title: Tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with an optimized allergen to adjuvant ratio under routine practice conditions: a noninterventional observational study.
abstract: OBJECTIVE
  A fast updosed immunologically enhanced subcutaneous immunotherapy (SCIT) formulation with an optimized allergen to aluminium hydroxide ratio was first introduced in September 2009 in Germany. A large randomized controlled trial showed that the formulation had considerable immunologic effects and good tolerability. In this open-label, uncontrolled, noninterventional study, tolerability was investigated during routine application.
  
  
  METHODS
  Patients with allergic rhinoconjunctivitis and/or asthma were treated with pollen and mite allergens using a 5-injection updosing schedule (AVANZ: 300, 600, 3000, 6000 and 15 000 SQ+ units) with weekly intervals, followed by a maintenance schedule with injections of 15,000 SQ+ units.Adverse events (AEs) were recorded by physicians, and symptoms and use of symptomatic medication were analyzed before the start of therapy and after an average 8-month treatment period.
  
  
  RESULTS
  SCIT was documented by 362 allergists in 1036 patients between September 2009 and February 2011. AEs mainly consisted of local reactions during updosing (in 24.5% of patients). Systemic reactions were observed during updosing (8.4%) and maintenance therapy (1.7%), the most frequent of which was dyspnea. Overall, tolerability and the effect of treatment were rated as good or very good by 94.9% and 86.6% of patients and by 96.2% and 89.6% of physicians, respectively.
  
  
  CONCLUSIONS
  In this open-label, noninterventional study, fast updosed immunologically enhanced SCIT (AVANZ) was well tolerated in a large group of patients.
authors.forename: B
authors.initials: B
authors.lastname: Hauswald
authors.forename: H
authors.initials: H
authors.lastname: Wolf
authors.forename: F
authors.initials: F
authors.lastname: Becker
authors.forename: S
authors.initials: S
authors.lastname: Becker
authors.forename: J
authors.initials: J
authors.lastname: Schnitker
authors.forename: E
authors.initials: E
authors.lastname: Wüstenberg
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001249:Asthma / Q000628:therapy*; D002648:Child; D003233:Conjunctivitis, Allergic / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000276:immunology; D039981:Pyroglyphidae / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic