title: European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): a real-life clinical assessment.
abstract: BACKGROUND
  Outside clinical trials, data on systemic reactions (SRs) due to allergen immunotherapy (AIT) are scarce.
  
  
  METHODS
  A prospective, longitudinal, web-based survey of 'real-life' respiratory allergen immunotherapy (AIT) clinical practice was conducted in France, Germany and Spain. SRs were recorded and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and risk factors associated with SRs were identified.
  
  
  RESULTS
  A total of 4316 patients (corresponding to 4363 ongoing courses of AIT) were included. A total of 109 SRs were recorded, and 90 patients (2.1%) presented at least one SR. Most of the SRs occurred in subcutaneous allergen immunotherapy (SCIT) (89%, n = 97). The most frequently reported symptoms were urticaria, rhinitis, dyspnoea and cough. Respiratory symptoms appeared before skin symptoms. Most SRs occurred during the up-dosing phase (75.8%) and were mild in severity (71.6%). Intramuscular adrenaline was administered in 17 SRs, but only 65% of these were subsequently classified as anaphylaxis. Independent risk factors for SRs during SCIT were as follows: the use of natural extracts (odds ratio, OR) [95% confidence interval (CI)] = 2.74 [1.61-4.87], P = 0.001), the absence of symptomatic allergy medications (1.707 [1.008-2.892], P = 0.047), asthma diagnosis (1.74 [1.05-2.88], P = 0.03), sensitization to animal dander (1.93 [1.21-3.09], P = 0.006) or pollen (1.16 [1.03-1.30], P = 0.012) and cluster regimens (vs rush) (4.18 [1.21-14.37], P = 0.023). A previous episode of anaphylaxis increased the risk for anaphylaxis in SCIT (OR [95% CI] = 17.35 [1.91-157.28], P = 0.01).
  
  
  CONCLUSIONS
  AIT for respiratory allergy is safe, with a low number of SRs observed in real-life clinical practice. A personalized analysis of risk factors could be used to minimize SRs.
authors.affiliation: Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, UK.
authors.forename: M A
authors.initials: MA
authors.lastname: Calderón
authors.affiliation: Allergy Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Vidal
authors.affiliation: Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Rodríguez Del Río
authors.affiliation: Service d'Allergologie, Centre de l'Asthme et des Allergies, Hôpital d'Enfants Armand-Trousseau (APHP)-Sorbonne Universités, UPMC Univ Paris 06, UMR-S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, France.
authors.forename: J
authors.initials: J
authors.lastname: Just
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.|Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: O
authors.initials: O
authors.lastname: Pfaar
authors.affiliation: Allergy Department, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: A I
authors.initials: AI
authors.lastname: Tabar
authors.affiliation: Allergy Management Unit, Hospital del Tórax, Complejo Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Sánchez-Machín
authors.affiliation: Ear, Nose and Throat Practice, Lutherstadt, Eisleben, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Bubel
authors.affiliation: Allergy Section, Hospital General Universitario, Ciudad Real, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Borja
authors.affiliation: Allergy Center, Kassel, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Eberle
authors.affiliation: Otorhinolaryngology and Allergology Center Schorndorf-Nord, Schorndorf, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Reiber
authors.affiliation: Allergology and Immunology Clinique, University Claude Bernard, Lyon, France.
authors.forename: M
authors.initials: M
authors.lastname: Bouvier
authors.affiliation: Medical Practitioner, Compiègne, France.
authors.forename: A
authors.initials: A
authors.lastname: Lepelliez
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Klimek
authors.affiliation: Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Sorbonne Universités, UPMC Paris 06, UMR-S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Demoly
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology; D003888:Desensitization, Immunologic / Q000009:adverse effects* / Q000379:methods; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis / Q000453:epidemiology* / Q000276:immunology / Q000628:therapy; D007114:Immunization; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D008137:Longitudinal Studies; D008297:Male; D016017:Odds Ratio; D011159:Population Surveillance; D011446:Prospective Studies; D012307:Risk Factors; D012882:Skin Tests; D011795:Surveys and Questionnaires; D063189:Symptom Assessment; D055815:Young Adult
chemical_list: D000485:Allergens; D007073:Immunoglobulin E
keywords: allergen immunotherapy; allergoid; asthma; risk factor; systemic reaction