Global evaluation of treatment effectiveness (GETE) is a validated tool, and has been used to evaluate the clinical response to omalizumab at Week 16 of therapy, in patients with moderate-to-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 and EXTRA) in severe allergic asthma patients were pooled to explore the association of the investigator GETE score at Week 16 of therapy with the response to the omalizumab treatment versus 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 versus placebo), baseline peripheral blood eosinophil count, baseline total IgE level, history of exacerbation, body mass index, age, smoking status and 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). Annualized 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).
Conclusions:
GETE is an accurate predictor of response to omalizumab and can be used as an effective tool to identify omalizumab responders at Week 16 of therapy. The tool also discriminates between the treatment and placebo responders.