title: Local Side Effects of Sublingual and Oral Immunotherapy.
abstract: Sublingual immunotherapy (SLIT) is increasingly used worldwide, and several products have been recently registered as drugs for respiratory allergy by the European Medicine Agency and the Food and Drug Administration. Concerning inhalant allergens, the safety of SLIT is overall superior to that of subcutaneous immunotherapy in terms of systemic adverse events. No fatality has been ever reported, and episodes of anaphylaxis were described only exceptionally. Looking at the historical and recent trials, most (>90%) adverse events are "local" and confined to the site of administration. For this reason, a specific grading system has been developed by the World Allergy Organization to classify and describe local adverse events. There is an increasing amount of literature concerning oral desensitization for food allergens, referred to as oral immunotherapy. Also, in this case, local side effects are predominant, although systemic adverse events are more frequent than with inhalant allergens. We review herein the description of local side effects due to SLIT, with a special focus on large trials having a declared sample size calculation. The use of the Medical Dictionary for Regulatory Activities nomenclature for adverse events is mentioned in this context, as recommended by regulatory agencies. It is expected that a uniform classification/grading of local adverse events will improve and harmonize the surveillance and reporting on the safety of SLIT.
authors.affiliation: Allergy and Respiratory Diseases, IRCCS San Martino - IST - University of Genoa, Genoa, Italy. Electronic address: passalacqua@unige.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Passalacqua
authors.affiliation: Icahn School of Medicine at Mount Sinai, Jaffe Food Allergy Institute, New York, NY.
authors.forename: Anna
authors.initials: A
authors.lastname: Nowak-Węgrzyn
authors.affiliation: Allergy and Respiratory Diseases, IRCCS San Martino - IST - University of Genoa, Genoa, Italy.
authors.forename: Giorgio Walter
authors.initials: GW
authors.lastname: Canonica
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000485:Allergens / Q000276:immunology / Q000627:therapeutic use*; D000707:Anaphylaxis / Q000209:etiology / Q000276:immunology*; D000818:Animals; D002986:Clinical Trials as Topic; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000276:immunology*; D005062:European Union; D005512:Food Hypersensitivity / Q000276:immunology / Q000628:therapy*; D006801:Humans; D063729:Sublingual Immunotherapy / Q000009:adverse effects / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000485:Allergens
keywords: Adverse events; Food allergy; Local side effects; Oral desensitization; Oral immunotherapy; Respiratory allergy; Safety; Sublingual immunotherapy