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阿普米司特联合卡泊三醇倍他米松治疗中重度斑块状银屑病。

Apremilast with Add-On Calcipotriene/Betamethasone Dipropionate for Treating Moderate to Severe Plaque Psoriasis.

出版信息

J Drugs Dermatol. 2020 Dec 1;19(12):1149-1155. doi: 10.36849/JDD.2020.5435.

Abstract

BACKGROUND

About 20% of patients taking apremilast alone obtain PASI 75 by week 8. This single-center, pilot study aimed to determine whether add-on topical therapy with calcipotriene/betamethasone dipropionate (C/BD) could improve responses of partial apremilast responders by week 12.

METHODS

Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks. Patients who achieved between PASI 25–74 at week 8 used add-on, daily topical C/BD (.005%/.064%) foam up to week 12; those with <PASI 25 at week 8 were discontinued.

RESULTS

Of 50 patients enrolled, 26 achieved PASI 25−74 and 8 PASI 75 at week 8. At week 12, 29 achieved PASI 75, and 24 at week 16. Of the week-8 partial responders, 21/26 achieved PASI 75 at week 12 on combination therapy and 15 maintained PASI 75 through week 16 on apremilast alone (4 did not maintain; 2 lost to follow up). In partial responders, mean PGA and BSA affected improved by 30% and 33% on apremilast, respectively, and by 67% and 86% at week 12 on the combination therapy, respectively. The most commonly reported adverse events (AEs; >5% occurrence) were headache (14%), diarrhea (10%), and nausea (8%); majority were mild. No related serious AEs occurred.

CONCLUSION

We show that most week-8 partial apremilast responders can achieve PASI 75 at week 12 with combination C/BD topical therapy, and maintain PASI 75 through week 16 with apremilast monotherapy. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5435.

摘要

背景

约 20%单独使用阿普司特的患者在第 8 周达到 PASI75。本单中心、先导研究旨在确定第 12 周时添加钙泊三醇/倍他米松二丙酸酯(C/BD)外用疗法是否能改善部分阿普司特应答者的应答。

方法

中重度斑块状银屑病患者(基线 PGA≥3、BSA 受累≥10%、PASI≥12)接受阿普司特(30mg 每日 2 次)治疗 8 周。第 8 周达到 PASI25-74 的患者加用每日外用 C/BD(0.005%/0.064%)泡沫剂直至第 12 周;第 8 周 PASI<25 的患者停药。

结果

50 例患者中,26 例达到 PASI25-74,8 例达到 PASI75。第 12 周时,29 例达到 PASI75,24 例达到 PASI16。第 8 周时的部分应答者中,26 例中的 21 例在联合治疗中达到 PASI75,15 例在单独使用阿普司特时维持 PASI75(4 例未维持;2 例失访)。在部分应答者中,阿普司特治疗的平均 PGA 和 BSA 受累分别改善 30%和 33%,联合治疗第 12 周分别改善 67%和 86%。最常见的不良事件(AE;发生率>5%)为头痛(14%)、腹泻(10%)和恶心(8%);多数为轻度。未发生与治疗相关的严重 AE。

结论

我们发现,大多数第 8 周的部分阿普司特应答者可在第 12 周通过联合 C/BD 外用治疗达到 PASI75,并且通过阿普司特单药治疗可维持至第 16 周的 PASI75。J 皮肤病药物学杂志。2020;19(12):doi:10.36849/JDD.2020.5435。

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