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1. Baseline Systemic Oral Corticosteroid Use in Patients with Asthma Initiating Dupilumab Treatment in the Real World: From the RAPID Global Registry

Author: Lugogo NL, Heffler E, Plaza V, Hilberg O, Xia C, Nash S, Pandit N, Jacob-Nara JA, Sacks HJ, Rowe PJ, Deniz Y, Hardin M, and Soler X
Subjects: Immunologic diseases. Allergy, RC581-607
Abstract: Nijra L Lugogo,1 Enrico Heffler,2,3 Vicente Plaza,4 Ole Hilberg,5 Changming Xia,6 Scott Nash,6 Nami Pandit,7 Juby A Jacob-Nara,7 Harry J Sacks,6 Paul J Rowe,7 Yamo Deniz,6 Megan Hardin,8 Xavier Soler6 1University of Michigan Medical School, Ann Arbor, MI, USA; 2IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; 3Humanitas University, Pieve Emanuele, Milan, Italy; 4Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 5Lillebaelt Hospital, Vejle, Denmark; 6Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 7Sanofi, Bridgewater, NJ, USA; 8Sanofi, Cambridge, MA, USACorrespondence: Nijra L Lugogo, University of Michigan Medical School, 300 North Ingalls St, Suite 2C40, Ann Arbor, MI, 48109, USA, Email nlugogo@med.umich.edu
Published: 2024

2. Adult Severe Asthma Registries: A Global and Growing Inventory

Author: Cushen B, Koh MS, Tran TN, Martin N, Murray R, Uthaman T, Goh CYY, Vella R, Eleangovan N, Bulathsinhala L, Maspero JF, Peters MJ, Schleich F, Pitrez P, Christoff G, Sadatsafavi M, Torres-Duque CA, Porsbjerg C, Altraja A, Lehtimäki L, Bourdin A, Taube C, Papadopoulos NG, Zsuzsanna C, Björnsdóttir U, Salvi S, Heffler E, Iwanaga T, al-Ahmad M, Larenas-Linnemann D, van Boven JF, Aarli BB, Kuna P, Loureiro CC, Al-lehebi R, Lee JH, Marina N, Bjermer L, Sheu CC, Mahboub B, Busby J, Menzies-Gow A, Wang E, and Price DB
Subjects: asia-pacific, biologics, covid-19, europe, isar, international severe asthma registry, oral corticosteroids, registry, middle east, severe asthma, latin america, usa, Medicine
Abstract: Breda Cushen,1,&ast; Mariko Siyue Koh,2,&ast; Trung N Tran,3 Neil Martin,3,4 Ruth Murray,5 Thendral Uthaman,6 Celine Yun Yi Goh,5,6 Rebecca Vella,7 Neva Eleangovan,5,6 Lakmini Bulathsinhala,5,6 Jorge F Maspero,8,9 Matthew J Peters,10 Florence Schleich,11 Paulo Pitrez,12 George Christoff,13 Mohsen Sadatsafavi,14 Carlos A Torres-Duque,15,16 Celeste Porsbjerg,17 Alan Altraja,18 Lauri Lehtimäki,19 Arnaud Bourdin,20 Christian Taube,21 Nikolaos G Papadopoulos,22,23 Csoma Zsuzsanna,24 Unnur Björnsdóttir,25 Sundeep Salvi,26 Enrico Heffler,27 Takashi Iwanaga,28 Mona al-Ahmad,29 Désirée Larenas-Linnemann,30 Job FM van Boven,31 Bernt Bøgvald Aarli,32,33 Piotr Kuna,34 Cláudia Chaves Loureiro,35,36 Riyad Al-lehebi,37 Jae Ha Lee,38 Nuria Marina,39 Leif Bjermer,40 Chau-Chyun Sheu,41,42 Bassam Mahboub,43 John Busby,44 Andrew Menzies-Gow,45 Eileen Wang,46 David B Price5,6,47 On behalf of ISAR Inventory Study Group1Department of Respiratory Medicine, Beaumont Hospital, Dublin, Ireland; 2Department of Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore, Singapore; 3AstraZeneca, Gaithersburg, MD, USA; 4Department of Respiratory Medicine, University of Leicester, Leicester, UK; 5Optimum Patient Care Global, Cambridge, UK; 6Observational Pragmatic Research Institute, Singapore, Singapore; 7Optimum Patient Care, Brisbane, Queensland, Australia; 8Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; 9University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina; 10Department of Thoracic Medicine, Concord Hospital, Sydney, Australia; 11CHU Sart-Tilman, GIGA I3, University of Liege, Liège, Wallonia, Belgium; 12Pulmonology Division, Hospital Santa Casa de Porto Alegre, Porto Alegre, Brazil; 13Faculty of Public Health, Medical University, Sofia, Bulgaria; 14Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, Canada; 15CINEUMO, Respiratory Research Center, Fundación Neumológica Colombiana, Bogotá, Colombia; 16Universidad de La Sabana, Chia, Colombia; 17Department of Respiratory Medicine and Infectious Diseases, Research Unit, Bispebjerg Hospital, Copenhagen, Denmark; 18Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia; 19Allergy Centre, Tampere University Hospital, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; 20PhyMedExp, Univ Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France; 21Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany; 22Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK; 23Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece; 24Asthma Outpatient Clinic, National Koranyi Institute for Pulmonology, Budapest, Hungary; 25Department of Allergy and Respiratory Medicine, University Hospital, Reykjavik, Iceland; 26Pulmocare Research and Education Foundation, Pune, India; 27Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; 28Kindai University Hospital, Osakasayama, Japan; 29Microbiology Department, College of Medicine, Kuwait University, Kuwait, Al-Rashed Allergy Center, Ministry of Health, Kuwait City, Kuwait; 30Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico; 31University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; 32Department of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway; 33Department of Clinical Science, University of Bergen, Bergen, Norway; 34Division of Internal Medicine Asthma and Allergy, Medical University of Lodz, Lodz, Poland; 35Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; 36Centre of Pneumology, Faculty of Medicine, University of Coimbra, Coimbra, Portugal; 37Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia, Alfaisal University, Riyadh, Saudi Arabia; 38Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea; 39Pneumology Service, Biocruces, Cruces University Hospital, Barakaldo, Spain; 40Respiratory Medicine and Allergology, Department of Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden; 41Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; 42Department of Internal Medicine, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; 43Rashid Hospital, Dubai Health Authority (DHA), Dubai, United Arab Emirates; 44Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, Northern Ireland, UK; 45Lung Division, Royal Brompton & Harefield Hospital, London, UK; 46Division of Allergy and Clinical Immunology, Department of Medicine, National Jewish Health and University of Colorado School of Medicine, Denver and Aurora, CO, USA; 47Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, UK&ast;These authors contributed equally to this workCorrespondence: David B Price, Observational and Pragmatic Research Institute (OPRI) Pte Ltd, 22 Sin Ming Lane, &num;06-76, Midview City, 573969, Singapore, Tel +65 3105 1489, Email dprice@opri.sgAim: The International Severe Asthma Registry (ISAR; http://isaregistries.org/) uses standardised variables to enable multi-country and adequately powered research in severe asthma. This study aims to look at the data countries within ISAR and non-ISAR countries reported collecting that enable global research that support individual country interests.Methods: Registries were identified by online searches and approaching severe asthma experts. Participating registries provided data collection specifications or confirmed variables collected. Core variables (results from ISAR’s Delphi study), steroid-related comorbidity variables, biologic safety variables (serious infection, anaphylaxis, and cancer), COVID-19 variables and additional variables (not belonging to the aforementioned categories) that registries reported collecting were summarised.Results: Of the 37 registries identified, 26 were ISAR affiliates and 11 non-ISAR affiliates. Twenty-five ISAR-registries and 4 non-ISAR registries reported collecting > 90% of the 65 core variables. Twenty-three registries reported collecting all optional steroid-related comorbidity variables. Twenty-nine registries reported collecting all optional safety variables. Ten registries reported collecting COVID-19 variables. Twenty-four registries reported collecting additional variables including data from asthma questionnaires (10 Asthma Control Questionnaire, 20 Asthma Control Test, 11 Asthma Quality of Life Questionnaire, and 4 EuroQol 5-dimension 5-level Questionnaire). Eight registries are linked to databases such as electronic medical records and national claims or disease databases.Conclusion: Standardised data collection has enabled individual severe asthma registries to collect unified data and increase statistical power for severe asthma research irrespective of ISAR affiliations.Keywords: Asia-Pacific, biologics, COVID-19, Europe, ISAR, International Severe Asthma Registry, oral corticosteroids, Registry, Middle East, Severe Asthma, Latin America, USA
Published: 2023

3. Characterization of Patients in the International Severe Asthma Registry with High Steroid Exposure Who Did or Did Not Initiate Biologic Therapy

Author: Chen W, Sadatsafavi M, Tran TN, Murray RB, Wong CBN, Ali N, Ariti C, Garcia Gil E, Newell A, Alacqua M, Al-Ahmad M, Altraja A, Al-Lehebi R, Bhutani M, Bjermer L, Bjerrum AS, Bourdin A, Bulathsinhala L, von Bülow A, Busby J, Canonica GW, Carter V, Christoff GC, Cosio BG, Costello RW, FitzGerald JM, Fonseca JA, Yoo KH, Heaney LG, Heffler E, Hew M, Hilberg O, Hoyte F, Iwanaga T, Jackson DJ, Jones RC, Koh MS, Kuna P, Larenas-Linnemann D, Lehmann S, Lehtimäki LA, Lyu J, Mahboub B, Maspero J, Menzies-Gow AN, Sirena C, Papadopoulos N, Papaioannou AI, Pérez de Llano L, Perng DW, Peters M, Pfeffer PE, Porsbjerg CM, Popov TA, Rhee CK, Salvi S, Taillé C, Taube C, Torres-Duque CA, Ulrik CS, Ra SW, Wang E, Wechsler ME, and Price DB
Subjects: severe asthma, biologics, real-world, treatment pattern, patient characteristics, Immunologic diseases. Allergy, RC581-607
Abstract: Wenjia Chen,1 Mohsen Sadatsafavi,2 Trung N Tran,3 Ruth B Murray,4 Chong Boon Nigel Wong,1 Nasloon Ali,4,5 Cono Ariti,4,5 Esther Garcia Gil,6 Anthony Newell,5,7 Marianna Alacqua,8 Mona Al-Ahmad,9 Alan Altraja,10 Riyad Al-Lehebi,11,12 Mohit Bhutani,13 Leif Bjermer,14 Anne Sofie Bjerrum,15 Arnaud Bourdin,16 Lakmini Bulathsinhala,4,5 Anna von Bülow,17 John Busby,18 Giorgio Walter Canonica,19,20 Victoria Carter,4,5 George C Christoff,21 Borja G Cosio,22 Richard W Costello,23 J Mark FitzGerald,24 João A Fonseca,25 Kwang Ha Yoo,26 Liam G Heaney,27 Enrico Heffler,19,20 Mark Hew,28,29 Ole Hilberg,30 Flavia Hoyte,31,32 Takashi Iwanaga,33 David J Jackson,34,35 Rupert C Jones,36 Mariko Siyue Koh,37,38 Piotr Kuna,39 Désirée Larenas-Linnemann,40 Sverre Lehmann,41 Lauri A Lehtimäki,42,43 Juntao Lyu,5,7 Bassam Mahboub,44,45 Jorge Maspero,46,47 Andrew N Menzies-Gow,48 Concetta Sirena,49 Nikolaos Papadopoulos,50,51 Andriana I Papaioannou,52 Luis Pérez de Llano,53,54 Diahn-Warng Perng,55,56 Matthew Peters,57 Paul E Pfeffer,58,59 Celeste M Porsbjerg,17 Todor A Popov,60 Chin Kook Rhee,61 Sundeep Salvi,62 Camille Taillé,63 Christian Taube,64 Carlos A Torres-Duque,65 Charlotte S Ulrik,66 Seung Won Ra,67 Eileen Wang,31,32 Michael E Wechsler,68 David B Price4,5,69 1Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore; 2Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada; 3AstraZeneca, Gaithersburg, MD, USA; 4Optimum Patient Care, Cambridge, UK; 5Observational and Pragmatic Research Institute, Singapore, Singapore; 6AstraZeneca, Barcelona, Spain; 7Optimum Patient Care, Queensland, VIC, Australia; 8AstraZeneca, Cambridge, UK; 9Microbiology Department, Faculty of Medicine, Kuwait University, Al-Rashed Allergy Center, Ministry of Health, Kuwait City, Kuwait; 10Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia; 11Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia; 12College of Medicine, Alfaisal University, Riyadh, Saudi Arabia; 13Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Western Canada, AB, Canada; 14Department of Clinical Sciences, Respiratory Medicine and Allergology, Skåne University Hospital, Lund University, Lund, Sweden; 15Department of Respiratory Medicine and Allergy, Aarhus University Hospital, Jutland, Aarhus, Denmark; 16PhyMedExp, Univ Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France; 17Respiratory Research Unit, Bispebjerg University Hospital, Copenhagen, Denmark; 18Centre for Public Health, Queen’s University Belfast, Belfast, Northern Ireland; 19Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Milan, Italy; 20Department of Biomedical Sciences, Humanitas University, Milan, Italy; 21Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria; 22Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain; 23Department of Respiratory Medicine, Clinical Research Centre, Smurfit Building Beaumont Hospital, RCSI, Dublin, Ireland; 24Department of Medicine, the University of British Columbia, Vancouver, BC, Canada; 25Comunity Health, Information and Decision Sciences Department (MEDCIDS) & Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of University of Porto, Porto, Portugal; 26KonKuk University School of Medicine in Seoul, Seoul, Korea; 27Wellcome-Wolfson Centre for Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland; 28Allergy, Asthma & Clinical Immunology Service, Alfred Health, Melbourne, VIC, Australia; 29Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; 30Medical Department, Vejle University Hospital, Jutland, Vejle, Denmark; 31Department of Medicine, Division of Allergy and Clinical Immunology, National Jewish Health, Denver, CO, USA; 32Department of Internal Medicine, Division of Allergy & Clinical Immunology, University of Colorado School of Medicine, Aurora, CO, USA; 33Center for General Medical Education and Clinical Training, Kindai University Hospital, Osakasayama, Japan; 34UK Severe Asthma Network and National Registry, Guy’s and St Thomas’ NHS Trust, London, UK; 35School of Immunology & Microbial Sciences, King’s College London, London, UK; 36Research and Knowledge Exchange, Plymouth Marjon University, Plymouth, UK; 37Respiratory & Critical Care Medicine, Singapore General Hospital, Singapore, Singapore; 38SingHealth Duke-NUS Lung Centre, Singapore, Singapore; 39Division of Internal Medicine, Asthma and Allergy Medical University of &Lstrok;ód&zacute;, &Lstrok;ód&zacute;, Poland; 40Directora Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Ciudad de México, Mexico; 41Section of Thoracic Medicine, Department of Clinical Science, University of Bergen, Bergen, Norway; 42Allergy Centre, Tampere University Hospital, Tampere, Finland; 43Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland; 44College of Medicine, University of Sharjah, Sharjah, United Arab Emirates; 45Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates; 46Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; 47University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina; 48Royal Brompton & Harefield Hospitals, London, UK; 49Severe Asthma Network in Italy (SANI), Milano, Italy; 50Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, UK; 51Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece; 52 2nd Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece; 53Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Lugo, Spain; 54Biodiscovery Research Group, Health Research Institute of Santiago de Compostela, Santiago de Compostela, Spain; 55Division of Clinical Respiratory Physiology Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan; 56COPD Assembly of the Asian Pacific Society of Respirology Hongo, Bunkyo-ku, Tokyo, Japan; 57Department of Thoracic Medicine, Concord Hospital, Sydney, NSW, Australia; 58Department of Respiratory Medicine, Barts Health NHS Trust, London, UK; 59Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK; 60University Hospital ”sv. Ivan Rilski”, Sofia, Bulgaria; 61Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Seoul St. Mary’s Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea; 62Pulmocare Research and Education Foundation, Pune, India; 63Department of Respiratory Diseases, Bichat Hospital, AP-HP Nord-Université de Paris, Paris, France; 64Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany; 65CINEUMO, Respiratory Research Center, Fundación Neumológica Colombiana, Bogotá, Colombia; 66Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark; 67Department of Internal Medicine, Division of Pulmonology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea; 68Department of Medicine, NJH Cohen Family Asthma Institute, National Jewish Health, Denver, CO, USA; 69Centre 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, &num;06 Midview City, Singapore, Singapore, 573969, Tel +65 3105 1489, Email dprice@opri.sgBackground: Many severe asthma patients with high oral corticosteroid exposure (HOCS) often do not initiate biologics despite being eligible. This study aimed to compare the characteristics of severe asthma patients with HOCS who did and did not initiate biologics.Methods: Baseline characteristics of patients with HOCS (long-term maintenance OCS therapy for at least 1 year, or ≥ 4 courses of steroid bursts in a year) from the International Severe Asthma Registry (ISAR; https://isaregistries.org/), who initiated or did not initiate biologics (anti-lgE, anti-IL5/5R or anti-IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson’s chi-squared tests for categorical variables, and t-tests for continuous variables, adjusting for potential errors in multiple comparisons.Results: Between January 2015 and February 2021, we identified 1412 adult patients with severe asthma from 19 countries that met our inclusion criteria of HOCS, of whom 996 (70.5%) initiated a biologic and 416 (29.5%) did not. The frequency of biologic initiation varied across geographical regions. Those who initiated a biologic were more likely to have higher blood eosinophil count (483 vs 399 cells/μL, p=0.003), serious infections (49.0% vs 13.3%, p< 0.001), nasal polyps (35.2% vs 23.6%, p< 0.001), airflow limitation (56.8% vs 51.8%, p=0.013), and uncontrolled asthma (80.8% vs 73.2%, p=0.004) despite greater conventional treatment adherence than those who did not start a biologic. Both groups had similar annual asthma exacerbation rates in the previous 12 months (5.7 vs 5.3, p=0.147).Conclusion: Around one third of severe HOCS asthma patients did not receive biologics despite a similar high burden of asthma exacerbations as those who initiated a biologic therapy. Other disease characteristics such as eosinophilic phenotype, serious infectious events, nasal polyps, airflow limitation and lack of asthma control appear to dictate biologic use.Keywords: severe asthma, biologics, real-world, treatment pattern, patient characteristics
Published: 2022

