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Susanne Hansen,1,2 Ming-Ju Tsai,3,4 Trung N Tran,5 John D Blakey,6,7 Benjamin Emmanuel,5 Shawn D Aaron,8 Yahya Habis,9,10 Valeria Perugini,11 Alan Altraja,12 Rohit K Katial,13 Luis Perez-de-Llano,14,15 Paul E Pfeffer,16,17 Nikolaos G Papadopoulos,18,19 John Townend,20,21 Ghislaine Scelo,20,21 Aaron Beastall,20,21 Lakmini Bulathsinhala,20,21 John Busby,20,21 Andrew W Lindsley,22 Wendy C Moore,23 Reynold A Panettieri Jr,24 Giorgio Walter Canonica,25,26 Enrico Heffler,25,26 Cristina Cardini,27 Giuseppe Guida,28 Celeste M Porsbjerg,1 Anne-Sofie Bjerrum,29 Anna Von Bülow,1,30 Ole Hilberg,31 Kjell Erik Julius Håkansson,1 Marianne Baastrup Soendergaard,1 Charlotte Suppli Ulrik,32 Eileen Wang,13,33 Michael E Wechsler,34 Nicholas Chapman,35,36 Flavia CL Hoyte,13 Kanao Otsu,13 Liam G Heaney,37 David J Jackson,38 Pujan H Patel,39 Dermot Ryan,40 Celine Bergeron,41,42 Shelley Abercromby,43 Mohit Bhutani,44 Kenneth R Chapman,45 Andréanne Côté,46 Beth E Davis,47 Delbert R Dorscheid,48 Leiana Hoshyari,48 Brianne Philipenko,49 Hana Serajeddini,50 Florence Schleich,51 Renaud Louis,52 Piotr Kuna,53 Borja G Cosio,54 Désirée Larenas-Linnemann,55 Carlos A Torres-Duque,56,57 María José Fernández-Sánchez,58,59 Elizabeth Garcia,60 Fabio Bolívar-Grimaldos,61 Libardo Jiménez-Maldonado,62,63 Diana Jimena Cano-Rosales,61 Ivan Solarte,64 Riyad Al-Lehebi,65,66 Adeeb A Bulkhi,67 Mona Al-Ahmad,68,69 Takashi Iwanaga,70,71 Soichiro Hozawa,72 Hisako Matsumoto,73 Tatsuya Nagano,74 Tomoko Tajiri,75 Bernt Bøgvald Aarli,76,77 Diahn-Warng Perng,78,79 Yi-Han Hsiao,78,80 Pin-Kuei Fu,81 Chau-Chyun Sheu,3,4 Konstantinos Kostikas,82 Mina Gaga,83 Athena Gogali,82 Maria Kallieri,84 Stelios Loukides,84 Michael Makris,85 Maria Dimosthenis Ntakoula,85 Andriana I Papaioannou,86 Giannis Paraskevopoulos,87 Fotios Psarros,88 Bassam Mahboub,89,90 Laila Salameh,89,91 Mariko Siyue Koh,92,93 Mei Fong Liew,94,95 Pee Hwee Pang,96 Tze Lee Tan,97 Tunn Ren Tay,98 Paulo Márcio Pitrez,99 Chin Kook Rhee,100 Njira Lugogo,101 Arjun Mohan,101 João A Fonseca,102,103 Ana Alves da Silva,102,103 Cláudia Chaves Loureiro,104,105 Hadassa Cristhina de Azevedo Soares dos Santos,102,103 Jorge Fernando Máspero,106,107 Ledit RF Ardusso,108 María Eugenia Franchi,109 Martin Sivori,110 Ana María Stok,111 Anahí Yañez,112 George Christoff,113 Todor A Popov,114 Patrick D Mitchell,115 Sundeep Santosh Salvi,116,117 Richard W Costello,118 Eve Denton,119,120 Mark Hew,119,121 Christine R Jenkins,122 David Langton,123,124 Peter G Middleton,125,126 Matthew J Peters,127,128 Lauri Lehtimäki,129,130 Arnaud Bourdin,131 Camille Taillé,132 Christian Taube,133 Zsuzsanna Csoma,134 Dóra Lúdvíksdóttir,135 Job FM van Boven,136 James Fingleton,137 Leif Bjermer,138 Helena Emery,11 Graham Lough,139 Roy Alton Pleasants,140 Diego J Maselli,141 Christopher S Ambrose,5 Cathy Emmas,142 Andrew N Menzies-Gow,142,143 Victoria Carter,20,21 Nevaashni Eleangovan,20,21 Ruth B Murray,20,21 Chris A Price,20,21 Mohsen Sadatsafavi,144 David B Price20,21,145, On behalf of the ISAR GLEAM Working Group1Respiratory Research Unit, Department of Respiratory Medicine and Infectious Diseases, Bispebjerg Hospital, Copenhagen, Denmark; 2Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; 3Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; 4Department of Internal Medicine, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; 5BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA; 6Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Australia; 7Curtin University Medical School, Perth, Australia; 8The Ottawa Hospital Research Institute, Ottawa, Canada; 9Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; 10Department of Medicine, King Abdulaziz University Hospital, Jeddah, Saudi Arabia; 11Respiratory Effectiveness Group (REG), Ely, Cambridgeshire, UK; 12Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia; 13Division of Allergy and Clinical Immunology, Department of Medicine, National Jewish Health, Denver, CO, USA; 14Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Monforte, Cervo, Lugo, Spain; 15Radiology, Public Health, Nursery and Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain; 16Department of Respiratory Medicine, Barts Health NHS Trust, London, UK; 17Blizard Institute, Queen Mary University of London, London, UK; 18Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK; 19Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece; 20Observational and Pragmatic