Primary end-points at T4–6 (time of first effectiveness assessment after 4–6 months of treatment) by blood eosinophil count measured in the year prior to omalizumab initiation (T−12) in minors (6–17 years) and adults (≥18 years)
| <300 cells·µL−1 | ≥300 cells·µL−1 | Total | ||||
| Minors | Adults | Minors | Adults | Minors | Adults | |
| Subjects | 39 | 346 | 110 | 377 | 149 | 723 |
| GETE score# | ||||||
| Responder | 25 (64.1) (47.2–78.8) | 231 (66.8) (61.5–71.7) | 90 (81.8) (73.3–88.5) | 255 (67.6) (62.7–72.3) | 115 (77.2) (69.6–83.7) | 486 (67.2) (63.7–70.6) |
| Reduction in annual exacerbation rate¶ | ||||||
| Exacerbations between T0 and T4–6 n | 1.6±1.3 | 1.7±1.1 | 2.1±1.6 | 1.8±1.3 | 1.9±1.5 | 1.8±1.2 |
| Annual rate change % | −64.7±67.5 | −52.5±89.6 | −58.6±95.4 | −44.9±97 | −60.2±88.8 | −48.5±93.5 |
| Responder with a ≥40% reduction in the annual exacerbation rate | 31 (79.5) (63.5–90.7) | 250 (72.3) (67.2–76.9) | 86 (78.2) (69.3–85.5) | 264 (70.0) (65.1–74.6) | 117 (78.5) (71.1–84.8) | 514 (71.1) (67.6–74.4) |
| Combination+ | ||||||
| Combined responder | 23 (59.0) (42.1–74.4) | 201 (58.1) (52.7–63.4) | 78 (70.9) (61.5–79.2) | 220 (58.4) (53.2–63.4) | 101 (67.8) (59.7–75.2) | 421 (58.2) (54.5–61.8) |
Data are presented as n, n (%) (95% CI) or mean±sd. GETE: Global Evaluation of Treatment Effectiveness. #: physician's overall evaluation (GETE scale for symptoms control) (responders include excellent responders (complete control of asthma) and good responders (marked improvement); data not presented for nonresponders (discernible, no appreciable change or worsening)); ¶: decrease in the yearly rate of exacerbations with omalizumab (a responder has a reduction of ≥40% in the yearly occurrence of exacerbations before and after omalizumab initiation); +: combination of both definitions (GETE and exacerbation rate decrease).