Efficacy and safety of standardized short ragweed sublingual immunotherapy tablet (SLIT-T) treatment in Canadian subjects with ragweed pollen-induced rhinitis with or without conjunctivitis
Bibliographic record
Abstract
Efficacy of standardized short ragweed sublingual immunotherapy tablet (SLIT-T), MK-3641 (Merck/ALK; 12 Amb a 1-U of Ambrosia artemisiifolia ) treatment on Canadian ragweed-allergic subjects was assessed using subgroup analysis of data from 2 multinational, randomized, double-blind, placebo-controlled clinical trials designed to evaluate ragweed SLIT-T efficacy and safety in adults with ragweed pollen-induced allergic rhinitis with or without conjunctivitis (AR/C), with or without asthma. We conducted pooled subgroup analysis of data from 2 studies (P05234, n=784; P05233, n=565) investigating efficacy and safety of once-daily ragweed SLIT-T [ 1 , 2 ]. In both trials, subjects were randomized to receive ragweed SLIT-T (of multiple doses tested, 12 Amb a 1-U was found most effective and is included here) or placebo. Treatment was started approximately 16 weeks before ragweed pollen season (RS) and continued during and after RS (total, approximately 52 weeks). Subjects recorded AR/C symptoms in daily e-diaries from randomization to end of RS. During RS, subjects also recorded AR/C rescue medication use. The primary efficacy endpoint was the average total combined score (TCS), the sum of the daily symptom score (DSS) and daily medication score (DMS) during peak RS (the 15 consecutive days within RS with the highest 15-day moving average pollen count). In the pooled study population of the 2 trials, approximately 80% of subjects were polysensitized and approximately 20% had asthma; mean age was approximately 36 years. The pooled Canadian subpopulation included 104 and 94 subjects receiving placebo and 12 Amb a 1-U SLIT-T respectively. Average pollen count for Canadian sites was approximately 100 grains/m during peak RS. Canadian subjects receiving 12 Amb a 1-U SLIT-T had a mean TCS of 5.13 over peak RS, representing a 42% reduction vs 8.90 for placebo (–3.77; 95% CI, –5.16 to –2.39). Reductions in the primary endpoint with 12 Amb a 1-U SLIT-T were supported by reductions in components DSS and DMS in the pooled population. Treatment-emergent adverse events (AEs) were reported for 80.9% and 94.5% of Canadian subjects in placebo and 12 Amb a 1-U SLIT-T groups respectively; treatment-related AEs were reported for 33.9% and 80.9% respectively. The majority of treatment-related AEs were mild, local, application-site reactions with no reports of serious treatment-related AEs or systemic allergic reactions. In pooled subgroup analysis from 2 trials, ragweed SLIT-T therapy reduced symptom and medication scores in Canadian subjects with ragweed pollen-induced 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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| 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".