Sun Pharmaceutical Industries has announced positive top-line results from two pivotal Phase 3 clinical studies evaluating tildrakizumab 100 mg (ILUMYA®) for the treatment of active psoriatic arthritis. Both the INSPIRE-1 and INSPIRE-2 trials successfully achieved their primary endpoints, demonstrating the drug's efficacy in improving disease symptoms over a 24-week treatment period.
Trial Results and Efficacy
The Phase 3 studies showed that treatment with tildrakizumab 100 mg resulted in greater improvements in psoriatic arthritis signs and symptoms at Week 24 compared to placebo treatment. Specifically, both trials achieved statistical significance with a higher proportion of patients treated with tildrakizumab achieving ACR20 responses at week 24 compared to those receiving placebo (p < 0.05).
The ACR20 response, a standard measure in rheumatology trials, indicates at least 20% improvement in tender and swollen joint counts along with similar improvement in three of five additional disease activity measures. This endpoint serves as a key indicator of treatment efficacy in psoriatic arthritis clinical trials.
Clinical Significance
Psoriatic arthritis is an inflammatory condition that affects both joints and skin, representing a chronic autoimmune disorder that can significantly impact patients' quality of life. The positive results from these Phase 3 trials mark an important step forward in evaluating treatment options for individuals living with this condition.
"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," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma.
Study Design and Timeline
Both INSPIRE-1 and INSPIRE-2 were designed as Phase 3 clinical studies evaluating the efficacy and safety of tildrakizumab 100 mg administered over 24 weeks. The trials assessed the drug's impact on key disease markers throughout this treatment period, with participants showing notable progress under the ILUMYA regimen compared to placebo controls.
Dr. Honczarenko expressed gratitude to the study participants and healthcare professionals, stating, "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."
The company has indicated that complete clinical data from both studies will be shared in the near future, though specific timelines for regulatory submissions or publication of detailed results were not disclosed in the current announcement.
