Effectiveness and Safety of Roflumilast in the Treatment of Psoriasis: A Systematic Review and Meta-Analysis

Psoriasis, a chronic autoimmune condition, can severely impact patients' well-being. It is characterized by erythema, thickening, and scaling of the skin. Plaque psoriasis, the most prevalent type, affects 80%-90% of psoriasis patients, ranging from localized to severe cases. Although corticosteroids are commonly used to treat psoriasis, prolonged use poses risks. Therefore, alternative therapies are needed. Roflumilast, a potent phosphodiesterase 4 inhibitor, is currently being considered as a treatment for plaque psoriasis.

We searched four electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Scopus, and Web of Science) up to March 2024 for relevant articles evaluating the efficacy and tolerability of roflumilast in the management of psoriasis. The quality of evidence from trials was assessed using the Cochrane Risk of Bias tool (RoB1). Data from the included studies were extracted into a standardized online sheet and analyzed using RevMan 5.4.

Roflumilast significantly increased the proportion of patients achieving an Investigator's Global Assessment score of 0 or 1 and a 2-point improvement score at both weeks 4 and 8 compared to placebo (RR = 3.48, 95% CI [2.04 to 5.92], P < 0.00001, and RR = 4.02, 95% CI [3.17 to 5.11], P < 0.00001, respectively). The pooled studies demonstrated homogeneity at both weeks 4 (P = 0.17, I² = 38%) and 8 (P = 0.38, I² = 5%). Regarding the results of the Psoriasis Area and Severity Index, 75% favored roflumilast over placebo (RR = 2.72, 95% CI [1.18 to 6.28], P < 0.00001, and RR = 3.41, 95% CI [2.19 to 5.32], P < 0.00001, at weeks 4 and 8, respectively). Subgroup analysis addressed the observed heterogeneity in the results.

This meta-analysis represents the first investigation into the efficacy and safety of roflumilast for treating psoriasis. Results suggest that roflumilast is both effective and well-tolerated in managing psoriasis. However, additional robust clinical trials are needed to validate these observations..