Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial.
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.


CONCLUSIONS
MK-7243 was effective in polysensitized grass-allergic North American children and adults with AR/C in this large trial, confirming previous research.
Merck & Co, Inc, Whitehouse Station, New Jersey. Electronic address: jennifer.maloney@merck.com.
Jennifer
J
Maloney
Bernstein Clinical Research Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
David I
DI
Bernstein
National Jewish Medical and Research Center, Denver, Colorado.
Harold
H
Nelson
Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Peter
P
Creticos
Centre de Recherche Appliquée en Allergie de Québec, Québec, Québec, Canada.
Jacques
J
Hébert
Allergy Associates Research Center, Portland, Oregon.
Michael
M
Noonan
Allegheny General Hospital, Pittsburgh, and Temple University School of Medicine, Philadelphia, Pennsylvania.
David
D
Skoner
Merck & Co, Inc, Whitehouse Station, New Jersey.
Yijie
Y
Zhou
Merck & Co, Inc, Whitehouse Station, New Jersey.
Amarjot
A
Kaur
Merck & Co, Inc, Whitehouse Station, New Jersey.
Hendrik
H
Nolte
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003231:Conjunctivitis / Q000276:immunology* / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D006109:Poaceae / Q000276:immunology*; D011058:Pollen / Q000276:immunology* / Q000506:poisoning; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D012680:Sensitivity and Specificity; D013607:Tablets; D055815:Young Adult
D013607:Tablets