J Drugs Dermatol. 2020 May 1;19(5):504-514.
Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.
In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).
The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.
HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.
两项 3 期研究的先前结果表明，固定组合卤倍他索丙酸 0.01%/他扎罗汀 0.045%（HP/TAZ）洗剂在中重度斑块状银屑病患者中具有疗效和安全性。这项事后分析评估了 HP/TAZ 洗剂在性别特异性方面的疗效和安全性。
在两项随机、双盲、3 期研究中，参与者按 2:1 的比例随机分配接受 HP/TAZ 或赋形剂洗剂，每天一次，持续 8 周。在这项汇总分析中，男性和女性参与者分别进行评估。疗效评估包括治疗成功（研究者全球评估[IGA]评分至少改善 2 级和评分清晰/几乎清晰）、对个体银屑病体征的影响以及受累体表面积（BSA）。
该分析包括 272 名男性（HP/TAZ，n=175；赋形剂，n=97）和 146 名女性（HP/TAZ，n=101；赋形剂，n=45）。在男性（38.4%对 9.8%）和女性（44.5%对 9.9%）亚组中，与赋形剂相比，在第 8 周时，接受 HP/TAZ 治疗的参与者中达到总体治疗成功的比例显著更高（均＜0.001）。在男性和女性中，红斑、斑块隆起和脱屑在第 8 周时也得到了改善，与接受赋形剂治疗的参与者相比，接受 HP/TAZ 治疗的参与者在每个银屑病体征上至少改善了 2 级，这一点在统计学上具有显著差异（均＜0.001）。在男性和女性中，与赋形剂洗剂相比，接受 HP/TAZ 治疗后，受累 BSA 的平均减少量也显著更大（均＜0.001）。在女性中最常见的治疗相关不良事件是接触性皮炎、瘙痒和用药部位疼痛（均为 4.0%），而在男性中最常见的不良事件是接触性皮炎（7.6%）。
在接受每天一次治疗 8 周的中重度银屑病男性和女性中，HP/TAZ 洗剂具有高度疗效和安全性。
