Tildrakizumab Shows Significant Efficacy in Psoriatic Arthritis Phase 3 Trials

Written by Dr. Kamal Kant Kohli Published On 2025-08-18T20:30:18+05:30 | Updated On 18 Aug 2025 8:30 PM IST

Tildrakizumab Shows Significant Efficacy in Psoriatic Arthritis Phase 3 Trials

Phase 3 trials have demonstrated that tildrakizumab 100mg significantly improved ACR20 response rates in patients with active psoriatic arthritis at 24 weeks compared to placebo, marking a promising advancement in PsA treatment.

Treatment with tildrakizumab 100 mg (ILUMYA) resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo. Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05).

"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 Specialty Development at Sun Pharma.

Safety data in the studies was consistent with the well-documented safety profile of ILUMYA, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.

Findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peerreviewed medical journal. Use of tildrakizumab 100 mg (ILUMYA) in psoriatic arthritis is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

About the INSPIRE-1 and INSPIRE-2 Phase 3 studies

The INSPIRE-1 and INSPIRE-2 are both 52-week global, multicenter, randomized, double-blind, single-dose, placebo-controlled Phase 3 studies aimed at assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA®) in adult patients with active psoriatic arthritis. The INSPIRE-1 enrolled patients having prior exposure to an antiTNF agent while the INSPIRE-2 enrolled anti-TNF naïve patients. A total of over 800 adult patients were enrolled for the two studies from clinical sites in the US, Europe and Asia. Patients were randomized to receive either tildrakizumab 100 mg (ILUMYA®) or placebo.

An induction dose was not administered in either study. Study participants were permitted to use concomitant methotrexate or leflunomide, provided the dose remained stable throughout the trial. In the INSPIRE-1 and INSPIRE-2 studies, tildrakizumab 100 mg (ILUMYA®) was administered at Week 0 and then every 12 weeks. In contrast, in Phase 3 studies for chronic plaque psoriasis, the treatment schedule included doses in Week 0, Week 4, and then every 12 weeks thereafter. ILUMYA® is approved by the regulatory Agencies for the indication of chronic plaques psoriasis.

The primary endpoint for both studies is the proportion of participants achieving an ACR20 response at Week 24. The key secondary efficacy endpoints at 24 weeks include ACR50, ACR70, and PASI75 and improvement. Learn more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531).

The ACR20 is a composite measure defined as a 20 percent improvement in both the number of tender and number of swollen joints and a 20 percent improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure (most often HAQ-DI), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). ACR50 and ACR70 are the same measurement with improvement levels of 50 percent and 70 percent, respectively.

About Psoriatic Arthritis (PsA)

Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system. It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones). Psoriatic arthritis can develop at any age. Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis [3]; typically, with psoriasis developing before psoriatic arthritis. While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis.

About ILUMYA® (tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States and other countries.

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Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751