Research Institute, Singapore, Singapore; 21Optimum Patient Care Global, Cambridge, UK; 22Amgen, Thousand Oaks, CA, USA; 23Pulmonary, Critical Care, Allergy, and Immunologic Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA; 24Rutgers, The State University of New Jersey, New Brunswick, NJ, USA; 25Personalized Medicine, Asthma and Allergy Clinic, IRCCS Humanitas Research Hospital, Rozzano, MI, Italy; 26Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; 27Fondazione per la Salute Respiratoria della Società Italiana di Pneumologia SIP-IRS, Milan, Italy; 28Department of Clinical and Biological Sciences, Severe Asthma Rare Lung Disease and Respiratory Pathophysiology Unit, San Luigi Gonzaga University Hospital, University of Turin, Orbassano, Turin, TO, Italy; 29Department of Respiratory Medicine and Allergy, Aarhus University Hospital, Aarhus, Denmark; 30Allergy Clinic, Dep. Of Dermatology and Allergy, Herlev and Gentofte Hospital, Copenhagen, Denmark; 31Medical department, Vejle University Hospital, Vejle, Denmark; 32Department of Respiratory Medicine, Copenhagen University Hospital - Hvidovre, Copenhagen, Denmark; 33Division of Allergy and Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA; 34National Jewish Health Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, CO, USA; 35Saint Joseph Hospital, Denver, CO, USA; 36National Jewish Health, Denver, CO, USA; 37Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast, UK; 38Guy’s Severe Asthma Centre, School of Immunology & Microbial Sciences, King’s College London, London, UK; 39Respiratory Medicine, Royal Brompton Hospital, London, UK; Imperial College London, London, UK; 40Usher Institute, University of Edinburgh, Edinburgh, UK; 41Department of Medicine, Vancouver General Hospital, Vancouver, British Columbia, Canada; 42Department of Medicine, Centre for Lung Health, University of British Columbia, Vancouver, British Columbia, Canada; 43The Centre for Lung Health, Vancouver Coastal Health Research Institute, UBC, Vancouver, Canada; 44Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; 45University of Toronto, Toronto, Ontario, Canada; 46Department of Medicine, Laval University, Quebec City, Quebec, Canada; 47Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada; 48Center for Heart Lung Innovation, Department of Medicine, The University of British Columbia, Vancouver, Canada; 49University of Saskatchewan, Saskatoon, Saskatchewan, Canada; 50Department of Medicine, Division of Respirology, Western University, London, Ontario, Canada; 51Department of Pneumology, University Hospital of Liège, GIGA I3 Research Group, Exercise Physiology Lab, Department of Physical Activity and Rehabilitation Sciences, University of Liège, Liège, Belgium; 52Department of Pneumology, University Hospital of Liège, GIGA I3 Research Group, University of Liège, Liège, Belgium; 53Division of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland; 54Son Espases University Hospital-IdISBa (Institut d’Investigació Sanitària Illes Balears)-Ciberes, Mallorca, Spain; 55Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico; 56CINEUMO, Respiratory Research Center, Fundación Neumológica Colombiana, Bogotá, Colombia; 57Doctoral Biosciences, Universidad de La Sabana, Chia, Colombia; 58Faculty of Medicine, Pontificia Universidad Javeriana, Bogotá, Colombia; 59Pulmonary Unit, Hospital Universitario San Ignacio, Bogotá, Colombia; 60Unidad Médica Quirúrgica de Otorrinolaringología - UNIMEQ-ORL, School of Medicine, Universidad de Los Andes, Fundación Santa Fe de Bogotá, Bogotá, Colombia; 61INO Asthma Program, Instituto Neumológico del Oriente (INO), Bucaramanga, Santander, Colombia; 62Fundación Neumológica Colombiana, ASMAIRE REXPIRA (Atención Integral, Educación Y Rehabilitación En Asma or Comprehensive Care, Education and Rehabilitation in Asthma) Program, Bogotá, Colombia; 63Departamento Cundinamarca, Universidad de La Sabana, Chia, Colombia; 64Department of Internal Medicine, Fundacion Santa Fe de Bogota, Bogota, Colombia; 65Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia; 66College of Medicine, Alfaisal University, Riyadh, Saudi Arabia; 67Department of Internal Medicine, College of Medicine, Umm Al-Qura University, Makkah, Saudi Arabia; 68Microbiology Department, College of Medicine, Kuwait University, Kuwait City, Kuwait; 69Al-Rashed Allergy Center, Ministry of Health, Kuwait City, Kuwait; 70Osaka Saiseikai Tondabayashi Hospital, Tondabayashi, Japan; 71The Kinki