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Hypersensitivity Reactions to Biologics (Part II): Classifications and Current Diagnostic and Treatment Approaches

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Hypersensitivity Reactions to Biologics (Part II): Classifications and Current Diagnostic and Treatment Approaches Hypersensitivity reactions to biologics (part II): classifications and current diagnostic and treatment approaches Askin Gülsen, Bettina Wedi & Uta Jappe Allergo Journal International Interdisciplinary Journal of Allergy, Clinical Immunology and Environmental Medicine e-ISSN 2197-0378 Allergo J Int DOI 10.1007/s40629-020-00127-5 1 23 Your article is published under the Creative Commons Attribution license which allows users to read, copy, distribute and make derivative works, as long as the author of the original work is cited. You may self- archive this article on your own website, an institutional repository or funder’s repository and make it publicly available immediately. 1 23 review Allergo J Int https://doi.org/10.1007/s40629-020-00127-5 Hypersensitivity reactions to biologics (part II): classifications and current diagnostic and treatment approaches Askin Gülsen · Bettina Wedi · Uta Jappe Received: 16 December 2019 / Accepted: 31 March 2020 © The Author(s) 2020 Abstract and basophil activation tests are used by centers with Purpose Biotechnological substances (BS) have rapidly research facilities. Although the treatment protocols expanded their clinical use. In parallel, there is an for acute conditions vary, the overall approach is the increase in expected or unexpected immunological same. or non-immunological adverse effects. In this part Conclusion HSRs to BS are gradually increasing with of the review, the current nomenclature of BSs, the the widening of their clinical use and indications. It is classification of hypersensitivity reactions (HSR), as very important to prevent HSRs and to know the de- well as diagnostic and treatment approaches are gree of severity as well as the emergency treatment al- documented to provide the tools to understand the gorithm. This review summarizes the diagnostic tests nomenclature used throughout the databases and the that should be applied: (a) immediately during/after need to harmonize it where applicable. a reaction, and (b) subsequently, and in the case that Methods Detailed searches were performed on Pub- a switch of BS is not possible, desensitization is an med, Web of Science, and Google Scholar to include option. all available publications. The search terms, such as specific BS, allergy, anaphylaxis, hypersensitivity, Keywords Allergy · Anaphylaxis · Anti-drug reactions, classification, diagnosis, grading, manage- antibodies · Biologicals · Desensitization ment, and desensitization, were determined for the search. Case reports, articles, and reviews on this Abbreviations subject were included. ADA Anti-drug antibodies Results Today, a variety of non-standardized methods ADR Adverse drug reaction α α are used to support the clinical diagnosis. These in- -Gal Galactose- -1,3-galactose clude prick-to-prick tests and intradermal tests with ARCN Airway Research Center North the drug itself and its potentially allergenic ingredi- BAT Basophil activation test ents. More rarely, anti-drug antibodies are detected BMBF Federal Ministry for Science and Educa- tion BS Biotechnological substances Part I see https://doi.org/10.1007/s40629-020-00126-6 BWH Brigham and Women’s Hospital A.Gülsen·Prof.Dr.U.Jappe,MD,MSc() CD Cluster of differentiation Division of Clinical and Molecular Allergology, Research CDR Complementarity-determining region Center Borstel, Airway Research Center North (ARCN), CRS Cytokine release syndrome Member of the German Center for Lung Research (DZL), EGFR Epidermal growth factor receptor Parkallee 35, 23845 Borstel, Germany ELISA Enzyme-linked immunosorbent assay Interdisciplinary Allergy Outpatient Clinic, Department of Erb Eukaryotic ribosome biogenesis protein Pneumology, University of Luebeck, Luebeck, Germany [email protected] GM-CSF Granulocyte-macrophage colony-stim- ulating factor B. Wedi HSR Hypersensitivity reaction Department of Dermatology and Allergy, Comprehensive IFN Interferon Allergy Centre, Hannover Medical School, 30625 Hannover, Germany Ig Immunoglobulin K Hypersensitivity reactions to biologics (part II): classifications and current diagnostic and treatment. review IL Interleukin Table 1 Classifcation of biotechnological substancesa INN International nonproprietary names Group Example substances/targets mAb Monoclonal antibody Monoclonal antibodies RDD Rapid drug desensitization Towards IgE antibodies Omalizumab, ligelizumab, quil- SPT Skin-prick test izumab TGF Transforming growth factor Towards cell surface molecules Rituximab (anti-CD20) TNF-α Tumor necrosis factor α Basiliximab (anti-IL-2 receptor) USAN United States’ adopted names Efalizumab (anti-LFA-1) Towards soluble mediators and