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FDA Approves Sotyktu for Active Psoriatic Arthritis as First TYK2 Inhibitor

The decision follows phase 3 POETYK trials showing clinically meaningful 16‑week responses with outcomes observed through one year.

Overview

  • The new indication covers once‑daily oral deucravacitinib 6 mg for adults with active psoriatic arthritis.
  • Across POETYK PsA‑1 and PsA‑2, 54% on deucravacitinib achieved ACR20 at week 16 versus 34%–39% with placebo.
  • Minimal disease activity at week 16 improved with deucravacitinib, reaching 19% vs 10% in PsA‑1 and 26% vs 15% in PsA‑2.
  • Trials enrolled biologic‑naive patients and those previously treated with TNF inhibitors, with PsA‑2 including an apremilast safety reference arm.
  • Common adverse reactions included upper respiratory infections, increased creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne, with label warnings for infections, malignancy risk, laboratory abnormalities, rhabdomyolysis, and immunization considerations.