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

• 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
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2018.11.018

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).