卡泊三醇倍他米松二丙酸酯固定复方气雾剂泡沫制剂治疗寻常型银屑病疗效显著：三项随机对照研究的汇总数据

Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies.

作者信息

Stein Gold Linda, Lebwohl Mark, Menter Alan, Villumsen John, Rosen Monika, Koo John

出版信息

J Drugs Dermatol. 2016 Aug 1;15(8):951-7.

Abstract

BACKGROUND

Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this formulation for 4 weeks of treatment.

METHODS

Patients aged ≥18 years with mild-severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity ('treatment success'); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).

RESULTS

1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: -30 mm), maintained to week 4 (change in itch VAS: -41 mm).

CONCLUSIONS

Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.

J Drugs Dermatol. 2016;15(8):951-957.

摘要

背景

0.005% 卡泊三醇（Cal）/0.064% 倍他米松二丙酸酯（BD）气雾剂泡沫被开发为银屑病患者的一种新治疗选择。这项汇总分析评估了该制剂4周治疗的疗效。

方法

年龄≥18岁的轻至重度银屑病患者被纳入三项II/III期研究（nCT01536886、nCT01536938、nCT01866163）；每项研究评估Cal/BD气雾剂泡沫与不同对照剂。终点包括：在医生对疾病严重程度的整体评估中改善≥2级的清除/几乎清除患者比例（“治疗成功”）；改良（不包括头部）银屑病面积和严重程度指数（mPASI）；mPASI降低≥75%的患者比例（PASI75）；瘙痒变化（根据视觉模拟量表[VAS]）。

结果

1104例患者纳入汇总分析：Cal/BD气雾剂泡沫（n = 564）、Cal/BD软膏（n = 135）、BD气雾剂泡沫（n = 101）、Cal气雾剂泡沫（n = 101）、气雾剂泡沫赋形剂（n = 152）、软膏赋形剂（n = 51）。在第4周，51%使用Cal/BD气雾剂泡沫的患者获得治疗成功，这一比例高于所有其他组（Cal/BD软膏，43%；BD气雾剂泡沫，31%；Cal气雾剂泡沫，15%；气雾剂泡沫赋形剂，5%；软膏赋形剂，8%）。在第4周，与其他治疗相比，Cal/BD气雾剂泡沫使mPASI的平均降低百分比更大（分别为72%对63%、53%、43%、32%和33%）；第4周的PASI75率也更高（分别为51%对41%、34%、18%、7%和10%）。无论基线疾病严重程度如何，Cal/BD气雾剂泡沫在所有评估的身体部位（手臂、腿部、躯干）均有效。Cal/BD气雾剂泡沫早在第1周就减轻了瘙痒（瘙痒VAS变化：-30 mm），持续到第4周（瘙痒VAS变化：-41 mm）。