دورية أكاديمية

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.

التفاصيل البيبلوغرافية
العنوان: Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.
المؤلفون: Novak, Natalija, Worm, Margitta, Staubach, Petra, Jutel, Marek, Sager, Angelika, Pfaar, Oliver
المصدر: Clinical & Translational Allergy; Oct2022, Vol. 12 Issue 10, p1-12, 12p
مصطلحات موضوعية: ALLERGIC rhinitis, POLLEN, ALLERGENS, CLINICAL trials, BIRCH
مستخلص: Background: Allergen immunotherapy (AIT) is an approved treatment for seasonal respiratory allergic diseases. A depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy (SCIT) has been demonstrated to be efficacious and safe in patients allergic to birch pollen and its homologous group. Objective: To determine whether SCIT with a birch pollen formulation (5000 depigmented polymerized (DPP) units/mL) shows sustained and long‐term efficacy in adults and adolescents with birch‐pollen induced allergic rhinitis with or without intermittent asthma. Methods: A multicentre (n = 66), double‐blind, placebo‐controlled Phase III clinical trial was performed in the Czech Republic, Finland, Germany, Latvia, Lithuania, Poland and Russia. Participants were randomized 2:1 to active treatment (birch 5000 DPP/ml) or placebo for three years of SCIT and followed up for two treatment‐free years. The primary efficacy endpoint was the EAACI's combined symptom and medication score for rhinoconjunctivitis (CSMSEAACI). Results: A total of 973 participants were screened and 649 were randomized (active treatment: n = 434; placebo: n = 215). The intention‐to‐treat analysis of the CSMSEAACI in the overall study population did not demonstrate statistically significant differences in years 1, 2 and 3. In a post‐hoc analysis, among the subgroup of patients monosensitized to birch pollen allergen only (n = 200), we observed a statistically significant difference (active treatment vs. placebo) in the CSMSEAACI in year 2, 3 and 5. The AIT's safety profile was good. Conclusions: SCIT with a depigmented polymerized birch pollen extract was safe. Sustained and long‐term efficacy in years 2, 3 and 5 in monosensitized patients, but not in polysensitized patients was demonstrated. (EudraCT 2012‐000414‐11) [ABSTRACT FROM AUTHOR]
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قاعدة البيانات: Complementary Index
الوصف
تدمد:20457022
DOI:10.1002/clt2.12185