Categories
Change Password!
Reset Password!
Topical Roflumilast 0.3% can serve as a promising alternative to address the unmet need for effective and safe topical treatments for plaque psoriasis.
In a systematic review and meta-analysis of randomized controlled trials (RCTs), topical Roflumilast 0.3% cream proved markedly more effective than vehicle in mitigating plaque psoriasis. The goal was to investigate Roflumilast cream's efficacy and safety for plaque psoriasis management.
A systematic search of ClinicalTrials.gov, Embase, Cochrane databases, and PubMed was conducted to assess endpoints including Investigator's Global Assessment (IGA) or body-IGA success, Psoriasis Area and Severity Index (PASI)-50, PASI-75, PASI-90, intertriginous-IGA positive accomplishment, and adverse events. Overall, 4 RCTs involving 1,403 subjects (885 treated with topical Roflumilast 0.3% and 518 with vehicle) were incorporated in the analysis. At week 8, volunteers using Roflumilast depicted markedly higher rates of IGA or body-IGA success when compared to the vehicle group (relative risk [RR] 5.07).
Similar improvements were witnessed in PASI-50 (RR 2.73), PASI-75 (RR 4.48), and PASI-90 (RR 5.61). These results were consistent at weeks 2, 4, and 6. Additionally, at week 8, a higher proportion of volunteers treated with Roflumilast attained intertriginous-IGA success (71.9% vs. 20.5%; RR 3.32). Although the overall incidence of adverse events was higher in the Roflumilast group, no prominent differences were noted in treatment-related adverse events, serious adverse events, or adverse events leading to study termination.
To sum up, topically applied 0.3% Roflumilast cream facilitated better attainment of clinical milestones when compared to vehicle, including increased rates of IGA or body-IGA success, intertriginous-IGA success, and remarkable improvements in PASI, all with a favorable safety profile in psoriasis-affected patients. The evidence supports its potential role in psoriasis care.
Clinical Drug Investigation
Efficacy and Safety of Topical Roflumilast for the Treatment of Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Rafaela de Moraes-Souza et al.
Comments (0)