4. Improvement in Health-Related Quality of Life with Dupilumab in Patients with Moderate-to-Severe Asthma with Comorbid Chronic Rhinosinusitis with/without Nasal Polyps: An Analysis of the QUEST Study

Author: Hopkins C, Buchheit KM, Heffler E, Cohen NA, Olze H, Khan AH, Msihid J, Siddiqui S, Nash S, Jacob-Nara JA, Rowe PJ, and Deniz Y
Subjects: asthma, chronic rhinosinusitis, nasal polyps, dupilumab, health-related quality of life, snot-22, Immunologic diseases. Allergy, RC581-607
Abstract: Claire Hopkins,1 Kathleen M Buchheit,2 Enrico Heffler,3,4 Noam A Cohen,5 Heidi Olze,6 Asif H Khan,7 Jérôme Msihid,8 Shahid Siddiqui,9 Scott Nash,9 Juby A Jacob-Nara,10 Paul J Rowe,10 Yamo Deniz9 1Department of Otorhinolaryngology – Head and Neck Surgery, Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 2Division of Allergy and Clinical Immunology, Brigham and Women’s Hospital, Boston, MA, USA; 3Personalized Medicine, Asthma & Allergy – Humanitas Clinical and Research Center IRCCS, Milan, Italy; 4Department of Biomedical Sciences, Humanitas University, Milan, Italy; 5Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; 6Department of Otorhinolaryngology, Head and Neck Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany; 7Global Medical Affairs, Sanofi, Chilly-Mazarin, France; 8Health Economics and Value Assessment, Sanofi, Chilly-Mazarin, France; 9Medical Affairs, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 10Global Medical Affairs, Sanofi, Bridgewater, NJ, USACorrespondence: Claire Hopkins, Department of Otorhinolaryngology – Head and Neck Surgery, Guy’s and St Thomas’ NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK, Tel +44 2071882215, Email clairehopkins@yahoo.comAbstract: Patients with asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, increasing disease burden and complicating treatment. These post hoc analyses investigated disease-specific health-related quality of life (HRQoL) and general health status in the randomized, placebo-controlled QUEST study (NCT02414854) in patients treated with dupilumab for moderate-to-severe asthma with comorbid CRS. Patients received 300 mg of dupilumab or placebo every 2 weeks for 52 weeks. CRS HRQoL was assessed by the 22-item Sino-Nasal Outcome Test (SNOT-22; items scored 0– 5). The 22 items are categorized into 5 domains (nasal, ear/facial, sleep, function, and emotion), and patients report the top 5 most important items affecting their health. General health status was assessed by Euro-QoL visual analog scale (EQ-VAS). Of 1902 patients, 382 (20.1%) self-reported comorbid CRS; 193 patients receiving dupilumab 300 mg q2w or matched placebo were included in this analysis. At baseline, the most impacted SNOT-22 domain was nasal, and general health status was below population norms. Patients rated “decreased sense of taste/smell,” “nasal blockage,” “cough,” “reduced productivity,” and “wake up tired” as the 5 most important SNOT-22 items affecting their health. Percentage change from baseline in SNOT-22 total score was significantly greater for dupilumab vs placebo at Weeks 24, 36, and 52 (all p < 0.05). Improvements from baseline were significantly greater for dupilumab vs placebo at Week 52 for all SNOT-22 domains (p < 0.05), except emotion. At Week 52, significant changes from baseline with dupilumab vs placebo were observed for all 5 most important SNOT-22 items affecting their health (all p < 0.05). EQ-VAS was significantly improved with dupilumab vs placebo by Week 12, with improvements sustained to Week 52 (all p < 0.01). In patients with moderate-to-severe asthma who self-reported comorbid CRS, dupilumab treatment vs placebo improved CRS-specific HRQoL and general health status.Keywords: asthma, chronic rhinosinusitis, nasal polyps, dupilumab, health-related quality of life, SNOT-22
Published: 2022

5. Immunoglobulin free light chains in severe asthma patient: Could they be a new biomarker?

Author: Caruso, C., Ciasca, G., Baglivo, I., Di Santo, R., Gasbarrini, A., Firinu, D., Bagnasco, D., Passalacqua, G., Schiappoli, M., Caminati, M., Canonica, G. W., Heffler, E., Crimi, C., Intravaia, R., Basile, V., Marino, M., Colantuono, S., and Del Giacco, S.
Subjects: IMMUNOGLOBULIN light chains, BLOOD sedimentation, ASTHMATICS, STAPHYLOCOCCUS aureus, IMMUNOGLOBULIN E, ATOPY
Abstract: Background: Increasing evidence is available about the presence of increased serum concentration of immunoglobulin (Ig) free light chains (FLCs) in both atopic and non‐atopic inflammatory diseases, including severe asthma, providing a possible new biomarker of disease. Methods: We analyzed clinical and laboratory data, including FLCs, obtained from a cohort of 79 asthmatic subjects, clinically classified into different GINA steps. A control group of 40 age‐matched healthy donors (HD) was considered. Particularly, HD have been selected according to the absence of monoclonal components (in order to exclude paraproteinemias), were tested for total IgE (that were in the normal ranges) and were negative for aeroallergens specific IgE. Moreover, no abnormality of common inflammatory markers (i.e., erythrocyte sedimentation rate and C‐reactive protein) was detectable. Results: FLC‐k levels were significantly increased in the asthmatic population, compared to the control group. Despite the absence of statistically significant differences in FLC‐λ levels, the FLC‐k/FLC‐λ ratio displayed remarkable differences between the two groups. A positive correlation between FLC‐κ and FLC‐λ levels was found. FLC‐ λ level displayed a significant negative correlation with the FEV1 value. Moreover, the FLC‐κ /FLC‐ λ ratio was negatively correlated with the SNOT‐22 score and a positive correlation was observed between FLCs and Staphylococcus Aureus IgE enterotoxins sensitization. Conclusions: Our findings confirmed the role of FLCs in asthma as a potential biomarker in an inflammatory disease characterized by different endotypes and phenotypes. In particular, FLC‐κ and FLC‐k/FLC‐λ ratio could be a qualitative indicator for asthma, while FLC‐λ levels could be a quantitative indicator for clinical severity parameters. [ABSTRACT FROM AUTHOR]
Published: 2024
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6. International Variation in Exacerbation Rates in Patients With Severe Asthma

Author: Yadav, C.P., primary, Lee, T.Y., additional, Price, D.B., additional, Roy, R., additional, Mien, L.L.H., additional, Wang, E., additional, Wechsler, M.E., additional, Jackson, D.J., additional, Busby, J., additional, Heaney, L.G., additional, Pfeffer, P.E., additional, Mahboub, B., additional, Perng, D.-W., additional, Cosio, B.G., additional, Perez-De-Llano, L., additional, AL Lohebi, R., additional, Linnemann, D.L., additional, Al-Ahmad, M., additional, Rhee, C.K., additional, Iwanaga, T., additional, Heffler, E., additional, Canonica, G.W., additional, Costello, R.W., additional, Papadopoulos, N., additional, Papaioannou, A., additional, Porsbjerg, C.M., additional, Torres-Duque, C.A., additional, Christoff, G.C., additional, Popov, T.A., additional, Hew, M., additional, Peters, M., additional, Gibson, P.G., additional, Maspero, J., additional, Bergeron, C., additional, Cerda, S., additional, Contreras, M.A., additional, Chen, W., additional, and Sadatsafavi, M., additional
Published: 2024
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7. Unveiling the Real-World Causal Interaction of Essential Risk Factors in Severe Asthma Exacerbation: A Bayesian Network Analysis

Author: Yadav, C.P., primary, Chakraborty, A., additional, Price, D., additional, Beasley, R., additional, Sadatsafavi, M., additional, Janson, C., additional, Siyue, M.K., additional, Wang, E., additional, Wechsler, M.E., additional, Jackson, D.J., additional, Busby, J., additional, Heaney, L.G., additional, Pfeffer, P.E., additional, Mahboub, B., additional, Perng, D.-W., additional, Cosio, B.G., additional, Perez-De-Llano, L., additional, AL Lohebi, R., additional, Linnemann, D.L., additional, Al-Ahmad, M., additional, Rhee, C.K., additional, Iwanaga, T., additional, Heffler, E., additional, Canonica, G.W., additional, Costello, R.W., additional, Papadopoulos, N., additional, Papaioannou, A., additional, Porsbjerg, C., additional, Torres-Duque, C.A., additional, Christoff, G.C., additional, Popov, T.A., additional, Hew, M., additional, Peters, M., additional, Gibson, P.G., additional, Maspero, J.F., additional, Bergeron, C., additional, Cerda, S., additional, Contreras, M.A., additional, and Chen, W., additional
Published: 2024
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8. Type 2-High Severe Asthma with and without Bronchiectasis: A Prospective Observational Multicentre Study

