Sublingual Immunotherapy Shows Sustained Control
Allergy Vaccine, Grazax, Shows Promise for Long Term Hayfever Relief
Oct 11, 2009 Christine Redmond
Allergy vaccines, also known as allergen Immunotherapy, have been available for some time to help alleviate symptoms in people with severe allergic rhinitis. Allergy vaccines can therefore reduce the person's need for medication to control symptoms and may be able to potentially cure a patient of their allergic disorder. While traditional allergen immunotherapy given by allergy injection can be effective at reducing symptoms in the long-term, a carry-over effect of a new sublingual immunotherapy product, such as Grazax, has not been reported until recently.
Grazax Allergy Vaccine - a Sublingual Immunotherapy for Allergic Rhinitis
The grass allergy vaccine, Grazax, was the first tablet-based allergy vaccine to become available, with ALK-Abello marketing the product in several European countries in 2006. Grazax is used to treat patients with hay fever allergy to grass pollen. The sublingual immunotherpy is a once-daily fast-dissolving tablet, which is to be taken at least four months before the start of the grass pollen season to achieve optimal results, and should be continued all year round.
Effectiveness of Grazax for Hayfever Treatment - the GT-08 Clinical Trial
Numerous clinical studies have been undertaken in order to demonstrate the effectiveness of Grazax at reducing hayfever symptoms and use of medication, such as antihistamines and intranasal corticosteroids, which are used for symptomatic treatment.
One major study being undertaken is the GT-08 clinical trial, which is a European phase 3 study investigating the long-term effectiveness of Gravax in adult patients suffering from hayfever due to grass pollen. In this study, The allergy vaccine was administered once daily for three years from 2006 to 2007, and taken continuously throughout the trial period. The study aims to determine improvements in hay fever symptoms, the reduction in use of rescue medication (medication used for symptom control) and improvements in quality-of-life for patients, following the three years of treatment as well as for the subsequent two years following cessation of treatment with the sublingual immunotherapy.
The most common symptoms of hay fever, which were assessed by the GT-08 trial, include sneezing, itchy or watery eyes and a runny, itchy or blocked nose.
Results following the three years of Grazax treatment prior to follow-up were reported at the XXVII Congress of the European Academy of Allergy and Clinical Immunology (EAACI) 2008. The GT-08 study showed that those patients who were treated with Grazax achieved on average a 29% improvement in hayfever symptoms and a 40% reduction in rescue medication. Further results after one year of follow-up were presented at the XXVII EAACI 2009 meeting to show that hayfever symptoms remained reduced by 25-60% in Grazax-treated patients, with quality-of-life having significantly improved by 23% above that achieved with symptomatic medication treatment alone.
Patients have had free access to symptomatic medication throughout the study; however, ALK-Abello is yet to report how the usage of rescue medication was affected after the one year of follow-up.
EU Approval of Gravax
To date, clinical studies have shown that after one year of follow-up upon completion of Grazax treatment, patients experience continued symptom control and improved quality of life with the new sublingual immunotherapy. Based on these sustained effects, Grazax has gained EU approval for use as an allergy vaccine in 27 European countries. The second year of follow-up of the GT-08 study is currently ongoing.
Sources:
Emminger et al., 2008, “Continuous clinical efficacy and progressive immunological effect of long-term specific immunotherapy with the ALK grass allergen tablet: Findings from a 3-year randomised adult trial”; in XXVII EAACI Congress 2008 Abstract Book, presented at EAACI Congress 2008, Barcelona, Spain
ALK-Abello, 2009, Improved quality of life and sustained symptom control of GRAZAX® after completion of treatment (EAACI 2009), viewed 11 October 2009
ALK-Abello, 2009 GRAZAX® approved as a disease modifying allergy treatment, viewed 11 October 2009
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