Merck announced data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243), a once-daily tablet designed to help treat the underlying cause of allergic rhinitis in adult and pediatric patients. Timothy grass sublingual allergy immunotherapy tablet generates an immune response to help protect patients against Timothy grass pollen.
This multicenter, double-blind, randomized, placebo-controlled, parallel-group study evaluated the efficacy and safety of the investigational MK-7243 sublingual tablet (2800 BAU) in 1,501 pediatric and adult patients with a clinical history of Timothy grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma (FEV1 ≥70% of predicted value). Patients received either MK-7243 or placebo once daily for at least 12 weeks prior to and during the grass pollen season.
The primary efficacy assessment of the study was total combined score (TCS), which was the sum of the rhinoconjunctivitis daily symptom score (DSS) and the daily medication score (DMS) averaged over the entire grass pollen season. The DSS consisted of daily ratings of four nasal symptoms (runny nose, blocked nose, sneezing and itchy nose) and two eye symptoms (gritty eyes and watery eyes) on a scale from zero (no symptoms) to three (severe symptoms). The DMS was based on the type and amount of allergy rescue medication (oral antihistamines, ocular antihistamines, intranasal corticosteroids or oral corticosteroids) used each day during the grass pollen season, which patients in both arms of the study were permitted to use.
Results from this study were as follows:
- Patients treated with MK-7243 (n=629) showed a 23% improvement in TCS compared to placebo (n=672) over the entire grass pollen season (median difference: -0.98, P<0.001)
- Patients treated with MK-7243 demonstrated a 20% improvement in DSS over the entire grass pollen season (median difference: -0.64, P=0.001), and a 35% improvement in DMS over the entire grass pollen season (mean difference: -0.48, P<0.001).
- During the peak grass pollen season, patients treated with MK-7243 demonstrated a 29% improvement in TCS (median difference: 1.33, P<0.001), and a 12% improvement in RQLQ (median difference: -0.13, P=0.027).
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