Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE),Journal of the American Academy of Dermatology

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Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE)
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2018-01-17 , DOI: 10.1016/j.jaad.2018.01.017
Eric L. Simpson , Carsten Flohr , Lawrence F. Eichenfield , Thomas Bieber , Howard Sofen , Alain Taïeb , Ryan Owen , Wendy Putnam , Marcela Castro , Kendra DeBusk , Chin-Yu Lin , Athina Voulgari , Karl Yen , Theodore A. Omachi

Background

Interleukin (IL)-13 plays a key role in type 2 inflammation and is an emerging pathogenic mediator in atopic dermatitis (AD).

Objective

We investigated the efficacy and safety of lebrikizumab, an IL-13 monoclonal antibody, as an add-on to topical corticosteroid (TCS) treatment.

Methods

A randomized, placebo-controlled, double-blind, phase 2 study. Adults with moderate-to-severe AD were required to use TCS twice daily and then randomized (1:1:1:1) to lebrikizumab 125 mg single dose, lebrikizumab 250 mg single dose, lebrikizumab 125 mg every 4 weeks for 12 weeks, or placebo every 4 weeks for 12 weeks, after a 2-week TCS run-in. The primary endpoint was percentage of patients achieving Eczema Area and Severity Index (EASI)-50 at week 12.

Results

In total, 209 patients received the study drug. At week 12, significantly more patients achieved EASI-50 with lebrikizumab 125 mg every 4 weeks (82.4%; P = .026) than placebo every 4 weeks (62.3%); patients receiving a single dose of lebrikizumab showed no statistically significant improvements in EASI-50 compared with placebo. Adverse events were similar between groups (66.7% all lebrikizumab vs 66.0% placebo) and mostly mild or moderate.

Limitations

Protocol-mandated twice daily TCS treatment limits our understanding of the efficacy of lebrikizumab as a monotherapy. The short study duration did not enable long-term efficacy or safety evaluations.

Conclusion

When combined with TCS, lebrikizumab 125 mg taken every 4 weeks led to a significant improvement and was well tolerated in patients with moderate-to-severe AD.

中文翻译：

Lebrikizumab（抗IL-13单克隆抗体）在局部至局部皮质类固醇激素控制不足的成人中度至重度特应性皮炎的疗效和安全性：一项随机，安慰剂对照的II期临床试验（TREBLE）

背景

白介素（IL）-13在2型炎症中起关键作用，并且是特应性皮炎（AD）中新兴的病原体。

客观的

我们研究了作为局部皮质类固醇（TCS）治疗的附加药物的Lebrikizumab（一种IL-13单克隆抗体）的功效和安全性。

方法

一项随机，安慰剂对照，双盲，2期研究。患有中度至重度AD的成年人每天需要使用TCS两次，然后随机（1：1：1：1）随机给予lebrikizumab 125 mg单剂，lebrikizumab 250 mg单剂，lebrikizumab 125 mg每4周一次，持续12周，在2周的TCS磨合后，每4周一次或安慰剂治疗12周。主要终点指标是在第12周达到湿疹面积和严重程度指数（EASI）-50的患者百分比。

结果

共有209名患者接受了该研究药物。在第12周时，与安慰剂相比，每4周获得EASI-50的Lebrikizumab 125 mg每4周的发生率显着增加（82.4％；P = .026）；与安慰剂相比，接受单剂量来昔单抗治疗的患者在EASI-50中无统计学上的显着改善。各组之间的不良事件相似（所有来布列单抗的发生率为66.7％，而安慰剂为66.0％），且多数为轻度或中度。