Allergen Immunotherapy has been available for some time to help alleviate symptoms in people with severe allergic rhinitis. This type of therapy 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 by injection can be effective at reducing patient symptoms in the long-term, a carry-over effect of new tablet-based vaccines, such as Grazax, has not been reported until recently.
Grazax Hay Fever Vaccine
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. Grazax is used to treat patients with hay fever allergy to grass pollen. It 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 Hay Fever Treatment - the GT-08 Trial
Numerous studies have been undertaken in order to demonstrate the effectiveness of Grazax at reducing hay fever symptoms and use of medication such as antihistamines and intranasal corticosteroid, which are used for symptomatic treatment.
One major study being undertaken is the GT-08 trial; a European phase 3 study investigating the long-term effectiveness of Gravax in adult patients suffering from hay fever due to grass pollen. In this study, Grazax 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 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.
The most common symptoms of hay fever, which were assessed by the 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). The GT-08 study showed that those patients who were treated with Grazax achieved on average a 29% improvement in hay fever symptoms and a 40% reduction in rescue medication. Further results after one year of follow-up were presented at the XXVII EAACI meeting to show that hay fever 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 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, 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. Based on these sustained effects, Grazax has gained EU approval for use as a disease modifying allergy treatment in 27 European countries. The second year of follow-up of the GT-08 study is ongoing