Efficacy and safety of apremilast monotherapy in moderate-to-severe plaque psoriasis: A systematic review and meta-analysis

Abstract

Psoriasis is a chronic, inflammatory, immune-mediated disease of the skin and joints. Plaque psoriasis is the most common clinical phenotype of psoriasis. Apremilast is an oral phosphodiesterase type 4 inhibitor recently approved by the US Food and Drug Administration (FDA) for the management of plaque psoriasis. The aim of this systematic review was to assess the efficacy and safety of apremilast monotherapy for the treatment of moderate-to-severe plaque psoriasis. This systematic review included randomized controlled trials (RCTs) comparing apremilast 20 mg twice daily (BID) and 30 mg BID with placebo for its efficacy on plaque psoriasis. We searched the Medline, Embase, and CENTRAL databases. We sought to evaluate the following outcomes: psoriasis area and severity index score (PASI)-50, PASI-75, PASI-90, static Physician Global Assessment (sPGA), and adverse events. The risk ratio (RR) was used to represent dichotomous outcomes and adverse events, and the data were pooled using the inverse variance weighting method. Eight RCTs that enrolled 2635 participants were deemed eligible. Apremilast 30 mg BID and 20 mg BID were significantly more efficacious than placebo in achieving PASI-75 over 16 weeks (RR = 4.60, 95% CI 3.29-6.41, and RR = 3.15, 95% CI 1.96-5.07, respectively). Apremilast 30 mg BID showed a significantly higher rate of adverse events than the placebo (RR = 1.24, 95% CI 1.16-1.33), whereas apremilast 20 mg BID did not exhibit any significant difference (RR = 1.13, 95% CI 0.91-1.42). This meta-analysis demonstrated that apremilast monotherapy is an effective therapeutic option for moderate-to-severe plaque psoriasis with acceptable tolerability and safety profile.

Keywords: Psoriasis Area and Severity Index score; apremilast monotherapy; phosphodiesterase 4 inhibitor; plaque psoriasis.