Rhinitis, sinusitis, and upper airway diseaseSafety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy
Section snippets
Trial population, design, and conduct
This was a multicenter, randomized, parallel-group, double-blind, placebo-controlled trial, initiated in autumn 2006. A total of 253 subjects age 5 to 16 from 26 centers in Germany were randomized 1:1 to once daily administration of either an orodispersible, fast-dissolving, SQ-standardized grass allergen tablet (Grazax; ALK, Hørsholm, Denmark; 75,000 SQ-T/2800 bioequivalent allergen units, approximately 15 μg Phl p 5, Phleum pratense major allergen 5) or a placebo tablet similar in taste,
Results
A total of 253 subjects were randomized, and 234 (92%) completed the trial. There were a total of 19 (8%) withdrawals from the trial. Of these withdrawals, 6 (2%) were due to adverse events (AEs), 4 (3%) in the active group and 2 (2%) in the placebo group. A diagram of the trial flow is presented in Fig 1.
The trial population comprised close to twice as many male as female subjects, and the majority (97%) were white. Generally, baseline parameters and vital signs were well balanced between the
Discussion
The efficacy of SCIT in treatment of IgE-mediated allergic disease is well established.1, 12 In recent years, SLIT has been intensively debated, with recent large phase III trials and meta-analyses supporting efficacy of this administration form as well, in adults.17, 19, 25 However, conflicting evidence has been presented regarding the efficacy of SLIT in children,26, 27 and 2 pediatric trials in Germany, where the current trial was conducted, failed to show reduction of rhinoconjunctivitis
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Extrapolating Evidence-Based Medicine of AIT Into Clinical Practice in the United States
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Disclosure of potential conflict of interest: L. Kilmek has received research support from ALK Denmark, Stallergenes France, AllergoPharma Germany, HAL Netherlands, Artu Biologicals Netherlands, Bencord Great Britain, and Leti Spain and has served as an expert witness for Novartis Germany and GlaxoSmithKline Great Britain. B. Tholstrup is employed by ALK and holds ALK shares. J. Funck has received research support from ALK and MSD-Merck. The rest of the authors have declared that they have no conflict of interest.