Efficacy, safety, and immunological effects of a 2-year immunotherapy with Depigoid birch pollen extract: a randomized, double-blind, placebo-controlled study

Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology
A-S HöibyS Rak

Abstract

Rhinoconjunctivitis due to birch pollen sensitization is common in Northern Europe. A depigmented polymerized birch pollen extract - Depigoid has been developed for immunotherapy. To evaluate its clinical efficacy, safety, and effects on immunological parameters. Sixty-one patients aged 7-69 years were included in a randomized, double-blind, placebo-controlled trial of subcutaneous immunotherapy (SCIT) using depigmented polymerized birch pollen extract. SCIT consisted of four increasing doses at 7-day intervals, followed by maintenance injections of 500 DPP (corresponding to 30 microg Bet v1 before depigmentation) at 6-week intervals for 18 months. The primary outcome was the combined symptom and medication score during the 2006 birch pollen season. The frequency of peripheral blood mononuclear cells (PBMC)producing IL-4, IL-10, IL-12, and IL-13 was assessed in a subgroup of patients by ELISPOT assay. After 18 months of treatment, the median combined symptom and medication score (upper/lower quartile) of treated patients was significantly lower than those on placebo: 8.0 (5.8-10.3) and 12.6 (8.6-16.2), respectively (P=0.004). Systemic reactions occurred in 29 patients (12 active, 17 placebo), were grades 1 or 2, and none requir...Continue Reading

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