Erkka Valovirta1, Thomas H Petersen2, Teresa Piotrowska3, Mette K Laursen4, Jens S Andersen4, Helle F Sørensen4, Rabih Klink5. 1. Department of Lung Disease and Clinical Allergology, University of Turku, Turku, Finland; Terveystalo Allergy Clinic, Turku, Finland. Electronic address: erkka.valovirta@terveystalo.com. 2. Department of Paediatrics, Kolding Hospital, Kolding, Denmark. 3. NZOZ Promedica, Białystok, Poland. 4. Global Clinical Development, ALK, Hørsholm, Denmark. 5. Office of Paediatrics and Allergology Pneumo Pédiatric, Laon, France.
Abstract
BACKGROUND: Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease. OBJECTIVE: The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma. METHODS: A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up. RESULTS: There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P < .036), during the 2-year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P < .005 for all 5 years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen-specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo. CONCLUSIONS: Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma.
RCT Entities:
BACKGROUND:Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease. OBJECTIVE: The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma. METHODS: A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up. RESULTS: There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P < .036), during the 2-year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P < .005 for all 5 years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen-specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo. CONCLUSIONS: Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma.
Authors: Jean Bousquet; Nhân Pham-Thi; Anna Bedbrook; Ioana Agache; Isabella Annesi-Maesano; Ignacio Ansotegui; Josep M Anto; Claus Bachert; Samuel Benveniste; Mike Bewick; Nils Billo; Sinthia Bosnic-Anticevich; Isabelle Bosse; Guy Brusselle; Moïses A Calderon; G Walter Canonica; Luis Caraballo; Victoria Cardona; Ana Maria Carriazo; Eugene Cash; Lorenzo Cecchi; Derek K Chu; Elaine Colgan; Elisio Costa; Alvaro A Cruz; Wienczyslawa Czarlewski; Stephen Durham; Motohiro Ebisawa; Marina Erhola; Jean-Luc Fauquert; Wytske J Fokkens; Joao A Fonseca; Nick Guldemond; Tomohisa Iinuma; Maddalena Illario; Ludger Klimek; Piotr Kuna; Violeta Kvedariene; Désirée Larenas-Linneman; Daniel Laune; Lan T T Le; Olga Lourenço; Joao O Malva; Gert Marien; Enrica Menditto; Joaquim Mullol; Lars Münter; Yoshitaka Okamoto; Gabrielle L Onorato; Nikos G Papadopoulos; Maritta Perala; Oliver Pfaar; Abigail Phillips; Jim Phillips; Hilary Pinnock; Fabienne Portejoie; Pablo Quinones-Delgado; Christine Rolland; Ulysse Rodts; Boleslaw Samolinski; Mario Sanchez-Borges; Holger J Schünemann; Mohamed Shamji; David Somekh; Alkis Togias; Sanna Toppila-Salmi; Ioanna Tsiligianni; Omar Usmani; Samantha Walker; Dana Wallace; Arunas Valiulis; Rianne Van der Kleij; Maria Teresa Ventura; Sian Williams; Arzu Yorgancioglu; Torsten Zuberbier Journal: J Thorac Dis Date: 2019-09 Impact factor: 2.895
Authors: Ayşe Arzu Yorgancıoğlu; Bilun Gemicioğlu; Cemal Cingi; Ömer Kalaycı; Ali Fuat Kalyoncu; Claus Bachert; Peter Hellings; Oliver Pfaar; Holger J Schünemann; Dana Wallace; Anna Bedbrook; Wienczyslawa Czarlewski; Jean Bousquet Journal: Turk Thorac J Date: 2020-03-01