A desensitization protocol for the mAb cetuximab

Division of Rheumatology, Allergy and Immunology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
The Journal of allergy and clinical immunology (Impact Factor: 11.25). 12/2008; 123(1):260-2. DOI: 10.1016/j.jaci.2008.09.046
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    ABSTRACT: To cite this article: Cernadas JR, Brockow K, Romano A, Aberer W, Torres MJ, Bircher A, Campi P, Sanz ML, Castells M, Demoly P, Pichler WJ, for the European Network of Drug Allergy and the EAACI interest group on drug hypersensitivity. General considerations on rapid desensitization for drug hypersensitivity – a consensus statement. Allergy 2010; 65: 1357–1366.AbstractDrug hypersensitivity reactions can occur with most drugs, are unpredictable, may affect any organ or system, and range widely in clinical severity from mild pruritus to anaphylaxis. In most cases, the suspected drug is avoided in the future. However, for certain patients, the particular drug may be essential for optimal therapy. Under these circumstances, desensitization may be performed. Drug desensitization is defined as the induction of a temporary state of tolerance of a compound responsible for a hypersensitivity reaction. It is performed by administering increasing doses of the medication concerned over a short period of time (from several hours to a few days) until the total cumulative therapeutic dose is achieved and tolerated. It is a high-risk procedure used only in patients in whom alternatives are less effective or not available after a positive risk/benefit analysis. Desensitization protocols have been developed and are used in patients with allergic reactions to antibiotics (mainly penicillin), insulins, sulfonamides, chemotherapeutic and biologic agents, and many other drugs. Desensitization is mainly performed in IgE-mediated reactions, but also in reactions where drug-specific IgE have not been demonstrated. Desensitization induces a temporary tolerant state, which can only be maintained by continuous administration of the medication. Thus, for treatments like chemotherapy, which have an average interval of 4 weeks between cycles, the procedure must be repeated for every new course. In this paper, some background information on rapid desensitization procedures is provided. We define the drugs and drug reactions indicated for such procedures, describe the possible mechanism of action, and discuss the indications and contraindications. The data should serve as background information for a database (accessible via the EAACI-homepage) with standardized protocols for rapid desensitization for antibiotics, chemotherapeutic agents, monoclonal antibodies/fusion proteins, and other drugs.
    Allergy 10/2010; 65(11):1357 - 1366. DOI:10.1111/j.1398-9995.2010.02441.x · 6.00 Impact Factor
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    ABSTRACT: Biotherapeutics expose us to undesirable effects, with certain agents leading, rarely, to an allergic hypersensitivity. Infusion reactions occur with molecules having very different actions. Later, infusion reactions occur in intensive care units in patients undergoing corticotherapy, with a very slow perfusion rate or with induction of tolerance. Anti-galactose-alpha-1,3-galactose can cause anaphylactic reactions to cetuximab. Exanthemas are frequent under treatment with anti-angiogenesis therapy, vemurafenib, and 2nd generation tyrosine kinase inhibitors. Imatinib very frequently induces eyelid edema but also severe cutaneous adverse drug reactions. Generalized reactions due to interferons used in the treatment of hepatitis C can be treated topically or by induction of tolerance. Anaphylactoid reactions due to omalizumab occur in 0.14% of the cases, especially during the early phases of treatment, which should therefore be done under surveillance of the patient, with adrenaline close at hand. Induction of tolerance has been tried after anaphylactic reactions to natalizumab.
    Revue Française d'Allergologie 04/2013; 53(3):174–178. DOI:10.1016/j.reval.2013.01.015 · 0.35 Impact Factor
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    ABSTRACT: Strictly speaking, biological drugs are defined as drugs obtained using biotechnology that act on the immune system. They encompass monoclonal antibodies, fusion proteins, and cytokines. Although they are restricted to specific diseases, they have been increasingly used in recent years, with the consequent reporting of adverse reactions, many of which occur during the postmarketing phase. Because of the characteristics of adverse reactions, a new classification has been proposed. Hypersensitivity reactions are beta-type reactions and include infusion reactions and injection site reactions. In some cases, an immune mechanism mediated by IgE, IgG, or T cells is involved. Clinical symptoms vary widely, from skin reactions to anaphylaxis. Diagnostic studies are based on skin tests and in vitro tests (specific IgE, basophil activation test). Most are not standardized and are conducted in small groups of patients, thus making it impossible to obtain sensitivity and specificity values. With some biological drugs, desensitization protocols have proven successful. In this review, we discuss hypersensitivity reactions to biological drugs and the diagnostic tests used to assess these reactions.


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Sep 22, 2014