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阿布罗替尼治疗青少年和成年人中重度特应性皮炎疗效显著
作者:小柯机器人 发布时间:2020/7/28 14:45:45

美国辉瑞公司Ricardo Rojo团队研究了阿布罗替尼治疗成人和青少年中重度特应性皮炎的疗效和安全性。2020年7月25日,该研究发表在《柳叶刀》杂志上。

在2b期临床试验中,口服选择性Janus激酶1抑制剂阿布罗替尼对患有中重度特应性皮炎的成年人有效且耐受良好。

在这项多中心、双盲、随机、临床3期试验中,2017年12月7日至2019年3月26日,研究组在澳大利亚、加拿大、欧洲和美国的69个地点招募了387名中重度特应性皮炎患者,年龄在12岁及以上,体重超过40kg。将这些患者按2:2:1随机分组,其中156名接受100mg阿布罗替尼治疗,154名接受200mg阿布罗替尼治疗,77名接受安慰剂治疗,均持续12周。主要终点为达到研究者总体评估缓解,即分数比基线改善超过2级,得分为0或1;以及湿疹面积和严重程度指数(EASI)得分比基线至少提高75%。

所有患者均至少接受了一剂研究治疗药物。在第12周,阿布罗替尼100mg组中达到研究者总体评估缓解的患者占24%,阿布罗替尼200mg组为44%,均显著高于安慰剂组(8%);阿布罗替尼100mg组中达到EASI-75缓解的患者占40%,阿布罗替尼200mg组为63%,均显著高于安慰剂组(12%)。阿布罗替尼100mg组中有69%的患者发生不良事件,阿布罗替尼200mg组中有78%,安慰剂组中有57%。阿布罗替尼100mg组中有3%的患者发生严重不良事件,阿布罗替尼200mg组中有3%,安慰剂组中有4%。三组均未发生治疗相关的死亡事件。

总之,口服阿布罗替尼治疗青少年和成年人中重度特应性皮炎疗效显著,耐受性良好。

附:英文原文

Title: Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial

Author: Eric L Simpson, Rodney Sinclair, Seth Forman, Andreas Wollenberg, Roland Aschoff, Michael Cork, Thomas Bieber, Jacob P Thyssen, Gil Yosipovitch, Carsten Flohr, Nina Magnolo, Catherine Maari, Claire Feeney, Pinaki Biswas, Svitlana Tatulych, Hernan Valdez, Ricardo Rojo

Issue&Volume: 2020/07/25

Abstract: Background

Abrocitinib, an oral selective Janus kinase 1 inhibitor, was effective and well tolerated in adults with moderate-to-severe atopic dermatitis in a phase 2b trial. We aimed to assess the efficacy and safety of abrocitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis.

Methods

In this multicentre, double-blind, randomised phase 3 trial (JADE MONO-1), patients (aged ≥12 years) with moderate-to-severe atopic dermatitis (Investigator Global Assessment score ≥3, Eczema Area and Severity Index [EASI] score ≥16, percentage of body surface area affected ≥10%, and Peak Pruritus Numerical Rating Scale score ≥4) with a bodyweight of 40 kg or more, were enrolled at 69 sites in Australia, Canada, Europe, and the USA. Patients were randomly assigned (2:2:1) to oral abrocitinib 100 mg, abrocitinib 200 mg, or placebo once daily for 12 weeks. Randomisation was done using an interactive response technology system, stratified by baseline disease severity and age. Patients, investigators, and the funder of the study were masked to study treatment. The coprimary endpoints were the proportion of patients who had achieved an Investigator Global Assessment response (score of 0 [clear] or 1 [almost clear] with a ≥2-grade improvement from baseline), and the proportion of patients who achieved at least a 75% improvement in EASI score from baseline (EASI-75) score, both assessed at week 12. Efficacy was assessed in the full analysis set, which included all randomised patients who received at least one dose of study medication. Safety was assessed in all randomised patients. This study is registered with ClinicalTrials.gov, NCT03349060.

Findings

Between Dec 7, 2017, and March 26, 2019, 387 patients were enrolled: 156 were assigned to abrocitinib 100 mg, 154 to abrocitinib 200 mg, and 77 to placebo. All enrolled patients received at least one dose of study treatment and thus were evaluable for 12-week efficacy. Of the patients with available data for the coprimary endpoints at week 12, the proportion of patients who had achieved an Investigator Global Assessment response was significantly higher in the abrocitinib 100 mg group than in the placebo group (37 [24%] of 156 patients vs six [8%] of 76 patients; p=0·0037) and in the abrocitinib 200 mg group compared with the placebo group (67 [44%] of 153 patients vs six [8%] of 76 patients; p<0·0001). Of the patients with available data for the coprimary endpoints at week 12, compared with the placebo group, the proportion of patients who had achieved an EASI-75 response was significantly higher in the abrocitinib 100 mg group (62 [40%] of 156 patients vs nine [12%] of 76 patients; p<0·0001) and abrocitinib 200 mg group (96 [63%] of 153 patients vs nine [12%] of 76 patients; p<0·0001). Adverse events were reported in 108 (69%) of 156 patients in the abrocitinib 100 mg group, 120 (78%) of 154 patients in the abrocitinib 200 mg group, and 44 (57%) of 77 patients in the placebo group. Serious adverse events were reported in five (3%) of 156 patients in the abrocitinib 100 mg group, five (3%) of 154 patients in the abrocitinib 200 mg group, and three (4%) of 77 patients in the placebo group. No treatment-related deaths were reported.

Interpretation

Monotherapy with oral abrocitinib once daily was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis.

DOI: 10.1016/S0140-6736(20)30732-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30732-7/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet