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.
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