TABLE IV.
Mechanistic parameter
|
Omalizumab
|
Omalizumab
|
Placebo
|
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Cell type | Method measured |
Readout* | No. | Prerandomization, mean (SD) |
Postrandomization, mean (SD) |
Ratio of geometric means (95% CI) |
P value |
No. | Prerandomization, mean (SD) |
Postrandomization, mean (SD) |
Ratio of geometric means (95% CI) |
P value |
pDCs‡ | Flow cytometry | Surface FcεRIα expression | 64 | 3231.2 (1.7) | 1381.7 (1.6) | 0.43 (0.37–0.49) | <.001 | 23 | 3540.0 (1.6) | 3974.9 (1.6) | 1.12 (0.85–1.48) | .40 |
| ||||||||||||
PBMCs | RT-PCR | FCER1A mRNA | 64 | 1.9 (1.8) | 1.9 (1.7) | 1.02 (0.91–1.13) | .78 | 23 | 1.5 (1.8) | 1.3 (2.1) | 0.85 (0.67–1.08) | .17 |
| ||||||||||||
Purified pDCs | RT-PCR | FCER1A mRNA | 18 | 0.4 (1.7) | 0.4 (1.9) | 1.07 (0.80–1.42) | .62 | 7 | 0.3 (2.1) | 0.2 (1.7) | 0.69 (0.53–0.9) | .02 |
Boldface indicates P < .05.
FCER1A mRNA values represent expression measured before ex vivo stimulation and normalized to HPRT expression (2−Δct).
Means are geometric means, and SDs are geometric SDs.
pDCs and basophils gated in total PBMCs for flow cytometric analysis (unstimulated cells).