alexa Intra-Seasonal Short-Time Up-Dosing with SQ-Standardised Subcutaneous Immunotherapy in Patients with Intermittent Allergic Rhinoconjunctivitis is Well Tolerated during Routine Application: A Non-Interventional, Observational Study
ISSN: 2155-6121

Journal of Allergy & Therapy
Open Access

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Research Article

Intra-Seasonal Short-Time Up-Dosing with SQ-Standardised Subcutaneous Immunotherapy in Patients with Intermittent Allergic Rhinoconjunctivitis is Well Tolerated during Routine Application: A Non-Interventional, Observational Study

Rainer Reiber1, Hendrik Wolf2*, Jörg Schnitker3 and Eike Wüstenberg2

1ENT-Physician, Schorndorf, Germany

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

3Institut für angewandte Statistik GmbH, Bielefeld, Germany

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

Received date: May 03, 2013; Accepted date: June 15, 2013; Published date: June 20, 2013

Citation: Reiber R, Wolf H, Schnitker J, Wüstenberg E (2013) Intra-Seasonal Short-Time Up-Dosing with SQ-Standardised Subcutaneous Immunotherapy in Patients with Intermittent Allergic Rhinoconjunctivitis is Well Tolerated during Routine Application: A Non-Interventional, Observational Study. J Allergy Ther 4:137. doi:10.4172/2155-6121.1000137

Copyright: © 2013 Reiber R, 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: For patients with pollen induced allergic rhinoconjunctivitis, a pre-seasonal start of subcutaneous specific immunotherapy is generally recommended in international guidelines. In a placebo-controlled trial intraseasonal up-dosing of subcutaneous immunotherapy to 10,000 SQ-U (Alutard SQ®) was shown to be well tolerated and to induce significant immunologic effects. The aim of our study was to investigate the feasibility of intra-seasonal up-dosing during routine application.

Methods: In an open, non-interventional observational study, data on tolerability of subcutaneous immunotherapy (Alutard SQ®) in patients with grass pollen induced allergic rhinoconjunctivitis were recorded by 110 physicians between May and November 2009 in Germany. Therapy was initiated within grass pollen season according to a 6-injection up-dosing schedule from 100 to 10,000 SQ-U with 1-3 days intervals, repeating this dose after 2 and 4 weeks during and up-dosing to the final maintenance dose of 100,000 SQ-U after the end of grass pollen season.

Results: Data for 250 patients could be evaluated, 198 patients had been up-dosed up to the peak grass pollen season and 52 after the peak. Adverse drug reactions were observed in 61.6% of patients with up-dosing up to the peak grass pollen season and in 48.1% with up-dosing after the peak with swelling at the injection site as most common reaction. The overall rate of systemic allergic reactions was low in both groups. Mild to moderate respiratory symptoms were more frequently reported in patients up-dosed up to the peak grass pollen season. Overall tolerability was assessed as “very good” or “good” by >90% of patients and physicians.

Conclusions: Intra-seasonal short-time up-dosing with Alutard SQ® grasses and rye by 6 injections from 100 to 10,000 SQ-U with 1-3 days interval was observed to be well-tolerated during routine application and thus confirms data obtained from the placebo-controlled clinical trial.

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