Author: Crimi C, Campisi R, Nolasco S, Ferri S, Cacopardo G, Impellizzeri P, Pistorio MP, Fagone E, Pelaia C, Heffler E, and Crimi N
Subjects: type 2 inflammation, severe asthma, bronchiectasis, chest-ct scan, phenotype, Immunologic diseases. Allergy, RC581-607
Abstract: Claudia Crimi,1 Raffaele Campisi,1 Santi Nolasco,2 Sebastian Ferri,3,4 Giulia Cacopardo,5 Pietro Impellizzeri,2 Maria Provvidenza Pistorio,2 Evelina Fagone,2 Corrado Pelaia,6 Enrico Heffler,3,4 Nunzio Crimi1,2 1Respiratory Medicine Unit, A.O.U. Policlinico “G. Rodolico - San Marco”, Catania, Italy; 2Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; 3Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy; 4Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy; 5Respiratory Intensive Care Unit, ARNAS Civico General Hospital, Palermo, Italy; 6Department of Medical and Surgical Sciences, University “Magna Graecia”, Catanzaro, ItalyCorrespondence: Claudia CrimiRespiratory Medicine Unit, A.O.U. Policlinico “G. Rodolico - San Marco”, Catania, ItalyEmail dott.claudiacrimi@gmail.comIntroduction: Type 2-high severe asthma (T2-SA) is often associated with several comorbidities. To this extent, the coexistence of T2-SA and bronchiectasis (BE) is considered an emerging phenotype.Methods: We performed a prospective observational multicentre study, including T2-SA patients. Chest HRCT confirmed the presence of BE. Data on exacerbations, pulmonary function, Asthma Control Test (ACT), chronic mucus hypersecretion (CMH), chronic rhinosinusitis (CRS), oral corticosteroid (OCS) dosage, eosinophils in peripheral blood and FeNO were recorded. The Bhalla score was used for radiological assessment of T2-SA+BE patients and the Bronchiectasis Severity Index (BSI) was calculated.Results: A total of 113 patients (mean age 55 ± 11 years, 59.3% female) were enrolled. Co-presence of BE was confirmed in 50/113 (44.2%) patients who identified the T2-SA+BE group. CRS and CRSwNP were more prevalent in T2-SA+BE vs T2-SA [respectively, 42/50 (84%) vs 37/63 (58.7%), p = 0.004 and 27/50 (54%) vs 27/63 (42.9%), p = 0.0165]. Furthermore, T2-SA+BE patients reported more CMH compared to T2-SA [29/50 (58%) vs 15/63 (23.8%), p = 0.0004], were more frequently on chronic OCSs intake [28/50 (56%) vs 22/63 (34.9%), p = 0.0357] and experienced more exacerbations/year [10 (4– 12) vs 6 (4– 12), p = 0.0487]. In a multivariate logistic regression model, the presence of CRS, CMH and daily OCS intake were associated with BE presence with a 78% (95% CI: 69– 88) accuracy. Median Bhalla score was 18.3 (16– 20) (Mild radiological severity). Median BSI was 6 (4– 8) and only 6/50 (12%) had a BSI score ≥ 9. Significant inverse linear relationship between BSI and ACT (r = − 0.6095, p < 0.0001), FEV1% (r = − 0.3297, p = 0.0353) and FEV1 mL (r = − 0.4339, p = 0.0046) were found.Conclusion: Type 2 inflammation could have a causative role in BE development. Chest HRCT is mandatory when a diagnosis of T2-SA is made, especially in presence of CRS, CMH and chronic OCS intake. Early BE detection may be crucial to improve T2-SA patients’ outcomes.Keywords: type 2 inflammation, severe asthma, bronchiectasis, chest-CT scan, phenotype
Published: 2021

9. Immunoglobulin free light chains in severe asthma patient: Could they be a new biomarker?

Author: Caruso, Cristiano, Ciasca, Gabriele, Baglivo, I, Di&nbsp, Santo, R, Gasbarrini, Antonio, Firinu, D, Bagnasco, D., Passalacqua, G., Schiappoli, M., Caminati, M., Canonica, Gw, Heffler, E, Crimi, C, Intravaia, R, Basile, V, Marino, Mariapaola, Colantuono, Stefania, Del&nbsp, Giacco, S, Caruso, C, Ciasca, G (ORCID:0000-0002-3694-8229), Gasbarrini, A (ORCID:0000-0002-7278-4823), Marino, M (ORCID:0000-0001-9155-6378), Colantuono, S, Caruso, Cristiano, Ciasca, Gabriele, Baglivo, I, Di&nbsp, Santo, R, Gasbarrini, Antonio, Firinu, D, Bagnasco, D., Passalacqua, G., Schiappoli, M., Caminati, M., Canonica, Gw, Heffler, E, Crimi, C, Intravaia, R, Basile, V, Marino, Mariapaola, Colantuono, Stefania, Del&nbsp, Giacco, S, Caruso, C, Ciasca, G (ORCID:0000-0002-3694-8229), Gasbarrini, A (ORCID:0000-0002-7278-4823), Marino, M (ORCID:0000-0001-9155-6378), and Colantuono, S
Abstract: BackgroundIncreasing evidence is available about the presence of increased serum concentration of immunoglobulin (Ig) free light chains (FLCs) in both atopic and non-atopic inflammatory diseases, including severe asthma, providing a possible new biomarker of disease.MethodsWe analyzed clinical and laboratory data, including FLCs, obtained from a cohort of 79 asthmatic subjects, clinically classified into different GINA steps. A control group of 40 age-matched healthy donors (HD) was considered. Particularly, HD have been selected according to the absence of monoclonal components (in order to exclude paraproteinemias), were tested for total IgE (that were in the normal ranges) and were negative for aeroallergens specific IgE. Moreover, no abnormality of common inflammatory markers (i.e., erythrocyte sedimentation rate and C-reactive protein) was detectable.ResultsFLC-k levels were significantly increased in the asthmatic population, compared to the control group. Despite the absence of statistically significant differences in FLC-lambda levels, the FLC-k/FLC-lambda ratio displayed remarkable differences between the two groups. A positive correlation between FLC-kappa and FLC-lambda levels was found. FLC- lambda level displayed a significant negative correlation with the FEV1 value. Moreover, the FLC-kappa /FLC- lambda ratio was negatively correlated with the SNOT-22 score and a positive correlation was observed between FLCs and Staphylococcus Aureus IgE enterotoxins sensitization.ConclusionsOur findings confirmed the role of FLCs in asthma as a potential biomarker in an inflammatory disease characterized by different endotypes and phenotypes. In particular, FLC-kappa and FLC-k/FLC-lambda ratio could be a qualitative indicator for asthma, while FLC-lambda levels could be a quantitative indicator for clinical severity parameters.This study aimed to describe clinical and laboratory.characteristics of a population of patients with asthma and to investigate the potential
Published: 2024

10. Revisiting Late-Onset Asthma: Clinical Characteristics and Association with Allergy

Author: Quirce S, Heffler E, Nenasheva N, Demoly P, Menzies-Gow A, Moreira-Jorge A, Nissen F, and Hanania NA
Subjects: asthma, diagnosis, age of onset, allergy, allergic asthma, asthma phenotypes, Immunologic diseases. Allergy, RC581-607
Abstract: Santiago Quirce,1 Enrico Heffler,2 Natalia Nenasheva,3 Pascal Demoly,4 Andrew Menzies-Gow,5 Ana Moreira-Jorge,6 Francis Nissen,7 Nicola A Hanania8 1Department of Allergy, La Paz University Hospital, IdiPAZ and Universidad Autónoma de Madrid, Madrid, Spain; 2Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, MI, Italy; 3Department of Allergology and Immunology of Russian Medical Academy for Continuous Medical Education, Moscow, Russian Federation; 4Department of Pulmonology, Division of Allergy, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Montpellier, France; 5Department of Respiratory Medicine, Royal Brompton Hospital, London, UK; 6Novartis Farmaceutica, S.A., Barcelona, Spain; 7London School of Hygiene and Tropical Medicine, London, UK; 8Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USACorrespondence: Santiago QuirceHospital Universitario La Paz, P. La Castellana, 261, Madrid, 28046 SpainEmail squirce@gmail.comAbstract: The Global Initiative for Asthma (GINA) 2020 defines late-onset asthma (LOA) as one of the clinical phenotypes of asthma wherein patients, particularly women, present with asthma for the first time in adult life, tend to be non-allergic and often require higher doses of inhaled corticosteroids (ICS) or are relatively refractory to corticosteroid treatment. In this review, we examine the published literature improve the understanding of the following aspects of LOA: 1) the age cut-off for its diagnosis; 2) its distinct clinical phenotypes, characteristics and risk factors; and 3) its association with allergic comorbidities and conditions. Overall, our review reveals that clinicians and researchers have used multiple age cut-offs to define LOA, with cut-off ages ranging from > 12 years to ≥ 65 years. LOA has also been classified into several distinct phenotypes, some of which drastically differ in their clinical characteristics, course and prognosis. Although LOA has traditionally been considered non-allergic in nature, our review indicates that it is commonly associated with allergic features and comorbidities. Our findings suggest that there is an urgent need for the development of more clear clinical practice guidelines that can provide more clarity on the definition and other aspects of LOA. In addition, the association of LOA and allergy needs to be re-examined to frame a more optimal treatment strategy for patients with LOA.Keywords: asthma, diagnosis, age of onset, allergy, allergic asthma, asthma phenotypes
Published: 2020

11. PCR200 Characteristics at Baseline of Patients with Asthma and Prior Systemic Corticosteroid Use Initiating Dupilumab Enrolled in the Real-World Study Rapid

Author: Lugogo, N.L., primary, Heffler, E., additional, Plaza, V., additional, Hilberg, O., additional, Xia, C., additional, Nash, S., additional, Pandit-Abid, N., additional, Jacob-Nara, J.A., additional, Sacks, H., additional, Rowe, P.J., additional, Deniz, Y., additional, Hardin, M., additional, Ledanois, O., additional, and Soler, X., additional
Published: 2023
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12. Frequency of Tiotropium Bromide Use and Clinical Features of Patients with Severe Asthma in a Real-Life Setting: Data from the Severe Asthma Network in Italy (SANI) Registry

Author: Puggioni F, Brussino L, Canonica GW, Blasi F, Paggiaro P, Caminati M, Latorre M, Heffler E, and Senna G
Subjects: severe asthma, registry, long-acting muscarinic antagonists, real-life., Immunologic diseases. Allergy, RC581-607
Abstract: Francesca Puggioni,1,2 Luisa Brussino,3 Giorgio Walter Canonica,1,2 Francesco Blasi,4,5 Pierluigi Paggiaro,6 Marco Caminati,7,8 Manuela Latorre,6 Enrico Heffler,1,2 Gianenrico Senna7,8 On behalf of the Severe Asthma Network in Italy (SANI) group1Personalized Medicine, Asthma and Allergy – Humanitas Clinical and Research Center, IRCCS – Rozzano (MI), Milan, Italy; 2Department of Biomedical Sciences, Humanitas University – Pieve Emanuele (MI), Milan, Italy; 3Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I – Torino, Torino, Italy; 4Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 5Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy; 6Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy; 7Department of Medicine, University of Verona, Verona, Italy; 8Allergy Unit and Asthma Center, Verona University Hospital, Verona, Verona, ItalyCorrespondence: Enrico HefflerPersonalized Medicine, Asthma and Allergy, Istituto Clinico Humanitas, Milan, ItalyTel +39 0288247013Fax + 39 0282246484Email enrico.heffler@hunimed.euPurpose: Patients with uncontrolled asthma despite high doses of inhaled corticosteroid therapy plus another controller are defined as severe asthmatics. Tiotropium bromide respimat (TBR) is the only long-acting muscarinic antagonists (LAMA) approved for severe asthma. The aim of this study was to explore the frequency of severe asthmatics treated with TBR and characterize their clinical features in a real-life, registry-based setting.Materials and Methods: Baseline data from the Severe Asthma Network in Italy (SANI) registry have been analyzed to determine the use of TBR and other LAMA, and to compare clinical, functional and inflammatory features associated with the use of LAMA.Results: Among a total of 698 enrolled patients, 35.9% were treated with LAMA (23.3% TBR, 4.5% tiotropium bromide handihaler, 4.5% aclidinium, 3.4% glycopyrronium bromide 0.3% umeclidinium bromide). Age of asthma onset was higher in patients taking LAMA, whom, compared to others were more frequently former smokers. They also had a higher annual exacerbation rate, experienced worst asthma control, worst disease-related quality of life and poorer lung function. Bronchiectasis was more frequently found in LAMA users (25.9% vs 13.1%).Conclusion: TBR is still underused in severe asthma in a real-life setting, while a relevant proportion of patients are treated with other LAMA that are not approved for severe asthma treatment. Patients taking LAMA have features characteristic of even more severe asthma.Keywords: severe asthma, registry, long-acting muscarinic antagonists, real-ligfe
Published: 2020

13. Vitamin D and disease severity in bronchiectasis

Author: Ferri, S., Crimi, C., Heffler, E., Campisi, R., Noto, A., and Crimi, N.
Published: 2019
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14. BASELINE DISEASE BURDEN AMONG PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS IN GLOBAL AROMA REGISTRY

Author: Peters, A., primary, Buchheit, K., additional, Shah, R., additional, Heffler, E., additional, Fujieda, S., additional, Xia, C., additional, DePrado-Gomez, L., additional, and Nash, S., additional
Published: 2023
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15. Eosinophilic esophagitis as a side-effect of allergen immunotherapy: protocol for a systematic review and meta-analysis

Author: Pitsios, C., primary, Rossi, C.M., additional, Terreehorst, I., additional, Heffler, E., additional, Votto, M., additional, Konstantinou, G.N., additional, Alvarez-Perea, A., additional, Bakirtas, A., additional, Apostolidou, E., additional, Antolin-Amerigo, D., additional, Nikolopoulos, G.K., additional, Pfaar, O., additional, and Cianferoni, A., additional
Published: 2023
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16. Utility of ultrasound assessment of diaphragmatic function before and after pulmonary rehabilitation in COPD patients

Author: Crimi C, Heffler E, Augelletti T, Campisi R, Noto A, Vancheri C, and Crimi N
Subjects: diaphragm ultrasound, COPD, pulmonary rehabilitation, Diseases of the respiratory system, RC705-779
Abstract: Claudia Crimi,1 Enrico Heffler,2 Teresa Augelletti,2 Raffaele Campisi,1 Alberto Noto,3 Carlo Vancheri,4 Nunzio Crimi2 1Respiratory Medicine Unit, AOU “Policlinico-Vittorio Emanuele”, Catania, Italy; 2Respiratory Medicine Unit, Department of Clinical and Experimental Medicine, AOU “Policlinico-Vittorio Emanuele”, University of Catania, Catania, Italy; 3Anesthesia and Intensive Care Unit, AOU Policinico “G. Martino”, Messina, Italy; 4Regional Referral Centre for Rare Lung Diseases, A.O.U. “Policlinico-Vittorio Emanuele”, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy Background: Pulmonary rehabilitation (PR) may improve respiratory symptoms and skeletal muscle strength in patients with COPD. We aimed to evaluate changes in ultrasound (US) measurements of diaphragmatic mobility and thickness after PR in COPD patients and to test its correlation with PR outcomes.Methods: Twenty-five COPD patients were enrolled and underwent a diaphragm US assessment before and after a 12-week PR program.Results: We found a correlation between the intraindividual percentage of change in the diaphragmatic length of zone of apposition at functional residual capacity (ΔLzapp%) and the change in 6-minute walking distance (6MWD) after PR (rho=0.49, P=0.02). ΔLzapp% was significantly higher in patients with improved 6MWD and COPD Assessment Test (CAT) score (mean rank=12.03±2.57 vs 6.88±4.37; P=0.02). A ΔLzapp% of ≥10% was able to discriminate among patients with improved 6MWD, with a sensitivity of 83% and a specificity of 74%. The area under the receiver operating characteristic curve for ΔLzapp% was 0.83. A cutoff value of ≥9% of ΔLzapp% had a positive predictive value in discriminating a reduction in ≥2 points of CAT score after PR, with a sensitivity and a specificity of 80% and 62%, respectively.Conclusion: Diaphragm US assessment represents a useful prognostic marker of PR outcomes in COPD patients. Keywords: diaphragm ultrasound, COPD, pulmonary rehabilitation
Published: 2018

17. EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023

Author: Fokkens, W J, primary, Viskens, A-S, additional, Backer, V, additional, Conti, D, additional, De Corso, E, additional, Gevaert, P, additional, Scadding, G K, additional, Wagemann, M, additional, Bernal-Sprekelsen, M, additional, Chaker, A, additional, Heffler, E, additional, Han, J K, additional, Van Staeyen, E, additional, Hopkins, C, additional, Mullol, J, additional, Peters, A, additional, Reitsma, S, additional, Senior, B A, additional, and Hellings, P W, additional
Published: 2023
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18. Major Allergen Content in Allergen Immunotherapy Products: The Limited Value of Numbers

Author: Becker, S, primary, Fassio, F, additional, Muñoz-Cano, R, additional, Klimek, L, additional, Vidal, C, additional, Heath, MD, additional, Kündig, TM, additional, Vogelberg, C, additional, Toran, C, additional, Jensen-Jarolim, E, additional, Heffler, E, additional, Tomazic, PV, additional, Feindor, M, additional, Hewings, S, additional, Carreno, T, additional, Morales, M, additional, Mösges, R, additional, Skinner, MA, additional, Graessel, A, additional, Hernandez, D, additional, and Kramer, MF, additional
Published: 2022
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19. Economic impact of oral corticosteroids in severe asthmatics: a simulation study in selected European countries

Author: Bourdin, A, primary, Bel, E H, additional, Dahlén, B, additional, Djukanovic, R, additional, Heffler, E, additional, Kuna, P, additional, Louis, R, additional, Porsbjerg, C, additional, Ramos-Barbon, D, additional, Škrgat, S, additional, Bruno, G M, additional, Di Matteo, S, additional, Martinotti, C, additional, Colombo, G L, additional, Paulsson, T, additional, and Mascialino, B, additional
Published: 2022
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20. Mepolizumab effectiveness in severe asthma supported by federated analysis of European SHARP data

Author: Kroes, J A, primary, Alfonso-Cristancho, R, additional, Bansal, A T, additional, Berret, E, additional, Bieksiene, K, additional, Bourdin, A, additional, Brussino, L, additional, Canhoto, D, additional, Cardini, C, additional, Celik, G, additional, Csoma, Z, additional, Dahlén, B, additional, Damadoğlu, E, additional, Eger, K, additional, Gauquelin, L, additional, Gemicioglu, B, additional, Goksel, O, additional, Graff, S, additional, Heffler, E, additional, Hofstee, H B, additional, Howarth, P, additional, Jakes, R, additional, Jaun, F, additional, Kalinauskaite-Zukauske, V, additional, Kopač, P, additional, Kwon, N, additional, Loureiro, C C, additional, Lozoya García, V, additional, Masoli, M, additional, Paula Rezelj, M, additional, Pérez De Llano, L, additional, Popović-Grle, S, additional, Ramos-Barbon, D, additional, Sà Sousa, A, additional, Samitas, K, additional, Schleich, F, additional, Sirena, C, additional, Skrgat, S, additional, Zervas, E, additional, Zichnalis, G, additional, Bel, E H, additional, Sont, J K, additional, Hashimoto, S, additional, and Ten Brinke, A, additional
Published: 2022
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21. Effect of dupilumab on asthma control and asthma-related quality of life in patients with uncontrolled, moderate-to-severe type 2 asthma: TRAVERSE OLE study

Author: Busse, W, primary, Pavord, I D, additional, Corren, J, additional, Menzies-Gow, A, additional, Heffler, E, additional, Msihid, J, additional, Siddiqui, S, additional, Lederer, D J, additional, Hardin, M, additional, Zhang, Y, additional, Khan, A H, additional, Jacob-Nara, J A, additional, Deniz, Y, additional, and Rowe, P J, additional
Published: 2022
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22. Very rapid improvement of extended nitric oxide parameters, associated with clinical and functional betterment, in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) treated with Dupilumab

Author: Paoletti, G, primary, Casini, M, additional, Malvezzi, L, additional, Pirola, F, additional, Russo, E, additional, Nappi, E, additional, Quintina Muci, G, additional, Montagna, C, additional, Messina, MR, additional, Ferri, S, additional, Racca, F, additional, Lamacchia, D, additional, Cataldo, G, additional, Puggioni, F, additional, De Virgilio, A, additional, Ferreli, F, additional, Mercante, G, additional, Spriano, G, additional, Canonica, GW, additional, and Heffler, E, additional
Published: 2022
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23. ORAL CORTICOSTEROID USAGE PATTERNS IN PATIENTS WITH ASTHMA INITIATING DUPILUMAB: THE RAPID REGISTRY STUDY

Author: Mosnaim, G., Lugogo, N., Heffler, E., Plaza, V., Hilberg, O., Xia, C., DePrado-Gomez, L., and Kwah, J.
Published: 2024
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24. The roadmap for allergology in Europe: The subspecialty of allergology as “stop‐over” on the way to a full specialty. An EAACI position statement

Author: Gerth van Wijk, R., Eguiluz‐Gracia, I., Gayraud, J., Gutermuth, J., Hamelmann, E., Heffler, E., Popov, T. A., Schmid‐Grendelmeier, P., Tomazic, P. V., Tsilochristou, O., and Muelleneisen, N.
Published: 2018
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25. Comorbid allergic rhinitis and asthma: important clinical considerations

Author: Nappi, E, primary, Paoletti, G, additional, Malvezzi, L, additional, Ferri, S, additional, Racca, F, additional, Messina, M R, additional, Puggioni, F, additional, Heffler, E, additional, and Canonica, G W, additional
Published: 2022
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26. CO174 Baseline Characteristics of Patients with Asthma and Prior Oral Systemic Corticosteroid Use Initiating Dupilumab in a Real-World Registry (RAPID)

Author: Lugogo, NL., Heffler, E., Plaza, V., Hilberg, O., Xia, C., Nash, S., Pandit-Abid, N.., Jacob-Nara, J.A.., Sacks, H., Rowe, PJ., Deniz, Y., Hardin, M., Reed, C., and Soler, X.
Published: 2024
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27. Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry

Author: Canonica, Gw, Blasi, F., Paggiaro, PL. Senna G. E., Passalacqua, G., Spanevello, A., Aliberti, S., Bagnasco, D., Bonavia, M. Bonini M., Bucca, C., Brussino, L., Caiaffa, M. F., Calabrese, C., Camiciottoli, G., Caminati, M., Carpagnano, G. E., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D’Alo, S., D’Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino Barbaro, M. P., Guarnieri, G., Guida, G., Latorre, M., Lo Cicero, S., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montagn, i. M., Montuschi, P., Nucera, E., Parente, R., Patella, V., Pelaia, G., Pini, L., Puggioni, F., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Spadaro, G., Yacoub, Mr., Vianello, A., Viviano, V., Zappa, M. C., Heffler, E., Canonica, G. W., Malvezzi, L., Blasi, F., Paggiaro, P., Mantero, M., Senna, G., Heffler, E., Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alo, S., D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B. P. M., Guarnieri, G., Latorre, M., Lombardi, C., Macchia, L., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F. L. M., Ricciardi, L., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M. R., Zappa, M. C., Canonica G.W., Malvezzi L., Blasi F., Paggiaro P., Mantero M., Senna G., Heffler E., Bonavia M., Caiaffa P., Calabrese C., Camiciottoli G., Caruso C., Centanni S., Conte M.E., Corsico A.G., Cosmi L., Costantino M.T., Crimi N., D'Alo S., D'Amato M., Del Giacco S., Favero E., Farsi A., Foschino B.P.M., Guarnieri G., Guida G., Latorre M., Lombardi C., Macchia L., Menzella F., Milanese M., Montuschi P., Nucera E., Parente R., Passalacqua G., Patella V., Pelaia G., Pini L., Ricciardolo F.L.M., Ricciardi L., Richeldi L., Ridolo E., Rolla G., Santus P., Scichilone N., Solidoro P., Spadaro G., Spanevello A., Vianello A., Yacoub M.R., and Zappa M.C.
Subjects: Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Severe asthma, Databases, Factual, Administration, Oral, Comorbidity, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Nitric Oxide, Severity of Illness Index, Comorbidities, Oral corticosteroid, Adrenal Cortex Hormones, Internal medicine, Severity of illness, Oral corticosteroids, medicine, Prevalence, Nasal polyps, Humans, Registries, Sinusitis, Asthma, Aged, Rhinitis, Internet, Bronchiectasis, business.industry, Nasal polyp, Settore MED/09 - MEDICINA INTERNA, Atopic dermatitis, Middle Aged, medicine.disease, Comorbidities, Nasal polyps, Oral corticosteroids, Severe asthma, Italy, Concomitant, Chronic Disease, Disease Progression, Female, Comorbiditie, business
Abstract: Background The clinical and laboratory features of patients enrolled in the Severe Asthma Network in Italy (SANI) registry, a web-based observatory collecting demographic, clinical, functional and inflammatory data of patients with severe asthma were evaluated, with a special emphasis to chronic rhinosinusitis with nasal polyposis (CRSwNP). Methods For each eligible patients the following information has been collected: demographic data, clinical features, asthma control in the previous month according to the GINA (Global INitiative for Asthma) Guidelines and standardized questionnaires, concomitant regular and on demand treatments and inflammatory markers. Results 695 patients with severe asthma enrolled in 66 SANI centers were analyzed. The prevalence of chronic rhinosinusitis with nasal polyposis was 40.6%. Atopic dermatitis and bronchiectasis was significantly more frequent in patients with CRSwNP than in subjects without nasal polyposis; similarly, FeNO values are significantly higher in subject with CRSwNP than in patients without nasal polyposis. Finally, patients with CRSwNP had a significantly higher number of asthma exacerbations per year, more days on oral corticosteroids and were more likely to be OCS long term users. Conclusion OCS sparing is needed in patients with severe asthma, mainly in subjects with CRSwNP, adopting adequate strategies such as a better adherence to the treatment with inhaled therapy according to the GINA recommendations, the use of biologic agents and a multidisciplinary approach of the patient.
Published: 2020

28. Characterization of Patients in the International Severe Asthma Registry with High Steroid Exposure Who Did or Did Not Initiate Biologic Therapy

Author: Chen, W, Sadatsafavi, M, Tran, TN, Murray, RB, Wong, CBN, Ali, N, Ariti, C, Garcia Gil, E, Newell, A, Alacqua, M, Al-Ahmad, M, Altraja, A, Al-Lehebi, R, Bhutani, M, Bjermer, L, Bjerrum, AS, Bourdin, A, Bulathsinhala, L, von Bulow, A, Busby, J, Canonica, GW, Carter, V, Christoff, GC, Cosio, BG, Costello, RW, FitzGerald, JM, Fonseca, JA, Ha Yoo, K, Heaney, LG, Heffler, E, Hew, M, Hilberg, O, Hoyte, F, Iwanaga, T, Jackson, DJ, Jones, RC, Koh, MS, Kuna, P, Larenas-Linnemann, D, Lehmann, S, Lehtimaki, LA, Lyu, J, Mahboub, B, Maspero, J, Menzies-Gow, AN, Sirena, C, Papadopoulos, N, Papaioannou, A, Perez de Llano, L, Perng, D-W, Peters, M, Pfeffer, PE, Porsbjerg, CM, Popov, TA, Rhee, CK, Salvi, S, Taille, C, Taube, C, Torres-Duque, CA, Ulrik, CS, Ra, SW, Wang, E, Wechsler, ME, Price, DB, Chen, W, Sadatsafavi, M, Tran, TN, Murray, RB, Wong, CBN, Ali, N, Ariti, C, Garcia Gil, E, Newell, A, Alacqua, M, Al-Ahmad, M, Altraja, A, Al-Lehebi, R, Bhutani, M, Bjermer, L, Bjerrum, AS, Bourdin, A, Bulathsinhala, L, von Bulow, A, Busby, J, Canonica, GW, Carter, V, Christoff, GC, Cosio, BG, Costello, RW, FitzGerald, JM, Fonseca, JA, Ha Yoo, K, Heaney, LG, Heffler, E, Hew, M, Hilberg, O, Hoyte, F, Iwanaga, T, Jackson, DJ, Jones, RC, Koh, MS, Kuna, P, Larenas-Linnemann, D, Lehmann, S, Lehtimaki, LA, Lyu, J, Mahboub, B, Maspero, J, Menzies-Gow, AN, Sirena, C, Papadopoulos, N, Papaioannou, A, Perez de Llano, L, Perng, D-W, Peters, M, Pfeffer, PE, Porsbjerg, CM, Popov, TA, Rhee, CK, Salvi, S, Taille, C, Taube, C, Torres-Duque, CA, Ulrik, CS, Ra, SW, Wang, E, Wechsler, ME, and Price, DB
Abstract: BACKGROUND: Many severe asthma patients with high oral corticosteroid exposure (HOCS) often do not initiate biologics despite being eligible. This study aimed to compare the characteristics of severe asthma patients with HOCS who did and did not initiate biologics. METHODS: Baseline characteristics of patients with HOCS (long-term maintenance OCS therapy for at least 1 year, or ≥4 courses of steroid bursts in a year) from the International Severe Asthma Registry (ISAR; https://isaregistries.org/), who initiated or did not initiate biologics (anti-lgE, anti-IL5/5R or anti-IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson's chi-squared tests for categorical variables, and t-tests for continuous variables, adjusting for potential errors in multiple comparisons. RESULTS: Between January 2015 and February 2021, we identified 1412 adult patients with severe asthma from 19 countries that met our inclusion criteria of HOCS, of whom 996 (70.5%) initiated a biologic and 416 (29.5%) did not. The frequency of biologic initiation varied across geographical regions. Those who initiated a biologic were more likely to have higher blood eosinophil count (483 vs 399 cells/µL, p=0.003), serious infections (49.0% vs 13.3%, p<0.001), nasal polyps (35.2% vs 23.6%, p<0.001), airflow limitation (56.8% vs 51.8%, p=0.013), and uncontrolled asthma (80.8% vs 73.2%, p=0.004) despite greater conventional treatment adherence than those who did not start a biologic. Both groups had similar annual asthma exacerbation rates in the previous 12 months (5.7 vs 5.3, p=0.147). CONCLUSION: Around one third of severe HOCS asthma patients did not receive biologics despite a similar high burden of asthma exacerbations as those who initiated a biologic therapy. Other disease characteristics such as eosinophilic phenotype, serious infectious events, nasal polyps, airflow limitation and lack of asthma control appear to dictate bio
Published: 2022

