Biologicals are crucial targeted therapeutic agents in oncological, immunological, and inflammatory diseases, and their use in clinical practice is broadening. In recent years, the spread of Personalized Precision Medicine has facilitated a proliferation of new treatment options, especially biologicals. Consequently, biologicals are now among the drugs that most frequently cause hypersensitivity reactions (HSRs). Patients can develop HSRs to these agents during the first-lifetime exposure or after repeated exposure, and these HSRs can be potentially life-threatening or limit therapeutic options. Despite the relatively high prevalence, the underlying mechanisms of these HSRs remain obscure, and the optimal management pathways are still a matter of discussion. In this Position Paper, the authors will provide evidence-based recommendations for diagnosing and managing HSRs to biologicals. Additionally, the document defines unmet needs as an opportunity to shape future research.

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Because of their selectivity, biologicals are crucial therapeutic agents in oncological, immunological, and inflammatory diseases and their use in clinical practice is broadening. Biologicals are among the most common drugs that can cause hypersensitivity reactions (HSRs), and this is primarily attributed to an explosion in new treatment options that has developed through personalized and precision medicine. Patients can develop HSRs to these agents during the first lifetime exposure or after repeated exposure. Despite its relatively high prevalence, the underlying mechanisms and optimal management of HSRs to biologicals remain incompletely explained. In this position paper, the authors provided evidence-based recommendations for the diagnosis and management of HSRs to biologicals. Additionally, the document defines unmet needs, which should be topics of future studies.

Chemotherapeutic drugs have been widely used in the treatment of cancer disease for about 70 years and, even with the development of new therapies, they are still prescribed by oncologists, alone or in combination with other antineoplastic agents. All chemotherapies are able to provoke hypersensitivity reactions, even with different incidences, depending on the different class of these drugs, and these reactions are the third leading cause of fatal drug-induced anaphylaxis in the United States. In Europe deaths related to chemotherapy have also been reported. In particular, most reactions are provoked by platinum compounds, taxanes, epipodophyllotoxins and asparaginase. However, currently there are different points of view about the best procedures for the diagnosis, treatment and prevention of these reactions. Thus, the European Network on Drug Allergy and Drug Allergy Interest Group of the European Academy of Allergy and Clinical Immunology organized a task force to provide data and recommendations regarding the allergological work up in this field of drug hypersensitivity reactions. The aims of this position paper were to provide consensus on the investigation of HSRs to chemotherapeutic drugs and to give practical suggestions for clinicians that treat these patients, such as oncologists, allergologists and internists. Key sections cover: risk factors, pathogenesis, symptoms, role of skin tests, in vitro tests, indications and contraindications of drug provocation tests and desensitization of neoplastic patients with allergic reactions to chemotherapeutic drugs. Statements, recommendations and unmet needs were discussed and proposed at the end of each section.