PMID- 25685162
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150216
LR  - 20200930
IS  - 1710-1484 (Print)
IS  - 1710-1492 (Electronic)
IS  - 1710-1484 (Linking)
VI  - 10
IP  - 1
DP  - 2014
TI  - The efficacy and safety of the Timothy grass allergy sublingual immunotherapy 
      tablet in Canadian adults and children.
PG  - 53
LID - 10.1186/1710-1492-10-53 [doi]
LID - 53
AB  - 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. CONCLUSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov identifiers NCT00562159, 
      NCT00550550, NCT01385371.
FAU - Hebert, Jacques
AU  - Hebert J
AD  - Centre de Recherche Appliquee en Allergie de Quebec, Quebec, Canada.
FAU - Blaiss, Michael
AU  - Blaiss M
AD  - University of Tennessee Health Science Center, Memphis, TN USA.
FAU - Waserman, Susan
AU  - Waserman S
AD  - McMaster University, Hamilton, ON Canada.
FAU - Kim, Harold
AU  - Kim H
AD  - McMaster University, Hamilton, ON Canada ; Western University, London, ON Canada.
FAU - Creticos, Peter
AU  - Creticos P
AD  - Johns Hopkins University School of Medicine, Baltimore, MD USA ; Creticos 
      Research Group, Crownsville, MD USA.
FAU - Maloney, Jennifer
AU  - Maloney J
AD  - Merck & Co., Inc, Whitehouse Station, NJ USA.
FAU - Kaur, Amarjot
AU  - Kaur A
AD  - Merck & Co., Inc, Whitehouse Station, NJ USA.
FAU - Li, Ziliang
AU  - Li Z
AD  - Merck & Co., Inc, Whitehouse Station, NJ USA.
FAU - Nelson, Harold
AU  - Nelson H
AD  - National Jewish Health, Denver, CO USA.
FAU - Nolte, Hendrik
AU  - Nolte H
AD  - Merck & Co., Inc, Whitehouse Station, NJ USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00562159
SI  - ClinicalTrials.gov/NCT00550550
SI  - ClinicalTrials.gov/NCT01385371
PT  - Journal Article
DEP - 20141030
PL  - England
TA  - Allergy Asthma Clin Immunol
JT  - Allergy, asthma, and clinical immunology : official journal of the Canadian 
      Society of Allergy and Clinical Immunology
JID - 101244313
PMC - PMC4326370
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - Conjunctivitis
OT  - Sublingual immunotherapy tablet
OT  - Timothy grass pollen
EDAT- 2015/02/17 06:00
MHDA- 2015/02/17 06:01
PMCR- 2014/10/30
CRDT- 2015/02/17 06:00
PHST- 2014/07/21 00:00 [received]
PHST- 2014/10/15 00:00 [accepted]
PHST- 2015/02/17 06:00 [entrez]
PHST- 2015/02/17 06:00 [pubmed]
PHST- 2015/02/17 06:01 [medline]
PHST- 2014/10/30 00:00 [pmc-release]
AID - 591 [pii]
AID - 10.1186/1710-1492-10-53 [doi]
PST - epublish
SO  - Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. 
      eCollection 2014.