29. Allergy in severe asthma

Author: Del Giacco, S. R., Bakirtas, A., Bel, E., Custovic, A., Diamant, Z., Hamelmann, E., Heffler, E., Kalayci, Ö., Saglani, S., Sergejeva, S., Seys, S., Simpson, A., and Bjermer, L.
Published: 2017
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30. Dupilumab Improved Health-Related Quality of Life in Asthma Patients with Comorbid Chronic Rhinosinusitis: QUEST Study

Author: Hopkins, C., primary, Buchheit, K., additional, Heffler, E., additional, Cohen, N., additional, Olze, H., additional, Khan, A., additional, Msihid, J., additional, Siddiqui, S., additional, Nash, S., additional, Jacob-Nara, J.A., additional, Rowe, P., additional, and Deniz, Y., additional
Published: 2022
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31. Clinical features associated with a doctor-diagnosis of bronchiectasis in the Severe Asthma Network in Italy (SANI) registry

Author: Malipiero, G., Paoletti, G., Blasi, F., Paggiaro, P., Senna, G., Latorre, M., Caminati, M., Carpagnano, G. E., Crimi, N., Spanevello, A., Aliberti, S., Canonica, G. W., Heffler, E., Bonavia, M., Bucca, C., Caiaffa, M. F., Calabrese, C., Camiciottoli, G, Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., D'Alo, S., D'Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino, B. M. P., Guarnieri, G., Guida, G., Lo Cicero, S., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montuschi, P., Montagni, M., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Vianello, A., Viviano, V., Yacoub, M. R., and Zappa, M. C.
Subjects: Pulmonary and Respiratory Medicine, Severe asthma, Pediatrics, medicine.medical_specialty, bronchiectasis, macromolecular substances, registry, phenotypes, real-life, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, Humans, Immunology and Allergy, Medicine, Registries, 030212 general & internal medicine, Bronchiectasis, business.industry, musculoskeletal, neural, and ocular physiology, Public Health, Environmental and Occupational Health, medicine.disease, Asthma, respiratory tract diseases, Italy, nervous system, 030228 respiratory system, Quality of Life, business
Abstract: Several severe asthma comorbidities have been identified: an emerging one is bronchiectasis. We evaluated the frequency of bronchiectasis on severe asthma in a real-life setting, through the 'Severe Asthma Network Italy' (SANI) registry.SANI registry encompasses demographic, clinical, functional and inflammatory data of Italian severe asthmatics. Data obtained by the enrolled patients were analyzed, focusing the attention on those patients with concomitant clinically relevant bronchiectasis.About 15.5% patients have bronchiectasis. Bronchiectasis diagnosis was associated with a higher prevalence of chronic rhinosinusitis with nasal polyps (54.6% vs. 38%, p = 0.001) and higher serum IgE levels (673.4 vs. 412.1 kUI/L, p = 0.013). Patients with bronchiectasis had worse asthma control (ACT: 16.7 vs 18.2, p = 0.013), worse quality of life (AQLQ: 4.08 vs. 4.60, p = 0.02) and lower lung function (FEVsevere asthma associated with bronchiectasis represents a particularly severe asthma variant, possibly driven by an eosinophilic endotype. We, therefore, suggest that bronchiectasis should necessarily be assessed in severe asthmatic patients.
Published: 2020

32. Allergic patients during the COVID-19 pandemic-Clinical practical considerations: An European Academy of Allergy and Clinical Immunology survey

Author: Alvaro M, Mónica Paola Sandoval Ruballos, Giovannini M, Jensen-Jarolim E, Sahiner U, Tomic Spiric V, Quecchia C, Chaker A, Heffler E, Klimek L, Brough H, Sturm G, Untersmayr E, Bonini M, and Pfaar O
Subjects: allergen immunotherapy, COVID-19, biologics, survey, allergy
Abstract: Background The COVID-19 pandemic has affected health care systems unexpectedly. However, data focusing on practical considerations experienced by health care professionals (HCPs) providing care to allergic patients is scarce. Methods Under the framework of the European Academy of Allergy and Clinical Immunology (EAACI), a panel of experts in the field of immunotherapy developed a 42-question online survey, to evaluate real-life consequences of the COVID-19 pandemic in allergy practice. Results The respondents in the survey were 618. About 80% of HCPs indicated being significantly affected in their allergy practice. A face-to-face visit reduction was reported by 93% of HCPs and about a quarter completely interrupted diagnostic challenges. Patients with severe uncontrolled asthma (59%) and anaphylaxis (47%) were prioritized for in-person care. About 81% maintained an unaltered prescription of inhaled corticosteroids (ICS) in asthmatics. About 90% did not modify intranasal corticosteroids (INCS) in patients with allergic rhinitis. Nearly half of respondents kept biological prescriptions unmodified for asthma. About 50% of respondents kept their allergen immunotherapy (AIT) prescription patterns unchanged for respiratory allergies; 60% for insect venom allergies. Oral immunotherapy (OIT) for food allergies was initiated by 27%. About 20% kept carrying out up-dosing without modifications and 14% changed to more prolonged intervals. Telemedicine practice was increased. Conclusions HCPs providing care to allergic patients were affected during the pandemic in diagnostic, management, and therapeutic approaches, including AIT for respiratory, insect-venom, and food allergies. Most HCPs maintained controller treatments for both asthma, and allergic rhinitis consistent with international recommendations, as well as biological agents in asthma. Remote tools are valuable in delivering allergy care.
Published: 2022

33. Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

Author: Porsbjerg, C.M. Menzies-Gow, A.N. Tran, T.N. Murray, R.B. Unni, B. Audrey Ang, S.L. Alacqua, M. Al-Ahmad, M. Al-Lehebi, R. Altraja, A. Belevskiy, A.S. Björnsdóttir, U.S. Bourdin, A. Busby, J. Canonica, G.W. Christoff, G.C. Cosio, B.G. Costello, R.W. FitzGerald, J.M. Fonseca, J.A. Hansen, S. Heaney, L.G. Heffler, E. Hew, M. Iwanaga, T. Jackson, D.J. Kocks, J.W.H. Kallieri, M. Bruce Ko, H.-K. Koh, M.S. Larenas-Linnemann, D. Lehtimäki, L.A. Loukides, S. Lugogo, N. Maspero, J. Papaioannou, A.I. Perez-de-Llano, L. Pitrez, P.M. Popov, T.A. Rasmussen, L.M. Rhee, C.K. Sadatsafavi, M. Schmid, J. Siddiqui, S. Taillé, C. Taube, C. Torres-Duque, C.A. Ulrik, C. Upham, J.W. Wang, E. Wechsler, M.E. Bulathsinhala, L. Carter, V. Chaudhry, I. Eleangovan, N. Hosseini, N. Rowlands, M.-A. Price, D.B. van Boven, J.F.M.
Abstract: Background: Regulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine. Objective: To compare global differences in ease of access to biologics. Methods: In April 2021, national prescription criteria for omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab were reviewed by severe asthma experts collaborating in the International Severe Asthma Registry. Outcomes (per country, per biologic) were (1) country-specific prescription criteria and (2) development of the Biologic Accessibility Score (BACS). The BACS composite score incorporates 10 prescription criteria, each with a maximum score of 10 points. Referenced to European Medicines Agency marketing authorization specifications, a higher score reflects easier access. Results: Biologic prescription criteria differed substantially across 28 countries from five continents. Blood eosinophil count thresholds (usually ≥300 cells/μL) and exacerbations were key requirements for anti-IgE/anti–IL-5/5R prescriptions in around 80% of licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require two or more moderate or severe exacerbations, whereas numbers ranged from none to four. Moreover, 0% (for reslizumab) to 21% (for omalizumab) of countries required long-term oral corticosteroid use. The BACS highlighted marked between-country differences in ease of access. For omalizumab, mepolizumab, benralizumab, and dupilumab, only two, one, four, and seven countries, respectively, scored equal or higher than the European Medicines Agency reference BACS. For reslizumab, all countries scored lower. Conclusions: Although some differences were expected in country-specific biologic prescription criteria and ease of access, the substantial differences found in the current study present a challenge to implementing precision medicine across the world. © 2022 The Authors
Published: 2022

34. Large expert-curated database for benchmarking document similarity detection in biomedical literature search

Author: Brown, P, Zhou, Y, Tan, A, El-Esawi, M, Liehr, T, Blanck, O, Gladue, D, Almeida, G, Cernava, T, Sorzano, C, Yeung, A, Engel, M, Chandrasekaran, A, Muth, T, Staege, M, Daulatabad, S, Widera, D, Zhang, J, Meule, A, Honjo, K, Pourret, O, Yin, C, Zhang, Z, Cascella, M, Flegel, W, Goodyear, C, van Raaij, M, Bukowy-Bieryllo, Z, Campana, L, Kurniawan, N, Lalaouna, D, Huttner, F, Ammerman, B, Ehret, F, Cobine, P, Tan, E, Han, H, Xia, W, Mccrum, C, Dings, R, Marinello, F, Nilsson, H, Nixon, B, Voskarides, K, Yang, L, Costa, V, Bengtsson-Palme, J, Bradshaw, W, Grimm, D, Kumar, N, Martis, E, Prieto, D, Sabnis, S, Amer, S, Liew, A, Perco, P, Rahimi, F, Riva, G, Zhang, C, Devkota, H, Ogami, K, Basharat, Z, Fierz, W, Siebers, R, Tan, K, Boehme, K, Brenneisen, P, Brown, J, Dalrymple, B, Harvey, D, Ng, G, Werten, S, Bleackley, M, Dai, Z, Dhariwal, R, Gelfer, Y, Hartmann, M, Miotla, P, Tamaian, R, Govender, P, Gurney-Champion, O, Kauppila, J, Zhang, X, Echeverria, N, Subhash, S, Sallmon, H, Tofani, M, Bae, T, Bosch, O, Cuiv, P, Danchin, A, Diouf, B, Eerola, T, Evangelou, E, Filipp, F, Klump, H, Kurgan, L, Smith, S, Terrier, O, Tuttle, N, Ascher, D, Janga, S, Schulte, L, Becker, D, Browngardt, C, Bush, S, Gaullier, G, Ide, K, Meseko, C, Werner, G, Zaucha, J, Al-Farha, A, Greenwald, N, Popoola, S, Rahman, S, Xu, J, Yang, S, Hiroi, N, Alper, O, Baker, C, Bitzer, M, Chacko, G, Debrabant, B, Dixon, R, Forano, E, Gilliham, M, Kelly, S, Klempnauer, K, Lidbury, B, Lin, M, Lynch, I, Ma, W, Maibach, E, Mather, D, Nandakumar, K, Ohgami, R, Parchi, P, Tressoldi, P, Xue, Y, Armitage, C, Barraud, P, Chatzitheochari, S, Coelho, L, Diao, J, Doxey, A, Gobet, A, Hu, P, Kaiser, S, Mitchell, K, Salama, M, Shabalin, I, Song, H, Stevanovic, D, Yadollahpour, A, Zeng, E, Zinke, K, Alimba, C, Beyene, T, Cao, Z, Chan, S, Gatchell, M, Kleppe, A, Piotrowski, M, Torga, G, Woldesemayat, A, Cosacak, M, Haston, S, Ross, S, Williams, R, Wong, A, Abramowitz, M, Effiong, A, Lee, S, Abid, M, Agarabi, C, 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Domingues, H, Esfahlani, S, Falk, S, Guisado, J, Kane, N, Kueberuwa, G, Lau, C, Liang, D, Liu, E, Luu, A, Ma, C, Ma, L, Moyer, R, Norris, A, Panthee, S, Parsons, J, Peng, Y, Pinto, I, Reschke, C, Sillanpaa, E, Stewart, C, Uhle, F, Yang, H, Zhou, K, Zhu, S, Ashry, M, Bergsland, N, Berthold, M, Chen, C, Colella, V, Cuypers, M, Eskew, E, Fan, X, Gajda, M, Gonzalezlez-Prendes, R, Goodin, A, Graham, E, Groen, E, Gutierrez-Sacristan, A, Habes, M, Heffler, E, Higginbottom, D, Janzen, T, Jayaraman, J, Jibb, L, Jongen, S, Kinyanjui, T, Koleva-Kolarova, R, Li, Z, Liu, Y, Lund, B, Lussier, A, Mier, P, Moore, M, Nagler, K, Orme, M, Pearson, J, Prajapati, A, Saito, Y, Troder, S, Uchendu, F, Verloh, N, Voutchkova, D, Abu-Zaid, A, Bakkach, J, Baumert, P, Dono, M, Hanson, J, Herbelet, S, Hobbs, E, Kulkarni, A, Liu, S, Loft, N, Reddan, T, Senghore, T, Vindin, H, Xu, H, Bannon, R, Chen, B, Cheung, J, Cooper, J, Esnakula, A, Feghali, K, Ghelardi, E, Gnasso, A, Horbar, J, Lai, H, Ma, R, Pan, Z, Peres, M, 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J., Ramula S., Rappsilber J., Rehfeldt F., Reiling J. H., Remacle C., Rezaei M., Riddick E. W., Ritter U., Roach N. W., Roberts D. D., Robles G., Rodrigues T., Rodriguez C., Roislien J., Roobol M. J., Rowe A., Ruepp A., van Ruitenbeek J., Rust P., Saad S., Sack G. H., Santos M., Saudemont A., Sava G., Schrading S., Schramm A., Schreiber M., Schuler S., Schymkowitz J., Sczyrba A., Seib K. L., Shi H. -P., Shimada T., Shin J. -S., Shortt C., Silveyra P., Skinner D., Small I., Smeets P. A. M., So P. -W., Solano F., Sonenshine D. E., Song J., Southall T., Speakman J. R., Srinivasan M. V., Stabile L. P., Stasiak A., Steadman K. J., Stein N., Stephens A. W., Stewart D. I., Stine K., Storlazzi C., Stoynova N. V., Strzalka W., Suarez O. M., Sultana T., Sumant A. V., Summers M. J., Sun G., Tacon P., Tanaka K., Tang H., Tanino Y., Targett-Adams P., Tayebi M., Tayyem R., Tebbe C. C., Telfer E. E., Tempel W., Teodorczyk-Injeyan J. A., Thijs G., Thorne S., Thrift A. 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Abstract: Document recommendation systems for locating relevant literature have mostly relied on methods developed a decade ago. This is largely due to the lack of a large offline gold-standard benchmark of relevant documents that cover a variety of research fields such that newly developed literature search techniques can be compared, improved and translated into practice. To overcome this bottleneck, we have established the RElevant LIterature SearcH consortium consisting of more than 1500 scientists from 84 countries, who have collectively annotated the relevance of over 180 000 PubMed-listed articles with regard to their respective seed (input) article/s. The majority of annotations were contributed by highly experienced, original authors of the seed articles. The collected data cover 76% of all unique PubMed Medical Subject Headings descriptors. No systematic biases were observed across different experience levels, research fields or time spent on annotations. More importantly, annotations of the same document pairs contributed by different scientists were highly concordant. We further show that the three representative baseline methods used to generate recommended articles for evaluation (Okapi Best Matching 25, Term Frequency-Inverse Document Frequency and PubMed Related Articles) had similar overall performances. Additionally, we found that these methods each tend to produce distinct collections of recommended articles, suggesting that a hybrid method may be required to completely capture all relevant articles. The established database server located at https://relishdb.ict.griffith.edu.au is freely available for the downloading of annotation data and the blind testing of new methods. We expect that this benchmark will be useful for stimulating the development of new powerful techniques for title and title/abstract-based search engines for relevant articles in biomedical science.
Published: 2019

