?Allergy pharmaceutical company ALK, producers of the Epipen adrenaline auto-injector, unveiled the results of two studies concerning their oral vaccine allergy immunotherapy tablets (AITs) at the annual congress of the European Academy of Allergy and Clinical Immunology, in Warsaw, Poland, on 8th June.
The first involved GRAZAX®, their AIT for grass-pollen allergy sufferers, launched in the UK in early 2007. Earlier data from the ongoing GT-08 study revealed significant improvement of clinical symptoms in up to 82% of patients undergoing treatment at the time.
GT-08’s three-year treatment period ended in 2008, and new data has been drawn from a proportion of the patients who have agreed to follow-up monitoring for the subsequent two years. These first-year results suggest that GRAZAX® continues to provide reduction in the use of medication, and in symptoms of hay fever, even after patients stop taking it. Figures for symptomatic reduction were 25% (itchy eyes), 30% (runny nose), 31% (sneezing), 43% (itchy nose), 51% (blocked nose) and 60% (watery eyes).
‘The results are encouraging as they emphasise that it is worthwhile going through the continuous all-year-round treatment course,’ says the study’s principal investigator, Professor Stephen Durham of Imperial College, London. ‘It pays off, not only during treatment, but also in the long run.’
Research into the benefits during the second follow-up season post-treatment is ongoing, and results from it are likely to be made available early 2010.
The second study (called MT-02) concerned ALK’s AIT for dust mite allergy, currently in development, and examined its effects on those with mild to moderate persistant asthma with confirmed IgE allergy to dust mite. Over 600 patients were treated with the oral vaccine for at least a year. Patients receiving high doses of the AIT managed an overall 50% reduction in their use of inhaled corticosteroids, compared to a 25% reduction in the placebo (dummy) group, while maintaining symptomatic control.
House dust mite allergy is a major trigger for asthma, and the most common indoor allergy in the world, affecting 70 million people in Europe and the USA.
‘The reduction in the use of asthma medicine without worsening of asthma symptoms seen in this study is remarkable,’ says Vibeke Backer, pulmonologist and professor at Bispebjerg Hospital, Copenhagen. ‘The
results point out an interesting future potential for allergy immunotherapy as a part of asthma treatment.’
ALK are continuing the clinical development programme with a view to obtaining a future European approval of their house dust mite AIT.
www.alk-abello.com and www.grazax.com
First Published in 2009
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