Sublingual Immunotherapy With Once-Daily Grass Allergen Tablets: A Randomized Controlled Trial in Seasonal Allergic Rhinoconjunctivitis
Bibliographic record
Abstract
Durham SR, Yang WH, Pedersen MR, Johansen N, Rak S. J Allergy Clin Immunol. 2006;117:802–809 PURPOSE OF THE STUDY. To examine the efficacy and safety of sublingual immunotherapy (SLIT) in seasonal allergic rhinoconjunctivitis using timothy-grass–allergen tablets. STUDY POPULATION. The study included 855 patients aged 18 to 65 from 55 centers in Canada and Europe with seasonal allergic rhinoconjunctivitis induced by grass pollen. METHODS. A double-blind, randomized, parallel-group, placebo-controlled trial was conducted during 2002–2003. Patients had a history of allergic rhinoconjunctivitis during grass-pollen season for at least 2 years with a positive skin-prick–test result and serum-specific immunoglobulin E (IgE) to Phleum pratense. Individuals were randomly assigned to receive placebo or 2500, 25 000, or 75 000 SQ-T sublingual tablets administered daily. Daily diaries of symptoms (0–3) and rescue-medication use from pre–through post–grass-pollen season were kept, and a rhinoconjunctivitis quality-of-life (QoL) questionnaire was completed. Well days were calculated as those with a symptom score of ≤2 and no rescue-medication use. RESULTS. A total of 790 (92%) participants completed the trial that included a mean duration of treatment of 18 weeks. Treatment with 75 000 SQ-T tabs revealed an improvement in symptom score (16%; P = .0710) and medication score (28%; P = .0470) when compared with placebo. The QoL score and number of well days also revealed improvement of 17% (P = .006) and 18% (P = .041), respectively. The 2 lower doses did not demonstrate significant change from placebo. Preseason treatment for 8 weeks with the 75 000 SQ-T dose showed an increased improvement of symptom score (21%; P = .002) and medication score (29%; P = .012) compared with placebo. In the 75 000 SQ-T group, specific IgG to P pratense was increased after 8 weeks of treatment and tripled posttreatment. Specific IgE levels increased after treatment initialized but remained unchanged thereafter. Therapy was well tolerated with only mild-to-moderate symptoms (consisting of primarily oral pruritis and throat irritation) noted in 53% of the patients. CONCLUSIONS. Grass-pollen SLIT has a dose-dependent efficacy, is well tolerated, and provides improved QoL for patients with seasonal allergic rhinoconjunctivitis. REVIEWER COMMENTS. SLIT for grass-pollen allergy holds promise as an alternative future therapy to subcutaneous immunotherapy that is attractive on many levels. Grass-pollen SLIT may have broader coverage range because of improved accessibility and more convenient administration, less discomfort than injections, and decreased risk of IgE-mediated severe systemic reactions. Preseason coverage with SLIT may improve symptoms and reduce medication requirements for treatment of seasonal allergic rhinoconjunctivitis.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".