35. Aligning the good practice mask with the objectives of the European innovation partnership on active and healthy ageing

Author: Bousquet, J., Farrell, J., Illario, M., Onorato, G.L., Bedbrook, A., Czarlewski, W., Micheli, Y., Arnavielhe, S., Ansotegui, I.J., Anto, J.M., Bachert, C., Basagana, X., Bedard, A., Benveniste, S., Bergmann, K.C., Bewick, M., Bindslev-Jensen, C., Bjermer, L., Blain, H., Bosnic-Anticevich, S., Bosse, I., Braido, F., Brussino, L., Camuzat, T., Canonica, G.W., Cardona, V., Martins, P.C., Cecchi, L., Chavannes, N.H., Chu, D.K., Sousa, J.C. da, Costa, D.J., Costa, E., Cruz, A.A., Silva, J. da, Devillier, P., Feo, G. de, Vries, G. de, Dray, G., Ebisawa, M., Erhola, M., Fauquert, J.L., Fokkens, W.J., Fonseca, J., Fontaine, J.M., Gemicioglu, B., Haahtela, T., Heffler, E., Hellings, P.W., Ivancevich, J.C., Jassem, E., Jutel, M., Kaidashev, I., Kalayci, O., Klimek, L., Kowalski, M.L., Kull, I., Kuna, P., Kvedariene, V., Grutta, S. la, Laune, D., Larenas-Linnemann, D., Ierodiakonou, D., L.T.T. le, Lourenco, O., Makris, M., Menditto, E., Monti, R., Morais-Almeida, M., Munter, L., Muraro, A., Murray, R., Maurer, M., Melen, E., Mosges, R., Mullol, J., Niedoszytko, M., O'Hehir, R.E., Okamoto, Y., Papadopoulos, N.G., Passalacqua, G., Patella, V., Pereira, A.M., Pfaar, O., Pham-Thi, N., Portejoie, F., Price, D., Prokopakis, E.P., Psarros, F., Raciborski, F., Regateiro, F., Reitsma, S., Roche, N., Rolland, C., Ryan, D., Samolinski, B., Sastre, J., Scadding, G.K., Schmid-Grendelmeier, P., Schunemann, H.J., Shamji, M., Sheikh, A., Stellato, C., Suppli-Ulrik, C., Somekh, D., Sova, M., Bom, A.T., Tomazic, P.V., Toppila-Salmi, S., Triggiani, M., Tsiligianni, I., Valero, A., Valiulis, A., Valovirta, E., Eerd, M. van, Vasankari, T., Ventura, M.T., Wallace, D., Waserman, S., Yorgancioglu, A., Zidarn, M., Zuberbier, T., ARIA-MASK Study Grp, Bousquet, J., Farrell, J., Onorato, G. L., Bedbrook, A., Czarlewski, W., Micheli, Y., Arnavielhe, S., Illario, M., Ansotegui, I. J., Anto, J. M., Bachert, C., Basagana, X., Bedard, A., Benveniste, S., Bergmann, K. C., Bewick, M., Bindslev-Jensen, C., Bjermer, L., Blain, H., Bosnic-Anticevich, S., Bosse, I., Braido, F., Brussino, L., Camuzat, T., Canonica, G. W., Cardona, V., Carreiro Martins, P., Cecchi, L., Chavannes, N. H., Chu, D. K., Correia da Sousa, J., Costa, D. J., Costa, E., Cruz, A. A., da Silva, J., Devillier, P., de Feo, G., de Vries, G., Dray, G., Ebisawa, M., Erhola, M., Fauquert, J. L., Fokkens, W. J., Fonseca, J., Fontaine, J. M., Gemicioglu, B., Haahtela, T., Heffler, E., Hellings, P. W., Ivancevich, J. C., Jassem, E., Jutel, M., Kaidashev, I., Kalayci, O., Klimek, L., Kowalski, M. L., Kull, I., Kuna, P., Kvedariene, V., la Grutta, S., Laune, D., Larenas-Linnemann, D., Ierodiakonou, D., Le, L. T. T., Lourenco, O., Makris, M., Menditto, E., Monti, R., Morais-Almeida, M., Munter, L., Muraro, A., Murray, R., Maurer, M., Melen, E., Mosges, R., Mullol, J., Niedoszytko, M., O'Hehir, R. E., Okamoto, Y., Papadopoulos, N. G., Passalacqua, G., Patella, V., Pereira, A. M., Pfaar, O., Pham-Thi, N., Portejoie, F., Price, D., Prokopakis, E. P., Psarros, F., Raciborski, F., Regateiro, F., Reitsma, S., Roche, N., Rolland, C., Ryan, D., Samolinski, B., Sastre, J., Scadding, G. K., Schmid-Grendelmeier, P., Schunemann, H. J., Shamji, M., Sheikh, A., Stellato, C., Suppli-Ulrik, C., Somekh, D., Sova, M., Todo Bom, A., Tomazic, P. V., Toppila-Salmi, S., Triggiani, M., Tsiligianni, I., Valero, A., Valiulis, A., Valovirta, E., van Eerd, M., Vasankari, T., Ventura, M. T., Wallace, D., Waserman, S., Yorgancioglu, A., Zidarn, M., Zuberbier, T., Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique (VIMA), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Ghent University Hospital, Department of Dermatology and Allergy Center, Odense University Hospital, The University of Sydney, Informatique, Image, Intelligence Artificielle (I3A), Laboratoire de Génie Informatique et d'Ingénierie de Production (LGI2P), IMT - MINES ALES (IMT - MINES ALES), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-IMT - MINES ALES (IMT - MINES ALES), and Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)
Subjects: Pulmonary and Respiratory Medicine, Process management, Allergy, IMPACT, Immunology, Mobile application, Review, health, Clinical decision support system, GLOBAL ALLIANCE, Asthma, Health, Healthy aging, Mobile applications, Rhinitis, Financial management, 03 medical and health sciences, [SPI]Engineering Sciences [physics], 0302 clinical medicine, Blueprint, QUALITY-OF-LIFE, HDE ALER, Health care, Medicine and Health Sciences, Immunology and Allergy, Medicine, TECHNOLOGY, 030223 otorhinolaryngology, Total quality management, Science & Technology, ARIA, business.industry, Digital transformation, GENERATION CARE PATHWAYS, ALLERGIC RHINITIS, CHRONIC RESPIRATORY-DISEASES, 030228 respiratory system, General partnership, GA(2)LEN, business, Life Sciences & Biomedicine, ASTHMA MULTIMORBIDITY, Health care quality
Abstract: The reference sites of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) were renewed in 2019. The DG Santé good practice Mobile Airways Sentinel networK was reviewed to meet the objectives of the EIP on AHA. It included 1) Management of care process, 2) Blueprint of digital transformation, 3) EIP on AHA, innovation to market, 4) Community for monitoring and assessment framework, 5) Political, organizational, technological and financial readiness, 6) Contributing to European co-operation and transferability, 7) Delivering evidence of impact against the triple win approach, 8) Contribution to the European Digital Transformation of Health and Care and 9) scale of demonstration and deployment of innovation. ispartof: ALLERGY ASTHMA & IMMUNOLOGY RESEARCH vol:12 issue:2 pages:238-258 ispartof: location:Korea (South) status: published
Published: 2020

36. Proposal of 0.5 mg of protein/100 g of processed food as threshold for voluntary declaration of food allergen traces in processed food—A first step in an initiative to better inform patients and avoid fatal allergic reactions: A GA²LEN position paper

Author: Zuberbier, T. Dörr, T. Aberer, W. Alvaro, M. Angier, E. Arasi, S. Arshad, H. Ballmer-Weber, B. Bartra, J. Beck, L. Bégin, P. Bindslev-Jensen, C. Bislimovska, J. Bousquet, J. Brockow, K. Bush, A. Cianferoni, A. Cork, M.J. Custovic, A. Darsow, U. de Jong, N. Deleanu, D. Del Giacco, S. Deschildre, A. Dunn Galvin, A. Ebisawa, M. Fernández-Rivas, M. Ferrer, M. Fiocchi, A. Gerth van Wijk, R. Gotua, M. Grimshaw, K. Grünhagen, J. Heffler, E. Hide, M. Hoffmann-Sommergruber, K. Incorvaia, C. Janson, C. Malte John, S. Jones, C. Jutel, M. Katoh, N. Kendziora, B. Kinaciyan, T. Knol, E. Kurbacheva, O. Lau, S. Loh, R. Lombardi, C. Mäkelä, M. Marchisotto, M.J. Makris, M. Maurer, M. Meyer, R. Mijakoski, D. Minov, J. Mullol, J. Nilsson, C. Nowak–Wegrzyn, A. Nwaru, B.I. Odemyr, M. Pajno, G.B. Paudel, S. Papadopoulos, N.G. Renz, H. Ricci, G. Ring, J. Rogala, B. Sampson, H. Senna, G. Sitkauskiene, B. Smith, P.K. Stevanovic, K. Stoleski, S. Szajewska, H. Tanaka, A. Todo-Bom, A. Topal, F.A. Valovirta, E. Van Ree, R. Venter, C. Wöhrl, S. Wong, G.W.K. Zhao, Z. Worm, M.
Subjects: digestive, oral, and skin physiology
Abstract: Background: Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as “may contain traces of” is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin. Methods: MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results. Results: In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds. Conclusion: Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement “this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product” for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged. © 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
Published: 2021

37. Eosinophilic and Noneosinophilic Asthma: An Expert Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe Asthma Cohort.

Author: Heaney, LG, Perez de Llano, L, Al-Ahmad, M, Backer, V, Busby, J, Canonica, GW, Christoff, GC, Cosio, BG, FitzGerald, JM, Heffler, E, Iwanaga, T, Jackson, DJ, Menzies-Gow, AN, Papadopoulos, NG, Papaioannou, AI, Pfeffer, PE, Popov, TA, Porsbjerg, CM, Rhee, CK, Sadatsafavi, M, Tohda, Y, Wang, E, Wechsler, ME, Alacqua, M, Altraja, A, Bjermer, L, Björnsdóttir, US, Bourdin, A, Brusselle, GG, Buhl, R, Costello, RW, Hew, M, Koh, MS, Lehmann, S, Lehtimäki, L, Peters, M, Taillé, C, Taube, C, Tran, TN, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Kerkhof, M, Murray, RB, Price, CA, Price, DB, Heaney, LG, Perez de Llano, L, Al-Ahmad, M, Backer, V, Busby, J, Canonica, GW, Christoff, GC, Cosio, BG, FitzGerald, JM, Heffler, E, Iwanaga, T, Jackson, DJ, Menzies-Gow, AN, Papadopoulos, NG, Papaioannou, AI, Pfeffer, PE, Popov, TA, Porsbjerg, CM, Rhee, CK, Sadatsafavi, M, Tohda, Y, Wang, E, Wechsler, ME, Alacqua, M, Altraja, A, Bjermer, L, Björnsdóttir, US, Bourdin, A, Brusselle, GG, Buhl, R, Costello, RW, Hew, M, Koh, MS, Lehmann, S, Lehtimäki, L, Peters, M, Taillé, C, Taube, C, Tran, TN, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Kerkhof, M, Murray, RB, Price, CA, and Price, DB
Abstract: BACKGROUND: Phenotypic characteristics of patients with eosinophilic and noneosinophilic asthma are not well characterized in global, real-life severe asthma cohorts. RESEARCH QUESTION: What is the prevalence of eosinophilic and noneosinophilic phenotypes in the population with severe asthma, and can these phenotypes be differentiated by clinical and biomarker variables? STUDY DESIGN AND METHODS: This was an historical registry study. Adult patients with severe asthma and available blood eosinophil count (BEC) from 11 countries enrolled in the International Severe Asthma Registry (January 1, 2015-September 30, 2019) were categorized according to likelihood of eosinophilic phenotype using a predefined gradient eosinophilic algorithm based on highest BEC, long-term oral corticosteroid use, elevated fractional exhaled nitric oxide, nasal polyps, and adult-onset asthma. Demographic and clinical characteristics were defined at baseline (ie, 1 year before or closest to date of BEC). RESULTS: One thousand seven hundred sixteen patients with prospective data were included; 83.8% were identified as most likely (grade 3), 8.3% were identified as likely (grade 2), and 6.3% identified as least likely (grade 1) to have an eosinophilic phenotype, and 1.6% of patients showed a noneosinophilic phenotype (grade 0). Eosinophilic phenotype patients (ie, grades 2 or 3) showed later asthma onset (29.1 years vs 6.7 years; P < .001) and worse lung function (postbronchodilator % predicted FEV1, 76.1% vs 89.3%; P = .027) than those with a noneosinophilic phenotype. Patients with noneosinophilic phenotypes were more likely to be women (81.5% vs 62.9%; P = .047), to have eczema (20.8% vs 8.5%; P = .003), and to use anti-IgE (32.1% vs 13.4%; P = .004) and leukotriene receptor antagonists (50.0% vs 28.0%; P = .011) add-on therapy. INTERPRETATION: According to this multicomponent, consensus-driven, and evidence-based eosinophil gradient algorithm (using variables readily accessible in real life)
Published: 2021

