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Local Side Effects of Sublingual and Oral Immunotherapy.
- Source :
-
The journal of allergy and clinical immunology. In practice [J Allergy Clin Immunol Pract] 2017 Jan - Feb; Vol. 5 (1), pp. 13-21. Date of Electronic Publication: 2016 Aug 12. - Publication Year :
- 2017
-
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.<br /> (Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Inhalation
Administration, Oral
Allergens immunology
Anaphylaxis etiology
Animals
Clinical Trials as Topic
Drug Dosage Calculations
European Union
Food Hypersensitivity immunology
Humans
Sublingual Immunotherapy adverse effects
United States
United States Food and Drug Administration
Allergens therapeutic use
Anaphylaxis immunology
Drug-Related Side Effects and Adverse Reactions immunology
Food Hypersensitivity therapy
Sublingual Immunotherapy methods
Subjects
Details
- Language :
- English
- ISSN :
- 2213-2201
- Volume :
- 5
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The journal of allergy and clinical immunology. In practice
- Publication Type :
- Academic Journal
- Accession number :
- 27527548
- Full Text :
- https://doi.org/10.1016/j.jaip.2016.06.020