 and INSPIRE-2 studies demonstrate the potential of tildrakizumab as a treatment option for patients with active psoriatic arthritis, and further research is needed to fully understand its efficacy and safety in this patient population.
Overall, the announcement from Sun Pharma highlights the potential of tildrakizumab as a treatment option for patients with active psoriatic arthritis, and the company’s commitment to advancing the development of this therapy for patients in need. The results of the INSPIRE-1 and INSPIRE-2 studies are a significant step forward in the treatment of psoriatic arthritis, and further research is expected to provide additional insights into the efficacy and safety of tildrakizumab in this patient population.