title: The efficacy assessment of a self-administered immunotherapy protocol.
abstract: BACKGROUND
  We previously reported the safety of a self-administered subcutaneous immunotherapy (SCIT) protocol. Here we report the results of the retrospective efficacy trial of the United Allergy Service (UAS) self-administered SCIT protocol. We hypothesized that by utilizing a slow SCIT buildup phase, designed to attain recommended allergen concentrations on a cumulative basis, efficacious outcomes and clinical relevance would be achieved.
  
  
  METHODS
  We enrolled 60 SCIT patients and 56 control patients. The study contrasted baseline and treatment period combined symptom plus medication scores (CSMS) as the primary outcome measure and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores as the secondary study outcome measure. Changes in pollen counts were also examined with regard to effects on these efficacy parameters.
  
  
  RESULTS
  The treatment group showed significantly improved CSMS (standardized mean difference [SMD]: -1.57; 95% confidence interval [CI], -1.97 to -1.18; p < 0.001) and RQLQ (SMD: -0.91; 95% CI, -1.23 to -0.59; p < 0.001). These treatment group outcome measures were respectively improved by 33% and 29% compared to baseline and greater than 40% in comparison to the control group (p < 0.0001). Significant results were also shown when examining these outcome measures with regards to either monotherapy or poly-allergen SCIT. Furthermore, a comparison to recent meta-analyses of SCIT studies showed equivalent efficacy and clinical relevance. Assessment of pollen counts during the baseline and treatment periods further corroborated the efficacy of the UAS SCIT protocol.
  
  
  CONCLUSIONS
  These efficacy results, and our previous safety results, show that a carefully designed and implemented self-administered SCIT protocol is efficacious and safe.
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.affiliation: United Allergy Services (UAS), San Antonio, TX.
authors.forename: Larry M
authors.initials: LM
authors.lastname: Garner
authors.affiliation: Division of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC.
authors.forename: Myla
authors.initials: M
authors.lastname: Ebeling
authors.affiliation: Allergy Testing and Treatment Center, Plano, TX.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Adelglass
authors.affiliation: Division of Pediatric Epidemiology, Medical University of South Carolina, Charleston, SC.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Hulsey
authors.affiliation: United Allergy Services (UAS), San Antonio, TX.
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Naples
mesh_terms: D000328:Adult; D000485:Allergens / Q000276:immunology; D002908:Chronic Disease; D003888:Desensitization, Immunologic / Q000379:methods*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000276:immunology; D012189:Retrospective Studies; D065631:Rhinitis, Allergic / Q000276:immunology / Q000628:therapy*; D012646:Self Administration; D012852:Sinusitis / Q000276:immunology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000485:Allergens
keywords: aeroallergens; allergic rhinitis; allergy immunotherapy; allergy injections; subcutaneous immunotherapy