Safety profile [1]
Key safety data for Xolair in CSU.
___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
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.