Rhinitis, sinusitis, and upper airway diseaseSustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen–induced rhinoconjunctivitis
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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Cited by (0)
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.