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The FDA has approved tildrakizumab (Ilumya), an IL-23 inhibitor, for active psoriatic arthritis (PsA) in adults — its second approved indication after plaque psoriasis. Backed by two phase 3 trials in over 800 patients, it becomes the third IL-23 inhibitor cleared for PsA. It's administered by a healthcare provider via subcutaneous injection.
The FDA has approved tildrakizumab (Ilumya), an interleukin-23 (IL-23) inhibitor made by Sun Pharma, for the treatment of active psoriatic arthritis (PsA) in adults. This marks the drug's second FDA-approved indication — it was first cleared for moderate-to-severe plaque psoriasis back in 2018. A notable feature: Ilumya is administered exclusively by a healthcare provider, making it a potential fit for patients who can't self-inject or who benefit from regular in-office care.
The approval was supported by two phase 3 trials — INSPIRE-1 and INSPIRE-2 — spanning 52 weeks and enrolling more than 800 adults with active PsA. At 24 weeks, significantly more patients on tildrakizumab 100 mg met the ACR20 response threshold compared to placebo. INSPIRE-1 enrolled patients previously treated with anti-TNF agents, while INSPIRE-2 focused on anti-TNF-naïve patients.
Key Takeaways:
Why it matters: PsA patients now have another targeted biologic option — one uniquely positioned for those who prefer or require provider-administered treatment, expanding the toolkit for rheumatologists managing this chronic inflammatory condition.
