Sublingual allergen immunotherapy with a liquid birch pollen product in patients with seasonal allergic rhinoconjunctivitis with or without asthma

Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III t...

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Bibliographic Details
Published in:	Journal of allergy and clinical immunology Vol. 143; no. 3; pp. 970 - 977
Main Authors:	Pfaar, Oliver, Bachert, Claus, Kuna, Piotr, Panzner, Petr, Džupinová, Mária, Klimek, Ludger, van Nimwegen, Maroesja J., Boot, Johan D., Yu, Donghui, Opstelten, Dirk Jan E., de Kam, Pieter-Jan
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-03-2019 Elsevier Limited
Subjects:	Adolescent Adult Aged allergen immunotherapy Allergens Allergens - immunology allergic rhinoconjunctivitis Allergies Antigens, Plant - immunology Asthma Asthma - therapy Betula - immunology Birch pollen allergy Clinical trials combined symptom and medication score Conjunctivitis, Allergic - therapy Double-Blind Method Drug therapy efficacy Female Humans Immunology Immunotherapy Male Medicin och hälsovetenskap Middle Aged Oral administration Patients pivotal phase III trial Pollen Pollen - immunology Population Quality of life Rhinitis, Allergic, Seasonal - therapy Rhinoconjunctivitis Safety Seasons sublingual immunotherapy Sublingual Immunotherapy - adverse effects Treatment Outcome Young Adult Netherlands PP allergic rhinoconjunctivitis dSS ITT CSMS dMS safety EMA AUN EAACI RQLQ SLIT allergen immunotherapy AE pivotal phase III trial combined symptom and medication score AIT efficacy EQ-VAS ACQ ARC TEAE sublingual immunotherapy quality of life Birch pollen allergy
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Summary:	Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration. We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollen allergy. A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety. Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P = .0025), were also demonstrated. In total, a good safety profile of SLIT was observed. This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollen allergy in a pivotal phase III trial (EudraCT: 2013-005550-30; ClinicalTrials.gov: NCT02231307).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-News-3 content type line 23
ISSN:	0091-6749 1097-6825 1097-6825
DOI:	10.1016/j.jaci.2018.11.018