New data from GAP landmark trial confirm Grazax prevents asthma symptoms in children

Patients showed modified immunological responses to grass pollen, indicating inhibition of disease progression.

The data, presented at the 2016 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, confirm that Grazax can prevent asthma symptoms, as well as offering sustained relief from grass allergy symptoms. Moreover, immunological findings were highly supportive of the disease-modifying nature of the treatment.

The GAP trial is the largest allergy immunotherapy trial ever conducted in children and investigated the effect of Grazax versus placebo on the risk of developing asthma. It involved a 3-year treatment phase and a 2-year follow-up phase and included 812 children aged 5-12 years at the start of treatment.

The detailed analysis of the GAP trial results confirmed that treatment with Grazax prevented asthma symptoms in children:

Grazax treatment reduced the proportion of patients with asthma symptoms or use of asthma medication. Asthma medication included short-acting beta-2-agonist (SABA), systemic corticosteroid, inhaled corticosteroid (ICS), leukotriene receptor antagonist (LTRA), long-acting beta-2-agonist (LABA), systemic corticosteroid, inhaled corticosteroid (ICS), sustained-release theophylline, or cromolyn sodium. when evaluated at end of trial; i.e., 2 years post treatment (Odds Ratio: 0.66, p<0.05)

Grazax treatment also reduced the proportion of patients experiencing asthma symptoms during the entire 5-year trial period (Odds Ratio: 0.71, p<0.05) with the effect most pronounced during the 2-year post-treatment period (Odds Ratio: 0.55, p<0.05).

In addition, the treatment effect increased with time and was apparent both during the grass pollen season and during winter.

Moreover, the GAP trial demonstrated the efficacy of Grazax on grass allergic rhinoconjunctivitis in children, with benefits persisting for 2 years after treatment.

The trial also yielded new data, with the detailed analysis of patients' immunological response supportive of early intervention with Grazax.

Two years after treatment, Grazax-treated children were less IgE sensitised to grass pollen and had lower total IgE, both indicating a reduced allergic response. Grazax patients also had higher grass pollen-specific IgG4 levels, indicating raised immunological tolerance. Meanwhile, the wheal size from the skin prick test using grass allergen - an indicator of the extent of an allergic reaction - was significantly smaller for the Grazax group than for the placebo group.

The continued analysis of data from the GAP landmark trial follows the initial release of top-line data in January 2016. This showed that Grazax treatment significantly reduced the proportion of children experiencing asthma symptoms or using asthma medication, however there was no detectable effect in terms of time to the first diagnosis of reversible impairment of lung function and the primary endpoint of the trial was therefore not met. The safety and tolerability of Grazax were both favourable and in line with previous studies, with no new or unexpected findings.

Erkka Valovirta, paediatric allergist, Adjunct Professor at the University of Turku, Finland, and principal investigator for the GAP trial, said: "These results further enhance our understanding of allergic disease and the benefit of Grazax treatment for children whose grass allergy is not well controlled by conventional therapies. For the first time, we also see that, by treating paediatric patients early enough, we can change the trajectory of their immune system development."

He added: "The GAP trial provides further evidence that it is possible to reprogramme the allergic immune response. It also suggests there may be benefit in offering early treatment to children to minimise the risk of a lifetime of respiratory disease."

Henrik Jacobi, ALK's Executive Vice President of Research and Development, said: "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 in children with moderate-to-severe allergies and who are at risk of developing asthma."

He continued: "These insights also reaffirm ALK's position as the leading innovator in allergy treatment and further advance our understanding of the way the human immune system responds to specific allergens."