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卡泊三醇倍他米松泡沫剂治疗轻度银屑病:三项随机试验的汇总结果。

Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials.

出版信息

J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.

Abstract

BACKGROUND

Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited.

OBJECTIVE

To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis.

METHODS

Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA BSA score.

RESULTS

Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA BSA score.

LIMITATIONS

These post hoc analyses need to be confirmed with prospective studies.

CONCLUSION

Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.

摘要

背景

寻常型银屑病即使病情较轻,也不易控制。对于这一人群,大多数局部治疗的疗效知识有限。

目的

评估卡泊三醇 0.005%加倍他米松二丙酸酯 0.064%(Cal/BD)泡沫剂治疗轻度银屑病患者的疗效。

方法

对 2 项 3 期和 1 项 2 期临床试验中基线轻度银屑病患者的汇总数据进行了事后分析。所有患者均每日使用 Cal/BD 泡沫剂或赋形剂泡沫剂治疗至少 4 周。疗效评估包括治疗成功(定义为 IGA=0)、mPASI、BSA 和 IGA BSA 综合评分。

结果

在 848 例患者中,有 164 例基线时有轻度银屑病。在这一轻度患者亚组中,Cal/BD 泡沫剂在第 4 周时在达到可见病变完全清除的患者比例(IGA=0)方面显示出优于赋形剂的显著疗效。mPASI、BSA 和 IGA BSA 评分也有显著改善。

局限性

这些事后分析需要前瞻性研究来证实。

结论

Cal/BD 泡沫剂每日 1 次,治疗 4 周,可有效治疗轻度银屑病患者,因为需要完全清除可见疾病,所以治疗成功在该人群中较难证明。Clinicaltrials.gov:NCT02132936、NCT01866163 和 NCT01536938 J 皮肤病学杂志。2021;20(8):822-828. doi:10.36849/JDD.5743.

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