Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. 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;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.