BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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).

ALIAN s r o Ambulancia alergológie a klinickej imunológie Bardejov Slovakia

Center for Rhinology and Allergology Wiesbaden Germany

Department of Immunology and Allergology Faculty of Medicine in Pilsen Charles University Pilsen Czech Republic

Department of Otorhinolaryngology Head and Neck Surgery Section of Rhinology and Allergy University Hospital Marburg Philipps Universität Marburg Germany; Department of Otorhinolaryngology Head and Neck Surgery Universitätsmedizin Mannheim Medical Faculty Mannheim Heidelberg University Mannheim Germany; Center for Rhinology and Allergology Wiesbaden Germany

Division of Internal Medicine Asthma and Allergy Medical University of Lodz Lodz Poland

HAL Allergy BV Leiden The Netherlands

Upper Airways Research Laboratory University of Ghent Ghent Belgium

References provided by Crossref.org

Biomarkers for diagnosis and prediction of therapy responses in allergic diseases and asthma

See more in PubMed

ClinicalTrials.gov
NCT02231307

EudraCT
2013-005550-30