Effectiveness of Omalizumab in Severe Allergic Asthma Confirmed by Real-World Data Analysis

Researchers conducted a meta-analysis of observational studies to evaluate real-world data of omalizumab in severe allergic asthma.

Jean Bousquet, MD, PhD, Hospital Center University De Montpellier, (Montpellier, France), and colleagues sought to assess real-world clinical outcomes to determine if the data confirms findings from randomized controlled trials.

For the study, 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 was reviewed.

Data retrieved from PubMed, Embase, and Cochrane included observational studies published from January 2005 to October 2018 of patients with severe allergic asthma (6 years or longer) treated with omalizumab for 16 weeks or longer. Heterogeneity was assessed with a random-effects model.

In sum, 86 publications were included. Global evaluation of treatment effectiveness (GETE) was good/excellent in 77% patients at 16 weeks (risk difference: 0.77; 95% 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 vs baseline.

Dr Bousquet and coauthors saw consistent improvements in GETE, lung function, and PROs, and reductions in asthma exacerbations, OCS use, and HCRU with add-on omalizumab. They concluded that the real-world data “confirm and complement the efficacy data of RCTs.”


—Amanda Del Signore



Bousquet J, Humbert M, Gibson PG, et al. Real-world effectiveness of omalizumab in severe allergic asthma: a meta-analysis of observational studies. J Allergy Clin Immunol Pract. 2021;9(7):2702-2714. doi:10.1016/j.jaip.2021.01.011

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