The FDA has cleared the interleukin (IL)-23 inhibitor tildrakizumab (Ilumya) for the treatment of active psoriatic arthritis (PsA) in adults.
Sun Pharma announced the approval on October 30.
“As an IL-23 inhibitor administered exclusively by a healthcare provider, Ilumya is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care,” Rick Ascroft, North America CEO of Sun Pharma, said in a statement.
This is the second indication for which tildrakizumab has received the FDA’s green light, with the administration approving tildrakizumab in 2018 for the treatment of moderate-to-severe plaque psoriasis, as reported by Medscape Medical News.
The decision to approve tildrakizumab for PsA was supported by INSPIRE-1 and INSPIRE-2, two phase 3, 52-week, multicenter, randomized, double-blind, single-dose, placebo-controlled studies in more than 800 adults with active PsA. Topline results were first reported in July 2025.
For INSPIRE-1, participants (n=510) had previously been treated with an anti-TNF agent, while INSPIRE-2 participants (n=296) were naive to anti-TNFs. Patients were randomly assigned to receive either tildrakizumab 100 mg or placebo and were permitted to use concomitant methotrexate or leflunomide as needed.
At 24 weeks, significantly more patients receiving subcutaneous tildrakizumab 100 mg met the endpoint of 20% improvement in American College of Rheumatology response criteria (ACR20) compared with placebo, according to Sun Pharma.
Tildrakizumab is the third IL-23 inhibitor to be approved for PsA. Guselkumab (Tremfya) was approved in 2020, and risankizumab (Skyrizi) was approved in 2022. In addition, the FDA cleared IL-12/23 inhibitor ustekinumab (Stelara) for PsA in 2013.
The recommended dosages for tildrakizumab are subcutaneous injections of 100 mg at weeks 0, 4, and every 12 weeks thereafter. The most common (≥ 1%) adverse reactions associated with treatment are upper respiratory infections, injection-site reactions, and diarrhea.
The FDA initially accepted Sun Pharma’s supplemental biologics license application for the indication of active PsA in March.
Full prescribing information for tildrakizumab can be found here.
Scott Harris has covered rheumatology for more than a decade. He lives near Washington, DC.
