Patient-Reported Outcomes (PROs) in Patients Receiving Omalizumab (OMB): A Systematic Literature Review
Sunday, March 6, 2016
South Exhibit Hall H (Convention Center)
Ashok V. Vegesna, PharmD, Reynold A Panettieri, MD, Susan Gabriel, MSc, Kimberly M. Ruiz, EdM, Jennifer A. Colby, PharmD, Brett Maiese, PhD, MHS, Jonathan Corren, MD
Rationale: To summarize clinical trial and real-world evidence describing the magnitude and duration of impact of OMB as add-on therapy on PROs in patients with moderate to severe allergic asthma.

Methods: Systematic literature review (MEDLINE/EMBASE) was conducted to identify studies of OMB in pediatric/adolescent/adult patients with moderate to severe allergic asthma. Outcomes of interest included measures of self-reported asthma control, asthma-specific and general quality of life assessments/questionnaires, and patient symptom reports.

Results: 25 randomized controlled trials (RCTs) and 34 non-randomized studies (NRSs) were included. Among 8 RCTS reporting the Asthma Quality of Life Questionnaire (AQLQ) overall score, statistically significant improvements favoring OMB versus placebo/control, were documented in 5 studies; at 52 weeks, mean/median changes from baseline in domain and overall scores ranged from 1.01-1.33 for OMB and from 0.8-0.98 for placebo (P<0.01). At 20‒52 weeks, proportions of patients with a minimally important difference (MID) in AQLQ improvement (≥0.5 points from baseline) ranged from 57.5%‒78.8% with OMB and from 22.2%‒69.8% with placebo/control. Statistically significant improvements in mean Asthma Control Test (ACT) scores from baseline to post study were found in 12 of 22 NRSs, ranging from 9.4-17.28 at baseline to 17.4-22.5 at 8 months to 6 years. Seventeen of 22 NRSs reported achievement of a MID in ACT (≥3 points from baseline) for patients treated with OMB.

Conclusions: Results from this systematic literature review confirm that OMB-treated patients with moderate to severe asthma achieve clinically meaningful improvements in PROs, which are observed across both RCTs and observational studies.