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Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS).
Szefler, Stanley J; Roberts, Graham; Rubin, Adalberto S; Zielen, Stefan; Kuna, Piotr; Alpan, Oral; Anzures-Cabrera, Judith; Chen, Qiang; Holweg, Cécile T J; Kaminski, Janusz; Putnam, Wendy S; Matthews, John G; Kamath, Nikhil.
Afiliação
  • Szefler SJ; Department of Pediatrics Children's Hospital Colorado and the University of Colorado School of Medicine Anschutz Medical Campus Aurora Colorado USA.
  • Roberts G; University of Southampton School of Medicine and Southampton Biomedical Research Centre University Hospital Southampton NHS Foundation Trust Southampton UK.
  • Rubin AS; David Hide Asthma and Allergy Research Centre Isle of Wight UK.
  • Zielen S; Federal University of Health Sciences of Porto Alegre and Santa Casa de Misericórdia Hospital Porto Alegre Brazil.
  • Kuna P; Goethe-Universität Klinik für Kinder- und Jugendmedizin Frankfurt Germany.
  • Alpan O; Medical University of Lódz Lodz Poland.
  • Anzures-Cabrera J; O&O Alpan LLC Fairfax Virginia USA.
  • Chen Q; Roche Products Ltd Welwyn Garden City UK.
  • Holweg CTJ; Roche (China) Holding Ltd Shanghai China.
  • Kaminski J; Genentech, Inc. South San Francisco California USA.
  • Putnam WS; Present address: Abbvie, IL USA.
  • Matthews JG; Roche Products Ltd Welwyn Garden City UK.
  • Kamath N; Present address: MSD London UK.
Clin Transl Allergy ; 12(7): e12176, 2022 Jul.
Article em En | MEDLINE | ID: mdl-35846226
Background: Lebrikizumab is a monoclonal antibody that modulates activity of interleukin-13. The Phase 3 ACOUSTICS study assessed lebrikizumab efficacy and safety in adolescents with uncontrolled asthma despite standard-of-care treatment. Methods: Adolescents (aged 12-17 years) with uncontrolled asthma, prebronchodilator forced expiratory volume in 1 s 40%-90% predicted, and stable background therapy were randomised 1:1:1 to receive lebrikizumab 125 or 37.5 mg or placebo subcutaneously once every 4 weeks. Primary efficacy endpoint was asthma exacerbation rate over 52 weeks. Results: Between August 2013 and July 2016, 579 patients were screened and 346 were randomised; 224 (65%) completed the study with 52 weeks of treatment. Lebrikizumab 125 mg (n = 116) reduced the exacerbation rate at 52 weeks versus placebo (n = 117; adjusted rate ratio [RR] 0.49 [95% CI 0.28-0.83]; 51% rate reduction). Lebrikizumab 37.5 mg (n = 113) was less effective at reducing exacerbations (RR 0.60 [95% CI 0.35-1.03]; 40% rate reduction). In patients with blood eosinophil counts ≥300 cells/µl, both lebrikizumab doses reduced exacerbations (125 mg: RR 0.44 [95% CI 0.21-0.89]; 37.5 mg: 0.42 [95% CI 0.19-0.93]). Treatment-emergent adverse events, serious adverse events, and adverse events leading to study discontinuation occurred in 155 (68%), 7 (3%), and 5 (2%) of 229 patients who received lebrikizumab (both 125 and 37.5 mg doses) and in 72 (62%), 4 (3%), and 1 (1%) of 117 who received placebo, respectively. No deaths occurred. Conclusion: Lebrikizumab 125 mg reduced asthma exacerbation rates in adolescents with uncontrolled asthma. However, the study was prematurely terminated (sponsor's decision) potentially limiting interpretation of results. Clinical trial registration: NCT01875003 (www.ClinicalTrials.gov).
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Revista: Clin Transl Allergy Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Revista: Clin Transl Allergy Ano de publicação: 2022 Tipo de documento: Article