Completed Studies

Safety and efficacy in children of an SQ-standardised grass allergen tablet for sublingual immunotherapy

Authors: Albrecht Bufe, Peter Eberle, Eivy Franke-Beckmann, Jürgen Funck, Martin Kimmig, Ludger Klimek, Roland Knecht, Volker Stephan, Bente Tholstrup, Christian Weißhaar, Friedrich Kaiser

Source: J Allergy Clin Immunol  (2009); 123: 167-73

Background: Immunotherapy with the SQ-standardised grass tablet Grazax is efficacious and welltolerated in adult rhinoconjunctivitis patients. Allergic asthma and rhinoconjunctivitis are closely linked, and a strategy combining treatment of the upper and lower airways is recommended.

Objective: To investigate the efficacy of treatment with the grass tablet on grass-pollen-induced rhinoconjunctivitis and asthma as well as the immunological response and the safety profile in children.
Methods: 253 children aged 5-16, with grass-pollen-induced rhinoconjunctivitis with/without asthma, were randomised 1:1 to active treatment or placebo. Treatment was initiated 8-23 weeks before the start of the grass pollen season 2007 and continued throughout the entire season. Symptomatic medication was provided as relief medication to both groups in a stepwise fashion. Primary endpoints were rhinoconjunctivitis symptom and medication scores.

Results: The rhinoconjunctivtis symptom and medication scores and the asthma symptom score were all statistically significantly different between the two treatment groups. The differences in medians relative to placebo were 24%, 34% and 64%, in favour of active treatment. The immunological response was similar to that observed in adults. The most common adverse reaction was oral pruritus, reported by 40 subjects (32%) in the active and 3 (2%) in the placebo group. Six subjects withdrew due to adverse events. No serious adverse events were assessed as treatment-related.

Conclusion: Immunotherapy with the grass tablet reduced grass-pollen-induced rhinoconjunctivitis and asthma symptoms in a paediatric population and introduced an immunomodulatory response, consistent with treatment of the underlying allergic disease. The treatment was well-tolerated.