title: The European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): A paediatric assessment.
abstract: Safety data on 'real-life' allergen immunotherapy (AIT) in children and adolescents is usually extrapolated from studies in adults.
  
  
  
  Patients aged 18 or under initiating aeroallergen AIT were evaluated in a prospective European survey. Patient profiles and systemic reactions (SRs) were recorded. Descriptive, univariate and multivariate analyses were used to identify risk factors for SRs.
  
  
  
  A total of 1563 patients (mean ± SD age: 11.7 ± 3.9 years; rhinitis: 93.7%; asthma: 61.5%; polysensitization: 62.5%) and 1578 courses of AIT were assessed. Single-allergen AIT was administered in 89.5% of cases (n = 1412; mites: 49%; grass pollen: 25.8%; tree pollen: 8.7%; Alternaria: 4.6%; dander: 0.8%; weed pollen: 0.6%). Subcutaneous AIT (SCIT) was used in 71.4% (n = 1127) of the treatments, including 574 (50.9%) with natural extracts. Sublingual AIT (SLIT) was used for the remaining 451 treatments (drops: 73.8%; tablets: 26.2%). The mean ± SD follow-up period was 12.9 ± 3.3 months. The estimated total number of doses was 19,669 for SCIT and 131,550 for SLIT. Twenty-four patients (1.53%) experienced 29 SRs. Respiratory (55.7%) and skin symptoms (37.9%) were most frequent. Anaphylaxis was diagnosed in 3 SRs (10.3%), and adrenaline was administered in 2 of these cases. In a univariate analysis, the risk of SRs was lower in mite-sensitized patients and higher in cases of pollen polysensitization (>3), grass pollen extracts and the use of natural extracts (vs. allergoids).
  
  
  
  In a real-life paediatric setting, AIT is safe. SRs are infrequent and generally not severe. Pollen polysensitization, grass pollen extracts and natural extracts (vs. allergoids) were risk factors for AIT-associated SRs.
authors.affiliation: Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Rodríguez Del Río
authors.affiliation: Allergy Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Vidal
authors.affiliation: Centre de l'Asthme et des Allergies, Hôpital d'enfant Armand Trousseau, Paris, France.
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Just
authors.affiliation: Allergy Department, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: Ana I
authors.initials: AI
authors.lastname: Tabar
authors.affiliation: Allergy Department, Hospital de Ofra, Santa Cruz de Tenerife, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Sanchez-Machin
authors.affiliation: Private Office, Kassel, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Eberle
authors.affiliation: Allergy Section, Hospital General Universitario, Ciudad Real, Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: Borja
authors.affiliation: Ear, Nose and Throat Practice, Lutherstadt, Eisleben, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Bubel
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.|Department of Otorhinolaryngology and Head and Neck Surgery, Medical Faculty Mannheim, Universitätsmedizin Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Pfaar
authors.affiliation: Département de Pneumologie et Addictologie, UMR-S 1136, IPLESP, Equipe EPAR, Hôpital Arnaud de Villeneuve, UPMC Paris 06, University Hospital of Montpellier, Sorbonne Universités, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Demoly
authors.affiliation: Imperial College-National Heart and Lung Institute, London, UK.
authors.forename: Moises A
authors.initials: MA
authors.lastname: Calderón
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000707:Anaphylaxis / Q000453:epidemiology* / Q000209:etiology; D039741:Antigens, Dermatophagoides / Q000276:immunology / Q000627:therapeutic use*; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D002648:Child; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D005060:Europe; D005076:Exanthema / Q000453:epidemiology* / Q000209:etiology; D005500:Follow-Up Studies; D006801:Humans; D011058:Pollen / Q000276:immunology; D015995:Prevalence; D011446:Prospective Studies; D065631:Rhinitis, Allergic / Q000276:immunology / Q000628:therapy*; D012307:Risk Factors; D011795:Surveys and Questionnaires
chemical_list: D039741:Antigens, Dermatophagoides
keywords: Medical Dictionary for Regulatory Activities; adrenaline; allergen immunotherapy; anaphylaxis; children; risk factor; subcutaneous; sublingual; systemic reaction