38. Severe asthma: One disease and multiple definitions

Author: Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Paggiaro, P., Latorre, M., Folli, C., Testino, E., Bassi, A., Milanese, M., Heffler, E., Manfredi, A., Riccio, A. M., De Ferrari, L., Blasi, F., Canevari, R. F., Canonica, G. W., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, G. E., Colle, A. D., Scioscia, G., Gerolamo, P., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Lombardi, Celestino Pio, Spadaro, G., Detoraki, C., Menzella, F., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Rolla, G., Brussino, L., Frazzetto, A. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, Cristiano, Colantuono, S., Senna, G., Caminati, M., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Lombardi C. (ORCID:0000-0001-8910-6693), Berti A., Bertolini F., Guida G., Eleonora Nucera. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Caruso C., Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.
Abstract: Introduction: There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods: Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED, NICE, WHO, ATS/ERS, GINA, ENFUMOSA, and TENOR. Results: 540 patients, were extracted from the SANI database. We observed that 462 (86%) met the ATS/ERS criteria as well as the GINA criteria, 259 (48%) the U-Biopred, 222 (41%) the NICE, 125 (23%) the WHO, 313 (58%) the Enfumosa, and 251 (46%) the TENOR criteria. The mean eosinophil value were similar in the ATS/ERS, U-Biopred, and Enfumosa (528, 532 and 516 cells/mcl), higher in WHO and Tenor (567 and 570 cells/mcl) and much higher in the NICE classification (624 cells/mcl). Lung function tests resulted similarly in all groups, with WHO (67%) and ATS/ERS-GINA (73%), respectively, showing the lower and upper mean FEV1 values. Conclusions: The present observations clearly evidence the heterogeneity in the distribution of patients when different definitions of severe asthma are used. However, the recent definition of severe asthma, provided by the GINA document, is similar to that indicated in 2014 by ATS/ERS, allowing mirror reclassification of the patients examined. This lack of homogeneity could complicate the access to biological therapies. The definition provided by the GINA document, which reflects what suggested by ATS/ERS, could partially overcome the problem.
Published: 2021

39. Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Author: Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), Lo Cicero S., Bagnasco, D., Povero, M., Pradelli, L., Brussino, L., Rolla, G., Caminati, M., Menzella, F., Heffler, E., Canonica, G. W., Paggiaro, P., Senna, G., Milanese, M., Lombardi, C., Bucca, C., Manfredi, A., Canevari, R. F., Passalacqua, G., Guarnieri, G., Patella, V., Maria Pia, F. B., Carpagnano, E., Colle, A. D., Scioscia, G., Gerolamo, P., Latorre, M., Puggioni, F., Racca, F., Favero, E., Iannacone, S., Savi, E., Montagni, M., Camiciottoli, G., Allegrini, C., Spadaro, G., Detoraki, C., Galeone, C., Ruggiero, P., Yacoub, M. R., Berti, Andrea, Colombo, G., Scichilone, N., Durante, C., Costantino, M. T., Roncallo, C., Braschi, M., Blasi, F., D'Adda, A., Ridolo, E., Triggiani, M., Parente, R., Maria, D. A., Verrillo, M. V., Cristina, Z. M., Lilli, M., Crimi, N., Bonavia, M., Corsico, A. G., Grosso, A., Del Giacco, S., Deidda, M., Ricciardi, L., Isola, S., Cicero, F., Amato, G., Vita, F., Spanevello, A., Pignatti, P., Cherubino, F., Visca, D., Aletti, E., Massimo Ricciardolo, F. L., Anna Carriero, V. M., Bertolini, Francesca, Santus, P., Barlassina, R., Airoldi, A., Guida, Maria Grazia, Nucera, Eleonora, Aruanno, A., Rizzi, Angela, Caruso, C., Colantuono, S., Arcolaci, A., Vianello, A., Bianchi, F. C., Marchi, M. R., Centanni, S., Luraschi, S., Ruggeri, S., Rinaldo, R., Parazzini, E., Calabrese, Anna Chiara, Flora, M., Cosmi, L., Di Pietro, L., Maggi, E., Pini, L., Macchia, L., Di Bona, D., Richeldi, Luca, Condoluci, Carola, Fuso, Leonello, Bonini, Matteo, Farsi, A., Carli, G., Montuschi, Paolo, Santini, G., Conte, M. E., Turchet, E., Barbetta, C., Mazza, F., D'Alo, S., Pucci, S., Caiaffa, M. F., Minenna, E., D'Elia, L., Pasculli, C., Viviano, V., Tarsia, P., Rolo, J., Di Proietto, M., Lo Cicero, Stefano, Berti A., Bertolini F., Guida G., Eleonora N. (ORCID:0000-0002-0565-7680), Rizzi A. (ORCID:0000-0002-6795-746X), Calabrese C., Richeldi L. (ORCID:0000-0001-8594-1448), Condoluci C., Fuso L. (ORCID:0000-0002-1198-6712), Bonini M. (ORCID:0000-0002-3042-0765), Montuschi P. (ORCID:0000-0001-5589-1750), and Lo Cicero S.
Abstract: Background and aims: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods: Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of working days lost due to the disease. The primary objective was to compare the annual total cost per patient pre- and post-MEP. Secondary outcomes included rates of exacerbations and number of OCS-dependent patients. Results: 106 patients were enrolled in the study: 46 male, median age 58 years. Mean annual cost pre- and post-MEP (cost of biologic excluded) was €3996 and €1,527, respectively. Total savings due to MEP resulted in €2469 (95%CI 1945–2993), 62% due to exacerbations reduction and 33% due to productivity increase. Such savings could fund about 22% of the total cost of MEP for one year. The introduction of MEP induced a clinical benefit by reducing both OCS-dependent patients (OR = 0.12, 95%CI 0.06–0.23) and exacerbation rate (RR = 0.19, 95%CI 0.15–0.24). Conclusions: Patients with severe eosinophilic asthma experienced a clinical benefit in asthma control adding MEP to standard therapy. Biologic therapy can be, partially, funded by the savings produced by patients’ improvement.
Published: 2021

40. Rapid and Sustained Effects of Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal Polyps: Analysis of the SINUS-24 and SINUS-52 Phase 3 Trails

Author: Hellings, P.W., primary, Peters, A., additional, Chaker, A.M., additional, Heffler, E., additional, Zhang, H., additional, Daizadeh, N., additional, Nash, S., additional, Khan, A.H., additional, Siddiqui, S., additional, and Jacob-Nara, J.A., additional
Published: 2021
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41. Sleep impairment during COVID-19 pandemic in Italy: an online survey

Author: Ferri, S, primary, Baiardini, I, additional, Di Trana, G, additional, Heffler, E, additional, Cirignotta, F, additional, and Puggioni, F, additional
Published: 2021
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42. International Severe Asthma Registry Mission Statement

Author: Canonica, GW, Alacqua, M, Altraja, A, Backer, V, Bel, E, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, GG, Christoff, GC, Cosio, BG, Costello, RW, FitzGerald, JM, Gibson, PG, Heaney, LG, Heffler, E, Hew, M, Iwanaga, T, Jones, RC, Siyue, MK, Rhee, CK, Lehmann, S, Lehtimaki, LA, Ludviksdottir, D, Maitland-van der Zee, AH, Menzies-Gow, AN, Papadopoulos, NG, Plaza, V, de Llano, LP, Peters, M, Porsbjerg, CM, Sadatsafavi, M, Cho, YS, Tohda, Y, Tran, TN, Wang, E, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Le, TL, Murray, RB, Price, CA, Price, DB, and ISAR Study Grp
Subjects: asma, ISAR, severe asthma, sistema de registros, International Cooperation, humanos, Humans, cooperación internacional, Registries, índice de gravedad de la enfermedad, Severity of Illness Index, Asthma
Abstract: Regional and/or national severe asthma registries provide valuable country-specific information. However, they are often limited in scope within the broader definitions of severe asthma, have insufficient statistical power to answer many research questions, lack intraoperability to share lessons learned, and have fundamental differences in data collected, making cross comparisons difficult. What is missing is a worldwide registry which brings all severe asthma data together in a cohesive way, under a single umbrella, based on standardized data collection protocols, permitting data to be shared seamlessly. The International Severe Asthma Registry (ISAR; http://isaregistries.org/) is the first global adult severe asthma registry. It is a joint initiative where national registries (both newly created and preexisting) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research purposes. Its strength comes from collection of patient-level, anonymous, longitudinal, real-life, standardized, high-quality data (using a core set of variables) from countries across the world, combined with organizational structure, database experience, inclusivity/openness, and clinical, academic, and database expertise. This gives ISAR sufficient statistical power to answer important research questions, sufficient data standardization to compare across countries and regions, and the structure and expertise necessary to ensure its continuance and the scientific integrity and clinical applicability of its research. ISAR offers a unique opportunity to implement existing knowledge, generate new knowledge, and identify the unknown, therefore promoting new research. The aim of this commentary is to fully describe how ISAR may improve our understanding of severe asthma., ISAR is conducted by Optimum Patient Care Global (OPC) Limited, and cofunded by OPC Limited and AstraZeneca.
Published: 2020

43. Frequency of tiotropium bromide use and clinical features of patients with severe asthma in a real-life setting: Data from the severe asthma network in Italy (sani) registry

Author: Puggioni, F., Brussino, L., Canonica, G. W., Blasi, F., Paggiaro, P., Caminati, M., Latorre, M., Heffler, E., Senna, G., Sani, Group, Bonavia, M., Caiaffa, Mf., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, Me., Corsico, Ag., Cosmi, L., Costantino, Mt., Crimi, N., D’Alo, S., D’Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino, Bmp., Guarnieri, G., Guida, G., Yacoub, Mr., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Paoletti, G., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardi, L., Ricciardolo, Flm., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Zappa, Mc., Concetta, Sirena., Daniela, Morrone, and Silvia, Rabotti
Subjects: lcsh:Immunologic diseases. Allergy, Pulmonary and Respiratory Medicine, severe asthma, registry, long-acting muscarinic antagonists, real-ligfe, medicine.medical_specialty, Registry, Severe asthma, Respimat, real-life, Exacerbation, Long-acting muscarinic antagonists, Real-life, Umeclidinium bromide, Internal medicine, Journal of Asthma and Allergy, Immunology and Allergy, Medicine, Glycopyrronium bromide, Original Research, Asthma, Bronchiectasis, biology, business.industry, Tiotropium bromide, Lama, medicine.disease, biology.organism_classification, respiratory tract diseases, real-ligfe, lcsh:RC581-607, business, medicine.drug
Abstract: Francesca Puggioni,1,2 Luisa Brussino,3 Giorgio Walter Canonica,1,2 Francesco Blasi,4,5 Pierluigi Paggiaro,6 Marco Caminati,7,8 Manuela Latorre,6 Enrico Heffler,1,2 Gianenrico Senna7,8 On behalf of the Severe Asthma Network in Italy (SANI) group1Personalized Medicine, Asthma and Allergy – Humanitas Clinical and Research Center, IRCCS – Rozzano (MI), Milan, Italy; 2Department of Biomedical Sciences, Humanitas University – Pieve Emanuele (MI), Milan, Italy; 3Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I – Torino, Torino, Italy; 4Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; 5Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy; 6Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy; 7Department of Medicine, University of Verona, Verona, Italy; 8Allergy Unit and Asthma Center, Verona University Hospital, Verona, Verona, ItalyCorrespondence: Enrico HefflerPersonalized Medicine, Asthma and Allergy, Istituto Clinico Humanitas, Milan, ItalyTel +39 0288247013Fax + 39 0282246484Email enrico.heffler@hunimed.euPurpose: Patients with uncontrolled asthma despite high doses of inhaled corticosteroid therapy plus another controller are defined as severe asthmatics. Tiotropium bromide respimat (TBR) is the only long-acting muscarinic antagonists (LAMA) approved for severe asthma. The aim of this study was to explore the frequency of severe asthmatics treated with TBR and characterize their clinical features in a real-life, registry-based setting.Materials and Methods: Baseline data from the Severe Asthma Network in Italy (SANI) registry have been analyzed to determine the use of TBR and other LAMA, and to compare clinical, functional and inflammatory features associated with the use of LAMA.Results: Among a total of 698 enrolled patients, 35.9% were treated with LAMA (23.3% TBR, 4.5% tiotropium bromide handihaler, 4.5% aclidinium, 3.4% glycopyrronium bromide 0.3% umeclidinium bromide). Age of asthma onset was higher in patients taking LAMA, whom, compared to others were more frequently former smokers. They also had a higher annual exacerbation rate, experienced worst asthma control, worst disease-related quality of life and poorer lung function. Bronchiectasis was more frequently found in LAMA users (25.9% vs 13.1%).Conclusion: TBR is still underused in severe asthma in a real-life setting, while a relevant proportion of patients are treated with other LAMA that are not approved for severe asthma treatment. Patients taking LAMA have features characteristic of even more severe asthma.Keywords: severe asthma, registry, long-acting muscarinic antagonists, real-ligfe
Published: 2020

44. Aligning the good practice mask with the objectives of the European innovation partnership on active and healthy ageing

