Immunotherapy With the SQ Tree SLIT-tablet in Adults and Adolescents With Allergic Rhinoconjunctivitis.

Autor: Mäkelä MJ; Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland., Gyllfors P; Asthma & Allergy Department, St. Göran's Hospital, Sweden., Valovirta E; Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland; Terveystalo Allergy Clinic, Helsinki, Finland., Steffensen MA; Global Research & Development, ALK, Hørsholm, Denmark. Electronic address: mafdk@alk.net., Grønager PM; Global Research & Development, ALK, Hørsholm, Denmark., Savolainen J; Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland., Winther L; Department of Dermato-Allergology, Copenhagen University Hospital, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: Clinical therapeutics [Clin Ther] 2018 Apr; Vol. 40 (4), pp. 574-586.e4. Date of Electronic Publication: 2018 Mar 16.
DOI: 10.1016/j.clinthera.2018.02.012
Abstrakt: Purpose: The SQ tree sublingual immunotherapy (SLIT)-tablet containing allergen extracts with the major allergen Bet v 1 from birch pollen is currently being developed for the treatment of tree pollen-induced allergic rhinitis/conjunctivitis with or without asthma. The aim of this Phase II trial was to investigate the dose-related efficacy and safety of the SQ tree SLIT-tablet.
Methods: This study was a randomized, parallel-group, double-blind, placebo-controlled, multi-national trial conducted in Europe. A total of 637 participants were randomized equally to receive placebo or treatment with the SQ tree SLIT-tablet in doses of 0.5, 1, 2, 4, 7, or 12 development units (DU). Treatment was initiated ~16 weeks before onset of the 2013 birch pollen season (BPS) and was continued throughout the BPS with a total duration of at least 6 months. During the BPS and tree pollen season (TPS), subjects assessed rhinoconjunctivitis symptoms and medication use on a daily basis in an electronic diary; weekly assessments of rhinoconjunctivitis quality of life were also made.
Findings: Analysis of the average daily symptom score during the BPS and the TPS showed that the difference between active treatment and placebo was statistically significant for the 7 DU group (BPS, P = 0.02; TPS, P = 0.03), with no clear dose-response relationship. All doses of the SQ tree SLIT-tablet induced changes from baseline in birch-specific IgE and IgG 4 that were statistically significant compared with placebo at all time points assessed (P < 0.0001) with a clear dose-response relationship for birch specific IgG 4 . In general, the SQ tree SLIT-tablet was well tolerated, with the majority of treatment-related adverse events (≥95%) being mild or moderate in severity. The most frequently reported treatment-related adverse events were generally related to the sublingual administration of the tablet (ie, they occurred in the oral cavity).
Implications: The results from this trial suggest that the SQ tree SLIT-tablet in doses up to 12 DU has a tolerability profile suitable for at-home administration. The immunomodulatory changes indicate a dose-response relationship, but clinical efficacy parameters were inconclusive, probably due to low pollen counts, emphasizing the importance of pollen exposure for the outcome of a pollen allergy immunotherapy trial. EudraCT no: 2012-000031-59.
(Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.)
Databáze: MEDLINE
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