Hokuriku Airway disease Conference (KiHAC), Osaka, Japan; 72Department of Respiratory Disease, Hiroshima Allergy and Respiratory Clinic, Hiroshima, Japan; 73Department of Respiratory Medicine & Allergology, Kindai University Faculty of Medicine, Osaka, Japan; 74Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; 75Department of Respiratory Medicine, Allergy and Clinical Immunology, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan; 76Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway; 77Department of Clinical Science, University of Bergen, Bergen, Norway; 78School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; 79Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; 80Division of General Chest Medicine, Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; 81Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan; 82Respiratory Medicine Department, University of Ioannina, Ioannina, Greece; 83st Respiratory Medicine Department, Hygeia Hospital, Athens, Greece; 84nd Respiratory Medicine Department, Attikon University Hospital, National and Kapodistrian University of Athens, Medical School, Athens, Greece; 85Allergy Unit, 2nd Department of Dermatology and Venereology, National and Kapodistrian University of Athens, University General Hospital ‘Attikon’, Athens, Greece; 86st Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, "Sotiria Chest Hospital”, Athens, Greece; 87Allergy Dpt in 401, General Military Hospital, Athens, Greece; 88Naval Hospital of Athens, Athens, Greece; 89Rashid Hospital, Dubai Health (DH), Dubai, United Arab Emirates; 90College of Medicine, University of Sharjah, Sharjah, United Arab Emirates; 91Hind Bint Maktoum CoNM, MBRU, Dubai Health (DH), Dubai, United Arab Emirates; 92Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore, Singapore; 93Duke-National University, Singapore Medical School, Singapore, Singapore; 94FAST and Chronic Programmes, Alexandra Hospital, National University Health System, Singapore, Singapore; 95Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System, Singapore, Singapore; 96Department of Respiratory & Critical Care Medicine, Tan Tock Seng Hospital, Singapore, Singapore; 97Department of Family Medicine, National University Health System, Singapore, Singapore; 98Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore, Singapore; 99Pulmonology Division, Hospital Santa Casa de Porto Alegre, Porto Alegre, Brazil; 100Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea; 101Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA; 102CINTESIS@RISE, MEDCIDS, Faculty of Medicine of the University of Porto, Porto, Portugal; 103Department of Community Medicine, Information and Health Decision Sciences - Faculty of Medicine, University of Porto, Porto, Portugal; 104Pneumology Unit, Unidade Local de Saúde Coimbra, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal; 105Centre of Pneumology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal; 106Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; 107University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina; 108Pulmonology, Allergy and Immunology Department, Rosario School of Medicine, National University of Rosario, Rosario, Santa Fe, Argentina; 109Hospital Universitario Austral, Buenos Aires, Argentina; 110Neumonology Center of School of Medicine, University of Buenos Aires, Hospital "Dr. J.M. Ramos Mejia”, Buenos Aires, Argentina; 111Investigaciones en Patologias Respiratorias, San Miguel de Tucuman, Tucuman, Argentina; 112Centro de Investigaciones en Enfermedades Alergicas y Respiratorias -InAER-, Buenos Aires, Argentina; 113Bulgarian Alliance for Clinical and Translational Allergy, Sofia, Bulgaria; 114University Hospital St. Ivan Rilski, Sofia, Bulgaria; 115School of Medicine, Trinity College Dublin, Dublin, Ireland; 116Pulmocare Research and Education Foundation, Pune, India; 117Symbiosis Medical College for Women & Symbiosis University Hospital and Research Centre, Symbiosis International (Deemed University), Pune, India; 118Clinical Research Centre, Smurfit Building Beaumont Hospital, Department of Respiratory Medicine, RCSI (Royal College of Surgeons Ireland), Dublin, Ireland; 119Allergy, Asthma & Clinical Immunology Service, Alfred Health, Melbourne, Victoria, Australia; 120Department of Translational Medicine, Central Clinical School, Monash University, Clayton, Melbourne, Victoria, Australia; 121Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; 122Head Respiratory