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J Am Acad Dermatol. 2018 May;78(5):863-871.e11. doi: 10.1016/j.jaad.2018.01.017. Epub 2018 Jan 17.

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).

Author information

1
Department of Dermatology, School of Medicine, Oregon Health & Science University, Portland, Oregon.
2
St. John's Institute of Dermatology, King's College London and Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom.
3
Department of Dermatology, University of California San Diego, San Diego, California.
4
Department of Dermatology and Allergy, University Medical Center, Bonn, Germany.
5
University of California Los Angeles School of Medicine, Los Angeles, California.
6
Department of Dermatology and Pediatric Dermatology, Bordeaux Hospital University Center, France.
7
Genentech, South San Francisco, California.
8
Global Product Development Clinical Science, Roche Products Limited, Welwyn Garden City, United Kingdom.
9
Roche, Grenzacherstrasse, Basel, Switzerland.
10
Genentech, South San Francisco, California. Electronic address: omachi.theodore@gene.com.

Abstract

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.

KEYWORDS:

EASI; anti-IL-13; atopic dermatitis; lebrikizumab; pruritus; topical corticosteroids

PMID:
29353026
DOI:
10.1016/j.jaad.2018.01.017
[Indexed for MEDLINE]
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