Breaking News:Roflumilast for Psoriasis: Early Efficacy, Safety– What Just Happened

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ROFLUMILAST for psoriasis improved Global Assessment scores and was well tolerated versus placebo by Week 8 in a systematic review.

Why Roflumilast for Psoriasis Was Studied

Psoriasis is a chronic inflammatory skin disease that can significantly affect quality of life, with erythema, thickening, and scaling as common clinical hallmarks. The most common phenotype is plaque psoriasis, accounting for the majority of cases and ranging from localized disease to extensive involvement. Topical corticosteroids remain widely used, but longer-term use can raise safety and tolerability concerns, reinforcing interest in alternative options. Roflumilast, a potent phosphodiesterase 4 inhibitor, has been explored as a treatment approach for psoriasis in controlled trials.

Roflumilast for Psoriasis: Efficacy Signals at Weeks 4 and 8

In a systematic review and meta-analysis of randomized trials identified across four databases through March 2024, roflumilast was associated with higher rates of improvement on Investigator’s Global Assessment outcomes compared with placebo. Specifically, more patients receiving roflumilast achieved an Investigator’s Global Assessment score of 0 or 1 and a 2 point improvement at both Week 4 and Week 8. The pooled analysis also favored roflumilast on measures related to the Psoriasis Area and Severity Index, with most comparisons indicating improved response versus placebo at the same timepoints. Reported heterogeneity was low at Week 8 and modest at Week 4, and subgroup analysis was used to explore variability in outcomes.

Safety and What Comes Next

Across included studies, roflumilast was described as well tolerated overall. The authors conclude that these findings support roflumilast as an effective and generally tolerable option for psoriasis management in the analyzed trials. However, they also emphasize the need for additional robust clinical trials to confirm the magnitude of benefit, clarify durability, and further characterize safety across broader patient populations.

Reference: Aleid AM et al. Effectiveness and Safety of Roflumilast in the Treatment of Psoriasis: A Systematic Review and Meta-Analysis. Curr Drug Saf. 2026; DOI: 10.2174/0115748863406187251031101244.