FDA approves tildrakizumab for psoriatic arthritis

The IL-23 inhibitor gains a new indication after 2 phase 3 trials show improved joint responses versus placebo.

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The FDA approved tildrakizumab-asmn for adults with active psoriatic arthritis, expanding its use beyond moderate-to-severe plaque psoriasis.
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The approval was supported by INSPIRE-1 and INSPIRE-2, phase 3 trials of tildrakizumab 100 mg in adults with active psoriatic arthritis.
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In a pooled analysis of 806 participants, week 24 ACR20 responses occurred in 38.8% of patients receiving tildrakizumab and 24.4% receiving placebo.
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Among participants with psoriasis affecting at least 3% of body surface area, 41.0% receiving tildrakizumab and 10.9% receiving placebo achieved at least 75% PASI improvement.
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The most common adverse reactions, each reported in at least 3% of patients with psoriatic arthritis, were upper respiratory tract infections and COVID-19.

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