Σφακιανάκης Αλέξανδρος
ΩτοΡινοΛαρυγγολόγος
Αναπαύσεως 5 Άγιος Νικόλαος
Κρήτη 72100
00302841026182
00306932607174
alsfakia@gmail.com

Αρχειοθήκη ιστολογίου

! # Ola via Alexandros G.Sfakianakis on Inoreader

Η λίστα ιστολογίων μου

Τρίτη 15 Ιανουαρίου 2019

Sublingual immunotherapy with the SQ tree SLIT-tablet is highly effective and well tolerated: results from a randomized, double-blind, placebo-controlled phase III trial

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

Graphical abstract for this article



http://bit.ly/2RqAqrD

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου

Αρχειοθήκη ιστολογίου