PURPOSE OF THE STUDY.
The goal of this study was to evaluate the safety and efficacy of treatment with a grass sublingual immunotherapy tablet (MK-7243) in children and adults with allergic rhinoconjunctivitis. Previous studies have been conducted outside of North America and have included only sparse pediatric data.
Studied were 1501 North American subjects aged 5 to 65 years. The study included 283 children with a physician-diagnosed history of grass pollen–induced allergic rhinoconjunctivitis, with or without asthma, who had received treatment of their symptoms during the previous grass pollen season. Inclusion criteria were positive skin prick test response to Phleum pratense (≥5-mm wheal); positive specific IgE against P pratense (≥0.7 kU/L); and a forced expiratory volume in 1 second at least 70% of the predicted value at screening and randomization visits.
The subjects (85% polysensitized, 25% with asthma) were randomized 1:1 to receive once-daily MK-7243 (2800 BAU P 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) (composed of rhinoconjunctivitis daily symptom score plus daily medication score) over the entire grass pollen season. Key secondary end points included entire-season daily symptom score, daily medication score, peak-season TCS, and rhinoconjunctivitis quality-of-life questionnaire scores. Safety outcomes included adverse events (AEs).
MK-7243 yielded improvements over placebo across all end points measured, with similar efficacy noted between children and adults. Specifically, there was a 23% improvement 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 daily symptom score (median difference: −0.64, P = .001), 35% in entire-season daily medication score(mean difference: −0.48, P < .001), and 12% in the peak-season rhinoconjunctivitis quality-of-life questionnaire (median difference: −0.13, P = .027). Most AEs were transient, local application-site reactions, with no serious treatment-related AEs or anaphylactic shock. Three subjects (1 receiving placebo, 2 receiving MK-7243) had moderate systemic allergic reactions
This study found that MK-7243 was effective in polysensitized, grass-allergic North American children and adults with allergic rhinoconjunctivitis, confirming findings from previous studies.
This study is the first large, randomized trial in North America analyzing the safety and efficacy of grass sublingual immunotherapy in both adults and children who had multiple allergies. Its results confirm the earlier findings of 2 smaller, North American, randomized, placebo-controlled studies (Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011;127:64–71 and Nelson HS, Nolte H, Creticos J, et al. Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. J Allergy Clin Immunol. 2011;127:72–80, 80.e1–2) looking at the efficacy of MK-7243 versus placebo in improving TCS. These accumulated data provide strong evidence of MK-7243’s efficacy in treating subjects who have allergic rhinoconjunctivitis due to grass pollen. This approach will provide children with an additional option for the management of seasonal allergies. It is important to remember, however, that these results apply only to sublingual therapy with this product and may not apply to other products or doses of sublingual immunotherapy.
- Copyright © 2014 by the American Academy of Pediatrics