Methods: Patients in ASTERIA I/II, symptomatic despite approved doses of H1-antihistamines, were randomized to omalizumab 75/150/300 mg or placebo. Patients in GLACIAL who were symptomatic despite H1-antihistamines (up to 4x approved dose) plus H2-antihistamines, leukotriene-receptor antagonists or both, received omalizumab 300 mg or placebo. Itch severity scores and weekly number of hives scores for omalizumab 150/300 mg and placebo groups were analysed as relative percentage change and absolute change from baseline to Week 12. P-values are for absolute values relative to placebo and derived using ANCOVA t-test. Omalizumab 75 mg data are not presented.
Results: Itch severity and weekly number of hives scores (% [absolute]) were significantly improved from baseline for omalizumab 300 and 150 mg vs placebo at Week 12, across all Phase III studies.
Itch severity scores: omalizumab 300 / 150 mg vs placebo
- ASTERIA I (n=318): 67% [-9.4] / 48% [-6.7] vs 26% [-3.6]; p<0.0001 / p=0.0012
- ASTERIA II (n=322): 71% [-9.8] / 56% [-8.1] vs 36% [-5.1]; p<0.001 / p<0.01
- GLACIAL (n=335): 62% [-8.6] vs 26% [-4.0]; p<0.001
Weekly number of hives scores: omalizumab 300 / 150 mg vs placebo
- ASTERIA I (n=318): 67% [-11.4] / 50% [-7.8] vs 25% [-4.4]; p<0.0001 / p=0.0017
- ASTERIA II (n=322): 74% [-12.0] / 57% [-9.8] vs 31% [-5.2]; p<0.001 / p<0.01
- GLACIAL (n=335): 62% [-10.5] vs 27% [-4.5]; p<0.001
No new safety signals were identified.
Conclusions: In all three Phase III studies, omalizumab improved symptoms in this post-hoc analysis of patients with inadequately controlled CSU/CIU; omalizumab 300 mg consistently showed the greatest improvements.