Efficacy and safety of MK-7243: a grass allergy sublingual immunotherapy tablet evaluated in Canadian adults and children
Bibliographic record
Abstract
The effect of MK-7243 (2800 BAU/75,000 SQ [~15 µg of Phleum pratense p 5], Merck/ALK-Abelló), a sublingual Timothy grass immunotherapy tablet, has been evaluated in several randomized, placebo-controlled, double-blind trials; three of these trials were conducted in adults and children in North America (the United States and Canada) who have allergic rhinitis with or without conjunctivitis (AR/C). We conducted a post-hoc analysis to investigate the effect of MK-7243 in Canadian subpopulations. Data from Canadian subjects from the three trials were used in this investigation: P05238 (adults ≥18 y; pollen season: 2009); P05239 (children 5−<18 y; pollen season=2009); and P08067 (adults ≥65 y and children 5−<18 y; pollen season: 2012). Trial data from the same grass pollen seasons (GPS) were pooled. Subjects received once-daily MK-7243 or placebo starting ≥12 wk before and continuing throughout the GPS, for a mean total of ≥23 wk. The therapeutic effect of MK-7243 was evaluated for rhinoconjunctivitis symptoms and symptomatic medication use, measured as a total combined score (TCS=daily-symptom score [DSS; max=18]+daily-medication score [DMS; max=36]) averaged over the entire GPS. Safety was assessed by monitoring adverse events (AEs). Canadian subjects taking MK-7243 (n=42) in the pooled adult-pediatric 2009 trials showed a 38% mean TCS reduction versus placebo (n=54; −2.06 difference [95% CI: −3.72, −0.39]; 3.32 vs. 5.37). Canadian subjects taking MK-7243 (n=122) in the adult-pediatric 2012 trial showed a 33% mean TCS reduction relative to placebo (n=122; −1.62 difference [95% CI: −2.54, −0.71]; 3.34 vs. 4.96). Approximately 90% of treatment-related AEs were mild or moderate in severity. No serious or life-threatening treatment-related AEs occurred. MK-7243 Timothy grass sublingual tablet significantly improved AR/C induced by Timothy grass pollen in Canadian adults and children 5 y and older. Similar efficacy and safety results were obtained for the overall populations of the three trials.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".