title: The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children.
abstract: BACKGROUND
  The effect of sublingual Timothy grass immunotherapy tablet 2800 BAU (grass SLIT-T) has been evaluated in three North American trials in adults and children who have allergic rhinitis with or without conjunctivitis (AR/C). This paper examines the effects of grass SLIT-T in Canadians.
  
  
  METHODS
  Data for grass-allergic Canadians in three randomized, placebo-controlled, double-blind trials were analyzed post hoc: 1) adults ≥18 y, grass-pollen season [GPS] 2009; 2) children 5- <18 y, 2009; and 3) adults 18-65 y and children 5- <18 y, GPS 2012. Data from the GPS 2009 trials were pooled to provide a more precise estimate of treatment effects than the individual studies would provide. In every trial, participants received once-daily grass SLIT-T or placebo approximately 12 weeks before and continuing throughout the GPS. Participants used daily electronic diaries to record AR/C symptoms and medication use for treatment of symptoms. The therapeutic effect of grass SLIT-T was measured as a total combined score (TCS = daily symptom score + daily medication score) averaged over the entire GPS. Safety was assessed by monitoring adverse events (AEs).
  
  
  RESULTS
  In the three trials, 386 Canadian participants were randomized; the overall population had 2284 participants. Canadian participants treated with grass SLIT-T in the pooled adult-pediatric 2009 trials showed a 38% mean TCS reduction relative to placebo (-2.06 difference [95% CI: -3.72, -0.39]; 3.32 vs. 5.37). Participants treated with grass SLIT-T in the adult-pediatric 2012 trial showed a 37% median TCS reduction relative to placebo (-1.53 difference [95% CI: -2.1, -0.3]; 2.58 vs. 4.11). Similar efficacy findings were observed over the peak GPS. Approximately 90% of treatment-related AEs were mild or moderate in severity. Two Canadian participants had moderate systemic allergic reactions (skin, respiratory, abdominal symptoms) to grass SLIT-T; symptoms resolved within 1 hour without medical intervention or treatment. No serious or life-threatening treatment-related AEs occurred.
  
  
  CONCLUSIONS
  The 2800 BAU Timothy grass SLIT-T significantly improved AR/C induced by Timothy grass pollen in adults and children ≥5 y in Canadians, which was consistent with the robust efficacy observed in the overall trial population. The treatment was generally well tolerated.
  
  
  BACKGROUND
  Clinicaltrials.gov identifiers NCT00562159, NCT00550550, NCT01385371.
authors: Centre de Recherche Appliquée en Allergie de Québec, Québec, Canada.
authors: Jacques
authors: J
authors: Hébert
authors: University of Tennessee Health Science Center, Memphis, TN USA.
authors: Michael
authors: M
authors: Blaiss
authors: McMaster University, Hamilton, ON Canada.
authors: Susan
authors: S
authors: Waserman
authors: McMaster University, Hamilton, ON Canada ; Western University, London, ON Canada.
authors: Harold
authors: H
authors: Kim
authors: Johns Hopkins University School of Medicine, Baltimore, MD USA ; Creticos Research Group, Crownsville, MD USA.
authors: Peter
authors: P
authors: Creticos
authors: Merck & Co., Inc, Whitehouse Station, NJ USA.
authors: Jennifer
authors: J
authors: Maloney
authors: Merck & Co., Inc, Whitehouse Station, NJ USA.
authors: Amarjot
authors: A
authors: Kaur
authors: Merck & Co., Inc, Whitehouse Station, NJ USA.
authors: Ziliang
authors: Z
authors: Li
authors: National Jewish Health, Denver, CO USA.
authors: Harold
authors: H
authors: Nelson
authors: Merck & Co., Inc, Whitehouse Station, NJ USA.
authors: Hendrik
authors: H
authors: Nolte
keywords: Allergic rhinitis; Conjunctivitis; Sublingual immunotherapy tablet; Timothy grass pollen