Apremilast is effective for reducing the severity of plaque psoriasis of the body and scalp and has an acceptable safety profile, according to study data published in Clinical, Cosmetic and Investigational Dermatology.
Researchers conducted a review of the evidence on apremilast regarding its safety, efficacy, and use in treating patients with moderate to severe plaque psoriasis of the body and scalp, nail psoriasis, and palmoplantar psoriasis in adults.
They performed a literature search in PubMed and Google Scholar on May 17, 2021, for clinical and randomized controlled trials from 2008 onward. A total of 24 articles conducted in humans with an in vivo experimental design for dermatologic indications for apremilast were included in the review.
A pair of key phase 3 clinical trials, cited by the investigators, assessed the safety and efficacy of apremilast for plaque psoriasis—the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM 1 and ESTEEM 2). In both trials, Psoriasis Area Severity Index (PASI)-75 response was significantly increased in patients who received apremilast vs the placebo group: ESTEEM 1 (33.1% of apremilast vs 5.3% of placebo; P <.0001); ESTEEM 2 (28.8% vs 5.8%; P <.001). A static Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) with 2-point or more reduction from baseline was also achieved by significantly more patients in the apremilast group vs the placebo group in both studies: ESTEEM 1 (21.7% vs 3.9%; P <.0001); ESTEEM 2 (20.4% vs 4.4%; P <.001).
A phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of apremilast for plaque psoriasis of the scalp, with a primary endpoint of scalp PGA response. That data indicated that significantly more patients who received apremilast achieved the primary endpoint vs those who received placebo (43.3% vs 13.7%; P <.0001), the investigators wrote.
Several clinical trials have found that apremilast is associated with rapid and sustained improvements in Dermatology Life Quality Index and Nail Psoriasis Area and Severity Index scores, it was noted. Few controlled trials have specifically assessed apremilast for palmoplantar psoriasis.
Overall, studies have found that apremilast is generally well tolerated with an acceptable safety profile, according to the researchers. The most common side effects are usually mild and resolve within weeks, and treatment-related weight loss is common. No increased incidence of infections or malignancies with apremilast therapy has been reported.
“Apremilast is efficacious in treating plaque psoriasis, portends no increased risk of tuberculosis, requires no laboratory monitoring, is administered orally, and may lead to weight loss—a side effect which may be valuable to patients,” stated the study authors. “The long-term safety and efficacy of apremilast should be further investigated as it remains to be seen whether there is reduced immunosuppression associated with apremilast compared with biologic agents.”
Gao JC, Wu AG, Contento MN, Maher JM, Cline A. Apremilast in the treatment of plaque psoriasis: differential use in psoriasis. Clin Cosmet Investig Dermatol. 2022;15:395-402. doi:10.2147/CCID.S266036