Jennifer Maloney1, David I Bernstein2, Harold Nelson3, Peter Creticos4, Jacques Hébert5, Michael Noonan6, David Skoner7, Yijie Zhou8, Amarjot Kaur8, Hendrik Nolte8. 1. Merck & Co, Inc, Whitehouse Station, New Jersey. Electronic address: jennifer.maloney@merck.com. 2. Bernstein Clinical Research Center and University of Cincinnati College of Medicine, Cincinnati, Ohio. 3. National Jewish Medical and Research Center, Denver, Colorado. 4. Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. Centre de Recherche Appliquée en Allergie de Québec, Québec, Québec, Canada. 6. Allergy Associates Research Center, Portland, Oregon. 7. Allegheny General Hospital, Pittsburgh, and Temple University School of Medicine, Philadelphia, Pennsylvania. 8. Merck & Co, Inc, Whitehouse Station, New Jersey.
Abstract
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.
RCT Entities:
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.
Authors: Guy W Scadding; Moises A Calderon; Mohamed H Shamji; Aarif O Eifan; Martin Penagos; Florentina Dumitru; Michelle L Sever; Henry T Bahnson; Kaitie Lawson; Kristina M Harris; Audrey G Plough; Joy Laurienzo Panza; Tielin Qin; Noha Lim; Nadia K Tchao; Alkis Togias; Stephen R Durham Journal: JAMA Date: 2017-02-14 Impact factor: 56.272
Authors: Harold S Nelson; Moises A Calderon; David I Bernstein; Thomas B Casale; Stephen R Durham; Jens S Andersen; Robert Esch; Linda S Cox; Hendrik Nolte Journal: Curr Allergy Asthma Rep Date: 2017-03 Impact factor: 4.806
Authors: Jacques Hébert; Michael Blaiss; Susan Waserman; Harold Kim; Peter Creticos; Jennifer Maloney; Amarjot Kaur; Ziliang Li; Harold Nelson; Hendrik Nolte Journal: Allergy Asthma Clin Immunol Date: 2014-10-30 Impact factor: 3.406