Key takeaways
- Ilumya demonstrated statistically significant ACR20 responses at Week 24 in both biologic-experienced and biologic-naïve patients with psoriatic arthritis.
- Safety outcomes remained consistent with Ilumya’s established profile, with no new safety signals reported across both Phase III trials.
- Trial design allowed for background DMARD use and followed a dosing regimen distinct from its psoriasis indication, highlighting the importance of tailored protocols in PsA development programs.
Sun Pharma has shared positive, top-line results from the INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) clinical trials evaluating Ilumya (tildrakizumab) given to participants over 24 weeks for treatment of active psoriatic arthritis (PsA).1
Ilumya shows significant efficacy at 24 weeks in PsA trials
According to the results, Ilumya treatment at a dose of 100 mg achieved greater improvements in PsA signs and symptoms at 24 weeks compared to placebo. The INSPIRE-1 and INSPIRE-2 studies met their primary endpoint of proportion of participants achieving an ACR20 response at Week 24, with positive outcomes for patients observed across both.
In a press release, Marek Honczarenko, MD, PhD, senior vice president and head of global specialty development at Sun Pharma, said: "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.”
Safety profile remains consistent with previous Ilumya data
Sun also reported that safety data from INSPIRE-1 and INSPIRE-2 were consistent with Ilumya’s well-established profile, with no new safety signals identified. The company plans on sharing additional findings from the studies at an upcoming medical conference.
INSPIRE trials enrolled global PsA population with and without prior TNF therapy
The INSPIRE-1 and INSPIRE-2 trials are both 52-week global, multicenter, randomized, double-blind, single-dose, placebo-controlled Phase III studies investigating the efficacy and safety of Ilumya at a dose of 100 mg in adult patients with PsA.
- The INSPIRE-1 trial enrolled adults with prior exposure to anti-TNF therapy, while INSPIRE-2 enrolled anti-TNF–naïve patients.
- Across both studies, more than 800 adult participants were recruited from sites in the US, Europe, and Asia.
- Patients were randomized to receive either Ilumya 100 mg or placebo, without an induction dose in either study.
- Participants were allowed to continue using stable doses of methotrexate or leflunomide throughout the trials.
- Ilumya was administered at Week 0 and then every 12 weeks, differing from its chronic plaque psoriasis regimen, which includes a dose at Week 4.
- The primary endpoint for both trials was the proportion of patients achieving an ACR20 response at Week 24.
- Key secondary endpoints at Week 24 included ACR50, ACR70, and PASI75 response rates.
Recent data reinforce Ilumya's benefit in nail psoriasis
Earlier in March, Sun shared data from a randomized, double-blind, placebo-controlled Phase IIIb trial evaluating Ilumya for the treatment of moderate-to-severe psoriasis affecting the nails in 99 participants. According to the results, treatment with Ilumya significantly improved nail psoriasis severity compared to placebo.2
- At Week 28, patients receiving Ilumya were significantly more likely to achieve a 75% improvement in nail psoriasis severity, with 25.5% reaching mNAPSI 75 compared to just 4.5% in the placebo group (P=0.003).
- Nearly 30% of Ilumya-treated patients achieved clear or nearly clear nails (ViSENPsO® score of 0 or 1), versus only 4.2% among those on placebo (P=0.0008).
- The treatment was well tolerated, with no Ilumya-related serious adverse events reported, and its safety profile aligned with prior studies.
Ilumya already approved in moderate-to-severe plaque psoriasis
Ilumya was approved by the FDA in March 2018 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Data from the Phase III reSURFACE clinical development program—consisting of two randomized, placebo-controlled, multicenter, three-part studies—supported the approval. Across both studies in the program (reSURFACE 1 and reSURFACE 2), Ilumya demonstrated significant clinical improvement at a dose of 100 mg compared to placebo.3
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 28, 2025. https://sunpharma.com/wp-content/uploads/2025/07/Press-Release-Phase-3-Clinical-Studies-PsA-ILUMYA-Topline.pdf
2. ILUMYA® (tildrakizumab-asmn) Found Effective for Treatment of Moderate-to-Severe Plaque Psoriasis Affecting Nails in Study Presented at 2025 AAD Conference. News release. Sun Pharma. March 7, 2025. Accessed July 28, 2025. https://sunpharma.com/wp-content/uploads/2025/04/ILUMYA%C2%AE-tildrakizumab-asmn-Found-Effective-for-Treatment-of-Moderate-to-Severe-Plaque-Psoriasis-Affecting-Nails-in-Study-Presented-at-2025-AAD-Conference.pdf
3. Sun Pharma Announces U.S. FDA Approval of ILUMYA™ (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis. News release. Sun Pharma. March 21, 2018. Accessed July 28, 2025. https://sunpharma.com/wp-content/uploads/2020/12/Sun-Pharma-Announces-U.S.-FDA-Approval-of-ILUMYA.pdf
