Ortonne J-P, Esposito M, Chimenti S, Kapińska-Mrowiecka M, Grodzińska A, Naldi L, Frangione V
Department of Dermatology, University Hospital of Nice, Nice, France.
J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1226-34. doi: 10.1111/jdv.12270. Epub 2013 Oct 29.
A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP).
This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients' quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group.
Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a -0.288 (95% CI: -0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group.
BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients' psoriasis and QoL.
已发现即用型0.1%戊酸倍他米松（BMV）敷料在治疗慢性斑块状银屑病（CPP）患者方面优于安慰剂敷料和对照0.1% BMV乳膏。
这项多中心、前瞻性、随机、研究者设盲、对照、非劣效性试验比较了BMV敷料与卡泊三醇倍他米松二丙酸酯（CBD）软膏在轻度至中度CPP患者4周治疗期间的疗效和安全性。主要疗效终点是第4周时的4项银屑病总严重程度评分（TSS-4），相关的非劣效界值为1分。次要结局指标包括银屑病整体评估（PGA）评分和患者生活质量（QoL）。通过各治疗组的不良事件（AE）报告评估安全性。
在325例筛查患者中，324例被随机分配至BMV组（N = 165）或CBD组（N = 159），并被视为可进行安全性和意向性治疗（ITT）疗效分析。符合方案（PP）人群分别包括BMV组和CBD组的133例和131例患者。在整个研究过程中，两组的平均调整后TSS-4均较基线显著降低。对第4周数据的PP（主要）分析显示，调整后均值的组间差异为-0.288（95%CI：-0.610至0.034），无统计学意义，表明BMV不劣于CBD。ITT分析也显示了非劣效性。两组在第4周时PGA和其他次要结局均较基线显著改善。第4周时CBD组的QoL评分略好，但随访时未观察到差异。两组均未观察到安全性或耐受性问题。
对于轻度至中度CPP患者，BMV敷料不劣于CBD软膏。两种治疗方法均能显著改善患者的银屑病和QoL。
