Landmark Data Presented At The British Society For Allergy And Clinical Immunology Shows Hay Fever Vaccine Could Be A Reality

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Immune System / Vaccines
Article Date: 01 Jul 2009 - 0:00 PDT

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New data presented at the British Society for Allergy and Clinical Immunology (BSACI) annual meeting demonstrate that Grazax® is the first tablet treatment to provide sustained disease control in patients with grass pollen rhinoconjunctivitis (hay fever) after the treatment period ended. This is the first time disease modification by sublingual allergy immunotherapy tablets has been achieved; effectively re-setting the immune system to reduce future allergic reactions to grass pollen.

The pivotal Grazax GT08 study is an international randomised, parallel-group, double-blind, placebo-controlled multicentre study. Patients were randomised to receive either three years of Grazax or placebo, followed by a two year treatment-free follow up period. Throughout the study all patients had free access to symptomatic medications such as antihistamines and nasal sprays.

Sneezing, watery eyes and a blocked nose are amongst the most common symptoms reported by patients with severe hay fever. All of these symptoms improved during the three years of continued treatment. Importantly, one year following discontinuation of treatment, these symptoms remained significantly reduced by 31% (sneezing), 60% (watery eyes) and 51% (blocked nose) compared to the patients who had previously received placebo tablets.1 Furthermore, the need for symptomatic medications was sustained during three years continued treatment and remained significantly reduced in the season one year after stopping treatment, thereby confirming a disease-modifying effect (p<0.02).1

Professor Stephen R. Durham, principal investigator, National Heart and Lung Institute, Imperial College, London and President of the BSACI states: "These results represent a significant benefit for sufferers of grass pollen rhinoconjunctivitis or moderate to severe 'hay fever'. The fact that patients continued to experience less nose and eye symptoms and an improved quality of life in the following grass pollen season after they had completed the course of treatment with Grazax clearly shows the disease modifying effect of this tablet".

"Severe hay fever has a huge impact on a person's ability to function, impairing their everyday quality of life for months during the grass pollen season. Sleep disturbance is a major issue for many sufferers often leading to day-time tiredness; increased absence from school and work as well as significantly impacting on children's exams results during the summer months".

Professor Stephen R. Durham continues: "Allergy services in the UK are woefully inadequate, with little action despite four Government reports calling for improved services. Hay fever in particular is a significantly under-treated and under-recognised disease yet it affects 1 in 4 of the UK adult population. A major overhaul of services needs to take place to improve allergy care in the UK and in turn improve the health outcomes of our patients"

References

1. Durham S, et al. Sustained, disease-modifying effect of grass allergen tablet immunotherapy 1 year after completion of treatment. XXVIII Congress of the European Academy of Allergy and Clinical Immunology; poster # 333

About Grazax

Grazax is a once daily fast-melting tablet which is placed under the tongue (sublingual) and is the first immunotherapy tablet to address the underlying cause of grass pollen allergy. Grazax became available for adults in January 2007 and for children aged 5 to 17 years in February 2009.

Grazax is generally well tolerated, with the majority of side effects being transient, local allergic reactions, such as oral pruritus (irritation in the mouth), which was classified as mild to moderate.

About the Grazax GT08 study

The pivotal Grazax GT08 study is a randomised, parallel-group, double-blind, placebo-controlled multicentre study. Patients were randomised to receive either 3 years of Grazax or placebo, followed by a 2 year follow up period. Throughout the study all patients had free access to symptomatic medications.

The data from the 4th year of the GT08 study is based upon a full analysis set that included 283 participants, with a history of grass pollen rhinoconjunctivitis uncontrolled by symptomatic medications

The main clinical study end points were:

- Rhinoconjunctivitis symptom score
- Rhinoconjunctivitis medication score
- Quality of Life (QoL)

Source
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