Apremilast Long‑Term Safety Up to 5 Years from 15 Pooled Randomized, placebo‑Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behçet’s Syndrome
Am J Clin Dermatol. 2023;24(5):809-820 doi: 10.1007/s40257-023-00783-7
This study confirms the safety of long-term apremilast use in patients with plaque PsO, active PsA, or oral ulcers associated with Behçet’s syndrome. In coming to this conclusion, investigators conducted a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety.
Interestingly, exposure-adjusted incidence rate for serious events and events of special interest were low (< 1%) in patients treated with apremilast 30mg twice daily despite significant exposure. Overall, apremilast provides a therapeutic option with established long-term safety and a favourable benefit–risk profile for patients with PsA, PsO, or Behçet’s syndrome requiring chronic, systemic therapy.
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