title: The safety of self-administered allergen immunotherapy during the buildup and maintenance phases.
abstract: BACKGROUND
  Self-administered allergen immunotherapy is considered controversial. We believe the implementation of a self-administration protocol characterized by patient preselection and a slow buildup phase is safe.
  
  
  METHODS
  We analyzed 23,614 patient records and associated immunotherapy injections for systemic reactions (SR) during a 1-year period (2011 to 2012). SRs were graded in accordance with the World Allergy Organization (WAO) criteria.
  
  
  RESULTS
  Thirty-seven SRs were reported for 23,614 patients who self-administered 2,021,600 injections yielding an annual SR rate of 0.16% (per patient) or 0.002% (per injection). Only 9 of 4643 pediatric (0.19%) and 28 of 18,971 adult patients (0.15%) experienced 1 or more SRs. No deaths (grade V SR) occurred. From 2009 through early 2014, over 90,000 patients received more than 10 million injections in accordance with the United Allergy Services (UAS) protocol without fatalities.
  
  
  CONCLUSIONS
  We believe this safety profile is due to a preselection of patients to exclude those with a high risk for adverse reactions and a slow immunotherapy buildup phase. In contrast, previous studies documented office-based SRs ranging from approximately 3% to greater than 14%. Thus, the UAS home-immunotherapy SR rate is significantly lower than office-based immunotherapy SR rates (p < 0.0001). The enhanced safety of this protocol results in a decreased frequency and severity of SRs. This safety report, derived from analyses of one of the largest patient cohorts studied, corroborates and expands the observations of previous studies of self-administered subcutaneous immunotherapy in a low-risk patient population by assessing self-administered allergen immunotherapy during the buildup and maintenance phases.
authors.affiliation: United Allergy Services (UAS), San Antonio, TX; Division of Pediatric Pulmonary, Allergy and Immunology, Medical University of South Carolina, Charleston, SC.
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Schaffer
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Naples
authors.forename: Myla
authors.initials: M
authors.lastname: Ebeling
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Hulsey
authors.forename: Larry M
authors.initials: LM
authors.lastname: Garner
mesh_terms: D000316:Adrenergic alpha-Agonists / Q000627:therapeutic use; D000328:Adult; D000485:Allergens / Q000009:adverse effects; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D004837:Epinephrine / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000188:drug therapy / Q000209:etiology; D008297:Male; D061214:Patient Safety; D012221:Rhinitis, Allergic, Perennial / Q000628:therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000628:therapy*; D012646:Self Administration
chemical_list: D000316:Adrenergic alpha-Agonists; D000485:Allergens; D004837:Epinephrine
keywords: allergen immunotherapy; epinephrine; safety; self-administration; systemic reaction