Safety: Adverse reactions

Similar incidences of adverse reactions between Xolair® and placebo patients:2

Adverse reactions reported during Weeks 1-12
From the pooled CSU safety database (ASTERIA I, ASTERIA II, GLACIAL)
Adverse reactions (%) Placebo§ Xolair® 300 mg§
Sinusitis 2.1 4.9
Headache 2.9 6.1
Arthralgia 0.4 2.9
Injection site reaction** 0.8 2.7
Adverse reactions* reported during Weeks 1-24
From the pooled CSU safety database (ASTERIA I, GLACIAL)
Upper respiratory tract infection 3.1 5.7

Events occuring in ≥1% of patients in my treatment group and ≥2% more frequently in any Xolair® treatment group than in the placebo group
**Despite not showing a 2% difference to placebo, injection site reactions were included as all cases were assessed as related to study treatment
§Patients were received background treatment of non-sedenting H1-antihistamines at approved doses (ASTERIA I/II) or non-sedating H1-antihistamines (up to 4x the approved dose) plus H2-antihistamines and/or leukotiene-receptor antagonists (GLACIAL)

Model is a hypothetical patient profile, for illustrative purposes only

*Data from ASTERIA II; two other phase III studies (ASTERIA I and GLACIAL) were also conducted to assess efficacy and safety of Xolair® in inadequately controlled CSU patients

Xolair® 300mg vs. baseline at 12 weeks; p<0.001 vs. placebo.

Xolair® is also available as a lyophilized formulation

References: 1. Maurer M, et al. N Engl J Med 2013;368:924-935. 2. Xolair® Summary of Product Characteristics 2016. 3. Maurer M, et al. N Engl J Med 2013;368:924-935. 4. Weller K, et al. J Eur Acad Dermatol Venereol 2013;27:43-50

NP4 code: GLDEIM/IGE025E/0181

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