Infliximab, adalimumab (an- Introduction cytokines ti-TNFα) Daclizumab (anti-IL-2 R alpha) Biotechnological substances (BS) have rapidly ex- Lanadelumab (plasma kallikrein) panded their clinical use since the years they were Towards tumor antigens Cetuximab (EGFR) first defined. In parallel, there is an increase in expected and unexpected side effects and various Trastuzumab (HER2/neu/ErbB2) adverse drug reactions (ADR) [1]. These reactions can Fusion proteins be acute infusion reactions, anaphylaxis, hypersen- Soluble receptors for cytokines Etanercept (TNFα-RII) sitivity reactions (HSR), cytokine release syndrome Soluble cellular ligands Anakinra (IL-1 receptor) due to intravenous injection, and local injection site Soluble receptor constructs Ritanercept (IL-1 β receptor) reactions, HSRs and anaphylaxis due to subcutaneous Cytokines Interferon-α administration. Interferon-β Moreover, BSs are different from most drugs in that GM-CSF they do not contain prodrugs or small chemical com- Interleukin-2 pounds, but are produced to make them as similar to human proteins as possible. Unlike other drugs, CD cluster of differentiation, IL interleukin, LFA lymphocyte function-as- sociated antigen, TNF tumor necrosis factor, EGFR endothelial growth they are not metabolized classically, but have func- factor receptor, HER human epidermal growth factor, GM-CSF granulocyte- tions like other proteins and can be digested from the macrophage colony-stimulating factor a gastrointestinal tract. Therefore, ADRs are also quite Adapted from http://biologics.clinimmsoc.org (WEBbook of Biologic Thera- pies) and Scherer et al. [1] with permission different. The adverse effects can be either immuno- logical or non-immunological, as well as due to the excessive response of the immune system depending Fusion proteins include soluble cytokine receptors, on the pharmacological properties of the drug [2]. soluble cellular ligands, and soluble receptor con- In this part of the review, the current nomenclature structs, and immunoglobulin fragments. Recombi- of BSs, the classification of hypersensitivity reactions, nant cytokines, including interferon-α, interferon-β, as well as diagnostic and treatment approaches will granulocyte-macrophage colony-stimulating factor be discussed. (GM-CSF), and interleukin (IL)-2, may also be effec- tive treatments for various conditions. Material and methods Biologics that neutralize tumor necrosis factor α (TNF-α), interferons, and ILs, or receptor blockers Detailed searches were performed on Pubmed, Web targeting receptors such as epidermal growth factor of Science, and Google Scholar to include all available receptor (EGFR), eukaryotic ribosome biogenesis pro- publications. The search terms, such as specific BS, tein (Erb) 1, Erb2, and human clusters of differentia- allergy, anaphylaxis, hypersensitivity, reactions, clas- tion (CD) 125 are currently available [3–5]. sification, diagnosis, grading, management, and de- sensitization, were determined for the search. Case International nomenclature of biotechnological reports, articles, and reviews on this subject were re- substances trieved. Systems of nomenclature most commonly used are Classification of biotechnological substances the World Health Organization’s International Non- proprietary Names (INN) and the United States’ Biologics include fully human and humanized mono- Adopted Names (USAN) for biologicals [6, 7]. The clonal antibodies (mAb), chimeric (human+ murine) syllables used in naming have various meanings. antibodies, and recombinant fusion proteins that af- The first one to two syllables have no specific mean- fect specific functions of the immune system. The ing. three most common classes of biologics are mAbs, fu- The second or third syllable defines the target or sion proteins, and cytokines (Table 1). indication of the drugs. As used herein, -li/-lim desig- Currently approved mAbs target immunoglobulin nates the immune system, -tu/-ti designates tumors, (Ig)-E antibodies, cell surface molecules, soluble me- -ki designates cytokines, -vi designates viruses, and diators, cytokines, viral proteins, and tumor antigens. -ci designates the cardiovascular system. Thus, oma- Hypersensitivity reactions to biologics (part II): classifications and current diagnostic and treatment. K review Table 2 Internationally ac- Syllable Explanation Syllable Explanation cepted nomenclature of First There is no specific meaning – – biotechnological substancesa Second or third Target of the biological agent -ci Cardiovascular system -ki Cytokine, interleukin -li/-lim Immune system -tu/-ti Tumor -vi Viral -ba Bacterial Third or fourth Source of the biological agent -mo/-mu Murine, mouse (0% human) -xi Chimeric (75% human) -zu Humanized (>90% human) -u (Fully) human (100% human) Last Mechanism of action -mab Monoclonal antibody -cept Soluble receptor -inib Receptor blocker aAdapted from World Health Organization [6] and
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