Department of Dermatology, Faculty of Medicine, Autonomous University of Madrid, La Paz University Hospital, Madrid, Comunidad de Madrid, Spain.
Division of Medicine, Albert Einstein Israeli Faculty of Health Sciences, São Paulo, São Paulo, Brazil.
Clin Drug Investig. 2024 Sep;44(9):655-665. doi: 10.1007/s40261-024-01368-w. Epub 2024 Aug 22.
Plaque psoriasis is commonly treated topically with glucocorticoids and vitamin D derivatives. However, potential side effects such as skin atrophy underscore the need for safe and effective alternative topical therapies. Recently, the US Food and Drug Administration (FDA) and Health Canada approved roflumilast 0.3% cream as an option for treating this disease. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to assess the efficacy and safety of topical roflumilast 0.3% compared with vehicle for plaque psoriasis.
PubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched from inception to 1 May 2024, assessing the outcomes of Investigator's Global Assessment (IGA) or body-IGA success (clear or almost clear status plus an at least 2-grade improvement from baseline), Psoriasis Area and Severity Index (PASI)-50, PASI-75, PASI-90, intertriginous-IGA success (clear or almost clear status on the intertriginous-IGA plus an at least 2-grade improvement from baseline), and adverse events (AEs). Statistical analysis was performed using Review Manager, R software, and RStudio. Heterogeneity was determined using the Cochran Q test and I statistics.
Four RCTs were included, comprising a total of 1403 patients, of whom 885 (63.1%) received topical roflumilast 0.3% and 518 (36.9%) received vehicle. At week 8, the achievement of IGA or body-IGA success was significantly higher among those treated with topical roflumilast than in the vehicle group [relative risk (RR) 5.07; 95% confidence interval (CI) 3.55-7.23; p < 0.01]. Similar findings were observed at week 8 for PASI-50 (RR 2.73; 95% CI 2.27-3.29; p < 0.01), PASI-75 (RR 4.48; 95% CI 2.26-8.89; p < 0.01), and PASI-90 (RR 5.61; 95% CI 2.57-12.25; p < 0.01). Corresponding outcomes were found at weeks 2, 4, and 6. Additionally, a higher percentage of patients treated with topical roflumilast 0.3% once daily achieved intertriginous-IGA success, compared with those receiving vehicle, at week 8 (71.9% versus 20.5%; RR 3.32; 95% CI 2.11-5.22; p < 0.01), with similar findings at weeks 2, 4, and 6. While a significant difference was observed in the overall incidence of AEs between the topical roflumilast and vehicle groups, there was no difference in treatment-related AEs, serious AEs, or AEs leading to study discontinuation.
These findings support the superiority of topical roflumilast 0.3% over vehicle and suggest its use as a valuable asset for the treatment of plaque psoriasis.
International Prospective Register of Systematic Reviews (PROSPERO), CRD42023456494.
斑块状银屑病通常采用局部糖皮质激素和维生素 D 衍生物进行治疗。然而，皮肤萎缩等潜在副作用突显了安全有效替代局部治疗的必要性。最近，美国食品和药物管理局（FDA）和加拿大卫生部批准了罗氟司特 0.3%乳膏作为治疗这种疾病的一种选择。本系统评价和随机对照试验（RCT）的荟萃分析旨在评估与载体相比，局部应用罗氟司特 0.3%治疗斑块状银屑病的疗效和安全性。
从成立到 2024 年 5 月 1 日，我们在 PubMed、Embase、ClinicalTrials.gov 和 Cochrane 数据库中进行了检索，评估了研究者全球评估（IGA）或体-IGA 成功（清晰或几乎清晰状态，加上基线至少 2 级改善）、银屑病面积和严重程度指数（PASI-50）、PASI-75、PASI-90、间擦部-IGA 成功（间擦部-IGA 清晰或几乎清晰状态，加上基线至少 2 级改善）和不良事件（AE）的结果。使用 Review Manager、R 软件和 RStudio 进行统计分析。使用 Cochran Q 检验和 I 统计量确定异质性。
纳入了 4 项 RCT，共纳入 1403 名患者，其中 885 名（63.1%）接受了局部罗氟司特 0.3%治疗，518 名（36.9%）接受了载体治疗。在第 8 周时，与载体组相比，接受局部罗氟司特治疗的患者 IGA 或体-IGA 成功率显著更高[相对风险（RR）5.07；95%置信区间（CI）3.55-7.23；p<0.01]。在第 8 周时，PASI-50（RR 2.73；95%CI 2.27-3.29；p<0.01）、PASI-75（RR 4.48；95%CI 2.26-8.89；p<0.01）和 PASI-90（RR 5.61；95%CI 2.57-12.25；p<0.01）也观察到了类似的发现。在第 2、4 和 6 周也发现了相应的结果。此外，与接受载体治疗的患者相比，每天接受一次局部罗氟司特 0.3%治疗的患者在第 8 周时达到间擦部-IGA 成功率更高，为 71.9%，而接受载体治疗的患者为 20.5%（RR 3.32；95%CI 2.11-5.22；p<0.01），在第 2、4 和 6 周也有类似的发现。虽然局部罗氟司特组和载体组之间的总体 AE 发生率存在显著差异，但在治疗相关 AE、严重 AE 或导致研究中止的 AE 方面没有差异。
这些发现支持局部罗氟司特 0.3%优于载体，并表明其可作为治疗斑块状银屑病的有价值资产。
国际前瞻性系统评价注册库（PROSPERO），CRD42023456494。
