Table 1.
Study designs and blood sampling times for studies contributing to the population pharmacokinetic analysis
| Subject no. | Background data (subjects used for analysis, mean ± SD and range) | |||||||
|---|---|---|---|---|---|---|---|---|
| Study | Purpose | Patient indication | Treated | Used in the analysis* | Study design | Treatment period (weeks) | Body weight (kg) | Baseline IgE (ng ml−1) |
| 1101 | Model building and internal validation using all samples | Healthy volunteer but atopic with high baseline IgE | 48 (Japanese: 48) | 48 | Single dose | – | 62.5 ± 6.4 (51–79) | 811 ± 473 (204–2143) |
| 1305 | “ | Seasonal allergic rhinitis | 154 (Japanese: 154) | 154 | Multiple dose with dosing table | 12 | 60.5 ± 10.2 (42–101) | 373 ± 317 (53–1316) |
| 007 | External validation using all samples | “ | 165 (White: 164) | 155 | “† | 8 | 73.7 ± 13.6 (48–110) | 356 ± 305 (72.6–1728) |
| 008 | External validation using steady-state trough samples | Allergic asthma | 268 (White: 238) | 206 | “ | 52 | 79.6 ± 18.6 (39–150) | 424 ± 361 (48.4–2081) |
| 009 | “ | “ | 274 (White: 256) | 170 | “ | 52 | 78.2 ± 16.9 (40.0–148) | 523 ± 387 (51–1970) |
*
Studies 1101 and 1305 had short treatment periods and used all the samples from the patients to build the model. Thus, nearly all the patients treated with omalizumab were available to contribute samples. Studies 008 and 009 had relatively long treatment periods. In these studies patients were more likely not to be available to contribute the needed steady-state trough sample (at least 240 days after first dose and postdose within 2 days of the planned dose interval) for inclusion into the analysis.
†
In study 007, 300 mg was administered every 3 weeks (IgE >363 ng ml−1) or 4 weeks (IgE ≤363 ng ml−1).