银屑病患者的瘙痒缓解：卡泊三醇倍他米松二丙酸酯泡沫的疗效。

Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam.

机构信息

Department of Dermatology, Bürgenstock Medical Center, Obbürgen, Switzerland.

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

出版信息

J Eur Acad Dermatol Venereol. 2019 Apr;33(4):709-717. doi: 10.1111/jdv.15393.

DOI:10.1111/jdv.15393

PMID:30520168

Abstract

BACKGROUND

Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep.

OBJECTIVE

We evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle.

METHODS

We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks.

RESULTS

Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n = 610; foam vehicle, n = 190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R = 0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P < 0.05]; Week 4: 83.0% vs. 45.8% [P < 0.001]). More Cal/BD-foam-treated patients achieved Itch70 at Day 3 (34.2% vs. 22.5%; P < 0.05) through to Week 4 (79.3% vs. 38.1%; P < 0.001). In patients with baseline itch VAS >40 and sleep loss >20, improvements in itch-related sleep loss occurred at Week 1 and continued through 4 weeks. Itch-related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD-foam- vs. foam-vehicle-treated patients with baseline DLQI >10 (n = 172 vs. n = 50) achieving DLQI ≤1 (25.0% vs. 4.0%; P = 0.001) and DLQI 0 (17.4% vs. 2.0%; P = 0.006) at Week 4.

CONCLUSION

Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.

摘要

背景

瘙痒是银屑病的常见症状，会对健康相关生活质量（HRQoL）和睡眠产生不利影响。

目的

评估固定剂量复方钙泊三醇 50μg/g 加倍他米松二丙酸酯 0.5mg/g 皮肤泡沫（Cal/BD 泡沫）与泡沫载体相比，在治疗瘙痒、瘙痒相关睡眠损失和 HRQoL 方面的疗效。

方法

我们汇总了三项关于 Cal/BD 泡沫与泡沫载体在轻度至重度银屑病成人患者中的 II/III 期试验（NCT01536886/NCT01866163/NCT02132936）的数据。对于瘙痒相关分析，纳入基线瘙痒视觉模拟量表（VAS）>40（范围 0-100）的患者。主要疗效终点包括瘙痒 VAS 改善>40、瘙痒改善≥70%（Itch70）或瘙痒相关睡眠损失、改良银屑病面积和严重程度指数（不包括头部；mPASI75）和皮肤病生活质量指数（DLQI）评分改善至 0/1 分在 4 周内。

结果

在 837 名患者中，800 名患者基线瘙痒 VAS >0（Cal/BD 泡沫组 n=610，泡沫载体组 n=190）；484 名患者基线瘙痒 VAS >40。瘙痒 VAS 评分与基线时 mPASI 无相关性（R=0.021）。在基线瘙痒 VAS >40 的患者中，从第 5 天开始，活性治疗组较载体组有更多患者达到瘙痒 VAS 改善>40（第 5 天：57.5% vs. 40.2% [P<0.05]；第 4 周：83.0% vs. 45.8% [P<0.001]）。更多接受 Cal/BD 泡沫治疗的患者在第 3 天（34.2% vs. 22.5%；P<0.05）和第 4 周（79.3% vs. 38.1%；P<0.001）达到 Itch70。在基线瘙痒 VAS >40 和睡眠损失>20 的患者中，瘙痒相关睡眠损失在第 1 周开始改善，并持续至第 4 周。瘙痒改善先于 mPASI75 的改善。基线时 DLQI >10（n=172）的 Cal/BD 泡沫治疗患者与 DLQI≤1（25.0% vs. 4.0%；P=0.001）和 DLQI 0（17.4% vs. 2.0%；P=0.006）的比例显著高于泡沫载体治疗患者。