ATLANTA, GA—Omalizumab therapy was associated with reduced exacerbation and hospitalization rates in U.S. clinics, according to findings from the prospective multicenter observational registry PROSPERO study (NCT01922037) presented at the 2017 AAAAI Annual Meeting
“In a real-world setting, patients treated with omalizumab had an improvement in asthma control as demonstrated by decreased asthma exacerbations and hospitalizations compared with baseline,” reported lead study author Bradley W. Chipps, MD, FAAP, FAAA, FCCP, is the Medical Director of Respiratory Therapy and the Cystic Fibrosis Center at the Sutter Medical Center in Sacramento, CA.
Asthma is a heterogeneous disease and real-world studies are needed “to supplement clinical trial data,” Dr. Chipps noted.
The research team enrolled 806 patients aged ≥12 years with allergic asthma, who were beginning omalizumab treatment in U.S. clinics. Participants had a mean age of 47 years; 64% were female. Seventy percent were white and 16% were African American. Eighty-six percent had completed at least 6 months on-study and 77% completed participation in the study.
“Patients reported a mean of 3.0 asthma exacerbations in the prior year that required oral corticosteroid use, emergency department visit, or hospitalization,” they reported. “Sixty-one percent reported 2 or more exacerbations and 22% reported 1 or more asthma-related hospitalizations in the past year.”
Compared to those baselines, at Month 12, participants had an exacerbation rate of 0.8 per year and only 19% had reported 2 or more exacerbations—indicating a drop by ~69%—the team found. In addition, patients reporting ≥1 asthma-related hospitalization(s) decreased by ~82% vs. the 12 months before study entry. No difference in hospitalization outcomes were seen between patients with high biomarkers vs. low biomarkers. Regarding lung function, it remained relatively unchanged from baseline at Month 12 across the total study population.
Predictors of experiencing an exacerbation included an exacerbation in the past year (odds ratio [OR] 2.19, 95% CI: 1.55–3.08; P<0.0001) and lower FEV1 at baseline (OR 0.65, 95% CI: 0.54–0.79; P<0.0001). Adverse events “appeared consistent” with clinical trial experience, he noted.