Exacerbations, Emergency Visits, and Hospitalizations in Patients Receiving Omalizumab in Real World Settings: A Systematic Literature Review of Nonrandomized Studies

SESSION TITLE: Allergy and Airway Posters SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM PURPOSE: The objective was to provide a summary of the real-world clinical and health economic outcomes associated with omalizumab in the treatment of moderate to severe allergic asthma. METHODS: A systematic literature review was conducted to identify studies of omalizumab in patients ≥12 years with moderate to severe allergic asthma. A search of MEDLINE and EMBASE reference databases was conducted for relevant studies published from 2003 to 2014. Prospective observational studies, retrospective studies, meta-analyses, and health economic studies were included. Outcomes of interest included the rate or number of severe or clinically significant exacerbations and the rate, number, or costs of emergency room (ER) visits and hospitalizations. Study quality was assessed by 2 reviewers using the Newcastle-Ottawa Quality Assessment Scale of Cohort Studies. RESULTS: A total of 42 studies were included; 24 studies evaluated asthma exacerbations, 11 evaluated ER visits and costs, and 17 evaluated hospitalizations. Statistically significant reductions in exacerbations were reported in 83% (20/24) of included studies; 18 studies utilized a pre/post design and 2 studies compared omalizumab treatment to standard of care. Significant decreases in the number of ER visits were reported in 82% of studies (9/11) across a variety of patient populations in numerous countries over 12-months. A significant reduction in hospitalizations was reported in 65% of included studies (11/17). The 2 studies that reported hospitalization costs observed a reduction in cost. Over 12 months, mean monthly hospitalization costs decreased from €133.85 to €0 (P<0.01), and the cost per inpatient day was reduced from €14,668 to €4,683 in a 6-month period. Overall, a reduction in clinically significant exacerbations, hospitalizations, including number of visits and percent of patients, and ER utilization occurred in patients utilizing omalizumab add-on therapy. CONCLUSIONS: While patient populations and outcome definitions in these studies are heterogeneous, results from this systematic literature review suggest that patients with moderate to severe asthma using omalizumab experienced a decrease in the rate of severe exacerbations, ER visits, and hospitalizations. CLINICAL IMPLICATIONS: Asthma patients administered omalizumab during routine clinical use experience substantial clinical and economic benefits, including a decrease in exacerbation rate, and reductions in ER and hospital utilization. DISCLOSURE: Jonathan Corren: Consultant fee, speaker bureau, advisory committee, etc.: Novartis consultant Susan Gabriel: Employee: Employee of Novartis Tom Karagiannis: Employee: Novartis employee Kimberly Ruiz: Consultant fee, speaker bureau, advisory committee, etc.: consultant to Novartis Bethany Sawchyn: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Jennifer Colby: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Meryl Mendelson: Employee: Novartis employee No Product/Research Disclosure Information