Omalizumab
DefinitionThis section has been translated automatically.
Omalizumab is a "humanized" mouse antibody containing approximately 5% mouse amino acids and is specifically designed to capture and neutralize immunoglobulin E antibodies (IgE) in human blood.
Pharmacodynamics (Effect)This section has been translated automatically.
The active ingredient binds free immunoglobulin E in the blood and blocks the receptor sites. In clinical tests, Omalizumab has proven to be effective and so far quite well tolerated. Up to now, its use has been investigated primarily in bronchial asthma and allergic rhinitis. However, the therapy of other allergic diseases, such as atopic eczema, is also conceivable. Omalizumab is only effective if the IgE level is reduced to very low levels. Patients with very high IgE levels are almost excluded from the therapy, as there are not sufficient amounts of Omalizumab available for this purpose. Even patients with very low IgE levels will hardly benefit from an Omalizumab treatment, as they will have symptoms despite low IgE levels.
IndicationThis section has been translated automatically.
- Approved in Germany since October 2005 for the treatment of patients (from 12 years of age) with moderate to severe asthma and allergies to allergens that are important all year round (e.g. house dust mites) and additionally insufficient freedom from symptoms under stadium-appropriate medication.
- Omalizumab has been approved for chronic spontaneous urticaria since 2014. Dosage: 300mg s.c./ every 4 weeks. Approval was granted on the basis of several studies in about 1000 patients (ASTERIA I and II; GALCIAL). The approved indication applies to patients who do not respond adequately to treatment with antihistamines from the age of 12 years.
- There are casuistic contributions on the efficacy in idiopathic cold urticaria, cholinergic urticaria, urticaria pigmentosa, urticaria factitia and latex allergy.
- A 16-week pre-treatment with omalizumab significantly reduced the rate of systemic side effects of SIT (see below immunotherapy, specific)(off-label use).
- Atopic eczema: A randomized, placebo-controlled, double-blind pilot study in 20 patients showed no superiority compared to placebo.
Dosage and method of useThis section has been translated automatically.
- The appropriate dosage and treatment frequency is determined on the basis of the IgE base value (IE/ml) measured before the start of treatment and the body weight. To determine the dose, it is necessary to determine the IgE value of the patient with a commercial serum total IgE test before the first application. Based on these measurements, 75-375 mg Xolair in the form of 1-3 injections may be required per administration. Maximum dose: 1 time/2 week 375 mg Omalizumab s.c.
- The therapy must be repeated at regular intervals (approximately every 2-4 weeks), as the injected antibodies are broken down again and the effect decreases (the higher the IgE levels at the beginning, the faster the effect decreases). Caution! High treatment costs.
Undesirable effectsThis section has been translated automatically.
Exanthema; anaphylactic reactions. However, anaphylactic reactions are rather rare. They were detected 41 times in 39,510 patients = 0.09% (Khan DA 2016). Possibly the polysorbates in the omalizumab play a triggering role.
Repeated cases of Churg-Strauss syndrome have been described with omalizumab.
PreparationsThis section has been translated automatically.
Xolair
Note(s)This section has been translated automatically.
Test concentrations for allergy (recommended test concentrations cited in Sachs B et al. 2018)
- Prick: 125mg/ml (stock solution) 1:10; 1:100; 1:1000
- i.c. 1.25 ug/ml (corresponds to 1:100,000)
LiteratureThis section has been translated automatically.
- Babu KS et al (2001) Anti-IgE treatment: an update. Allergy 56: 1121-1128
- Buhl R et al (2003) Omalizumab provides long-term control in patients with moderate to severe allergic asthma. European Respiratory Journal 20: 73-78
- Durack A et al (2014) Omalizumab for the treatment of chronic idiopathic or spontaneous
urticaria: a critical appraisal. Br J Dermatol 171:10-13. - Finn A et al (2003) Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. Journal of Allergy and Clinical Immunology 111: 278-284
- Heil PM et al (2010) Omalizumab therapy of atopic dermatitis: IgE depletion does not lead to clinical improvement - a randomized, placebo-controlled, double-blind pilot study. JDDG 8: 990-999
- Khan DA (2016) Hypersensitivity and immunologic reactions to biologics: opportunities for theallergist
. Ann Allergy Asthma Immunol 117:115-120. - Kühr J et al (2002) Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis. Journal of Allergy and Clinical Immunology 109: 274-280
- Lane JE et al (2005) Treatment of recalcitrant atopic dermatitis with omalizumab. J Am Acad Dermatol 54: 68-72
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Rosén K et al (2014) Response to: 'Omalizumab for the treatmentof
chronic idiopathic or spontaneous urticaria: a critical appraisal. Br JDermatol
171:15-16.