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
Notice bibliographique
Résumé
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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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».