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Biologicals in Childhood Severe Asthma: the European PERMEABLE Survey on the Status Quo

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Biologicals in Childhood Severe Asthma: the European PERMEABLE Survey on the Status Quo ERJ OPEN RESEARCH ORIGINAL RESEARCH ARTICLE E. SANTOS-VALENTE ET AL. Biologicals in childhood severe asthma: the European PERMEABLE survey on the status quo Elisangela Santos-Valente 1, Heike Buntrock-Döpke1,2, Rola Abou Taam3, Stefania Arasi 4, Arzu Bakirtas5, Jaime Lozano Blasco6, Klaus Bønnelykke7, Mihai Craiu8, Renato Cutrera 9, Antoine Deschildre 10, Basil Elnazir 11,12, Louise Fleming 13,14, Urs Frey15, Monika Gappa16, Antonio Nieto García 17, Kirsten Skamstrup Hansen7, Laurence Hanssens18, Karina Jahnz-Rozyk19, Milos Jesenak20,21,SebastianKerzel1,MatthiasV.Kopp22,23,GerardH.Koppelman24,25, Uros Krivec 26, Kenneth A. MacLeod 27, Mika Mäkelä28, Erik Melén 29,30, Györgyi Mezei31, Alexander Moeller 32, Andre Moreira 33,34, Petr Pohunek 35, Predrag Minić36, Niels W.P. Rutjes37, Patrick Sammut38, Nicolaus Schwerk39,40, Zsolt Szépfalusi41, Mirjana Turkalj42, Iren Tzotcheva43, Alexandru Ulmeanu44, Stijn Verhulst45,46, Paraskevi Xepapadaki47, Jakob Niggel48, Susanne Vijverberg49,50, Anke H. Maitland-van der Zee49,50,Uroš Potočnik51,52, Susanne M. Reinartz53, Cornelis M. van Drunen54 and Michael Kabesch1,2 1Dept of Pediatric Pneumology and Allergy, University Children’s Hospital Regensburg (KUNO) at the Hospital St Hedwig of the Order of St John, University of Regensburg, Regensburg, Germany. 2Member of the Research and Development Campus Regensburg (WECARE) at the Hospital St Hedwig of the Order of St John, Regensburg, Germany. 3Service de pneumologie pédiatrique, AP-HP, Hôpital Necker Enfants-Malades, Paris, France. 4Translational Research in Pediatric Specialities Area, Division of Allergy, Bambino Gesù Children’s Research Hospital, IRCCS, Rome, Italy. 5Dept of Pediatrics, Division of Pediatric Allergy and Asthma, Gazi University School of Medicine, Ankara, Turkey. 6Dept of Pediatric Allergy and Clinical Immunology, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain. 7Dept of Pediatrics, Herlev and Gentofte Hospital, University Hospital Copenhagen, Denmark. 8Respiratory Dept, National Institute for Mother and Child Health “Alessandrescu-Rusescu”, Bucharest, Romania. 9Pediatric Pulmonology and Respiratory Intermediate Care Unit, Sleep and Long-Term Ventilation Unit, Academic Dept of Pediatrics, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy. 10University of Lille, CHU Lille, Paediatric Pulmonology and Allergy Unit, Hôpital Jeanne de Flandre, Lille, France. 11Children’s Health Ireland (CHI) at Tallaght University Hospital, Dublin, Ireland. 12Trinity College, Dublin, Ireland. 13Respiratory Paediatrics, National Heart and Lung Institute, Imperial College London, London, UK. 14Paediatric Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK. 15University Children’s Hospital Basel, University of Basel, Basel, Switzerland. 16Evangelisches Krankenhaus Düsseldorf, Children’s Hospital, Düsseldorf, Germany. 17Pediatric Allergy and Pneumology Unit, Children’s Hospital La Fe and Health Research Institute La Fe, Valencia, Spain. 18Service de Pneumologie-Allergologie, Centre de reference de Mucoviscidose de l’ULB, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium. 19Dept of Internal Medicine, Pneumonology, Allergology and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defense, Military Institute of Medicine, Warsaw, Poland. 20Dept of Paediatrics, Jessenius Faculty of Medicine, Comenius University in Bratislava, Martin, Slovakia. 21Dept of Clinical Immunology and Allergology, University Teaching Hospital in Martin, Martin, Slovakia. 22University Children’s Hospital Bern, Inselspital, University of Bern, Switzerland. 23German Center for Lung Research DZL, Airway Center North (ARCN) Lübeck and Biomedical Research in End-stage and Obstructive Lung Disease Hannover (BREATH), Hannover, Germany. 24Dept of Pediatric Pulmonology and Pediatric Allergology, University Medical Center Groningen, University of Groningen, Beatrix Children’s Hospital, Groningen, The Netherlands. 25Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. 26Dept of Paediatric Pulmology, University Children’s Hospital Ljubljana, University Medical Centre Ljubljana, Ljubljana, Slovenia. 27Royal Hospital for Children and Young People, Edinburgh, UK. 28Skin and Allergy Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 29Sachs’ Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden. 30Dept of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden. 31Allergy Unit, First Dept of Pediatrics, Faculty of Medicine, Semmelweis University, Budapest, Hungary. 