Group, The George Institute, Randwick, New South Wales, Australia; 123Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Frankston, Australia; 124Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Australia; 125Westmead Clinical School, University of Sydney, Sydney, Australia; 126CF & Bronchiectasis Service, Department Respiratory & Sleep Medicine, Westmead Hospital, Westmead, Australia; 127Department of Thoracic Medicine, Concord Hospital, Sydney, New South Wales, Australia; 128Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia; 129Allergy Centre, Tampere University Hospital, Tampere, Finland; 130Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; 131PhyMedExp, Université Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France; 132Department of Respiratory Diseases, Bichat Hospital, Assistance Publique – Hôpitaux de Paris, Université Paris Cité, Paris, France; 133Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany; 134Asthma Outpatient Clinic, National Koranyi Institute for Pulmonology, Budapest, Hungary; 135Department of Respiratory Medicine, Landspitali University Hospital Reykjavik Iceland, University of Iceland, Reykjavik, Iceland; 136University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Department of Clinical Pharmacy & Pharmacology, Groningen, The Netherlands; 137Health New Zealand, Capital and Coast District Health Board, Wellington, New Zealand; 138Respiratory Medicine and Allergology, Department of Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden; 139Leicester Real World Evidence Unit, University of Leicester, Leicester, UK; 140Marsico Lung Institute, University of North Carolina, Chapel Hill, NC, USA; 141Division of Pulmonary Diseases & Critical Care, University of Texas, San Antonio, TX, USA; 142BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK; 143Lung Division, Royal Brompton & Harefield Hospital, London, UK; 144Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada; 145Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David B Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06, Midview City, 573969, Singapore, Tel +65 82822594, Email dprice@opri.sgPurpose: Time to biologic initiation for the treatment of severe asthma (SA) is affected by many factors, including ease of access to biologics, which is often subject to approval by regulatory authorities and reimbursement criteria by relevant agencies. We investigated the association between ease of biologic access (using the biologic accessibility score [BACS] as a proxy) and post-biologic asthma outcomes, including remission.Methods: This ecological study, using data from CHRONICLE (a US severe asthma registry), the International Severe Asthma Registry (ISAR), and the Optimum Patient Care Research Database (OPCRD), included patients with SA from 21 countries. Associations at the country level, between BACS, a composite score of prescription criteria for biologics in SA, and the proportion of patients with a favorable asthma outcome 1-year post-biologic in each setting (ie ISAR country or in the CHRONICLE or OPCRD datasets) were tested. Several definitions of favorable outcome were used, including proportion of patients who achieved clinical remission (defined using 2, 3 and 4 domains), experienced no exacerbations, had well- or partly controlled asthma, a percent predicted forced expiratory volume in 1 second (ppFEV1) or percent predicted peak expiratory flow rate (ppPEFR) ≥ 80%, and no long-term oral corticosteroid (LTOCS) use.Results: A total of 9,183 patients were included. A higher BACS (as a proxy of easier access to biologics) was associated with a higher likelihood of achieving clinical remission (p≤ 0.001), no exacerbations (p< 0.001), well- or partly controlled asthma (p=0.047), a ppFEV1 or ppPEFR ≥ 80% (p=0.004), and no need for LTOCS (p=0.045) 1 year post-biologic initiation.Conclusion: Easier access to biologics for patients with SA, a prerequisite for shorter time-to-initiation, was associated with a greater probability of achieving clinical remission and other favorable asthma outcomes. Initiating biologics earlier in the asthma disease course may help unlock greater therapeutic potential in SA. These findings warrant confirmation in additional studies to further establish the causal relationship between biologic accessibility, timing of initiation, and clinical outcomes in SA.Keywords: control, exacerbations, long-term oral corticosteroids, lung function, time to biologic initiation |