Top-line data from a five-year trial of ALK’s allergy immunotherapy Grazax show that the pill failed to prevent the onset of asthma but offered other benefits such as reducing symptoms and medicines use.
The primary endpoint of the Grazax Asthma Prevention (GAP) trial was “time to first diagnosis of reversible impairment of lung function”, but no significant difference was observed between children taking the drug and those taking a placebo.
On the plus side, treatment with Grazax did have a positive effect on the children's asthma symptoms and use of asthma medication; the odds ratio for these at the end of the five-year evaluation period was 0.66 in favour of ALK’s therapy, the firm said.
The proportion of patients experiencing asthma symptoms or using asthma medication was significantly reduced from year two and onwards in the treatment arm, with relative risk reductions ranging from 36%-50% compared to placebo, and a disease modifying effect was sustained during the two-year follow-up period.
Also, data from GAP trial showed a 23%-30% reduction in the symptoms of grass allergic rhinoconjunctivitis symptoms in patients treated with the drug compared to those on a placebo. The finding is consistent with earlier studies, and confirms the drug’s effectiveness in this area. Grazax was approved in Europe as a grass allergy immunotherapy in 2006.
“When children are treated with Grazax they will not only have a beneficial effect on their nose and eye symptoms, but also a reduced risk of experiencing asthma symptoms and of using asthma medication in the years following end of treatment,” noted Henrik Jacobi, who heads up ALK's R&D.