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Original Article

 

Specific Immunotherapy with High Dose SQ Standardized Grass Allergen Tablets was Safe and Well Tolerated

 

M. Calderon1, M. Essendrop2

1 Upper Respiratory Medicine, Royal Brompton Hospital, Imperial College, London, United Kingdom
2 Group Clinical Development, ALK-Abelló A/S, Hřrsholm, Denmark

J Investig Allergol Clin Immunol 2006; Vol. 16(6): 338-344

 

 Abstract


Background: Sublingual immunotherapy with grass allergen tablets may be the future treatment for grass pollen allergy because it reduces symptoms and medication use, improves quality of life and is easy to use. Rhinoconjunctivitis and asthma co-exist and we aimed to fi nd a safe dose range of a self-administered grass
allergen tablet (ALK Abello A/S) in patients suffering from rhinoconjunctivitis and asthma.

Methods: Four doses were investigated in a randomised, double-blind, placebo-controlled, dose escalation trial. Outside the pollen season 4 groups of 12 patients commenced treatment in a staggered manner, at intervals of 1 week. For 28 days doses of 75 000 (approximately 15µg Phleum pratense protein 5), 150 000, 300 000, 500 000
standardised quality tablet (SQ-T) units or placebo were given once daily as sublingual tablets.

Results: Fourty three patients were randomised to receive either active treatment or placebo (3:1). Each dose group consisted of 12 patients except the 500 000 SQ-T group (5 active, 2 placebo). No asthma exacerbations were seen and no serious or severe adverse events were reported. The majority of adverse events were local reactions. The
number of adverse events was dose related. No patients withdrew from the study.

Conclusions: Treatment with grass allergen tablets in doses up to 500 000 SQ-T in patients with asthma and
rhinoconjunctivitis was safe and well tolerated.

Key words: Asthma. Immunotherapy. Rhinoconjunctivitis. Sublingual. Tablet.