Objective: The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet has demonstrated effective treatment of HDM-induced allergic asthma in patients 18 years or older in European trials. This study investigated its safety and immunology profile in Japanese adult patients with mild-to-moderate HDM-induced allergic asthma. Methods: In this randomized, double-blind, placebo-controlled study, 48 Japanese patients were randomly assigned to a daily treatment of SQ HDM SLIT-tablet or placebo (3:1) for 14 d with or without an up-dosing regimen. Active groups comprised 5000, 10,000 or 20,000 Japanese Allergy Unit (JAU) for 14 d, and the up-dosing group comprised 5,000 JAU in day 1-3, 10,000 JAU in day 4-7 and 20,000 JAU in day 8-14. Results: No marked differences were observed in the incidence rate of adverse events (AEs) and their severity among active groups. The five most common investigational medicinal product (IMP)-related AEs were local events at the application site observed within 30 min after the intake of the SQ HDM SLIT-tablet. Although most events recovered within 1 h, mouth edema indicated a different profile of duration with more than 25% of the events lasting for more than 1 h. Conclusions: The SQ HDM SLIT-tablet of up to 20,000 JAU was well tolerated, and safety profile was acceptable for Japanese subjects with HDM-induced allergic asthma.
RCT Entities:
Objective: The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet has demonstrated effective treatment of HDM-induced allergic asthma in patients 18 years or older in European trials. This study investigated its safety and immunology profile in Japanese adult patients with mild-to-moderate HDM-induced allergic asthma. Methods: In this randomized, double-blind, placebo-controlled study, 48 Japanese patients were randomly assigned to a daily treatment of SQ HDM SLIT-tablet or placebo (3:1) for 14 d with or without an up-dosing regimen. Active groups comprised 5000, 10,000 or 20,000 Japanese Allergy Unit (JAU) for 14 d, and the up-dosing group comprised 5,000 JAU in day 1-3, 10,000 JAU in day 4-7 and 20,000 JAU in day 8-14. Results: No marked differences were observed in the incidence rate of adverse events (AEs) and their severity among active groups. The five most common investigational medicinal product (IMP)-related AEs were local events at the application site observed within 30 min after the intake of the SQ HDM SLIT-tablet. Although most events recovered within 1 h, mouth edema indicated a different profile of duration with more than 25% of the events lasting for more than 1 h. Conclusions: The SQ HDM SLIT-tablet of up to 20,000 JAU was well tolerated, and safety profile was acceptable for Japanese subjects with HDM-induced allergic asthma.
Entities:
Keywords:
Allergy immunotherapy; JapicCTI number 111624; atopic march; clinical trial
Authors: Oliver Pfaar; Tobias Ankermann; Matthias Augustin; Petra Bubel; Sebastian Böing; Randolf Brehler; Peter A Eng; Peter J Fischer; Michael Gerstlauer; Eckard Hamelmann; Thilo Jakob; Jörg Kleine-Tebbe; Matthias Volkmar Kopp; Susanne Lau; Norbert Mülleneisen; Christoph Müller; Katja Nemat; Wolfgang Pfützner; Joachim Saloga; Klaus Strömer; Peter Schmid-Grendelmeier; Antje Schuster; Gunter Johannes Sturm; Christian Taube; Zsolt Szépfalusi; Christian Vogelberg; Martin Wagenmann; Wolfgang Wehrmann; Thomas Werfel; Stefan Wöhrl; Margitta Worm; Bettina Wedi; Susanne Kaul; Vera Mahler; Anja Schwalfenberg Journal: Allergol Select Date: 2022-09-06