The Impact of Lebrikizumab on Vaccine-Induced Immune Responses: Results from a Phase 3 Study in Adult Patients with Moderate-to-Severe Atopic Dermatitis.

Autor: Soung J; Southern California Dermatology, 1125 E 17th St., Santa Ana, CA, 92701, USA. doctorsoung@gmail.com.; Harbor University of California Los Angeles, Torrance, CA, USA. doctorsoung@gmail.com., Laquer V; First OC Dermatology Research, Fountain Valley, CA, USA., Merola JF; University of Texas Southwestern Medical Center, Austin, TX, USA., Moore A; Baylor University Medical Center, Dallas, TX, USA.; Arlington Research Center, Arlington, TX, USA., Elmaraghy H; Eli Lilly and Company, Indianapolis, IN, USA., Hu C; Eli Lilly and Company, Indianapolis, IN, USA., Piruzeli MLB; Eli Lilly and Company, Indianapolis, IN, USA., Pierce E; Eli Lilly and Company, Indianapolis, IN, USA., Garcia Gil E; Almirall, Barcelona, Spain., Jarell AD; allCUTIS Research, Portsmouth, NH, USA.
Jazyk: angličtina
Zdroj: Dermatology and therapy [Dermatol Ther (Heidelb)] 2024 Aug; Vol. 14 (8), pp. 2181-2193. Date of Electronic Publication: 2024 Jul 15.
DOI: 10.1007/s13555-024-01217-w
Abstrakt: Introduction: Lebrikizumab, a high-affinity IgG4 monoclonal antibody that selectively inhibits interleukin-13 with high binding affinity and slow dissociation rate, prevents the formation of the interleukin-4Rα/interleukin-13Rα1 heterodimer receptor signaling complex. Here we report the impact of lebrikizumab on responses to two non-live vaccines in adult patients with moderate-to-severe atopic dermatitis (AD).
Methods: ADopt-VA (NCT04626297) was a double-blind, placebo-controlled, parallel-group, 16-week, phase 3 randomized study to assess the impact of lebrikizumab treatment on non-live vaccine immune responses, and efficacy and safety of lebrikizumab compared with placebo. Eligible patients included adults from 18 to 55 years of age with moderate-to-severe chronic AD who were randomly assigned 1:1 to lebrikizumab 250 mg every 2 weeks or placebo and stratified according to disease severity. The primary endpoints were the development of a booster response to tetanus toxoid and a positive antibody response to meningococcal conjugate vaccine (MCV), 4 weeks after administration of the corresponding vaccine.
Results: At week 16, 73.6% of patients in the lebrikizumab group (n = 78/106) achieved Tdap booster response compared with 73.4% of patients in the placebo group (n = 58/79). MCV vaccine response was observed in 86.9% of patients in the lebrikizumab group (n = 86/99) and 75.0% of patients in the placebo group (n = 60/80). At week 16, IGA 0,1 with ≥ 2-point improvement from baseline was achieved by 40.6% (n = 51/125) of patients treated with lebrikizumab and 18.9% (n = 23/122) of patients who received placebo (p < 0.001). There was a higher proportion of patients achieving EASI 75 at week 16 in the lebrikizumab-treated patients (58.0%, n = 72/125) compared with placebo (32.7%, n = 40/122, p < 0.001).
Conclusions: Treatment with lebrikizumab did not impact response to non-live vaccines Tdap and MCV in this study. Lebrikizumab treatment had a significant degree of efficacy compared to placebo across multiple endpoints.
Trial Registration: ClinicalTrials.gov identifier NCT04626297.
(© 2024. The Author(s).)
Databáze: MEDLINE
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