Pulmonary Function and Rescue Medication Use in Patients Receiving Omalizumab in Real World Settings: A Systematic Literature Review of Nonrandomized Studies

Abstract

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. Outcomes of interest included rescue medication use and pulmonary function assessments (FEV1, FVC, and PEF). Patient-reported outcomes (PROs) were also reviewed for included studies. Study quality was assessed by 2 reviewers using the Newcastle-Ottawa Quality Assessment Scale of Cohort Studies and the International Society of Pharmacoeconomics and Outcomes Research checklist. RESULTS: A total of 42 studies were included; 20 studies evaluated pulmonary function and 9 evaluated rescue beta-agonist use. Statistically significant improvements in FEV1 were reported in 75% (15/20) of included studies. Improvements in FEV1 ranged from 3.2%-43.6%. Five studies reported changes in FVC or FEV1/FVC. Significant improvements in FVC were observed in 3 studies and in FEV1/FVC in 2 studies. Six studies analyzed PEF with 5 finding significant improvements. Seven studies reported significant reductions in rescue medication use. The percentage of patients with any rescue medication use ranged from 87.0%-97.7% at baseline to 12.5%-49.8% at follow-up. In studies examining change in use from baseline, change at follow-up ranged from 56.1%-78.8%. Among the included studies, 14 utilized patient-reported health-related quality of life (HRQoL) outcomes. The ACT (12 studies) and the AQLQ (4 studies) were the most commonly used surveys to assess asthma control and HRQoL, and improvements were consistently seen after omalizumab was added to therapy. CONCLUSIONS: While patient populations and outcome definitions are heterogeneous, overall, patients with moderate to severe asthma using omalizumab had improvements in FEV1 and PEF and experienced a decrease in the need for rescue beta-agonist medications. Patient-reported asthma control and HRQoL appears to improve among patients utilizing omalizumab in clinical settings. CLINICAL IMPLICATIONS: Asthma patients administered omalizumab during routine clinical use experience significant clinical benefits, including an improvement in pulmonary function and decrease in rescue medication usage. DISCLOSURE: Jonathan Corren: Consultant fee, speaker bureau, advisory committee, etc.: Consultant to Novartis Susan Gabriel: Employee: Novartis Employee 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