Adding apremilast to a topical corticosteroid regimen in patients with moderate plaque-type psoriasis is safe and effective, with those who had insufficient response to topical corticosteroids achieving notable and objective clinical improvements, according to a study published in the Journal of Drugs in Dermatology.
Researchers in this open-label, single-arm, 16-week study assessed the safety and efficacy of adding apremilast to a regimen of topical corticosteroids in 20 patients with moderate plaque-type psoriasis with a 4-week off-treatment follow-up. Each subject received 30 mg apremilast twice daily (after titration) through week 16.
Assessments included static Physicians Global Assessment, Psoriasis Area and Severity Index (PASI), body surface area (BSA), dermatology life quality index, pruritis, and treatment satisfaction questionnaire for medication. The primary efficacy measure was mean change and mean percent change in product of BSA (%) x static Physicians Global Assessment at week 16 compared with baseline. Participants were assessed at baseline and weeks 4, 8, 16, and 20 (after 4 weeks off treatment).
Statistically significant mean and median reductions in BSA were achieved by week 8, and participants achieved a 36% improvement in median BSA (P =.008) by week 16. By week 8, 15% of participants had achieved PASI-50, and 40% had done so by week 16, at which time 30% of participants had achieved PASI-75. Pruritus reductions became evident at week 4 and became statistically significant at week 8.
Decreases in dermatology life quality index scores showed statistically significant improvements from baseline to week 8 and week 16. By week 4, 2 of the 4 domains of the treatment satisfaction questionnaire for medication (Convenience and Satisfaction) achieved statistical significance, which continued through week 20.
Thirty-four adverse events in 17 participants were reported, the majority of which were gastrointestinal and related to the study medication.
Despite the need for more studies with larger populations and control groups, study investigators concluded that the study findings demonstrate the safety and efficacy of adding apremilast to a regimen of topical corticosteroids and that participants “who had insufficient response to [topical corticosteroids] achieved notable and objective clinical improvement with the addition of apremilast.”
Disclosure: Leon H. Kircik MD, is an investigator, consultant, speaker, and advisory board member for Celgene.
Aljaser M, Amar L, Kircik LH. Use of apremilast in patients who are dissatisfied with stable maintenance topical therapy. J Drugs Dermatol. 2019;18(4):336-340.