PMID- 24468255
OWN - NLM
STAT- MEDLINE
DCOM- 20140326
LR  - 20140128
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 112
IP  - 2
DP  - 2014 Feb
TI  - Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large 
      randomized controlled trial.
PG  - 146-153.e2
LID - S1081-1206(13)00903-4 [pii]
LID - 10.1016/j.anai.2013.11.018 [doi]
AB  - BACKGROUND: In North America, few studies have evaluated sublingual immunotherapy 
      for allergic rhinitis with or without conjunctivitis (AR/C); pediatric data are 
      sparse. The authors report findings from the largest published immunotherapy 
      trial yet conducted in adults and children. OBJECTIVE: To evaluate grass 
      sublingual immunotherapy tablet (MK-7243) treatment in subjects with AR/C. 
      METHODS: North American subjects (5-65 years old) with grass allergy were 
      randomized 1:1 to once-daily MK-7243 (2,800 BAU Phleum pratense) or placebo. The 
      first dose was given at the investigator's office; subsequent doses were 
      self-administered at home. The primary end point was total combined score (TCS; 
      rhinoconjunctivitis daily symptom score [DSS] plus daily medication score [DMS]) 
      over the entire grass pollen season (GPS). Key secondary end points included 
      entire-season DSS, DMS, peak-season TCS, and rhinoconjunctivitis quality-of-life 
      questionnaire scores. Safety outcomes included adverse events (AEs). RESULTS: One 
      thousand five hundred one subjects were randomized (85% polysensitized, 25% had 
      asthma). MK-7243 yielded improvements vs placebo of 23% in entire-season TCS 
      (median difference -0.98, P < .001), 29% in peak-season TCS (median 
      difference -1.33, P < .001), 20% in entire-season DSS (median difference -0.64, 
      P = .001), 35% in entire-season DMS (mean difference -0.48, P < .001), and 12% in 
      peak-season rhinoconjunctivitis quality-of-life questionnaire (median 
      difference -0.13, P = .027). Efficacy between children and adults was similar. 
      Most AEs were transient local application-site reactions, with no serious 
      treatment-related AEs or anaphylactic shock. Three subjects (1 placebo, 2 
      MK-7243) had moderate systemic allergic reactions. CONCLUSION: MK-7243 was 
      effective in polysensitized grass-allergic North American children and adults 
      with AR/C in this large trial, confirming previous research.
CI  - Copyright (c) 2014 American College of Allergy, Asthma & Immunology. Published by 
      Elsevier Inc. All rights reserved.
FAU - Maloney, Jennifer
AU  - Maloney J
AD  - Merck & Co, Inc, Whitehouse Station, New Jersey. Electronic address: 
      jennifer.maloney@merck.com.
FAU - Bernstein, David I
AU  - Bernstein DI
AD  - Bernstein Clinical Research Center and University of Cincinnati College of 
      Medicine, Cincinnati, Ohio.
FAU - Nelson, Harold
AU  - Nelson H
AD  - National Jewish Medical and Research Center, Denver, Colorado.
FAU - Creticos, Peter
AU  - Creticos P
AD  - Division of Allergy and Clinical Immunology, Johns Hopkins University School of 
      Medicine, Baltimore, Maryland.
FAU - Hebert, Jacques
AU  - Hebert J
AD  - Centre de Recherche Appliquee en Allergie de Quebec, Quebec, Quebec, Canada.
FAU - Noonan, Michael
AU  - Noonan M
AD  - Allergy Associates Research Center, Portland, Oregon.
FAU - Skoner, David
AU  - Skoner D
AD  - Allegheny General Hospital, Pittsburgh, and Temple University School of Medicine, 
      Philadelphia, Pennsylvania.
FAU - Zhou, Yijie
AU  - Zhou Y
AD  - Merck & Co, Inc, Whitehouse Station, New Jersey.
FAU - Kaur, Amarjot
AU  - Kaur A
AD  - Merck & Co, Inc, Whitehouse Station, New Jersey.
FAU - Nolte, Hendrik
AU  - Nolte H
AD  - Merck & Co, Inc, Whitehouse Station, New Jersey.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20131221
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Tablets)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis/*immunology/*therapy
MH  - Desensitization, Immunologic/*methods
MH  - Humans
MH  - Middle Aged
MH  - Poaceae/*immunology
MH  - Pollen/*immunology/poisoning
MH  - Rhinitis, Allergic, Seasonal/immunology/*therapy
MH  - Sensitivity and Specificity
MH  - Tablets
MH  - Young Adult
EDAT- 2014/01/29 06:00
MHDA- 2014/03/29 06:00
CRDT- 2014/01/29 06:00
PHST- 2013/07/23 00:00 [received]
PHST- 2013/11/19 00:00 [revised]
PHST- 2013/11/20 00:00 [accepted]
PHST- 2014/01/29 06:00 [entrez]
PHST- 2014/01/29 06:00 [pubmed]
PHST- 2014/03/29 06:00 [medline]
AID - S1081-1206(13)00903-4 [pii]
AID - 10.1016/j.anai.2013.11.018 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 
      10.1016/j.anai.2013.11.018. Epub 2013 Dec 21.