Sun Pharma Announces Positive Phase 3 Results for Tildrakizumab in Psoriatic Arthritis

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This week, Sun Pharma has shared top-line results from phase 3 clinical research on tildrakizumab 100 mg (Ilumya) for psoriatic arthritis.¹ After 24 weeks of treatment in both the INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) studies, patients saw significant improvements in psoriatic arthritis signs and symptoms, when compared to 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,” Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, said in a press release.

The INSPIRE-1 and INSPIRE-2 are both 52-week global, multicenter, randomized, double-blind, single-dose, placebo-controlled studies. Over 800 eligible patients with active psoriatic arthritis were enrolled at clinical sites in the US, Europe, and Asia. In INSPIRE-1, participants had previously been treated with an anti-TNF agent, while in INSPIRE-2, participants were naïve to anti-TNFs. Patients were randomized to receive either tildrakizumab 100 mg or placebo and were granted permission to use stable doses of concomitant methotrexate or leflunomide, if needed. Tildrakizumab was administered every 12 weeks.

The primary endpoint for both studies is the proportion of participants achieving an American College of Rheumatology 20% response criteria (ACR20) at Week 24. This is defined as improvement in the number of tender and swollen joints, along with 20% improvement in 3 criteria, including patient global assessment, physician global assessment, functional ability measure (HAQ-DI), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The endpoint was met in both INSPIRE-1 and INSPIRE-2. Secondary efficacy endpoints at 24 weeks were ACR50, ACR70, and Psoriasis Area Severity Index (PASI) 75.

Tildrakizumab is a high-affinity humanized immunoglobulin antibody that targets the p19 subunit of IL-23. Its long-term clinical efficacy and safety have been tested in randomized trials such as reSURFACE 1 and reSURFACE 2. It has been approved for the treatment of plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.² Significant improvements in PASI and Dermatology Life Quality Index (DLQI) were noted in prior research. The safety data observed in INSPIRE-1 and INSPIRE-2 research aligns with the well-documented safety profile of tildrakizumab for moderate-to-severe plaque psoriasis. Tildrakizumab is also being evaluated for the treatment of stable nonsegmental vitiligo.

According to the press release, these findings “support the potential regulatory submission of ILUMYA for the treatment of active psoriatic arthritis in the US.” Full results will be presented at upcoming conferences and published in a peer-reviewed medical journal.

References

1. Sun Pharma’s Phase 3 Clinical Studies Evaluating Tildrakizumab 100 mg (ILUMYA®) in Active Psoriatic Arthritis Meet their Primary Endpoint. News release. Sun Pharma. July 21, 2025. Accessed July 22, 2025. https://sunpharma.com/blog/sun-pharmas-phase-3-clinical-studies-evaluating-tildrakizumab-100-mg-ilumya-in-active-psoriatic-arthritis-meet-their-primary-endpoint/

2. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials [published correction appears in Lancet. 2017 Jul 15;390(10091):230. doi: 10.1016/S0140-6736(17)31834-2.]. Lancet. 2017;390(10091):276-288. doi:10.1016/S0140-6736(17)31279-5