TY - JOUR
T1 - Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243
T2 - A large randomized controlled trial
AU - Maloney, Jennifer
AU - Bernstein, David I.
AU - Nelson, Harold
AU - Creticos, Peter
AU - Hébert, Jacques
AU - Noonan, Michael
AU - Skoner, David
AU - Zhou, Yijie
AU - Kaur, Amarjot
AU - Nolte, Hendrik
N1 - Funding Information:
Disclosures: This study was funded by Merck & Co, Inc (Whitehouse Station, New Jersey). Medical writing and editorial assistance was provided by Rob Coover, MPH, of Adelphi Communications, New York, New York. This assistance was funded by Merck & Co. Editorial assistance also was provided by Jorge Moreno-Cantu, PhD, Global Scientific and Medical Publications, Office of the Chief Medical Officer, Merck & Co. Additional statistical assistance was provided by Ziliang Li, PhD, of Merck & Co. Dr Bernstein has served on the advisory board of Merck & Co, received funding as principal investigator from Merck & Co, Stollegan, and Greer Laboratories, and served on the immunotherapy committee for the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. Dr Nelson has served on the advisory board of Merck & Co and received funding as principal investigator from Circassia. Dr Creticos served as editor for UpToDate, received funding from Merck & Co and Greer Laboratories , and served on committees for the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology. Dr Skoner has received honoraria from Merck & Co and grants from Merck & Co and Greer Laboratories. Dr Hébert has served on the boards of Merck & Co, Paladin, and Novartis and received funding from Schering and Merck & Co.
PY - 2014/2
Y1 - 2014/2
N2 - 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.
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.
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U2 - 10.1016/j.anai.2013.11.018
DO - 10.1016/j.anai.2013.11.018
M3 - Article
C2 - 24468255
AN - SCOPUS:84893646699
SN - 1081-1206
VL - 112
SP - 146-153.e2
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 2
ER -