Abstract
Introduction
Global evaluation of treatment effectiveness is a validated tool, and has been used to evaluate the clinical response to omalizumab at 16 weeks of therapy, in patients with moderate-severe allergic asthma. The relationship of investigator GETE with response to omalizumab was further explored in recent studies of severe allergic asthma.
Methods
Data from three omalizumab studies (INNOVATE, EXALT & EXTRA) in severe allergic asthma patients were pooled to explore the association of the investigator GETE score at 16 weeks of therapy with the response to the omalizumab treatment vs placebo. A negative binomial model was used to measure the association of the post treatment exacerbation with investigator GETE adjusted for baseline percentage predicted FEV1, treatment received (omalizumab vs placebo), baseline peripheral blood eosinophil count, baseline total IgE level, history of exacerbation, body mass index, age, smoking status & gender.
Results
In the negative binomial regression model investigator GETE was an accurate predictor of exacerbations (p<0.001). GETE also discriminated and predicted response to omalizumab versus placebo (p<0.001). Annualised exacerbation rates in the omalizumab GETE responders group (0.29) were significantly lower than placebo GETE responders (0.46, relative rate reduction [RRR] 36%, p<0.001) and omalizumab GETE non-responders (0.67, RRR 57%, p<0.001).
Conclusion
GETE is an accurate predictor of response to omalizumab and can be used as an effective tool to identify omalizumab responders at 16 weeks of therapy. The tool also discriminates between the treatment and placebo responders.
- © 2014 ERS