Safety profile [1]
Key safety data for Xolair in CSU.
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Xolair has an established safety profile in CSU since 2014 and severe allergic asthma since 20051–4
Common reported side effects are headache, sinusitis, upper respiratory tract infection, arthralgia and injection-site reaction.2
Incidence of adverse events
ASTERIA I5,6† | ASTERIA II7,8‡ | GLACIAL9† | ||||
---|---|---|---|---|---|---|
Placebo | 300 mg | Placebo | 300 mg | Placebo | 300 mg | |
Number of patients | 80 | 81 | 79 | 79 | 83 | 252 |
Any AE |
53 (66.3%) |
57 (70.4%) |
51 (64.6%) |
52 (65.8%) |
65 (78.3%) |
211 (83.7) |
Severe AE |
8 (10.0%) |
13 (16.0%) |
7 (8.9%) |
6 (7.6%) |
NR | NR |
Serious AE (SAE) |
5 (6.3%) |
2 (2.5%) |
2 (2.5%) |
5 (6.3%) |
5 (6.0%) |
18 (7.1%) |
AE leading to treatment withdrawal |
7 (8.8%) |
2 (2.5%) |
– | – |
1 (1.2%) |
3 (1.2%) |
AE suspected to be caused by drug study |
4 (5.0%) |
14 (17.3%) |
3 (3.8%) |
7 (8.9%) |
11 (13.3%) |
28 (11.1%) |
Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
Anaphylaxis | 0 | 0 | 0 | 0 | 0 | 0 |
*Post hoc analysis of phase 3 studies (ASTERIA I & II, and GLACIAL), demonstrated clinically meaningful improvements in quality of life (measured using DLQI) in patients with CSU.10
†Incidence of AEs observed across duration of study including treatment period and follow-up = 40 weeks.
‡Incidence of AEs observed across duration of study including treatment period and follow-up = 28 weeks.
Indication: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.2
AE, adverse event; CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; IgE, immunoglobulin E; NR, not reported.
References
- Zuberbier T et al. Allergy 2018;73(7):1393–1414.
- Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
- Novartis, data on file XSU15-C006. Patient treatment years and clinical subjects in Xolair studies.
- EMA Xolair CSU 2014; EMA/CHMP/20684/2014; Committee for Medicinal Products for Human Use (CHMP) January 2014.
- Saini S et al. J Invest Dermatol 2015;135(1):67–75.
- Saini S et al. J Invest Dermatol 2015;135(1):67–75 (supplementary information).
- Maurer M et al. N Engl J Med 2013;368(10):924–935.
- Maurer M et al. N Engl J Med 2013;368(10):924–935 (supplementary information).
- Kaplan A et al. J Allergy Clin Immunol 2013;132(1):101–109.
- Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.