Patients with psoriasis in difficult-to-treat special areas have significant improvements in their skin-related quality of life, according to results from EMBRACE (ClinicalTrials.gov Identifier: NCT03774875), a phase 4 randomized, placebo-controlled, multinational study published in the Journal of the European Academy of Dermatology & Venereology.
Investigators included adult patients with plaque psoriasis in 1 or more special area (face, neck, hairline, dorsal hand, scalp, nails, genital areas, or palmoplantar areas) which was not controlled by topical therapy, or patients who had a contraindication, inadequate response, or intolerance to conventional first-line systemic therapy. They randomly assigned patients 2:1 to receive either apremilast 30 mg or placebo twice daily for 16 weeks, and stratified randomization based on plaque psoriasis location. The primary outcome was Dermatology Life Quality Index (DLQI) response, defined as 4-points or more of reduction, at week 16. The investigators analyzed discrete endpoints by Cochran-Mantel-Haenszel test adjusted for stratification at randomization.
There were 277 patients included in the analysis, 185 treated with apremilast and 92 given a placebo. The mean age was 49 years and 58.8% were men. Of these patients, 221 remained in the study until week 16.
Significantly more patients receiving apremilast met the primary outcome than those given a placebo (73.3% vs 41.3%; P <.0001). The treatment difference for DLQI least-squares was also significant at -5.3 (P <.0001). Patients with a higher baseline DLQI treated with apremilast showed greater improvement at week 16 than those with a lower baseline DLQI; however, only a small number of patients had a higher baseline DLQI. Those treated with apremilast also had significantly greater improvements in body surface area and Psoriasis Area Severity Index by week 16, as well as significantly greater reductions in itch numeric rating scale. There were no new safety concerns.
The study is limited by lack of an active comparator and short study duration.
“The consistency across EMBRACE and clinical trials provides strong support for apremilast as an effective treatment to reduce the impact of psoriasis on quality of life,” the study authors wrote.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mrowietz U, Barker J, Conrad C, et al. Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas, and impaired quality of life: results from the EMBRACE randomized trial. J Eur Acad Dermatol Venereol. Published online October 27, 2022. doi:10.1111/jdv.18689