Magnitude of changes in patient symptom and medication scores in grass allergy immunotherapy trials: dependency on levels of pollen exposure
Bibliographic record
Abstract
Seasonal allergic rhinitis/rhinoconjunctivitis symptoms are dependent on pollen exposure and may impact the observed treatment effect of drugs used to treat seasonal allergic rhinitis. We conducted a post-hoc analysis to investigate the impact of pollen exposure on the overall magnitude of the recorded immunotherapy treatment effect across multiple seasons and trials of Timothy grass sublingual immunotherapy tablet MK-7243 (2800 BAU/75,000 SQ-T Phleum pratense p 5, Merck/ALK-Abelló). Data from seven North American and European randomized placebo-controlled trials of MK-7243 were included in the analysis (GT-02, GT-07, GT-08, GT-12, P05238, P05239, and P08067; data from GT-14 were not included since the observed lack of pollen-count/symptom relationship in this trial suggested etiology other than grass pollen exposure). Boundaries of three consecutive days with a pollen count ≥10 grains/m defined the grass pollen seasons (GPS). We assessed the correlation of between-treatment difference in total combined score (TCS; combined symptom+medication scores) per trial or trial year to the first-20-days-of-GPS cumulative grass pollen count and entire-GPS average pollen count. Data from 1798 subjects on MK-7243 and 1765 subjects on placebo were included in the analysis. TCS for both groups increased with grass pollen counts. The treatment effect in TCS in each trial (or trial year) was correlated to the cumulative grass pollen count during the first 20 days of GPS (R =0.803). A correlation was also seen between TCS and average pollen count over the entire GPS (R =0.464). Post-hoc analysis of seven MK-7243 trials demonstrates that the magnitude of the treatment effect observed in the trials was highly correlated to the early-season grass pollen exposure observed in each trial. Therefore, differences in pollen exposure levels should be considered when comparing results among pollen immunotherapy trials and may contribute to observed differences in magnitude of efficacy between trials using the same immunotherapy formulation.
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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 | 0.050 | 0.036 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| 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".