Jean Bousquet1, Marc Humbert2, Peter G Gibson3, Konstantinos Kostikas4, Xavier Jaumont5, Pascal Pfister5, Francis Nissen5. 1. Contre les Maladies Chroniques pour un VIeillissement Actif (MACVIA) en France European Innovation Partnership on Active and Healthy Ageing Reference Site, Montpellier, France; Centre Hospitalier Universitaire de Montpellier, Montpellier, France; Charité, Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Department of Dermatology and Allergy, Comprehensive Allergy Center, Berlin Institute of Health, Berlin, Germany. Electronic address: jean.bousquet@orange.fr. 2. School of Medicine, Université Paris-Saclay, Le Kremlin-Bicêtre, France; INSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis-Robinson, France; AP-HP, Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin-Bicêtre, France. 3. Department of Respiratory and Sleep Medicine, John Hunter Hospital, Hunter Medical Research Institute, Newcastle, NSW, Australia; Priority Research Centre for Asthma and Respiratory Disease, the University of Newcastle, Newcastle, NSW, Australia. 4. Respiratory Medicine Department, University of Ioannina Medical School, Ioannina, Greece. 5. Novartis Pharma AG, Basel, Switzerland.
Abstract
BACKGROUND: Assessment of clinical outcomes in the real-world corroborates findings from randomized controlled trials (RCTs). OBJECTIVE: This meta-analysis evaluated real-world data of omalizumab on treatment response, lung function, exacerbations, oral corticosteroid (OCS) use, patient-reported outcomes (PROs), health care resource utilization (HCRU), and school/work absenteeism at 4, 6, and 12 months after treatment. METHODS: Observational studies in patients with severe allergic asthma (≥6 years) treated with omalizumab for ≥16 weeks, published from January 2005 to October 2018, were retrieved from PubMed, Embase, and Cochrane. A random-effects model was used to assess heterogeneity. RESULTS: In total, 86 publications were included. Global evaluation of treatment effectiveness (GETE) was good/excellent in 77% patients at 16 weeks (risk difference: 0.77; 95% confidence interval [CI]: 0.70-0.84; I2 = 96%) and in 82% patients at 12 months (0.82, 0.73-0.91; 97%). The mean improvement in forced expiratory volume in 1 second was 160, 220, and 250 mL at 16 weeks, 6 months, and 12 months, respectively. There was a decrease in Asthma Control Questionnaire score at 16 weeks (-1.14), 6 months (-1.56), and 12 months (-1.13) after omalizumab therapy. Omalizumab significantly reduced annualized rate of severe exacerbations (risk ratio [RR]: 0.41, 95% CI: 0.30-0.56; I2 = 96%), proportion of patients receiving OCS (RR: 0.59, 95% CI: 0.47-0.75; I2 = 96%), and number of unscheduled physician visits (mean difference: -2.34, 95% CI: -3.54 to -1.13; I2 = 98%) at 12 months versus baseline. CONCLUSION: The consistent improvements in GETE, lung function, and PROs, and reductions in asthma exacerbations, OCS use, and HCRU with add-on omalizumab in real-life confirm and complement the efficacy data of RCTs.
BACKGROUND: Assessment of clinical outcomes in the real-world corroborates findings from randomized controlled trials (RCTs). OBJECTIVE: This meta-analysis evaluated real-world data of omalizumab on treatment response, lung function, exacerbations, oral corticosteroid (OCS) use, patient-reported outcomes (PROs), health care resource utilization (HCRU), and school/work absenteeism at 4, 6, and 12 months after treatment. METHODS: Observational studies in patients with severe allergic asthma (≥6 years) treated with omalizumab for ≥16 weeks, published from January 2005 to October 2018, were retrieved from PubMed, Embase, and Cochrane. A random-effects model was used to assess heterogeneity. RESULTS: In total, 86 publications were included. Global evaluation of treatment effectiveness (GETE) was good/excellent in 77% patients at 16 weeks (risk difference: 0.77; 95% confidence interval [CI]: 0.70-0.84; I2 = 96%) and in 82% patients at 12 months (0.82, 0.73-0.91; 97%). The mean improvement in forced expiratory volume in 1 second was 160, 220, and 250 mL at 16 weeks, 6 months, and 12 months, respectively. There was a decrease in Asthma Control Questionnaire score at 16 weeks (-1.14), 6 months (-1.56), and 12 months (-1.13) after omalizumab therapy. Omalizumab significantly reduced annualized rate of severe exacerbations (risk ratio [RR]: 0.41, 95% CI: 0.30-0.56; I2 = 96%), proportion of patients receiving OCS (RR: 0.59, 95% CI: 0.47-0.75; I2 = 96%), and number of unscheduled physician visits (mean difference: -2.34, 95% CI: -3.54 to -1.13; I2 = 98%) at 12 months versus baseline. CONCLUSION: The consistent improvements in GETE, lung function, and PROs, and reductions in asthma exacerbations, OCS use, and HCRU with add-on omalizumab in real-life confirm and complement the efficacy data of RCTs.
Keywords:
Global evaluation of treatment effectiveness; Health care resource utilization; Lung function; Meta-analysis; Omalizumab; Patient-reported outcomes; Real-world evidence; Severe allergic asthma; Severe exacerbations
Authors: Safwat Eldaboussi; Ahmed Qabil; Ahmed Lotfi; Amgad Awad; Eman Abdel Salam; Abdullah Alkhamis; Usama E Abuelhassan Journal: Multidiscip Respir Med Date: 2021-12-29