The European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): A paediatric assessment

• Published in: Pediatric allergy and immunology Vol. 28; no. 1; pp. 60 - 70
• Main Authors: Rodríguez del Río, Pablo, Vidal, Carmen, Just, Jocelyne, Tabar, Ana I., Sanchez‐Machin, Inmaculada, Eberle, Peter, Borja, Jesus, Bubel, Petra, Pfaar, Oliver, Demoly, Pascal, Calderón, Moises A.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.02.2017; Wiley
• Subjects: Adolescent; adrenaline; Adult; Adverse Drug Reaction Reporting Systems; allergen immunotherapy; Allergies; Allergology; Alternaria; anaphylaxis; Anaphylaxis - epidemiology; Anaphylaxis - etiology; Antigens, Dermatophagoides - immunology; Antigens, Dermatophagoides - therapeutic use; Asthma - immunology; Asthma - therapy; Child; children; Desensitization, Immunologic - adverse effects; Desensitization, Immunologic - methods; Europe; Exanthema - epidemiology; Exanthema - etiology; Follow-Up Studies; Human health and pathology; Humans; Immunology; Immunotherapy; Life Sciences; Medical Dictionary for Regulatory Activities; Pediatrics; Pollen - immunology; Prevalence; Prospective Studies; Rhinitis, Allergic - immunology; Rhinitis, Allergic - therapy; risk factor; Risk Factors; subcutaneous; sublingual; Surveys and Questionnaires; systemic reaction; subcutaneous; systemic reaction; adrenaline; allergen immunotherapy; children; anaphylaxis; risk factor; Medical Dictionary for Regulatory Activities; sublingual
• ISSN: 0905-6157; 1399-3038
• DOI: 10.1111/pai.12660

Background Safety data on ‘real‐life’ allergen immunotherapy (AIT) in children and adolescents is usually extrapolated from studies in adults. Methods 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. Results 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). Conclusions 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.