TABLE I.
Mechanistic parameter |
Omalizumab
|
Placebo
|
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Cell type |
Ex vivo stimulus |
No. | Pre- randomization, mean (SD) |
Post- randomization, mean (SD) |
Ratio of geometric means (95% CI) |
P value |
No. | Pre- randomization, mean (SD) |
Post- randomization, mean (SD) |
Ratio of geometric means (95% CI) |
P value |
PBMC | Rhinovirus | 64 | 1365.8 (6.1) | 1035.8 (7.0) | 0.76 (0.47–1.22) | .25 | 23 | 1443.1 (6.3) | 764.2 (7.9) | 0.53 (0.21–1.32) | .16 |
| |||||||||||
Anti-IgE plus rhinovirus | 56 | 201.7 (6.9) | 415.7 (8.2) | 2.06 (1.20–3.55) | .01 | 23 | 169.7 (5.5) | 129.0 (6.4) | 0.76 (0.34–1.71) | .49 | |
| |||||||||||
Influenza virus | 64 | 7304.7 (2.2) | 7301.8 (2.4) | 1.00 (0.80–1.24) | >.99 | 23 | 6864.2 (3.7) | 6371.6 (2.6) | 0.93 (0.50–1.74) | .81 | |
| |||||||||||
Anti-IgE plus influenza virus | 38 | 4352.1 (2.6) | 6814.9 (2.3) | 1.57 (1.09–2.25) | .02 | 10 | 4043.6 (5.6) | 4637.1 (3.9) | 1.15 (0.20–6.51) | .86 | |
| |||||||||||
Gardiquimod | 64 | 856.4 (3.8) | 1167.3 (4.1) | 1.36 (1.00–1.87) | .05 | 23 | 1314.3 (4.7) | 985.4 (3.4) | 0.75 (0.49–1.16) | .18 | |
| |||||||||||
pDC | Rhinovirus | 25 | 125.2 (5.3) | 237.5 (7.1) | 1.90 (0.83–4.34) | .12 | 12 | 216.3 (7.6) | 260.4 (8.0) | 1.2 (0.26–5.64) | .80 |
| |||||||||||
Anti-IgE plus rhinovirus | 14 | 94.8 (4.4) | 393.6 (6.4) | 4.15 (1.76–9.77) | .003 | 7 | 174.8 (7.2) | 277.7 (6.7) | 1.59 (0.19–13.14) | .61 | |
| |||||||||||
Influenza | 25 | 236.6 (3.7) | 317.5 (3.5) | 1.34 (0.87–2.08) | .18 | 11 | 171.6 (4.7) | 340.2 (3.4) | 1.98 (0.84–4.70) | .11 | |
| |||||||||||
pDC | Gardiquimod | 21 | 936.6 (6.5) | 1900.2 (4.7) | 2.03 (0.85–4.83) | .10 | 11 | 1280.3 (6.6) | 1955.4 (2.7) | 1.53 (0.33–7.14) | .55 |
Boldface indicates P < .05.
IFN-α concentrations (in picograms per milliliter) measured in supernatants after depicted ex vivo stimulations.
Means are geometric means, and SDs are geometric SDs.