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The European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): A paediatric assessment
Pablo Rodríguez Del Río1, Carmen Vidal2, Jocelyne Just3
1Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
Insights
Allergen immunotherapy (AIT) is safe for children and adolescents in real-world settings, with infrequent and mild side effects. Risk factors for reactions include pollen polysensitization and the use of natural extracts.
Area of Science:
- Allergy and Immunology
- Pediatric Medicine
- Pharmacovigilance
Background:
- Real-world safety data for allergen immunotherapy (AIT) in pediatric populations is often inferred from adult studies.
- This study addresses the need for specific safety data in children and adolescents undergoing AIT.
Purpose of the Study:
- To evaluate the safety and identify risk factors for systemic reactions (SRs) in pediatric patients initiating aeroallergen AIT in a real-life European setting.
- To provide evidence-based safety information for AIT in children and adolescents.
Main Methods:
- A prospective European survey assessed patients aged 18 or under starting aeroallergen AIT.
- Data collected included patient profiles, types of AIT (SCIT/SLIT), allergens, and recorded systemic reactions (SRs).
- Descriptive, univariate, and multivariate analyses were performed to identify risk factors for SRs.
Main Results:
- 1563 pediatric patients and 1578 AIT courses were analyzed, with a mean follow-up of 12.9 months.
- Overall, 1.53% of patients experienced 29 SRs, predominantly respiratory and skin symptoms; anaphylaxis occurred in 3 cases.
- Risk factors for SRs included pollen polysensitization (>3 allergens), grass pollen extracts, and use of natural extracts compared to allergoids.
Conclusions:
- Real-life allergen immunotherapy (AIT) is safe in the pediatric population.
- Systemic reactions associated with AIT in children are infrequent and generally not severe.
- Pollen polysensitization, grass pollen extracts, and natural extracts are identified as risk factors for AIT-related SRs in this age group.
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.
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