Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis

Background: Rhinoconjunctivitis because of tree pollen sensitization is common in Northern Europe. Specific subcutaneous immunotherapy (SCIT) is the only disease-modifying treatment, but unmodified allergen extracts carry a risk of allergic side-effects. Our objective was to examine efficacy and saf...

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Hauptverfasser: Pfaar, Oliver (VerfasserIn) , Robinson, D. S. (VerfasserIn) , Sager, A. (VerfasserIn) , Emuzyte, R. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 29 October 2010
In: Allergy
Year: 2010, Jahrgang: 65, Heft: 12, Pages: 1614-1621
ISSN:1398-9995
DOI:10.1111/j.1398-9995.2010.02413.x
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1111/j.1398-9995.2010.02413.x
Verlag, lizenzpflichtig, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1398-9995.2010.02413.x
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Verfasserangaben:O. Pfaar, D.S. Robinson, A. Sager & R. Emuzyte

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520 |a Background: Rhinoconjunctivitis because of tree pollen sensitization is common in Northern Europe. Specific subcutaneous immunotherapy (SCIT) is the only disease-modifying treatment, but unmodified allergen extracts carry a risk of allergic side-effects. Our objective was to examine efficacy and safety of a depigmented-polymerized mixed tree pollen extract. Methods: A double-blind, placebo-controlled trial of 184 tree pollen allergic adults was performed. SCIT consisted of four increasing doses at 7-day intervals, then maintenance injections every 6 weeks for 18 months. Primary outcome was combined symptom and medication score during the 2008 season. Secondary outcomes included analysis at different levels of pollen exposure and a responder analysis. Adverse events were classified using the EAACI scale. Birch pollen-specific IgE and IgG4 were measured before and after treatment. Results: The combined symptom and medication score of actively treated patients was significantly lower than those on placebo (P < 0.04). Increased efficacy was seen at high pollen exposure (median score 2.1 for active [IQR 0.7-3.4] vs 4.2 [IQR 2.4-5.3] for placebo for days with 500 or more pollen grains per m3, a 50% reduction, P < 0.01). A modified responder analysis revealed 64% responders in the active and 32% in the placebo group (P < 0.01). There were 17 systemic reactions. All were mild (grade 1 or 2) and required no treatment. Serum birch-specific IgG4 increased in the SCIT group (P < 0.01). Conclusions: SCIT with depigmented- polymerized tree pollen extract was clinically effective and well tolerated. Responder analysis suggested that one-third of patients treated with immunotherapy may not respond. 
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