Apremilast led to improved clinical outcomes and quality of life for adults with mild to moderate psoriasis, and had a tolerable safety profile, according to data from the extension phase of a randomized, phase 3 study published in the Journal of the American Academy of Dermatology.
ADVANCE, a 16-week phase 3 study of adults with mild to moderate psoriasis intolerant to or inadequately controlled by 1 or more topical therapy, found apremilast to be efficacious and tolerable. It was followed by an extension phase to assess apremilast’s safety and efficacy. Investigators randomly assigned patients 1:1 to receive either apremilast 30 mg twice daily or placebo for 16 weeks. The primary endpoint was the percentage of patients who achieved a static Physician’s Global Assessment (sPGA) score of 0 or 1 (clear or almost clear) and a 2-point or greater reduction in sPGA from baseline at week 16.
There were 595 patients included in the trial: 257 on apremilast and 246 given a placebo. At week 16, 21.6% of apremilast patients achieved an sPGA score of 0 or 1 and a 2-point or greater reduction from baseline compared with 4.1% of patients given a placebo (P <.0001). At week 32, sPGA status remained the same for 30.2% of apremilast patients as well as 34.3% of patients initially randomly assigned to placebo who subsequently were randomly assigned to apremilast (n=210). At week 32, 29.3% of patients continuing apremilast treatment achieved Psoriasis Area Severity Index (PASI)-75 compared with 27.2% of patients who switched to apremilast from placebo.
The majority of treatment-emergent adverse events (TEAEs) were mild or moderate, with the most common TEAEs being diarrhea (14.3%), headache (12.9%), nausea (12.7%), upper respiratory infection (8.5%), and nasopharyngitis (6.8%). This was consistent with the known apremilast safety profile.
“Although topical therapies are commonly prescribed for mild-to-moderate psoriasis, systemic treatment may benefit patients with intractable pruritis or special area involvement,” the study authors wrote, noting that apremilast demonstrated “sustained clinical improvements in overall disease severity, scalp psoriasis, itch, and quality of life for patients with mild-to-moderate psoriasis.”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Stein Gold L, Papp K, Pariser D, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022;86(1):77-85. doi:10.1016/j.jaad.2021.07.040