Pascal Demoly1, Jonathan Corren2, Peter Creticos3, Frédéric De Blay4, Philippe Gevaert5, Peter Hellings6, Krzysztof Kowal7, Martine Le Gall8, Natalia Nenasheva9, Giovanni Passalacqua10, Oliver Pfaar11, Miguel Tortajada-Girbés12, Carmen Vidal13, Margitta Worm14, Thomas B Casale15. 1. Department of Pulmonology and Addictology, Arnaud de Villeneuve Hospital, Montpellier University, Montpellier, France; Sorbonne Université, UMR-S 1136 INSERM, IPLESP, EPAR Team, Paris, France. Electronic address: pascal.demoly@inserm.fr. 2. Departments of Medicine and Pediatrics, David Geffen School of Medicine at the University of California, Los Angeles, Calif. 3. Division of Allergy & Clinical Immunology, Johns Hopkins Medicine, Baltimore, Md; Creticos Research Group with Charleston Allergy & Asthma, Charleston, SC. 4. Allergy Division, Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France. 5. Upper Airways Research Laboratory, Ghent University, Ghent, Belgium. 6. Department of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium. 7. Department of Experimental Allergology and Immunology, Medical University of Bialystok, Bialystok, Poland. 8. Global Clinical Development Department, Stallergenes Greer, Antony, France. 9. Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia. 10. Allergy and Respiratory Diseases, IRCCS Policlinico S. Martino, University of Genoa, Genoa, Italy. 11. Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany. 12. Pediatric Pulmonology and Allergy Unit, Department of Pediatrics, Dr Peset University Hospital, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology. University of Valencia, Valencia, Spain; IVI Foundation, Valencia, Spain. 13. Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain. 14. Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité, Universitätsmedizin, Berlin, Germany. 15. Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
Abstract
BACKGROUND: Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies. OBJECTIVE: We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate to severe HDM-induced allergic rhinitis. METHODS: In a phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300 IR tablet. The primary end point was the average total combined score during 4 weeks at the end of the treatment period. RESULTS:A total of 1607 participants were randomized, and 1476 (including 555 [37.6%] with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean average total combined score in the 300 IR group (3.62) was significantly lower (P < .0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% (95% CI, -24.0% to -9.2%). All prespecified secondary end points were consistently improved in the 300 IR group, relative to placebo. The 300 IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300 IR group and 14.9% in the placebo group. CONCLUSIONS: The 300 IR sublingual HDM tablet is an effective, safe treatment for HDM-induced allergic rhinitis.
RCT Entities:
BACKGROUND:Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies. OBJECTIVE: We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate to severe HDM-induced allergic rhinitis. METHODS: In a phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300 IR tablet. The primary end point was the average total combined score during 4 weeks at the end of the treatment period. RESULTS: A total of 1607 participants were randomized, and 1476 (including 555 [37.6%] with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean average total combined score in the 300 IR group (3.62) was significantly lower (P < .0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% (95% CI, -24.0% to -9.2%). All prespecified secondary end points were consistently improved in the 300 IR group, relative to placebo. The 300 IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300 IR group and 14.9% in the placebo group. CONCLUSIONS: The 300 IR sublingual HDM tablet is an effective, safe treatment for HDM-induced allergic rhinitis.
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