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

Background and objectives: a fast updosed immunologically enhanced subcutaneous immunotherapy (scit) formulation with an optimized allergen to aluminium hydroxide ratio was fi rst 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. patients and 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. © 2013 esmon publicidad.