Publication date: Available online 15 January 2019
Source: Journal of Allergy and Clinical Immunology
Author(s): Tilo Biedermann, Piotr Kuna, Petr Panzner, Erkka Valovirta, Morgan Andersson, Frederic de Blay, Dorthe Thrane, Sanja Hald Jacobsen, Brian Sonne Stage, Lone Winther
Abstract
Background
The SQ tree SLIT-tablet (ALK) is developed for treatment of tree pollen induced allergic rhinoconjunctivitis (ARC).
Objective
The aim of this pivotal phase III trial was to demonstrate efficacy and safety of the SQ tree SLIT-tablet.
Methods
This was a randomized, double-blind, placebo-controlled trial with 634 subjects (12-65 years) with moderate-severe ARC despite use of symptom-relieving medication. Eligible subjects were randomized 1:1 to active or placebo. The primary endpoint was the average daily ARC total combined score (TCS) during the birch pollen season (BPS) analyzed for subjects with diary data during the BPS. Secondary endpoints included average daily symptom score (DSS) during the BPS, average TCS and DSS during the tree pollen season (TPS), and average daily medication score (DMS) in the BPS and TPS.
Results
The primary and key secondary endpoints demonstrated statistically significant and clinically relevant effects of the SQ tree SLIT-tablet compared to placebo were found. For the BPS, absolute (relative) differences to placebo were: 3.02 (40%) for TCS, 1.32 (37%) for DSS and 1.58 (49%) for DMS (all p<0.0001). For the TPS, absolute (relative) differences to placebo were: 2.27 (37%) for TCS, 0.99 (33%) for DSS and 1.20 (47%) for DMS (all p<0.0001). Treatment was well tolerated. The most frequently reported treatment-related AEs were mild or moderate local reactions related to the sublingual administration.
Conclusion
The trial demonstrated efficacy and safety of the SQ tree SLIT-tablet compared to placebo during the BPS and TPS in adolescents and adults with birch pollen induced ARC.
Graphical abstract
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