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

Journal of Investigational Allergology and Clinical Immunology

E Wüstenberg¹  J Schnitker³  S Becker⁴  F Becker⁴  H Wolf¹  B Hauswald² 

[1] ALK-Abelló Arzneimittel GmbH, Clinical Development / Medical & Regulatory Affairs, Hamburg, Germany;Universitätsklinikum Carl Gustav Carus, Clinic for Otolaryngology, Dresden, Germany;Institut für angewandte Statistik GmbH, Bielefeld, Germany;ENT-physicians, Hamburg, Germany

关键词: Tolerability;    Subcutaneous immunotherapy;    Short updosing;    Immunology;    Immunomodulators;    Adjuvant;   

Others  :  1183749

【 摘 要 】

Background and objectives: 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.

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.