Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis - 01/03/14
, Robert E. Esch, PhD b, Peter Couroux, MD c, Deborah Gentile, MD d, Pina D'Angelo, MSc e, Brad Whitlow, BS b, Michael Alexander, MD f, Terrance C. Coyne, MD bAbstract |
Background |
Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis (ARC), but a lack of robust evidence has deterred its use in North America.
Objective |
To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid (RW-SAIL) extract in subjects with ragweed-related ARC.
Methods |
This phase 3, randomized, placebo-controlled trial was conducted in North America. Subjects (age range, 18-55 years) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed. Subjects self-administered the maximum tolerated dose of RW-SAIL (n = 218) or placebo (n = 211) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season. The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores (TCS).
Results |
During the entire season, there was a 43% decrease in TCS in subjects treated with RW-SAIL compared with placebo. Similar decreases were observed in TCS between the 2 groups during peak season (42%) and in daily symptom scores during the entire (42%) and peak (41%) seasons. The occurrence of adverse events was similar between the treatment groups; most were mild in severity. Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited. No anaphylaxis occurred.
Conclusions |
This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract for the treatment of ARC.
Le texte complet de cet article est disponible en PDF.Key words : Allergen-specific IgE, allergen-specific IgG4, allergy immunotherapy, combined score, ragweed, specific immunotherapy, sublingual immunotherapy
Abbreviations used : AE, ANCOVA, ARC, DSS, FDA, ITT, LS, MTD, RW-SAIL, SLIT, TCS, TRAE
Plan
| Supported by Greer Laboratories. |
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| Disclosure of potential conflict of interest: P. Creticos has consultant arrangements with and receives research support from Greer Laboratories Inc, Merck, and Circassia and receives royalties from UpToDate. R. Esch is employed by and receives stock/stock options from Greer Laboratories Inc. P. Courox has received research support from Cetero Research. D. Gentile has received research support from Greer Laboratories Inc, Merck, TEVA, GlaxoSmithKline, and Sunovian and has received payment for lectures from Merck and TEVA. P. D'Angelo is a paid statistical consultant for Greer Laboratories Inc. B. Whitlow is employed by Greer Laboratories Inc. M. Alexander has received research support from Greer Laboratories Inc, is a board member for and has consultant arrangements with Allergan, and has received payment for lectures from Merck and AstraZeneca. T. Coyne is employed by, has received travel support from, has received fees for participation in review activities from, has received payment for writing or reviewing the manuscript from, has received payment for manuscript preparation from, has received payment for development of educational presentations from, and has received stock/stock options from Greer Laboratories, Inc. |
Vol 133 - N° 3
P. 751-758 - mars 2014 Retour au numéro
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