Impact of omalizumab on quality-of-life outcomes in patients with moderate-to-severe allergic asthma.
BACKGROUND
Moderate-to-severe allergic asthma has a substantial impact on patients' quality of life (QOL). Despite care consistent with treatment guidelines, many patients with moderate-to-severe asthma still experience variability in asthma control, signaling an unmet need within this population. Omalizumab has recently demonstrated clinical efficacy and safety in treating IgE-mediated asthma.


OBJECTIVE
To summarize asthma-related QOL outcomes associated with omalizumab therapy in moderate-to-severe allergic asthma.


METHODS
A systematic review and meta-analysis of asthma-related QOL on data from published clinical trials and unpublished clinical study reports were conducted on omalizumab. The Juniper Asthma Quality of Life Questionnaire (AQLQ) measured asthma-related QOL.


RESULTS
Statistically significant results for asthma-related QOL end points consistently favored omalizumab over placebo. Moderate to large effect sizes in the omalizumab groups were observed across the clinical trials and during study extension phases. A meta-analysis indicated a 1.6- to 2-fold increase in moderate (> or = 1 point) and a 1.8- to 2.1-fold increase in large (> or = 1.5 point) improvements in AQLQ overall scores in the omalizumab-treated group compared with placebo during the steroid-stabilization and steroid-reduction phases of the trials.


CONCLUSIONS
Significant differences and large effect sizes favoring omalizumab were observed despite the control group receiving active, guideline-consistent treatment. The meta-analysis findings demonstrate that omalizumab treatment provides QOL benefits in patients with moderate-to-severe allergic asthma.
Center for Health Outcomes Research, The MEDTAP Institute at United BioSource Corporation, Bethesda, Maryland 20814, USA.
Kimberly
K
Niebauer
Sarah
S
Dewilde
Julia
J
Fox-Rushby
Dennis A
DA
Revicki
D000328:Adult; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003710:Demography; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology* / Q000378:metabolism; D008297:Male; D000069444:Omalizumab; D011788:Quality of Life; D012189:Retrospective Studies; D011795:Surveys and Questionnaires
D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab; D007073:Immunoglobulin E