Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels
| Autor: | Leif Bjermer, Sivan Weiss, Catherine Lemière, Jorge Maspero, Matthew Germinaro, James Zangrilli |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine medicine.medical_specialty Placebo Critical Care and Intensive Care Medicine 03 medical and health sciences chemistry.chemical_compound FEV1/FVC ratio 0302 clinical medicine Reslizumab Internal medicine medicine Eosinophilia Asthma business.industry Eosinophil medicine.disease Benralizumab 030104 developmental biology medicine.anatomical_structure 030228 respiratory system chemistry Asthma Control Questionnaire Anesthesia medicine.symptom business Cardiology and Cardiovascular Medicine medicine.drug |
| Zdroj: | Chest. 150(4):789-798 |
| ISSN: | 0012-3692 |
| DOI: | 10.1016/j.chest.2016.03.032 |
| Popis: | Background This phase 3 study further characterizes the efficacy and safety of reslizumab (a humanized anti-IL-5 monoclonal antibody) in patients aged 12 to 75 years with asthma inadequately controlled by at least a medium-dose inhaled corticosteroid and with a blood eosinophil count ≥ 400 cells/μL. Methods Patients were randomized to receive reslizumab 0.3 or 3.0 mg/kg or placebo administered once every 4 weeks for 16 weeks (total four doses). The primary end point was change from baseline in pre-bronchodilator FEV 1 over 16 weeks. Secondary end points included FVC, forced expiratory flow at 25% to 75% of FVC (FEF 25%-75% ), patient-reported control of asthma symptoms, short-acting β-agonist (SABA) use, blood eosinophil levels, and safety. Results Reslizumab significantly improved FEV 1 (difference vs placebo [reslizumab 0.3 and 3.0 mg/kg], 115 mL [95% CI, 16-215; P = .0237] and 160 mL [95% CI, 60-259; P = .0018]). Clinically meaningful increases in FVC (130 mL) and FEF 25%-75% (233 mL/s) were observed with reslizumab 3.0 mg/kg. Reslizumab improved scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) vs placebo (greater effects seen with 3.0 mg/kg; P Conclusions Reslizumab improved lung function, asthma control and symptoms, and quality of life. It was well tolerated in patients with inadequately controlled asthma (despite standard therapy) and elevated blood eosinophil levels. Overall, the 3.0-mg/kg dose of reslizumab provided greater improvements in asthma outcomes vs the 0.3-mg/kg dose, with comparable safety. Trial Registry ClinicalTrials.gov; No.: NCT01270464; URL: www.clinicaltrials.gov. |
| Databáze: | OpenAIRE |
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