title: Immunotherapy safety: a prospective multi-centric monitoring study of biologically standardized therapeutic vaccines for allergic diseases.
abstract: BACKGROUND
  The fear of side-effects has led to strict regulations preventing a more widespread use of specific immunotherapy (SIT) in some countries, in spite of the low risk of systemic reactions (SRs) reported in well-controlled studies. The goal of the study was to carry out a prospective and multi-centric trial to evaluate the safety, risk factors and compliance degree of commercially available SIT.
  
  
  METHODS
  The study was carried out in 14 allergy departments from Spain. Four-hundred and eighty-eight patients with rhinitis and/or asthma were submitted to treatment with biologically standardized allergen extracts commercially available. They were administered following the European Academy of Allergy and Clinical Immunology guidelines.
  
  
  RESULTS
  Four hundred and twenty-three patients (86.7%) completed the treatment and remained under control at the end of the trial. Out of 17,526 administered doses, 17,368 doses (99.1%) were not associated with a reaction. Eighteen patients (3.7%) experienced 53 (0.3% of the doses) SRs. All immediate SRs were mild or moderate and responded well to ordinary treatment measures. There were no fatal reactions, anaphylactic shock or life-threatening reactions. A higher ratio of SRs was found among asthmatic and dust mite allergic patients, although multi-variable logistic analysis did not demonstrate any risk factor associated with SRs. There was also a subgroup of patients at risk for recurrent reactions, and therefore 40% of SRs had been avoided if the maximal number of SRs had been previously limited to only three SRs.
  
  
  CONCLUSIONS
  This multi-centric study showed that SIT was a safe treatment with a very good compliance. Future guidelines of SIT should limit the maximal number of SRs.
authors.affiliation: Allergy Department, Hospital Reina Sofia, Cordoba, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Moreno
authors.forename: J
authors.initials: J
authors.lastname: Cuesta-Herranz
authors.forename: L
authors.initials: L
authors.lastname: Fernández-Távora
authors.forename: E
authors.initials: E
authors.lastname: Alvarez-Cuesta
mesh_terms: D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D012220:Rhinitis / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index