Results of the GAP (Grazax Asthma Prevention) trial, the largest study ever staged to examine allergy symptoms and immune system reactions in children, were revealed at the 2016 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, Austria
The trial included 812 children, ages 5-12, in a three-year treatment phase and a two-year follow-up period.
Grazax is an immunotherapy agent that stimulates the production of antibodies to neutralize grass pollen. It is delivered via sublingual tablets, which are placed under the tongue.
Study findings demonstrated that Grazax is effective for the treatment of asthma symptoms in kids. The medication also reduced grass and pollen allergy symptoms. Researchers measured direct reductions in immune system reactions in response to Grazax use, supporting that it helps modifies disease progression.
In the GAP trial, Grazax reduced both asthma symptoms during the entire five-year time period, as well as the use of common asthma medications, including corticosteroids and beta-2-agonists. Treatment effectiveness increased over time, and the medication appeared to work both in the winter as well as during plant pollination season, also called allergy season.
In press release, pediatric allergist Erkka Valovirta, the lead investigator for the GAP trial and a professor at the University of Turku in Finland, said the results give a better understanding about allergic disease and the the benefit of Grazax for children – especially among kids with grass allerigies that are difficult to control with other therapies.
“For the first time, we also see that, by treating pediatric patients early enough, we can change the trajectory of their immune system development,” Valovirta said.
Valovirta said the trial also offers evidence that allergic responses could be reprogrammed and risks for lifelong respiratory disease could be minimized.
Henrik Jacobi, ALK’s executive vice president of Research and Development, supported the use of Grazax in children with moderate-to-severe allergies and who are at risk of developing asthma.
“We are particularly excited about these new results. They confirm the benefit of Grazax in offering sustained relief from childhood allergic rhinitis both during and after treatment. They also provide the strongest evidence yet for the early use of Grazax,” Jacobi said.