Presentation: Efficacy and Safety Of Grass Sublingual Immunotherapy Tablet (SLIT-T) Treatment In a Large Randomized Controlled Trial In North American Children and Adults (2013 WAO Symposium on Immunotherapy and Biologics)

Saturday, 14 December 2013

Michigan Ballroom (Westin - Michigan Avenue)

Hendrik Nolte, MD, PhD , Merck, Whitehouse Station, NJ

Jennifer Maloney, MD , Merck, Whitehouse Station, NJ

David Bernstein, MD , University of Cincinnati College of Medicine, Bernstein Clinical Research Center, Cincinnati, OH

Harold Nelson, MD , National Jewish Health, Denver, CO

Peter Creticos, MD , Johns Hopkins University School of Medicine, Division of Allergy & Clinical Immunology, Baltimore, MD

Jacques Hébert, MD , Centre De Recherche Appliqué En Allergie De Québec, Québec City, QC, Canada

Michael Noonan, MD , Allergy Associates Research Center, Portland, OR

David Skoner, MD , Allegheny General Hospital, Pittsburgh, PA

Yijie Zhou, PhD , Merck, Whitehouse Station, NJ

Amarjot Kaur, PhD , Merck, Whitehouse Station, NJ

Background: In North America, few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis (AR/C), and pediatric data are sparse. We report findings from the largest presented immunotherapy trial yet conducted in adults and children. This multicenter trial evaluated grass sublingual immunotherapy tablet (SLIT-T) treatment in subjects with AR/C.

Methods: North American subjects (5-65 yrs) with grass allergy were randomized 1:1 to once-daily standardized timothy grass SLIT-T, MK-7243 (Merck/ALK; 2800 BAU of Phleum pratense) or placebo. Approval was obtained from appropriate IRBs and informed consent obtained from all research subjects. The primary efficacy endpoint was total combined score (TCS = rhinoconjunctivitis daily symptom score [DSS] plus daily medication score [DMS]) over entire grass pollen season (GPS). Key secondary endpoints included entire-season DSS and DMS and peak-season TCS and rhinoconjunctivitis quality-of-life questionnaire (RQLQ) scores. Safety endpoints included adverse events (AEs).

Results: 1501 subjects were randomized; 85% were multisensitized and 25% had asthma. Timothy grass SLIT-T yielded improvements versus 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 RQLQ (median difference: –0.13, P= .027). Efficacy was similar between children and adults. Most AEs were transient local application-site reactions, with no serious treatment-related AEs or anaphylactic shock. Three subjects (2 SLIT-T, 1 placebo) had moderate systemic allergic reactions.

Conclusions: In the largest immunotherapy trial presented to date, timothy grass SLIT-T was effective in grass-allergic North American children and adults with AR/C, confirming previous research.

2018 Efficacy and Safety Of Grass Sublingual Immunotherapy Tablet (SLIT-T) Treatment In a Large Randomized Controlled Trial In North American Children and Adults