Andrzej Bożek1, Krzysztof Kołodziejczyk2, Jerzy Jarząb3. 1. Clinical Department of Internal Disease, Dermatology and Allergology in Zabrze, Medical University of Silesia, Katowice, Poland. Electronic address: andrzejbozek@o2.pl. 2. Allergy Outpatient Clinic, Katowice, Poland. 3. Clinical Department of Internal Disease, Dermatology and Allergology in Zabrze, Medical University of Silesia, Katowice, Poland.
Abstract
BACKGROUND:Local allergic rhinitis (LAR) is a relatively new disease. OBJECTIVE: To ascertain the effects of allergen-specific immunotherapy in LAR. METHODS: A randomized, double-blind, placebo-controlled trial of birch subcutaneous allergen immunotherapy (AIT) for LAR was performed in 28 patients. The therapy was performed for 24 months in 15 patients with AIT and 13 patients givenplacebo. The primary end point was decrease in symptom medication score (SMS). In addition, we monitored serum-specific immunoglobulin E (IgE), serum-specific immunoglobulin G4, nasal-specific IgE to Bet v 1, and safety and quality-of-life parameters. RESULTS: After 24 months of treatment, there was a significant decrease in the median area under the curve for SMS of the active group vs the placebo group: 2.14 (range, 1.22-4.51) vs 6.21 (range, 5.12-7.89), at the P < .05 level. During AIT, the active group showed a significant decrease in SMS of up to 65% vs baseline. A significant increase in immunoglobulin G4 and decrease in nasal-specific IgE were observed in the active group during AIT compared with the placebo group. AIT was well-tolerated and without systemic reactions. CONCLUSION: This study demonstrates that AIT for birch pollen in patients with LAR was clinically effective and exhibited good tolerance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03157505.
RCT Entities:
BACKGROUND: Local allergic rhinitis (LAR) is a relatively new disease. OBJECTIVE: To ascertain the effects of allergen-specific immunotherapy in LAR. METHODS: A randomized, double-blind, placebo-controlled trial of birch subcutaneous allergen immunotherapy (AIT) for LAR was performed in 28 patients. The therapy was performed for 24 months in 15 patients with AIT and 13 patients given placebo. The primary end point was decrease in symptom medication score (SMS). In addition, we monitored serum-specific immunoglobulin E (IgE), serum-specific immunoglobulin G4, nasal-specific IgE to Bet v 1, and safety and quality-of-life parameters. RESULTS: After 24 months of treatment, there was a significant decrease in the median area under the curve for SMS of the active group vs the placebo group: 2.14 (range, 1.22-4.51) vs 6.21 (range, 5.12-7.89), at the P < .05 level. During AIT, the active group showed a significant decrease in SMS of up to 65% vs baseline. A significant increase in immunoglobulin G4 and decrease in nasal-specific IgE were observed in the active group during AIT compared with the placebo group. AIT was well-tolerated and without systemic reactions. CONCLUSION: This study demonstrates that AIT for birch pollen in patients with LAR was clinically effective and exhibited good tolerance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03157505.
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