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Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials

BACKGROUND: Lebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. OBJECTIVES: To report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from...

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Autores principales: Stein Gold, Linda, Thaçi, Diamant, Thyssen, Jacob P., Gooderham, Melinda, Laquer, Vivian, Moore, Angela, Natalie, Chitra R., Zhao, Fangyi, Meskimen, Eric, Elmaraghy, Hany, Montmayeur, Sonia, Gallo, Gaia, Jimenez, Gemma, de Bruin-Weller, Marjolein
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10191071/
https://www.ncbi.nlm.nih.gov/pubmed/37195407
http://dx.doi.org/10.1007/s40257-023-00792-6
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author Stein Gold, Linda
Thaçi, Diamant
Thyssen, Jacob P.
Gooderham, Melinda
Laquer, Vivian
Moore, Angela
Natalie, Chitra R.
Zhao, Fangyi
Meskimen, Eric
Elmaraghy, Hany
Montmayeur, Sonia
Gallo, Gaia
Jimenez, Gemma
de Bruin-Weller, Marjolein
author_facet Stein Gold, Linda
Thaçi, Diamant
Thyssen, Jacob P.
Gooderham, Melinda
Laquer, Vivian
Moore, Angela
Natalie, Chitra R.
Zhao, Fangyi
Meskimen, Eric
Elmaraghy, Hany
Montmayeur, Sonia
Gallo, Gaia
Jimenez, Gemma
de Bruin-Weller, Marjolein
author_sort Stein Gold, Linda
collection PubMed
description BACKGROUND: Lebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. OBJECTIVES: To report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies. METHODS: Five 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. RESULTS: A 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). CONCLUSION: The 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. CLINICALTRIALS.GOV: NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154 VIDEO ABSTRACT: SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40257-023-00792-6.
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spelling pubmed-101910712023-05-19 Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials Stein Gold, Linda Thaçi, Diamant Thyssen, Jacob P. Gooderham, Melinda Laquer, Vivian Moore, Angela Natalie, Chitra R. Zhao, Fangyi Meskimen, Eric Elmaraghy, Hany Montmayeur, Sonia Gallo, Gaia Jimenez, Gemma de Bruin-Weller, Marjolein Am J Clin Dermatol Original Research Article BACKGROUND: Lebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. OBJECTIVES: To report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies. METHODS: Five 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. RESULTS: A 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). CONCLUSION: The 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. CLINICALTRIALS.GOV: NCT02465606, NCT02340234, NCT03443024, NCT04146363, NCT04178967, NCT04250337, NCT04250350, NCT04392154 VIDEO ABSTRACT: SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40257-023-00792-6. Springer International Publishing 2023-05-17 2023 /pmc/articles/PMC10191071/ /pubmed/37195407 http://dx.doi.org/10.1007/s40257-023-00792-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Stein Gold, Linda
Thaçi, Diamant
Thyssen, Jacob P.
Gooderham, Melinda
Laquer, Vivian
Moore, Angela
Natalie, Chitra R.
Zhao, Fangyi
Meskimen, Eric
Elmaraghy, Hany
Montmayeur, Sonia
Gallo, Gaia
Jimenez, Gemma
de Bruin-Weller, Marjolein
Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title_full Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title_fullStr Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title_full_unstemmed Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title_short Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: An Integrated Analysis of Eight Clinical Trials
title_sort safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis: an integrated analysis of eight clinical trials
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10191071/
https://www.ncbi.nlm.nih.gov/pubmed/37195407
http://dx.doi.org/10.1007/s40257-023-00792-6
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