title: Systemic reactions to immunotherapy: influence of composition and manufacturer.
abstract: BACKGROUND
  Although immunotherapy clearly demonstrated the benefit of reducing allergic symptoms, it has the drawback of adverse events, mainly systemic reactions that could be very inconvenient for patients and even life-threatening.
  
  
  OBJECTIVE
  The aim of the present study was to assess the incidence of systemic reactions to immunotherapy in a large number of patients, and its potential relationship with the characteristics of therapy, such as allergen composition or manufacturing laboratory.
  
  
  METHODS
  This study analysed the administration of specific immunotherapy during a period of 5 years, involving 1212 patients affected by respiratory hypersensitivity or hymenoptera venom anaphylaxis. Commercial extracts were supplied by five different laboratories. All the patients were attended at an out-clinic immunotherapy unit by the same experienced staff. Immunotherapy was given following a conventional schedule, modified according the usual recommendations.
  
  
  RESULTS
  A total of 250 adverse reactions have been recorded, resulting in a frequency of 0.84% over the total number of injections. Seventy-nine of them (32%) were systemic reactions (0.27% SR/injection). The 79 systemic reactions were observed in 60 patients (5% of the patients). The frequency of systemic reactions was significantly lower (P < 0.01) on the group of mites than on the other groups. The frequency of systemic reactions varies according to the manufacturing laboratory. In the case of mite extracts, although one of the laboratories had a lower frequency of adverse systemic reactions, it did not reach the level of statistical significance. However, in relation to pollen extracts, preparations of one of the manufacturers had a significantly lower frequency of systemic reactions. Concerning the time of occurrence, 27% of systemic reactions were delayed, thus they appeared at least 30 min after the vaccine injection, most of them due to pollen extracts.
  
  
  CONCLUSIONS
  This is a preliminary study to evaluate the factors that could facilitate the appearance of systemic reactions demonstrating that not only the composition but also the manufacturer is connected to systemic reactions. Although further studies are needed to clearly establish the influence of manufacturer on frequency and time of appearance of systemic reactions, it seems necessary to reach a wide consensus on allergen extract standardization methods.
authors.affiliation: Servicio de Alergología, Hospital Santiago Apóstol, Hospital de Txagorritxu, Osakidetza-Servicio Vasco de Salud, Vitoria-Gasteiz, Basque Country, Spain. ggastaminza@hsan.osakidetza.net
authors.forename: G
authors.initials: G
authors.lastname: Gastaminza
authors.forename: J
authors.initials: J
authors.lastname: Algorta
authors.forename: M
authors.initials: M
authors.lastname: Audicana
authors.forename: M
authors.initials: M
authors.lastname: Etxenagusia
authors.forename: E
authors.initials: E
authors.lastname: Fernández
authors.forename: D
authors.initials: D
authors.lastname: Muñoz
mesh_terms: D000485:Allergens / Q000008:administration & dosage*; D000818:Animals; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D004334:Drug Administration Schedule; D006801:Humans; D006927:Hymenoptera; D006967:Hypersensitivity / Q000276:immunology* / Q000517:prevention & control; D011058:Pollen; D012189:Retrospective Studies
chemical_list: D000485:Allergens