1. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma
- Author
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Michael E. Wechsler, Elliot Israel, Primal Kaur, Janet M. Griffiths, Christopher E. Brightling, Arnaud Bourdin, Andrew Menzies-gow, Gene L. Colice, Geoffrey Chupp, Gun Almqvist, Jonathan Corren, Karin Bowen, Sandhia Ponnarambil, Åsa Hellqvist, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
- Subjects
Adult ,Thymic stromal lymphopoietin ,Adolescent ,medicine.drug_class ,Injections, Subcutaneous ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Antibodies, Monoclonal, Humanized ,Monoclonal antibody ,[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract ,Pathogenesis ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,medicine ,Humans ,Anti-Asthmatic Agents ,030212 general & internal medicine ,[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology ,Young adult ,Child ,Aged ,Asthma ,Aged, 80 and over ,biology ,business.industry ,[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy ,General Medicine ,Middle Aged ,medicine.disease ,3. Good health ,Cytokine ,Monoclonal ,Immunology ,Quality of Life ,biology.protein ,Antibody ,business - Abstract
International audience; BACKGROUND: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial-cell–derived cytokine implicated in the pathogenesis of asthma. The efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma require further assessment.METHODS: We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Patients (12 to 80 years of age) were randomly assigned to receive tezepelumab (210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. The primary end point was the annualized rate of asthma exacerbations over a period of 52 weeks. This end point was also assessed in patients with baseline blood eosinophil counts of less than 300 cells per microliter. Secondary end points included the forced expiratory volume in 1 second (FEV1) and scores on the Asthma Control Questionnaire–6 (ACQ-6; range, 0 [no impairment] to 6 [maximum impairment]), Asthma Quality of Life Questionnaire (AQLQ; range, 1 [maximum impairment] to 7 [no impairment]), and Asthma Symptom Diary (ASD; range, 0 [no symptoms] to 4 [worst possible symptoms]).RESULTS: Overall, 1061 patients underwent randomization (529 were assigned to receive tezepelumab and 532 to receive placebo). The annualized rate of asthma exacerbations was 0.93 (95% confidence interval [CI], 0.80 to 1.07) with tezepelumab and 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P
- Published
- 2021