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.

Efficacy and safety profile of phosphodiesterase 4 inhibitor in the treatment of psoriasis: A systematic review and meta-analysis of randomized controlled trials

“…Patients with PsA also have psoriatic skin lesions. And this study only assessed general physical signs (Psoriasis Area Severity Index, PASI; Static Physician Global Assessment, sPGA), not localized lesions, such as nail and scalp ( 12 ).…”

Biologics and Small Molecule Inhibitors: an Update in Therapies for Allergic and Immunologic Skin Diseases

“…Results from an analysis of 8 trials showed that, at 16 weeks, PASI-75 was achieved by 30.81%, 25.19%, and 6.42% of subjects receiving apremilast 30 mg, 20 mg, and placebo, respectively. While significantly more adverse events were reported in those receiving 30 mg compared to 20 mg, most AEs were mild-to-moderate in severity [50]. These results suggest that apremilast remains an effective, safe, and well-tolerated therapeutic alternative for the treatment of psoriasis.…”

Comparing Meta-Analyses with ChatGPT in the Evaluation of the Effectiveness and Tolerance of Systemic Therapies in Moderate-to-Severe Plaque Psoriasis

“…We identified 28 MAs/NMAs published between January 2021 and May 2023, investigating and comparing the effect of systemic therapies for moderate-to-severe adult plaque psoriasis [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. A total of 10 analyses were excluded for the following reasons: insufficient information on the compared therapies in the abstract, the absence of the full text [ 28 , 29 , 30 ], the full text being in a language other than English [ 31 ], being a comparison to a placebo [ 32 , 33 , 34 , 35 , 36 ], or the absence of a direct comparison between therapies [ 37 ]. Two older versions or corrections of older MAs were also excluded [ 38 , 39 ] ( Figure 1 ).…”