alexa Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet is well Tolerated in Children, Adolescents and Adults in Real Life Application-A Non-Interventional Observational Study
ISSN: 2155-6121

Journal of Allergy & Therapy
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Research Article

Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet is well Tolerated in Children, Adolescents and Adults in Real Life Application-A Non-Interventional Observational Study

Christine Gronke1, Hendrik Wolf2*, Jörg Schnitker3 and Eike Wüstenberg2

1Pediatrician, D-14974 Ludwigsfelde, Germany

2Clinical Development/Medical and Regulatory Affairs, ALK-Abelló Arzneimittel GmbH, Hamburg, Germany

3Institut für angewandte Statistik GmbH, Bielefeld, Germany

*Corresponding Author:
Hendrik Wolf
ALK-Abelló Arzneimittel GmbH, Griegstr. 75
Haus 25 D-22763 Hamburg, Germany
Tel: +49 40 703845-342
Fax: +49 40 70384555-30
E-mail: [email protected]

Received date: July 16, 2013; Accepted date: August 16, 2013; Published date: August 21, 2013

Citation: Gronke C, Wolf H, Schnitker J, Wüstenberg E (2013) Treatment with the SQ-Standardised Grass Allergy Immunotherapy Tablet is well Tolerated in Children, Adolescents and Adults in Real Life Application-A Non-Interventional Observational Study. J Allergy Ther 4:146. doi:10.4172/2155-6121.1000146

Copyright: © 2013 Gronke C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Background: Efficacy and safety of the SQ-standardised grass allergy immunotherapy tablet (GRAZAX®) has been reported in a large number of randomised, controlled clinical trials in children and adults performed in Europe and the US. GRAZAX® became available for routine treatment in children from 5 years of age in Germany and Austria in 2008.To examine the safety and tolerability of GRAZAX® in patients that were less highly selected as in the controlled trials we performed an open label, uncontrolled, non-interventional study in children and adults who were routinely treated in allergists´ offices.

Materials and methods: Patients with allergic rhinoconjunctivitis with or without asthma were treated with GRAZAX® and observed for 3-4 visits every 3 months with the last visit after the first grass pollen season. Adverse seasons before and during therapy.

Results: Treatment was documented in 1,761 patients (797 <18 years; 964 ≥18 years) treated by 373 allergists in Germany and Austria between November 2008 and January 2010. Adverse drug reactions were reported in 31.8% of patients (27.3% ≥18 years, 37.3% <18 years). The higher number of patients <18 years with reactions was due to a higher frequency of local oral reactions. The overall tolerability profile was similar in children and adults. Nasal symptoms improved in 82.7% of patients and no or less symptomatic medication was used by 89.7%.The compliance was rated >75% in 89.8% of patients, >95% of patients and physicians were satisfied with treatment.

Conclusion: The results of our study confirm the safety and tolerability profile observed in controlled clinical trials with GRAZAX®. Treatment satisfaction during routine application was rated high and was combined with a high compliance.

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