Rhinitis, sinusitis, and upper airway diseaseLong-term clinical efficacy in grass pollen–induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet
Section snippets
Clinical trial design
Details of the randomized, double-blind, placebo-controlled trial conducted according to the Declaration of Helsinki20 at 43 centers in 7 countries have been published previously (see also ClinicalTrials.gov no. NCT00227279).18, 19 From originally 1 year of treatment, the trial was extended to cover 3 years of treatment and 2 years of follow-up to investigate long-term and sustained efficacy (extension implemented April 20, 2005). The ethics committees in each country approved the trial, as
Results
An overview of the subjects during the third year of treatment (2007) and during the follow-up year (2008) is provided in Fig 1. Diary data during the 2007 grass pollen season were obtained from 287 subjects (160 in the active group and 127 in the placebo group) and during 2008 from 257 subjects (142 in the active group and 115 in the placebo group). A complete overview of the trial is available in Fig E1 in this article's Online Repository at www.jacionline.org.
At inclusion, all subjects had a
Discussion
This study has, for the first time in a large-scale, placebo-controlled trial, demonstrated that sublingual tablet immunotherapy has the ability to provide a statistically significant and clinically relevant, sustained disease-modifying effect 1 year after the completion of a 3-year treatment period. This effect was clearly demonstrated by the consistent improvements in nasal and ocular symptoms, use of symptomatic medications, and rhinoconjunctivitis quality of life in the active group. The
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Cited by (0)
The trial is sponsored by ALK-Abelló, Hørsholm, Denmark. S.R.D. has consultant arrangements with, has received grant support from, and is on the speakers' bureau for ALK-Abelló. A.K. has consultant arrangements with DPC; has received grant support from Novartis, Astellas, UCB, ALK-Abelló, and DPC; and is on the speakers' bureau for Novartis, Astellas, UCB, and ALK. J.G.R.d.M. has received a grant from ALK-Abelló. S.R. has received grant support from the Swedish Asthma and Allergy Association. R.D. has consultant arrangements with Altana, GlaxoSmithKline, Boehringer Ingelheim, Novartis, and Fertin and has received grant support from Altana, GlaxoSmithKline, Boehringer Ingelheim, Novartis, AstraZeneca, ALK-Abelló, Roche, and Pfizer. G.K.S. has been on advisory boards and is on the speakers' bureau for ALK-Abelló and is advisor and speaker for Schering-Plough. J.S.A. and B.R. are employed by ALK-Abelló.
Disclosure of potential conflict of interest: S. R. Durham has received research support from ALK-Abelló and GlaxoSmithKline. W. Emminger and A. Kapp have received research support from ALK-Abelló. J. G. R. de Monchy has received research support from Novartis, Organon (Schering-Plough), and ALK-Abelló. S. Rak has received honoraria from Stallergenes, ALK-Abelló, and Allergopharma and has received research support from ALK-Abelló and Allergopharma. G. K. Scadding is on an advisory board for and has given lectures sponsored by ALK-Abelló and has received research support from ALK-Abelló and GlaxoSmithKline. J. S. Andersen and B. Riis are employees of ALK-Abelló. G. Colombo has declared that she has no conflict of interest.