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. 2017 Jan 17;31(6):1056–1063. doi: 10.1111/jdv.14075

Table 5.

LS mean differences in the change from baseline on the overall DLQI score with omalizumab vs. placebo (95% CI) at Week 12 in ASTERIA I, ASTERIA II and GLACIAL (pooled) and Week 24 in ASTERIA I and GLACIAL (pooled) for patients with and without baseline angioedema

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
a

Number of patients with or without baseline angioedema.

b

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.