Sublingual allergen immunotherapy with a liquid birch pollen product in seasonal allergic rhinoconjunctivitis with/without asthma*

Publication date: Available online 30 November 2018

Source: Journal of Allergy and Clinical Immunology

Author(s): Oliver Pfaar, Claus Bachert, Piotr Kuna, Peter Panzner, Mária Džupinová, Ludger Klimek, Maroesja J. van Nimwegen, Johan D. Boot, Donghui Yu, Dirk Jan E. Opstelten, Pieter-Jan de Kam

Abstract

Background

Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinical 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

To investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 AUN/ml) in birch pollen allergic adult patients.

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 3-6 months prior to the birch pollen season and was continued during the season in 40 clinical study centers in 5 European countries. For primary endpoint assessment the recommended combined symptom and medication score (CSMS) of the European Academy of Allergy and Clinical Immunology (EAACI) was used. Secondary endpoints included Quality of Life assessments, immunological parameter and safety.

Results

The primary efficacy results demonstrate a significant (p< 0.0001) and clinically relevant (32%) reduction in the CSMS compared to placebo after 3-6 months of SLIT. Significant better rhinoconjunctivitis quality of life scores (p<0.0001) and patients' own overall assessment of their health status: visual analogue scale (EQ-VAS; p=0.0025) were also demonstrated. In total, a good safety profile of SLIT was observed.

Conclusion

This study confirmed clinical efficacy as well as safety of a sublingual liquid birch pollen extract in birch pollen allergic adult patients in a pivotal phase III trial. (EudraCT: 2013-005550-30; ClinicalTrials.gov: NCT02231307).

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