Pivotal Tildrakizumab Trials Meet Endpoint for Psoriatic Arthritis

Tildrakizumab 100mg has demonstrated a significant benefit for treating active psoriatic arthritis (PsA), according to new data from 2 pivotal phase 3 trials of the therapy, which have both met their primary end points of improving ACR20 response rates at 24 weeks compared to placebo.1

"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 PsA. 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 statement.1

Tildrakizumab-asmn is an IL-23–inhibiting monoclonal antibody. The therapy, sponsored by Sun Pharma, is currently FDA-approved under the name Ilumya for adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, as of 2018.2

The new data are from the INSPIRE-1 and INSPIRE-2 trials, which are 52-week global, multicenter, randomized, double-blind, single-dose, placebo-controlled phase 3 studies. INSPIRE-1 enrolled patients having prior exposure to an antiTNF agent and INSPIRE-2 enrolled anti-TNF naïve patients for a total of over 800 adult patients enrolled across US, Europe and Asia.

Both trials randomized patients to receive either tildrakizumab 100 mg or placebo without an induction dose was not administered in either study. Concomitant methotrexate or leflunomide was permitted provided the dose remained stable throughout the trial. Tildrakizumab was administered at Week 0 and then every 12 weeks, which differed from the dosing scheme in the therapy’s PsO trials (doses in Week 0, Week 4, and then every 12 weeks thereafter).

In addition to the primary endpoint of achieving ACR20 response at Week 24, both studies shared key secondary efficacy endpoints at 24 weeks including ACR50, ACR70, and PASI75 and improvement.

Investigators found that tildrakizumab 100 mg resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo. Both studies achieved the primary endpoint, with a higher proportion of patients treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (P <.05).1

The investigators found that the INSPIRE studies displayed a safety profile of tildrakizumab similar to that seen in the pivotal reSURFACE 1 and reSURFACE 2 that supported the therapy’s approval for PsO. Sun Pharma shared that findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal in the future.

Other recent real-world research into tildrakizumab’s benefit for psoriasis found that after 1 year, tildrakizumab demonstrated overall safety and efficacy among patients, including efficacy in regions of the body deemed challenging-to-treat. There was also a decline in PASI score from 13.6 to 2.3, and the team further noted that an increase in the SF-12 mental component score was observed from 41 to 48.7.3 The analysis further highlighted DLQI improvements from 10.4 to 2.5. Despite such gains, it was noted that some participants remained dissatisfied. This dissatisfaction was noted along with a citation of concerns about psoriasis relapse and the persistent mental health burden linked to the inflammatory disease in the long term.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. https://sunpharma.com/blog/sun-pharmas-phase-3-clinical-studies-evaluating-tildrakizumab-100-mg-ilumya-in-active-psoriatic-arthritis-meet-their-primary-endpoint/

2. Kunzmann K. FDA Approves Tildrakizumab for Certain Plaque Psoriasis Patients. HCPLive. Article. March 21, 2018. https://www.hcplive.com/view/fda-approves-tildrakizumab-for-certain-plaque-psoriasis-patients

3. Reguiai, Z., Becherel, P.A., Maccari, F, et al. (2025). Patient's Perspective on the Impact of Psoriasis on Their Quality of Life After 1 Year of Tildrakizumab Treatment: Despite Clinical Improvement, Persistence of a Potential Mental Cicatricial Memory of the Disease. JEADV Clinical Practice. https://doi.org/10.1002/jvc2.70021.