Lebrikizumab in Uncontrolled Asthma: Reanalysis in a Well-Defined Type 2 Population

Jonathan Corren, Stanley J. Szefler, Ellen Sher, Phillip Korenblat, Weily Soong, Nicola A. Hanania, Gary Berman, Guy Brusselle, Ralph Zitnik, Chitra R. Natalie, Luna Sun, Kimberly Siu, Wen Shuo Wu, Peter Lio, April W. Armstrong

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background: LAVOLTA (L)I, LII, and ACOUSTICS were randomized, placebo-controlled, Phase 3 trials of lebrikizumab, a monoclonal antibody targeting IL-13 in patients with uncontrolled asthma. Failure to demonstrate efficacy may have been related to patient selection in those trials. Objective: To assess the efficacy in a well-defined subpopulation of patients with elevated blood eosinophil counts and a minimum number of prior asthma exacerbations. We performed an additional analysis in a subpopulation of patients with elevated FeNO and prior exacerbations. Methods: Adult (LI and LII) and adolescent patients (aged 12-17 years weighing ≥40 kg, ACOUSTICS) with uncontrolled asthma received lebrikizumab (125 mg, n = 832; or 37.5 mg, n = 829) or placebo (n = 833) subcutaneously every 4 weeks. Post hoc analysis of the annualized adjusted exacerbation rate (AER) was performed in a subpopulation of patients with baseline blood eosinophils of 300 cells/μL or greater and history of one or more exacerbations. In this subpopulation, there were 227 patients in the placebo group, 222 in the lebrikizumab 37.5-mg group, and 217 in the lebrikizumab 125-mg group. We summarized safety in patients who received at least one dose of lebrikizumab using adverse events. Results: Lebrikizumab significantly reduced AER compared with placebo in adults (AER reduction: 125 mg [38%]; and 37.5 mg [41%]) and adolescents (AER reduction:125 mg [59%]; 37.5 mg [64%]) with baseline blood eosinophils of 300 cells/μL or greater and one or more exacerbations. Most adverse events were mild or moderate in severity and did not lead to treatment discontinuation. Conclusion: Lebrikizumab significantly reduced asthma exacerbations in a subpopulation of patients with elevated blood eosinophils, elevated FeNO, and a history of asthma exacerbation.

Original languageEnglish
Pages (from-to)1215-1224.e3
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume12
Issue number5
DOIs
StatePublished - May 2024
Externally publishedYes

Keywords

  • Allergic asthma
  • Efficacy
  • IL-13
  • Lebrikizumab
  • Post hoc analysis
  • Safety

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