Volume 10 Supplement 2
Efficacy and safety of MK-7243: a grass allergy sublingual immunotherapy tablet evaluated in Canadian adults and children
© Hébert et al; licensee BioMed Central Ltd. 2014
Published: 18 December 2014
The effect of MK-7243 (2800 BAU/75,000 SQ [~15 µg of Phleum pratense p 5], Merck/ALK-Abelló), a sublingual Timothy grass immunotherapy tablet, has been evaluated in several randomized, placebo-controlled, double-blind trials; three of these trials were conducted in adults and children in North America (the United States and Canada) who have allergic rhinitis with or without conjunctivitis (AR/C). We conducted a post-hoc analysis to investigate the effect of MK-7243 in Canadian subpopulations.
Data from Canadian subjects from the three trials were used in this investigation: P05238 (adults ≥18 y; pollen season: 2009); P05239 (children 5−<18 y; pollen season=2009); and P08067 (adults ≥65 y and children 5−<18 y; pollen season: 2012). Trial data from the same grass pollen seasons (GPS) were pooled. Subjects received once-daily MK-7243 or placebo starting ≥12 wk before and continuing throughout the GPS, for a mean total of ≥23 wk. The therapeutic effect of MK-7243 was evaluated for rhinoconjunctivitis symptoms and symptomatic medication use, measured as a total combined score (TCS=daily-symptom score [DSS; max=18]+daily-medication score [DMS; max=36]) averaged over the entire GPS. Safety was assessed by monitoring adverse events (AEs).
Canadian subjects taking MK-7243 (n=42) in the pooled adult-pediatric 2009 trials showed a 38% mean TCS reduction versus placebo (n=54; −2.06 difference [95% CI: −3.72, −0.39]; 3.32 vs. 5.37). Canadian subjects taking MK-7243 (n=122) in the adult-pediatric 2012 trial showed a 33% mean TCS reduction relative to placebo (n=122; −1.62 difference [95% CI: −2.54, −0.71]; 3.34 vs. 4.96). Approximately 90% of treatment-related AEs were mild or moderate in severity. No serious or life-threatening treatment-related AEs occurred.
MK-7243 Timothy grass sublingual tablet significantly improved AR/C induced by Timothy grass pollen in Canadian adults and children 5 y and older. Similar efficacy and safety results were obtained for the overall populations of the three trials.
ClinicalTrials.gov Identifiers: NCT00562159; NCT00550550; NCT01385371
Medical writing and editorial assistance was provided by Erin P. Scott, PhD. This assistance was funded by Merck & Co., Inc., Whitehouse Station, NJ, USA. Editorial assistance was also provided by Jorge Moreno-Cantu, PhD, Global Scientific and Medical Publications, Office of the Chief Medical Officer, Merck & Co., Inc., Whitehouse Station, NJ, USA.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.