Table 5.
Patients with angioedema at baseline | Patients without angioedema at baseline | |||||||
---|---|---|---|---|---|---|---|---|
N a | n b | Treatment difference in LS mean (95% CI) | P‐value | N a | n b | Treatment difference in LS mean (95% CI) | P‐value | |
ASTERIA I, ASTERIA II and GLACIAL (pooled)—12 weeks | ||||||||
PBO | 115 | 87 | 127 | 108 | ||||
OMA 75 mg | 66 | 50 | −1.15 (−3.33 to 1.03) | 0.2991 | 93 | 84 | −1.09 (−2.76 to 0.58) | 0.1982 |
OMA 150 mg | 76 | 55 | −1.87 (−3.83 to 0.10) | 0.0627 | 86 | 78 | −2.47 (−4.19 to −0.75) | 0.0052 |
OMA 300 mg | 203 | 169 | −4.49 (−5.92 to −3.06) | <0.0001 | 209 | 192 | −3.57 (−4.76 to −2.38) | <0.0001 |
ASTERIA I and GLACIAL (pooled)—24 weeks | ||||||||
PBO | 85 | 47 | 78 | 60 | ||||
OMA 75 mg | 35 | 23 | 2.41 (−1.20 to 6.03) | 0.1868 | 42 | 36 | −1.78 (−3.89 to 0.32) | 0.0962 |
OMA 150 mg | 38 | 22 | −0.35 (−3.83 to 3.13) | 0.8427 | 42 | 33 | −1.32 (−3.36 to 0.71) | 0.1999 |
OMA 300 mg | 171 | 133 | −3.32 (−5.27 to −1.36) | 0.001 | 162 | 136 | −2.64 (−3.98 to −1.29) | 0.0001 |
Number of patients with or without baseline angioedema.
Number of patients with data at Week 12 or Week 24.
CI, confidence interval; DLQI, Dermatology Life Quality Index; LS, least squares; OMA, omalizumab; PBO, placebo. Modified intent‐to‐treat population (all patients with baseline angioedema). The LS mean was estimated using ancova model with baseline overall DLQI score as covariate, and baseline weight (<80 kg vs. ≥80 kg) as strata. P‐value derived from ancova model.