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Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.

ABSTRACT: Background:Atopic dermatitis (AD) is a chronic, relapsing skin condition with a wide disease spectrum. Moderate-to-severe cases often need systemic treatment. Conventional immunosuppressants have extensive side effect profiles and require close monitoring. In recent decades, there has been increasing interest in developing targeted systemic immunomodulators for AD, as they have been shown to have efficacy for AD as well as favorable safety profiles. Herein, we review the recent data on lebrikizumab, an interleukin (IL)-13 inhibitor, and its potential role in the treatment of AD. Objective:Review the mechanism of action, and available data on the efficacy and safety of lebrikizumab for the treatment of AD. Methods:PubMed, Google Scholar, and clinicaltrials.gov searches were performed with the following terms: "atopic dermatitis," "dermatitis," "eczema," "lebrikizumab," "IL-4," and "IL-13." Results:Two Phase II randomized controlled clinical trials have been conducted to evaluate the use of lebrikizumab in a total of 289 patients with moderate-severe AD and inadequate response to topical corticosteroids. Patients treated with lebrikizumab experienced significantly more improvement in their AD compared to placebo, as measured by Eczema Area and Severity Index (EASI)-50 and EASI-75 scores, pruritus scores, and reduction in body surface area (BSA). Its clinical efficacy appears to be dose-dependent, and it has a favorable side effect profile and is generally well tolerated. Conclusion:Lebrikizumab appears to be a promising emerging targeted biologic for the treatment of moderate-to-severe AD. Further Phase III studies investigating optimal dosing regimens and safety profile are needed.

SUBMITTER: Loh TY

PROVIDER: S-EPMC7023853 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.

Loh Tiffany Y TY Hsiao Jennifer L JL Shi Vivian Y VY

Journal of asthma and allergy 20200211

<h4>Background</h4>Atopic dermatitis (AD) is a chronic, relapsing skin condition with a wide disease spectrum. Moderate-to-severe cases often need systemic treatment. Conventional immunosuppressants have extensive side effect profiles and require close monitoring. In recent decades, there has been increasing interest in developing targeted systemic immunomodulators for AD, as they have been shown to have efficacy for AD as well as favorable safety profiles. Herein, we review the recent data on l ...[more]

PMID: 32104006

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Project description:BackgroundLebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency.ObjectivesTo report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies.MethodsFive double-blind, randomized placebo-controlled studies; one randomized open-label study; one adolescent open-label, single-arm study; and one long-term safety study were summarized in two datasets: (1) placebo-controlled week 0-16 (All-PC Week 0-16) in patients who received lebrikizumab 250 mg every 2 weeks (LEBQ2W) versus placebo and (2) patients who received any dose of lebrikizumab at any time during the studies (All-LEB). Exposure-adjusted incidence rates (IR)/100 patient-years (PY) are provided.ResultsA total of 1720 patients received lebrikizumab (1637.0 PY exposure). In All-PC Week 0-16, the frequency of treatment-emergent adverse events (TEAEs) was similar between treatment groups; most events were nonserious and mild or moderate in severity. The most frequently reported TEAEs were atopic dermatitis (placebo) and conjunctivitis (LEBQ2W). Frequencies of conjunctivitis cluster were 2.5% (placebo) and 8.5% (LEBQ2W), and all events were mild or moderate (All-LEB 10.6%, IR, 12.2). Frequencies of injection site reactions were 1.5% (placebo) and 2.6% (LEBQ2W; All-LEB 3.1%, IR, 3.3). Frequencies of adverse events leading to treatment discontinuation were 1.4% (placebo) and 2.3% (LEBQ2W; All-LEB 4.2%, IR, 4.5).ConclusionThe safety profile for lebrikizumab consisted of TEAEs that were mostly nonserious, mild or moderate in severity, and did not lead to treatment discontinuation. The safety profile was similar in both adults and adolescents.ClinicaltrialsGOV: NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154 Safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials (MP4 34165 KB).

Dataset Information

Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.

Publications

Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.

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