Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy ( SLIT ) was demonstrated in previous short-term studies.
The aim of the study was to evaluate the sustained efficacy of 2 dosing regimens of a pre- and coseasonal treatment with 300 IR ( index of reactivity ) 5-grass-pollen SLIT tablets ( Oralair ) compared with placebo assessed by using the average adjusted symptom score ( AAdSS ) at season 3 in adults with grass pollen-induced rhinoconjunctivitis.
Six hundred thirty-three patients were treated for either 2 or 4 months before and then during the grass pollen season with active or placebo treatment for 3 consecutive seasons.
The primary outcome was the AAdSS, a symptom score adjusted for rescue medication use, after 3 consecutive treatment seasons.
Secondary outcomes were symptoms and rescue medication score, quality-of-life, and safety assessments.
The mean AAdSS was reduced by 36.0% and 34.5% at season 3 in the 2- and 4-month pre- and coseasonal active treatment groups, respectively, compared with that in the placebo group ( P less than 0.0001 for both ).
Reductions were observed in total symptom scores and ISSs and the medication score, with a marked improvement in quality of life for both active groups compared with the placebo group at season 3.
Most treatment-emergent adverse events were local reactions expected with SLIT, decreasing in number and intensity in each treatment season.
In conclusions, sustained efficacy of 2- and 4-month pre- and coseasonal treatment with the 300 IR tablet over 3 pollen seasons was demonstrated, with reduction in symptoms and rescue medication use.
The treatment was well tolerated. Adverse events decreased in number and intensity over the 3 seasons. ( Xagena )
Didier A et al, J Allergy Clin Immunol 2011;128 : 559-566