32Division of Respiratory Medicine, University Children’s Hospital Zurich and Childhood Research Center, Zurich, Switzerland. 33Serviço de Imunoalergologia, Centro Hospitalar Universitário de São João, Porto, Portugal. 34EPIUnit – Instituto de Saúde Pública, Universidade do Porto, Porto, Portugal. 35Pediatric Pulmonology, Pediatric Dept, 2nd Faculty of Medicine, Charles University, Prague, University Hospital Motol, Prague, Czech Republic. 36Mother and Child Health Institute of Serbia, Belgrade, Serbia. 37Dept of Paediatric Pulmonology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 38Dept of Paediatrics, Respiratory Medicine and Allergy, Mater Dei Hospital, Malta. 39Dept of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany. 40German Center for Lung Research, Biomedical Research in End Stage and Obstructive Lung Disease/BREATH, German Center for Lung Research, Hannover, Germany. 41Division of Pediatric Pulmonology, Allergology and Endocrinology, Dept of Pediatrics and Adolescent Medicine, Comprehensive Center Pediatrics, Medical University of Vienna, Vienna, Austria. 42Srebrnjak Children’s Hospital, Zagreb, and School of Medicine, University of Osijek “Josip Juraj Strossmayer”, Osijek, and Catholic University of Croatia, Zagreb, Croatia. 43Dept of Pediatrics, University Hospital for Emergency Medicine “N. I. Pirogov”, Medical University, Sofia, Bulgaria. 44“Grigore Alexandrescu” Emergency Hospital for Children, Bucharest, Romania. 45Dept of Pediatrics, Antwerp University Hospital, Edegem, Belgium. 46Laboratory of Experimental Medicine and Pediatrics, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. 47Allergy Dept, 2nd Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece. https://doi.org/10.1183/23120541.00143-2021 ERJ Open Res 2021; 7: 00143-2021 ERJ OPEN RESEARCH ORIGINAL RESEARCH ARTICLE | E. SANTOS-VALENTE ET AL. 48Datadesk Limited, Regensburg, Germany. 49Dept of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 50Dept of Paediatric Respiratory Medicine and Allergy, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 51Laboratory for Biochemistry, Molecular Biology and Genomics, Faculty of Chemistry and Chemical Engineering, University of Maribor, Maribor, Slovenia. 52Centre for Human Molecular Genetics and Pharmacogenomics, Medical Faculty, University of Maribor, Maribor, Slovenia. 53Dept of Otorhinolaryngology, Tergooi Hospitals, Hilversum, the Netherlands. 54Dept of Otorhinolaryngology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. Corresponding author: Michael Kabesch ([email protected]) Shareable abstract (@ERSpublications) This study reveals enormous differences in therapy with biologicals for childhood severe asthma across Europe, and demonstrates the urgent need for harmonisation in medication choice, definition of therapy success and how/when to discontinue treatment https://bit.ly/3tnJMTY Cite this article as: Santos-Valente E, Buntrock-Döpke H, Abou Taam R, et al. Biologicals in childhood severe asthma: the European PERMEABLE survey on the status quo. ERJ Open Res 2021; 7: 00143-2021 [DOI: 10.1183/23120541.00143-2021]. Copyright ©The authors 2021 Abstract Introduction Severe asthma is a rare disease in children, for which three biologicals, anti-immunoglobulin E, This version is distributed under the terms of the Creative anti-interleukin-5 and anti-IL4RA antibodies, are available in European countries. While global guidelines Commons Attribution Non- exist on who should receive biologicals, knowledge is lacking on how those guidelines are implemented in Commercial Licence 4.0. For real life and which unmet needs exist in the field. In this survey, we aimed to investigate the status quo commercial reproduction rights and identify open questions in biological therapy of childhood asthma across Europe. and permissions contact Methods Structured interviews regarding experience with biologicals, regulations on access to the different [email protected] treatment options, drug selection, therapy success and discontinuation of therapy were performed. Content Received: 4 March 2021 analysis was used to analyse data. Accepted: 11 April 2021 Results We interviewed 37 experts from 25 European countries and Turkey and found a considerable range in the number of children treated with biologicals per centre. All participating countries provide public access to at least one biological. Most countries allow different medical disciplines to prescribe biologicals to children with asthma, and only a few restrict therapy to specialised centres. We observed significant variation in the time point at which treatment success
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