Oliver Pfaar1, Claus Bachert2, Piotr Kuna3, Petr Panzner4, Mária Džupinová5, Ludger Klimek6, Maroesja J van Nimwegen7, Johan D Boot7, Donghui Yu7, Dirk Jan E Opstelten7, Pieter-Jan de Kam7. 1. Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Germany; Department of Otorhinolaryngology, Head and Neck Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Center for Rhinology and Allergology, Wiesbaden, Germany. Electronic address: oliver@pfaar.org. 2. Upper Airways Research Laboratory, University of Ghent, Ghent, Belgium. 3. Division of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland. 4. Department of Immunology and Allergology, Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic. 5. ALIAN s.r.o. Ambulancia alergológie a klinickej imunológie, Bardejov, Slovakia. 6. Center for Rhinology and Allergology, Wiesbaden, Germany. 7. HAL Allergy BV, Leiden, The Netherlands.
Abstract
BACKGROUND:Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration. OBJECTIVE: We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollen allergy. METHODS: A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety. RESULTS: Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P = .0025), were also demonstrated. In total, a good safety profile of SLIT was observed. CONCLUSION: This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollen allergy in a pivotal phase III trial (EudraCT: 2013-005550-30; ClinicalTrials.gov: NCT02231307).
RCT Entities:
BACKGROUND:Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration. OBJECTIVE: We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollenallergy. METHODS: A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety. RESULTS: Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P = .0025), were also demonstrated. In total, a good safety profile of SLIT was observed. CONCLUSION: This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollenallergy in a pivotal phase III trial (EudraCT: 2013-005550-30; ClinicalTrials.gov: NCT02231307).
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
Authors: Elena Cantone; Stefania Gallo; Sara Torretta; Aikaterini Detoraki; Carlo Cavaliere; Claudio Di Nola; Luca Spirito; Tiziana Di Cesare; Stefano Settimi; Daniela Furno; Lorenzo Pignataro; Eugenio De Corso Journal: J Pers Med Date: 2022-06-09
Authors: B Nothegger; N Reider; C E Covaciu; V Cova; L Ahammer; R Eidelpes; J Unterhauser; S Platzgummer; M Tollinger; T Letschka; K Eisendle Journal: J Eur Acad Dermatol Venereol Date: 2020-02-16 Impact factor: 6.166
Authors: Bettina Nothegger; Norbert Reider; Claudia E Covaciu; Valentina Cova; Linda Ahammer; Reiner Eidelpes; Jana Unterhauser; Stefan Platzgummer; Elisabeth Raffeiner; Martin Tollinger; Thomas Letschka; Klaus Eisendle Journal: Immun Inflamm Dis Date: 2021-02-23