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JADE COMPARE 随机 3 期研究中阿泊替尼治疗中重度特应性皮炎成人患者的患者报告结局。

Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis.

机构信息

Department of Dermatology and Venereology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

Department of Dermatology and Itch Center, University of Miami, Miami, FL, USA.

出版信息

J Eur Acad Dermatol Venereol. 2022 Mar;36(3):434-443. doi: 10.1111/jdv.17813. Epub 2021 Dec 13.

DOI:10.1111/jdv.17813
PMID:34779063
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9300205/
Abstract

BACKGROUND

In JADE COMPARE, abrocitinib improved severity of atopic dermatitis (AD) and demonstrated rapid itch relief.

OBJECTIVES

We examined clinically meaningful improvements in selected patient-reported outcomes (PROs).

METHODS

JADE COMPARE was a multicentre, phase 3 randomized, double-blind, placebo-controlled trial. Adults with moderate-to-severe AD were randomized 2:2:2:1 to receive 16 weeks of oral abrocitinib 200 or 100 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo, with background topical therapy. PROs included Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Night Time Itch Scale (NTIS), Pruritus and Symptoms Assessment for Atopic Dermatitis, Patient Global Assessment, SCORing Atopic Dermatitis, and Hospital Anxiety and Depression Scale.

RESULTS

At week 16, the proportion of patients achieving POEM scores <3 was 21.3% and 11.7% for 200 and 100 mg abrocitinib, 12.4% for dupilumab, and 4.8% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.04). Proportion achieving ≥4-point improvement from baseline in NTIS severity was 64.3% and 52.4% for 200 and 100 mg abrocitinib, 54.0% for dupilumab, and 34.4% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.007). Proportion achieving ≥4-point improvement from baseline in DLQI was 85.0% and 74.4% for 200 and 100 mg abrocitinib, 83.4% for dupilumab, and 59.7% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.005).

CONCLUSION

Significant improvements in PROs were demonstrated with both abrocitinib doses vs. placebo, and abrocitinib 200 mg provided numerically greater effects compared with dupilumab in patients with moderate-to-severe AD.

摘要

背景

在 JADE COMPARE 中,阿布昔替尼改善了特应性皮炎(AD)的严重程度,并迅速缓解了瘙痒。

目的

我们检查了选定的患者报告结局(PROs)的临床有意义的改善。

方法

JADE COMPARE 是一项多中心、3 期、随机、双盲、安慰剂对照试验。中重度 AD 成人患者按 2:2:2:1 的比例随机接受 16 周的口服阿布昔替尼 200 或 100mg 每日一次、度普利尤单抗 300mg 每 2 周皮下注射或安慰剂治疗,同时接受背景局部治疗。PROs 包括皮肤病生活质量指数(DLQI)、患者导向的湿疹测量(POEM)、夜间瘙痒量表(NTIS)、特应性皮炎瘙痒和症状评估、患者整体评估、SCORing 特应性皮炎和医院焦虑和抑郁量表。

结果

在第 16 周时,达到 POEM 评分<3 的患者比例分别为阿布昔替尼 200mg 和 100mg 组为 21.3%和 11.7%,度普利尤单抗组为 12.4%,安慰剂组为 4.8%(与阿布昔替尼相比,P<0.0001 和 P=0.04)。达到 NTIS 严重程度从基线至少改善 4 分的比例分别为阿布昔替尼 200mg 和 100mg 组为 64.3%和 52.4%,度普利尤单抗组为 54.0%,安慰剂组为 34.4%(与阿布昔替尼相比,P<0.0001 和 P=0.007)。达到 DLQI 从基线至少改善 4 分的比例分别为阿布昔替尼 200mg 和 100mg 组为 85.0%和 74.4%,度普利尤单抗组为 83.4%,安慰剂组为 59.7%(与阿布昔替尼相比,P<0.0001 和 P=0.005)。

结论

与安慰剂相比,两种剂量的阿布昔替尼均显示出 PROs 的显著改善,并且与中度至重度 AD 患者的度普利尤单抗相比,阿布昔替尼 200mg 提供了更大的效果。

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