Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis : 52-week results of two randomized double-blinded placebo-controlled phase III trials
Blauvelt, Andrew (Oregon Medical Research Center)
Thyssen, Jacob Pontoppidan (University of Copenhagen)
Guttman-Yassky, Emma (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica))
Bieber, Thomas (Christine Kühne Center for Allergy Research and Education)
Serra Baldrich, Esther (Institut d'Investigació Biomèdica Sant Pau)
Simpson, Eric L. (Oregon Health & Science University)
Rosmarin, David M. (Indiana University)
Elmaraghy, Hany (Eli Lilly and Company)
Meskimen, Eric (Eli Lilly and Company)
Natalie, Chitra R. (Eli Lilly and Company)
Liu, Zhuqing (Eli Lilly and Company)
Xu, Chenjia (Eli Lilly and Company)
Pierce, Evangeline J. (Eli Lilly and Company)
Morgan-Cox, Mary Ann (Eli Lilly and Company)
García-Gil, Esther (Almirall, S.A)
Silverberg, Jonathan (George Washington University)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to interleukin (IL)-13. Objectives: To evaluate the efficacy and safety of lebrikizumab monotherapy in adolescent and adult patients with moderate-to-severe atopic dermatitis (AD) over 52 weeks of treatment in ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Patients who responded to lebrikizumab 250 mg every 2 weeks (Q2W) at the end of the 16-week induction period were re-randomized 2: 2: 1 to receive lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W) or placebo Q2W (lebrikizumab withdrawal) for 36 additional weeks. Response at week 16 was defined as achieving a 75% reduction in Eczema Area Severity Index (EASI 75) or an Investigator's Global Assessment (IGA) of 0 or 1, with a ≥ 2-point improvement and no rescue medication use. Multiple imputation was used to handle missing data. Intermittent use of topical therapy was permitted during the maintenance period. After 52 weeks, an IGA of 0 or 1 with a ≥ 2 point improvement was maintained by 71. 2% of patients treated with lebrikizumab Q2W, 76. 9% of patients treated with lebrikizumab Q4W and 47. 9% of patients in the lebrikizumab withdrawal arm. EASI 75 was maintained by 78. 4% of patients treated with lebrikizumab Q2W, 81. 7% of patients treated with lebrikizumab Q4W and 66. 4% of patients in the lebrikizumab withdrawal arm at week 52. Across treatment arms, proportions of patients using any rescue therapy were 14. 0% (ADvocate1) and 16. 4% (ADvocate2). During the combined induction and maintenance periods of ADvocate1 and ADvocate2, 63. 0% of lebrikizumab-treated patients reported any treatment emergent adverse event, with most events (93. 1%) being mild or moderate in severity. After a 16-week induction period with lebrikizumab Q2W, lebrikizumab Q2W and Q4W maintained similar improvement of the signs and symptoms of moderate-to-severe AD, with a safety profile consistent with previously published data.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Adolescent ; Adult ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Dermatitis, Atopic ; Double-Blind Method ; Humans ; Immunoglobulin A ; Injections, Subcutaneous ; Interleukin-13 ; Severity of Illness Index ; Treatment Outcome
Published in:	British journal of dermatology, Vol. 188 Núm. 6 (june 2023) , p. 740-748, ISSN 1365-2133

DOI: 10.1093/bjd/ljad022
PMID: 36994947

9 p, 916.1 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles