The efficacy and safety of the short ragweed sublingual immunotherapy tablet MK-3641 is similar in asthmatic and nonasthmatic subjects treated for allergic rhinitis with/without conjunctivitis
Bibliographic record
Abstract
We conducted a post-hoc analysis of two short-ragweed sublingual immunotherapy tablet (SLIT-T) trials to investigate whether the subjects with allergic rhinitis with/without conjunctivitis (AR/C) and comorbid asthma reported different efficacy or safety events than those with AR/C and no asthma. Data from two trials evaluating the short-ragweed SLIT-T MK-3641 ( Ambrosia artemisiifolia ; Merck/ALK-Abelló) were pooled. Subjects with ragweed-pollen–induced AR/C were randomized to once-daily MK-3641 (6 or 12 Amb a 1-U doses) or placebo for approximately 52 weeks. Subjects with AR/C and stable asthma not requiring medium- or high-dose inhaled corticosteroids and ≥70% predicted FEV 1 were eligible. Efficacy and safety outcomes were assessed in subjects with AR/C with/without reported asthma. Efficacy measurements included AR/C total combined score (TCS; combined symptom+medication scores); safety was assessed by reported adverse events (AEs). Among subjects with AR/C and asthma receiving MK-3641 6 or 12 Amb a 1-U, TCS was reduced by 17% (−1.27; 95% CI: −3.48, 0.93; n=56) and 22% (−1.68; 95% CI: −3.69, 0.33; n=64), respectively, versus placebo (mean TCS=7.65; n=64) over the 15-day peak season. Among subjects without asthma receiving MK-3641 6 or 12 Amb a 1-U, TCS was reduced by 21% (−1.83; 95% CI: −2.84, −0.82; n=261) and 27% (−2.34; 95% CI: −3.33, −1.35; n=247), respectively, versus placebo (mean TCS=8.73; n=269). At least one treatment-related AE was experienced by 33%, 63%, and 65% of placebo and MK-3641 6 and 12 Amb a 1-U subjects with asthma, respectively, versus 24%, 54%, and 60% of subjects without asthma. No treatment-related serious or life-threatening AEs or hypersensitivity or systemic reactions were observed. The overall number of subjects with asthma was low and the data must be interpreted with caution. However, the SLIT-T treatment MK-3641 appeared to demonstrate similar efficacy and safety results in subjects with ragweed AR/C with or without asthma.
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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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.006 |
| Bibliometrics | 0.001 | 0.000 |
| 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) | 0.003 | 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".