Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber
| Autor: | Friedrich Horak, Philippe Devillier, Michel Melac, Petra Zieglmayer, Philippe Moingeon, René Zieglmayer, Martine Le Gall, A. Montagut, Laurence Van Overtvelt, Patrick Lemell, S. Galvain, Stephanie Jean-Alphonse |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Immunology Population Provocation test Administration Sublingual Placebo Gastroenterology Sublingual administration law.invention Young Adult Randomized controlled trial law Internal medicine Hypersensitivity otorhinolaryngologic diseases medicine Humans Immunology and Allergy education education.field_of_study Throat irritation Intention-to-treat analysis business.industry food and beverages Allergens Middle Aged Surgery Pollen Female Immunotherapy Onset of action medicine.symptom business Tablets |
| Zdroj: | Journal of Allergy and Clinical Immunology. 124:471-477.e1 |
| ISSN: | 0091-6749 |
| DOI: | 10.1016/j.jaci.2009.06.006 |
| Popis: | Background The efficacy and safety of a 5-grass-pollen sublingual immunotherapy (SLIT) tablet (Stallergenes SA, Antony, France) have been evaluated in clinical studies during the pollen season. The allergen challenge chamber (ACC) has been developed as a pharmacodynamic assessment tool to control the environmental allergens and to avoid all problems associated with unpredictable pollen seasons. Objective We sought to evaluate the onset of action and efficacy of 300-IR (index of reactivity) SLIT tablets by using an ACC. Methods Patients with grass pollen–induced rhinoconjunctivitis were randomized into the active or placebo groups. A standardized allergen challenge with grass pollen and symptom evaluation every 15 minutes was performed at baseline, 1 week, and 1, 2, and 4 months of treatment. The primary end point was the average rhinoconjunctivitis total symptom score (ARTSS). Allergen-specific basophil activation, T-cell proliferation, and plasmatic IgE and IgG responses were assessed before and after treatment. Results In the intention-to-treat population (n = 89) a significant treatment effect was achieved after the first month ( P = .0042) and second month ( P = .0203) and was maintained through to the fourth month ( P = .0007). In the active group the ARTSS (means ± SDs) decreased at each challenge: week 1, 7.40 ± 2.682; month 1, 5.89 ± 2.431; month 2, 5.09 ± 2.088; and month 4, 4.85 ± 1.999. An improvement (vs placebo) of 29.3% for the mean ARTSS (median, 33.3%) was observed at end point. Furthermore, the induction of grass pollen allergen–specific IgGs was associated with clinical response. The most frequent adverse reactions were local: oral pruritus, ear pruritus, and throat irritation. Conclusions In this ACC study the 300-IR 5-grass-pollen SLIT tablets had a significant effect on rhinoconjunctivitis symptoms (vs placebo) from the first month of treatment onward. |
| Databáze: | OpenAIRE |
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