Efficacy of short-ragweed sublingual immunotherapy tablet MK-3641 in monosensitized and polysensitized subjects
Bibliographic record
Abstract
Immunotherapy for allergic rhinitis with/without conjunctivitis (AR/C) may exhibit different efficacy characteristics in patients with multiple allergen sensitizations than monosensitized patients. It has been considered that monosensitized patients may benefit more from immunotherapy than polysensitized patients. Evidence from randomized, blinded, placebo-controlled trials of Timothy grass sublingual immunotherapy tablet (SLIT-T) MK-7243 (Merck/ALK-Abelló) indicates that treatment in mono- and polysensitized subjects is equally effective. A prospective efficacy analysis was performed between monosensitized and polysensitized subjects treated with the short-ragweed SLIT-T MK-3641 ( Ambrosia artemisiifolia ; Merck/ALK-Abelló). Pooled data from 2 randomized placebo-controlled trials investigating MK-3641 (6 and 12 Amb a 1-U doses) were used. The primary efficacy outcome was the total combined score (TCS=symptom+medication scores) during the 15-day peak season. Differences versus placebo for the MK-3641 6 and 12 Amb a 1-U pooled groups (mono- and polysensitized subjects combined) for the peak season TCS were 20% (−1.70; 95% CI, −2.55 to −0.86) and 23% (−2.02; 95% CI, −2.87 to −1.17), respectively ( P <0.001 for both). Differences versus placebo in the monosensitized MK-3641 pool (n = 175) were 15% (−1.34; 95% CI, −3.40 to 0.73) and 19% (−1.72; 95% CI, −3.63 to 0.20) for 6 and 12 Amb a 1-U, respectively. In the polysensitized MK-3641 pool (n = 784) difference versus placebo were 21% (−1.78; 95% CI, −2.80 to −0.75) and 27% (−2.27; 95% CI, −3.27 to −1.28) for 6 and 12 Amb a 1-U, respectively. In the whole study population, treatment with MK-3641 6 and 12 Amb a 1-U for ragweed-induced AR/C was superior to placebo. Although the sample size for the 2 subpopulations was not balanced and data must be interpreted cautiously, it appears that the treatment effect is similar in the mono- and polysensitized subpopulations, with a numerical trend of a greater treatment effect in polysensitized subjects.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".