Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy
Authors: Erkka Valovirta, Thomas H. Petersen, Teresa Piotrowska, Mette K. Laursen, Jens S. Andersen, Helle F. Sørensen, Rabih Klink, Eva-Maria Varga, Isidor Huttegger, Lone Agertoft, Susanne Halken, Merete Jørgensen, Lars G. Hansen, Roswitha Cronjäger, Kirsten Skamstrup Hansen, Thomas Houmann Petersen, Sune Rubak, Erkka Valovirta, Péter Csonka, Ove Mickelsson, Jacques de Blic, Nham Pham Thi, Luc Refabert, Christine Pasquet, Anne Broue-Chabbert, Agnes Juchet, Bruno Lebeaupin, François Durand-Perdriel, François Wessel, Francois Payot, Bruno Girodet, Jean-Marc Houssel, Sylvie-Anne Andre-Gomez, Françoise Riotte-Flandrois, Dominique Basset, Dominique Mounier, Marie Noelle Robberecht, Laure Delbecque, Rabih Klink, Jean-Luc Fauquert, Anne Prud'Homme, Annick Auffret, Béatrice Luet-Gautier, Montserrat Agell Perello, Fabrice Bouillot, Albrecht Bufe, Andrea von Berg, Monika Gappa, Christian Vogelberg, Eckhard Hamelmann, Uwe Schauer, Volker Stephan, Peter Eberle, Raffi Bedikian, Peter Bosch, J. Peter Christmann, Egbert Franke, Marcus Dahlheim, Friedrich Kaiser, Roland Knecht, Bernard Sandner, Christine Gronke, Ralph Köllges, Eivy Franke-Beckmann, Ludger Klimek, Matthias Hoffmann, Ingrid Bretschneider, Aud Katrine Herland Berstad, Bente Kvenshagen, Knut A. Øymar, Bjarne Dag Andersen, Espen Kolsrud, Anne Søyland, Andrzej Dyczek, Juliusz Bokiej, Teresa Hofman, Ewa Springer, Maria Lisiecka, Anna Madaj, Teresa Piotrowska, Ewa Trębas-Pietraś, Krzysztof Wytrychowski, Malgorzata Zurowska Żurowska-Gębala, Danuta Moszyńska, Artur Kwaśniewski, Pedro Ojeda, Ma Dolores Ibáñez, Mercedes Cimarra, Sonsoles Infante, Santiago Quirce, Eloina González, Arancha Vega, Carmen Panizo, Ana Isabel Tabar, Carmen Vidal, Alicia Alonso Gómez, Beatriz Fernández Parra, Inger Winnergård, Hampus Kiotseridis, Päivi Söderman, Johan Alm, Jan-Åke Jönsson, Anders Berner, Östen Jonsson, Lennart Nilsson, Alice Koehli-Wiesner, Peter Schmid-Grendelmeier, Peter Eng, Graham Roberts, Rajiv Sood, Adam Fox, Adnan Custovic
Journal: Journal of Allergy and Clinical Immunology (2017)

Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease.The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma.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.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.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.