Abstract
SummaryBackgroundThe optimal dose (300IR) of a five-grass pollen sublingual immunotherapy tablet in terms of efficacy was previously demonstrated from the first pollen season.ObjectiveHere, we aim to confirm whether this dose remained optimal during the peak of the pollen season by assessing the efficacy and quality of life data.MethodsA total of 628 subjects with grass pollen rhinoconjunctivitis were randomized in a double-blind, placebo-controlled, multi-centre, pan-European trial. Subjects received once-daily tablets (Stallergenes, Antony, France) of 100IR, 300IR, 500IR or placebo, starting 4 months before and throughout the 2005 grass pollen season. The pollen season was defined as the first day of 3 consecutive days with a grass pollen count above 30 grains/m3 of air, recorded using Hirst-type volumetric pollen traps, to the last day before 3 consecutive days with a pollen count below 30 grains/m3.ResultsThe grass pollen season lasted an average of 30 days, with a peak of 12 days. The mean treatment duration before the grass pollen season was similar in the four treatment groups (121.4±31.1 to 128.6±15.4 days in the safety population). Both the 300IR and 500IR groups had highly significant improvements in Rhinoconjunctivitis Total Symptom Score (RTSS) vs. placebo at the peak pollen season (P=0.0005 and 0.0014, respectively), which agreed with improvements in RTSS in the primary evaluations. The average RTSS scores were slightly elevated during the peak pollen season in all treatment groups. The overall Rhinoconjunctivitis Quality of Life Questionnaire score confirmed the optimal dosage 300IR at peak (P<0.0001) and at the end (P⩽0.0031) of the pollen season. All doses were well tolerated.ConclusionAt the peak pollen season, the efficacy and quality of life data for both 300IR and 500IR groups was significantly improved vs. the placebo group. These results confirm the conclusions of the primary evaluations and validate the use of 300IR tablets for clinical practice.
Highlights
Prevalence of respiratory allergic diseases in Europe has been on the increase in the past decades [1]
These results confirm the conclusions of the primary evaluations and validate the use of 300IR tablets for clinical practice
Based on recognized efficacy measures, the current study has shown that the 300IR sublingual immunotherapy (SLIT) tablet containing five grass pollens was well tolerated and effective in reducing the symptoms of rhinitis and conjunctivitis and represents the optimal dose [9]
Summary
Prevalence of respiratory allergic diseases in Europe has been on the increase in the past decades [1]. Allergic rhinitis is a global health problem that affects 30% of the population world-wide. Using the European Community Health Respiratory Survey I data, the geographical variation in sensitization to environmental allergen was recently measured and published. Sensitization was most common for allergens Dermatophagoides pteronyssinus (21.7%), grass pollen (16.9%) and cat (8.8%) [3]. Inhalation of pollen grains induces respiratory allergy symptoms in sensitized individuals, and the characteristic of seasonal allergy is the recurrent occurrence of symptoms. Patients experience symptoms only during the circulation season of aeroallergens to which they are sensitive [4]. Grass allergens induce mostly nasal and conjunctival symptoms and natural exposure to grass pollen may exacerbate asthma by inducing an inflammatory response (T cells, mast cells, eosinophils) [2]
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