Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma Across Multiple Clinically Relevant Subgroups in the NAVIGATOR Study.

Autor: Carr TF; Asthma and Airway Disease Research Center, University of Arizona, Tucson, AZ, USA., Moore WC; Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, NC, USA., Kraft M; Department of Medicine, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA., Brusselle G; Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium., Castro M; Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA., Chupp GL; Yale Center for Asthma and Airway Disease, Yale School of Medicine, Yale University, New Haven, CT, USA., Wechsler ME; National Jewish Health, Denver, CO, USA., Hunter G; Biometrics, Late-Stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK., Lindsley AW; US Medical Affairs, Amgen, Thousand Oaks, CA, USA., Llanos JP; Global Medical Affairs, Amgen, Thousand Oaks, CA, USA., Burke LK; Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK., Chandarana S; Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA., Ambrose CS; Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, 1 MedImmune Way, Gaithersburg, MD, 20878, USA. chris.ambrose@astrazeneca.com.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2024 Jul; Vol. 41 (7), pp. 2978-2990. Date of Electronic Publication: 2024 May 27.
DOI: 10.1007/s12325-024-02889-8
Abstrakt: Introduction: Many patients with severe asthma continue to experience symptoms and exacerbations despite treatment with standard-of-care therapy. In the phase 3 NAVIGATOR study, tezepelumab significantly reduced exacerbations over 52 weeks compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the efficacy of tezepelumab in reducing asthma exacerbations in various clinically relevant subgroups of patients in NAVIGATOR.
Methods: NAVIGATOR was a phase 3, multicentre, randomized, double-blind, placebo-controlled study. Participants (12-80 years old) with severe, uncontrolled asthma were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Pre-specified and post hoc analyses were performed to evaluate the annualized asthma exacerbation rate (AAER) over 52 weeks in clinically relevant subgroups of patients defined by baseline patient characteristics, medical history, exacerbation triggers, medication eligibility and medication use before and during the study.
Results: Tezepelumab reduced the AAER over 52 weeks compared with placebo across a wide range of patient subgroups assessed. Reductions in exacerbations were similar across subgroups defined by baseline patient characteristics, ranging from 48% (95% confidence interval [CI]: 21, 65) to 60% (95% CI: 44, 71) in subgroups analysed by sex, smoking history and body mass index. Among the asthma-related comorbidity subgroups investigated, patients with aspirin or NSAID sensitivity had the greatest reductions in AAER with tezepelumab compared with placebo (83%; 95% CI: 66, 91). In patients eligible to receive dupilumab, tezepelumab reduced exacerbations compared with placebo by 64% (95% CI: 54, 71). Reductions in the AAER with tezepelumab compared with placebo were also observed irrespective of exacerbation trigger category and the number of asthma controller medications patients were receiving at baseline.
Conclusion: These findings further support the benefits of tezepelumab in patients with severe, uncontrolled asthma and can help to inform healthcare providers' treatment decisions.
Clinical Trial Registration: NAVIGATOR (NCT03347279).
(© 2024. The Author(s).)
Databáze: MEDLINE
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