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Xolair Decreases Asthma Exacerbations and Hospitalizations
According to real-world data, patients treated with Xolair (omalizumab; Genentech) experienced decreased asthma exacerbations and hospitalizations compared with baseline. Researchers reported the results from the PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab) study during the 2017 AAAAI Annual Meeting.
“Real-world data are important to supplement clinical trial data in heterogeneous diseases like asthma,” wrote Bradley W Chipps, MD, Capital Allergy and Respiratory Disease Center in Sacramento, California, and colleagues.
PROSPERO was a US-based, multicenter, prospective, 48-week observational registry of patients with allergic asthma initiating treatment with Xolair. The researchers studied 806 patients aged ≥12 years who were identified as candidates for treatment with Xolair by their physicians, with access to treatment through insurance or other funding. The mean age of the cohort was 47.3 years, and 64% were female. During the 48 weeks, asthma-related exacerbations and health care use were recorded monthly. Patients also underwent semiannual spirometry and type 2 biomarker testing (ie, blood eosinophils, serum periostin, and fractional exhaled nitric oxide [FeNO]).
The majority of patients (86%) completed ≥6 months of the study; 77% completed the study. Patients reported a mean 3.0 asthma exacerbations in the prior year that required oral corticosteroid use, emergency department visit, or hospitalization. More than half of patients (61%) reported ≥2 exacerbations and 22% reported ≥1 asthma-related hospitalization in the past year. At 12 months, Dr Chipps and colleagues observed a mean rate of 0.8 exacerbations per year; 19% reported ≥2 exacerbations and 4% reported ≥1 hospitalizations. The researchers identified predictors for experiencing an exacerbation, which included an exacerbation in the past year, higher FeNO, and lower forced expiratory volume in the first second of expiration (FEV1). Baseline elevation of a type 2 biomarker was linked with FEV1 improvement.
The safety profile was consistent with adverse events described in the Xolair prescribing information. —Eileen Koutnik-Fotopoulos