Rhinitis, sinusitis, and upper airway disease
Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen–induced rhinoconjunctivitis

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Background

Seasonal allergic rhinoconjunctivitis affects millions of persons. The efficacy of allergen sublingual immunotherapy (SLIT) was demonstrated in previous short-term studies.

Objectives

We sought 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.

Methods

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.

Results

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 < .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.

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.

Section snippets

Study design

We performed a randomized, multicenter, double-blind, placebo-controlled, 5-year, ongoing phase III study with 3-season treatment and 2-year follow-up phases. Six hundred thirty-three men and women 18 to 50 years of age with seasonal grass pollen–induced allergic rhinoconjunctivitis for at least the 2 previous pollen seasons were enrolled. The study was conducted in Austria, Canada, Czech Republic, Denmark, France, Germany, Italy, Poland, Russia, and Slovakia. The use of antihistamines, nasal

Population and baseline characteristics

Of 633 patients randomized in the study, 219 received placebo, 207 received 300 IR tablets for a pre- and coseasonal treatment of 4 months before and then during the pollen season, and 207 received 300 IR tablets for a pre- and coseasonal treatment of 2 months before and then during the pollen season. The full analysis set of the first year comprises 581 patients. At study year 3, 465 patients entered the treatment period (Fig 2). Discontinuations from the study were uncommon and decreased

Discussion

This is the first study of a pollen allergy immunotherapy to be specifically designed and statistically powered as a 3-season treatment study with a long-term follow-up. It demonstrated the efficacy and safety of 300 IR tablets for grass pollen–induced rhinoconjunctivitis over 3 seasons of therapy. Active treatment was started 2 or 4 months before the pollen season and continued during the pollen season for 3 consecutive years. AAdSSs were lower in both active groups in the third pollen season

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Supported by Stallergenes S.A.

Disclosure of potential conflict of interest: A. Didier is a consultant for AstraZeneca, Stallergenes, ALK-Abelló, MSD, and GlaxoSmithKline. M. Worm is a consultant for and has received lecture honoraria from Stallergenes. F. Horak has received research support from Venti RX, Calistoga, and Stallergenes. G. Sussman is a medical advisor for King Pharma; has received research support from Mast Cell Pharma, Novartis, Schering-Plough, and Stallergenes; has provided legal consultation/expert witness testimony for the Canadian Transportation Agency on food allergies in commercial airline cabins; is an expert advisor for the Canadian Medical Protective Association regarding specific allergy legal claims; is a medical advisor for Anaphylaxis Canada and the Ontario Allergy Society; and is a professional partner of Discovery Research International. H.-J. Malling is a consultant for and has received research support from Stallergenes. The rest of the authors have declared that they have no conflict of interest.

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