Table 1.
Patient numbers and baseline demographic data for studies contributing to the population PK/PD model analysis
| Patient numbers | Demographic data, mean ± SD (range) | ||||||
|---|---|---|---|---|---|---|---|
| Study | Treatment | Active, placebo | Treated | Used in analysis | Age (years) | Bodyweight (kg) | Baseline IgE (ng ml−1) |
| 10 | 1 year, washout, 3-year extension then washout | A | 225 | 225 | 9 ± 2 (5–12) | 39 ± 13 (20–79) | 841 ± 645 (48–3 071) |
| P | 108 | 80 | 10 ± 2 (6–12) | 39 ± 14 (20–78) | 853 ± 710 (75–2 933) | ||
| 10E1* | A | 189 | 189 | 9 ± 2 (5–12) | 38 ± 14 (20–79) | 808 ± 624 (48–3 071) | |
| EXCELS† | Up to 5 years | A | 127 | 81 | 51 ± 14 (12–76) | 85 ± 21 (46–143) | 907 ± 2 281 (44–15 799) |
| IA05 | 1 year plus washout | A | 421 | 373 | 9 ± 2 (6–11) | 34 ± 11 (19–92) | 1 155 ± 846 (65–3 318) |
| P | 207 | 181 | 8 ± 2 (6–11) | 34 ± 12 (20–78) | 1 116 ± 795 (70–3 027) | ||
| 8 | 1 year | A | 268 | 268 | 39 ± 13 (12–73) | 80 ± 20 (39–150) | 417 ± 341 (48–2 081) |
| P | 257 | 257 | 39 ± 14 (12–74) | 78 ± 19 (39–136) | 451 ± 345 (51–1 699) | ||
| 9 | 1 year | A | 274 | 271 | 40 ± 15 (12–76) | 77 ± 17 (46–136) | 541 ± 411 (51–1 900) |
| P | 272 | 266 | 39 ± 14 (12–72) | 78 ± 18 (40–148) | 501 ± 391 (53–1 970) | ||
| 11 | 32 weeks | A | 175 | 144 | 43 ± 14 (12–73) | 76 ± 18 (41–135) | 578 ± 461 (63–2 553) |
| P | 164 | 130 | 43 ± 14 (12–74) | 74 ± 14 (41–115) | 613 ± 450 (46–1 902) | ||
| 2306 | 28 weeks plus washout | A | 245 | 226 | 42 ± 14 (12–79) | 79 ± 20 (45–148) | 509 ± 375 (51–1 692) |
| P | 232 | 214 | 43 ± 13 (14–74) | 77 ± 17 (39–143) | 479 ± 387 (53–2 173) | ||
| 2204 | Single dose, | A | 155 | 152 | 35 ± 12 (18–64) | 71 ± 12 (48–91) | 186 ± 124 (47–620) |
| 2101 | 12-week washout | A | 180 | 180 | 38 ± 13 (18–65) | 71 ± 10 (46–90) | 204 ± 114 (73–719) |
| Q0673g‡ | 47 weeks plus washout | A | 47 | 47 | 31 ± 8 (19–55) | 77 ± 13 (51–112) | 535 ± 249 (204–1 255) |
*
Study 10E1 was an extension to study 10 in which patients randomized initially to omalizumab or placebo received only omalizumab.
†
The epidemiologic study EXCELS had only a small subset of patients in which IgE measurements were taken. The numbers in the table reflect only the data set that was utilized at the time of analysis. Studies 2204 and 2101 were used only for the estimation of the absorption rate constant and volume for the omalizumab–IgE complex, as these parameters require rich sampling in the first week post dose.
‡
Study Q0673g was not used in the model-building process.