40666 Long-term Safety of Apremilast From a Pooled Analysis of 15 Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Oral Ulcers Associated With Behçet's Syndrome
Recommended Citation
Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A. 40666 Long-term Safety of Apremilast From a Pooled Analysis of 15 Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Oral Ulcers Associated With Behçet's Syndrome. J Am Acad Dermatol 2023; 89(3):AB190.
Document Type
Conference Proceeding
Publication Date
9-19-2023
Publication Title
J Am Acad Dermatol
Abstract
Background: As of March 20, 2022, 706,585 patients (557,379 patient-years of exposure) have been treated with apremilast worldwide for approved indications: plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s syndrome. This analysis is the largest yet that focuses on long-term safety of apremilast. Methods: Data from up to 5 years’ exposure were pooled from 15 randomized, placebo-controlled studies across 3 indications and divided into placebo-controlled and all apremilast exposure groups. Long-term safety and tolerability of apremilast 30 mg BID were analyzed. Treatment-emergent adverse events (TEAEs) were assessed, focusing on TEAEs of special interest. Results: The analysis included 4,183 patients exposed to apremilast (6,788 patient-years). TEAEs were primarily mild to moderate in the placebo-controlled period (96.6%) and throughout all apremilast exposure (91.6%). Rates of TEAEs of special interest were similar between placebo and apremilast groups in the placebo-controlled period. For all apremilast exposure, the exposure-adjusted incident rate per 100 patient-years was: •6.20, any serious TEAE; •1.78, depression; •1.10, serious infections; •1.04, malignancies (0.48, nonmelanoma skin cancer; 0.03, lymphomas); •0.30, major adverse cardiac events; •0.21, serious opportunistic infections; •0.10, venous thromboembolism events (deep vein thrombosis [0.07] and pulmonary embolism [0.03]). The most common TEAEs were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis. Conclusions: The incidence of TEAEs of special interest and serious TEAEs was low despite long term apremilast exposure, further establishing apremilast as a safe oral option with a favorable benefit-risk profile for long-term treatment for psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s syndrome.
Volume
89
Issue
3
First Page
AB190
