INSPIRE: Joint, Skin Gains Support Tildrakizumab PsA Approval: Philip Mease, MD

The FDA approval of tildrakizumab (Ilumya) for adults with active psoriatic arthritis (PsA) is supported by pooled data from the phase 3 INSPIRE 1 and INSPIRE 2 trials, in which the interleukin-23 (IL-23) inhibitor improved joint and skin responses versus placebo at week 24.¹˒² Philip J. Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, discussed the data in an interview.

Mease is first author of the pooled analysis presented at the ACR Convergence 2026, held November 6-11 in Orlando, Florida, shortly after the FDA approved tildrakizumab for PsA. INSPIRE 1 (NCT04314544) enrolled patients with prior tumor necrosis factor (TNF) inhibitor exposure and INSPIRE 2 (NCT04314531) enrolled TNF inhibitor-naive patients, randomizing 806 participants 1:1 to tildrakizumab 100 mg or placebo at weeks 0 and 12 without a loading dose.¹ Tildrakizumab is administered by a health care provider every 12 weeks.²

“You get to see the patient every 12 weeks and really hone in on how they are doing. For some patients, it will be a hassle, especially if they have to drive in from a distance, but for many patients, this will be kind of a nice touch point for physicians to have with their patients,” Mease said.

At week 24, ACR20 response occurred in 38.8% of patients receiving tildrakizumab versus 24.4% receiving placebo (nominal P < .001), with higher ACR50 (21.5% vs 12.5%; P = .001) and ACR70 (8.6% vs 3.5%; P = .006) rates.¹ Among patients with psoriasis covering at least 3% of body surface area, 41.0% reached PASI75 versus 10.9% with placebo (P < .0001). Change in Health Assessment Questionnaire-Disability Index score did not differ significantly (least squares mean difference, −0.05; P = .09).

Mease said IL-23 inhibitors typically need at least 24 weeks to reach optimal benefit, with further gains possible beyond that, unlike the faster onset seen with IL-17 and TNF inhibitors. He said the class has shown a strong safety record and noted tildrakizumab adds another IL-23 option for patients early in their disease course or after other therapies fail. The abstract reported no new safety concerns, and these pooled data have not been peer reviewed.

Mease’s disclosures include Sun Pharmaceuticals and others.

References

1. Mease P, Nishandar T, Mehta S, et al. Tildrakizumab for the treatment of prior anti-tumor necrosis factor-experienced or -naïve participants with active psoriatic arthritis: pooled week 24 results of two phase 3, randomized, double-blind, placebo-controlled studies, INSPIRE 1 and INSPIRE 2. Abstract 2313. Presented at: ACR Convergence 2026; November 6-11, 2026; Orlando, FL.

2. Tildrakizumab receives FDA approval for active psoriatic arthritis. RheumatologyLive. Accessed November 7, 2026. https://www.rheum-live.com/view/tildrakizumab-receives-fda-approval-for-active-psoriatic-arthritis