Author: Bousquet, J. and Farrell, J. and Onorato, G.L. and Bedbrook, A. and Czarlewski, W. and Micheli, Y. and Arnavielhe, S. and Illario, M. and Ansotegui, I.J. and Anto, J.M. and Bachert, C. and Basagaña, X. and Bédard, A. and Benveniste, S. and Bergmann, K.C. and Bewick, M. and Bindslev-Jensen, C. and Bjermer, L. and Blain, H. and Bosnic-Anticevich, S. and Bosse, I. and Braido, F. and Brussino, L. and Camuzat, T. and Canonica, G.W. and Cardona, V. and Carreiro Martins, P. and Cecchi, L. and Chavannes, N.H. and Chu, D.K. and Correia da Sousa, J. and Costa, D.J. and Costa, E. and Cruz, A.A. and da Silva, J. and Devillier, P. and de Feo, G. and de Vries, G. and Dray, G. and Ebisawa, M. and Erhola, M. and Fauquert, J.L. and Fokkens, W.J. and Fonseca, J. and Fontaine, J.M. and Gemicioğlu, B. and Haahtela, T. and Heffler, E. and Hellings, P.W. and Ivancevich, J.C. and Jassem, E. and Jutel, M. and Kaidashev, I. and Kalayci, O. and Klimek, L. and Kowalski, M.L. and Kull, I. and Kuna, P. and Kvedariene, V. and la Grutta, S. and Laune, D. and Larenas-Linnemann, D. and Ierodiakonou, D. and Le, L.T.T. and Lourenço, O. and Makris, M. and Menditto, E. and Monti, R. and Morais-Almeida, M. and Münter, L. and Muraro, A. and Murray, R. and Maurer, M. and Melén, E. and Mösges, R. and Mullol, J. and Niedoszytko, M. and O'Hehir, R.E. and Okamoto, Y. and Papadopoulos, N.G. and Passalacqua, G. and Patella, V. and Pereira, A.M. and Pfaar, O. and Pham-Thi, N. and Portejoie, F. and Price, D. and Prokopakis, E.P. and Psarros, F. and Raciborski, F. and Regateiro, F. and Reitsma, S. and Roche, N. and Rolland, C. and Ryan, D. and Samolinski, B. and Sastre, J. and Scadding, G.K. and Schmid-Grendelmeier, P. and Schünemann, H.J. and Shamji, M. and Sheikh, A. and Stellato, C. and Suppli-Ulrik, C. and Somekh, D. and Sova, M. and Todo Bom, A. and Tomazic, P.V. and Toppila-Salmi, S. and Triggiani, M. and Tsiligianni, I. and Valero, A. and Valiulis, A. and Valovirta, E. and van Eerd, M. and Vasankari, T. and Ventura, M.T. and Wallace, D. and Waserman, S. and Yorgancioglu, A. and Zidarn, M. and Zuberbier, T., CHU Arnaud de Villeneuve, Montpellier, France, MACVIA-France, Montpellier, France, INSERM U 1168, VIMA: Ageing and Chronic Diseases Epidemiological and Public Health Approaches, Villejuif, France, UMR-S 1168, Université Versailles St-Quentin-en-Yvelines, Montigny le Bretonneux, France, Euforea, Brussels, Belgium, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Berlin, Germany, Department of Dermatology and Allergy, Berlin Institute of Health, Comprehensive Allergy Center, Berlin, Germany, LANUA International Healthcare Consultancy, Belfast, Northern Ireland, United Kingdom, Medical Consulting Czarlewski, Levallois, France, KYomed INNOV, Montpellier, France, Division for Health Innovation, Campania Region and Federico II University Hospital Naples (R&D Unit and Department of Public Health), Naples, Italy, Department of Allergy and Immunology, Hospital Quirónsalud Bizkaia, Erandio, Spain, ISGlobAL, Centre for Research in Environmental Epidemiology (CREAL), Barcelona, Spain, Hospital del Mar Research Institute (IMIM), Barcelona, Spain, CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain, Universitat Pompeu Fabra (UPF), Barcelona, Spain, Upper Airways Research Laboratory, Department of ENT, Ghent University Hospital, Ghent, Belgium, National Center of Expertise in Cognitive Stimulation (CEN STIMCO), Broca Hospital, Paris, France, Mines ParisTech CRI - PSL Research University, Fontainebleau, France, iQ4U Consultants Ltd, London, United Kingdom, Department of Dermatology and Allergy Centre, Odense University Hospital, Odense Research Center for Anaphylaxis (ORCA), Odense, Denmark, Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden, Department of Geriatrics, Montpellier University Hospital, Montpellier, France, EA 2991, Euromov, University, Montpellier, France, Woolcock Institute of Medical Research, University of Sydney and Woolcock Emphysema Centre and Sydney Local Health District, Glebe, Australia, La Rochelle, France, University of Genoa, Department of Internal Medicine, DiMI) and IRCCS Ospedale Policlinico San Martino, Genova, Italy, Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino, Mauriziano Hospital, Torino, Italy, Région Occitanie, Montpellier, France, Personalized Medicine Clinic Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano (MI), Italy, Allergy Section, Department of Internal Medicine, Hospital Vall d'Hebron and ARADyAL Research Network, Barcelona, Spain, Serviço de Imunoalergologia, Hospital de Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal, CEDOC-CHRC, Faculdade de Ciências Médicas (FCM), Universidade Nova de Lisboa, Lisbon, Portugal, SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, Canada, Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal, ICVS/3B's, PT Government Associate Laboratory, Braga/Guimarães, Portugal, Nîmes, France, UCIBIO, REQUIMTE, Faculty of Pharmacy, and Competence Center on Active and Healthy Ageing of University of Porto (AgeUPNetWork), University of Porto, Porto, Portugal, ProAR - Nucleo de Excelencia em Asma, Federal University of Bahia, Salvador, Brazil, WHO GARD Planning Group, Salvador, Brazil, Allergy Service, University Hospital of Federal University of Santa Catarina (HU-UFSC), Florianópolis, Brazil, UPRES EA220, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France, Department of Medicine, Surgery and Dentistry 'Scuola Medica Salernitana', University of Salerno, Salerno, Italy, Peercode BV, Geldermalsen, Netherlands, IMT Mines Alès, Université Montpellier, France, Clinical Reserch Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan, National Insitute for Health and Welfare, Helsinki, Finland, CHU Clermont-Ferrand, Unité d'allergologie de l'enfant, Pôle pédiatrique, Hôpital Estaing, Clermont-Ferrand, France, Department of Otorhinolaryngology, Amsterdam University Medical Centres, AMC, Amsterdam, Netherlands, CINTESIS, Center for Research in Health Technology and Information Systems, Faculdade de Medicina da Universidade do Porto, Porto, Portugal, Medida, Lda, Porto, Portugal, Reims, France, Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istambul, Turkey, Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland, Department of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands, Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina, Department of Allergology, Medical University of Gdańsk, Gdańsk, Poland, Department of Clinical Immunology, Wrocław Medical University, Poland, Ukrainina Medical Stomatological Academy, Poltava, Ukraine, Pediatric Allergy and Asthma Unit, Hacettepe University School of Medicine, Ankara, Turkey, Center for Rhinology and Allergology, Wiesbaden, Germany, Department of Immunology and Allergy, Healthy Ageing Research Center, Medical University of Lodz, Poland, Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden, Sach's Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden, Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Poland, Institute of Biomedical Sciences, Department of Pathology, Faculty of Medicine, Vilnius University, Institute of Clinical Medicine, Clinic of Chest diseases and Allergology, Faculty of Medicine, Vilnius, Lithuania, Institute for Research and Biomedical Innovation (IRIB), National Research Council (CNR), Palermo, Italy, Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico, Department of Social Medicine, Faculty of Medicine, University of Crete, International Primary Care Respiratory Group, Crete, Greece, International Primary Care Respiratory Group IPCRG, Aberdeen, United Kingdom, University of Medicine and Pharmacy, Ho Chi Minh City, Viet Nam, Faculty of Health Sciences and CICS - UBI, Health Sciences Research Centre, University of Beira Interior, Covilhã, Portugal, Allergy Unit 'D Kalogeromitros', 2nd Department of Dermatology and Venereology, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece, CIRFF, Center of Pharmacoeconomics, University of Naples Federico II, Naples, Italy, Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal, Danish Commitee for Health Education, Copenhagen East, Denmark, Food Allergy Referral Centre Veneto Region, Department of Women and Child Health, Padua General University Hospital, Padua, Italy, MedScript, Paraparaumu, New Zealand, Optimum Patient Care, Cambridge, United Kingdom, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, Institute of Medical Statistics, and Computational Biology, Medical Faculty, University of Cologne, Germany and CRI-Clinical Research International-Ltd, Hamburg, Germany, Rhinology Unit and Smell Clinic, Department of ENT, Hospital Clínic, Barcelona, Spain, Clinical and Experimental Respiratory Immunoallergy, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain, Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Central Clinical School, Monash University, Melbourne, Australia, Department of Immunology, Monash University, Melbourne, Australia, Department of Otorhinolaryngology, Chiba University Hospital, Chiba, Japan, Division of Infection, Immunity and Respiratory Medicine, Royal Manchester Children's Hospital, University of Manchester, Manchester, United Kingdom, Department of Allergy, 2nd Pediatric Clinic, Athens General Children's Hospital 'P&A Kyriakou,', University of Athens, Athens, Greece, Allergy and Respiratory Diseases, Ospedale Policlino San Martino, University of Genoa, Italy, Division of Allergy and Clinical Immunology, Department of Medicine, Agency of Health ASL Salerno, Santa Maria della Speranza Hospital, Salerno, Italy, Allergy Unit, CUF-Porto Hospital and Institute, Porto, Portugal, Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Germany, Department of Allergy, Pasteur Institute, Paris, France, Observational and Pragmatic Research Institute, Singapore, Singapore, Department of Otorhinolaryngology, University of Crete, School of Medicine, Heraklion, Greece, Allergy Department, Athens Naval Hospital, Athens, Greece, Department of Prevention of Envinronmental Hazards and Allergology, Medical University of Warsaw, Warsaw, Poland, Imunoalergologia, Centro Hospitalar Universitário de Coimbra, Faculty of Medicine, University of Coimbra, Portugal, Pneumologie et Soins Intensifs Respiratoires, Hôpitaux Universitaires Paris, Centre Hôpital Cochin, Paris, France, Association Asthme et Allergie, Paris, France, Allergy and Respiratory Research Group, University of Edinburgh, Edinburgh, United Kingdom, Faculty of Medicine, Autnonous University of Madrid, Spain, Royal National TNE Hospital, University College London, London, United Kingdom, Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zürich, Switzerland, Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Imperial College London, London, United Kingdom, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, United Kingdom, Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark, European Health Futures Forum (EHFF), Dromahair, Ireland, Department of Respiratory Medicine, University Hospital Olomouc, Olomouc, Czech Republic, Imunoalergologia, Centro Hospitalar Universitário de Coimbra, Faculty of Medicine, University of Coimbra, Coimbra, Portugal, Department of General ORL, H1NS, Medical University of Graz, Graz, Austria, Vilnius University Faculty of Medicine, Institute of Clinical Medicine, Institute of Health Sciences, Vilnius, Lithuania, European Academy of Paediatrics (EAP/UEMS-SP), Brussels, Belgium, Department of Lung Diseases and Clinical Immunology, University of Turku and Terveystalo Allergy Clinic, Turku, Finland, FILHA, Finnish Lung Association, Helsinki, Finland, University of Bari Medical School, Unit of Geriatric Immunoallergology, Bari, Italy, Nova Southeastern University, Fort Lauderdale, FL, United States, Department of Pulmonary Diseases, Celal Bayar University, Faculty of Medicine, Manisa, Turkey, and University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia
Abstract: The reference sites of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) were renewed in 2019. The DG Santé good practice Mobile Airways Sentinel networK was reviewed to meet the objectives of the EIP on AHA. It included 1) Management of care process, 2) Blueprint of digital transformation, 3) EIP on AHA, innovation to market, 4) Community for monitoring and assessment framework, 5) Political, organizational, technological and financial readiness, 6) Contributing to European co-operation and transferability, 7) Delivering evidence of impact against the triple win approach, 8) Contribution to the European Digital Transformation of Health and Care and 9) scale of demonstration and deployment of innovation. © 2020 The Korean Academy of Asthma, Allergy and Clinical Immunology • The Korean Academy of Pediatric Allergy and Respiratory Disease This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https:// creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Published: 2020

45. Acute asthma management during SARS-CoV2-pandemic 2020

Author: Levin, M. Ansotegui, I.J. Bernstein, J. Chang, Y.-S. Chikhladze, M. Ebisawa, M. Fiocchi, A. Heffler, E. Martin, B. Morais-Almeida, M. Papadopoulos, N.G. Peden, D. Wong, G.W.K.
Abstract: Background: The current COVID-19 pandemic has changed many medical practices in order to provide additional protection to both our patients and healthcare providers. In many cases this includes seeing patients through electronic means such as telehealth or telephone rather than seeing them in person. Asthma exacerbations cannot always be treated in this way. Problem: Current emergency unit asthma guidelines recommend bronchodilators be administered by metered dose inhaler (MDI) and spacer for mild-moderate asthma and include it as a choice even in severe asthma, but many emergency units continue to prefer nebulised therapy for patients who urgently require beta-agonists. The utilization of nebulised therapy potentially increases the risk of aerosolization of the coronavirus. Since nosocomial transmission of respiratory pathogens is a major threat in the context of the SARS-CoV-2 pandemic, use of nebulised therapy is of even greater concern due to the potential increased risk of infection spread to nearby patients and healthcare workers. Practical implications: We propose a risk stratification plan that aims to avoid nebulised therapy, when possible, by providing an algorithm to help better delineate those who require nebulised therapy. Protocols that include strategies to allow flexibility in using MDIs rather than nebulisers in all but the most severe patients should help mitigate this risk of aerosolised infection transmission to patients and health care providers. Furthermore, expedient treatment of patients with high dose MDI therapy augmented with more rapid initiation of systemic therapy may help ensure patients are less likely to deteriorate to the stage where nebulisers are required. © 2020 The Author(s)
Published: 2020

46. International severe asthma registry (ISAR): Protocol for a global registry

Author: Fitzgerald, J.M. Tran, T.N. Alacqua, M. Altraja, A. Backer, V. Bjermer, L. Bjornsdottir, U. Bourdin, A. Brusselle, G. Bulathsinhala, L. Busby, J. Canonica, G.W. Carter, V. Chaudhry, I. Cho, Y.S. Christoff, G. Cosio, B.G. Costello, R.W. Eleangovan, N. Gibson, P.G. Heaney, L.G. Heffler, E. Hew, M. Hosseini, N. Iwanaga, T. Jackson, D.J. Jones, R. Koh, M.S. Le, T. Lehtimäki, L. Ludviksdottir, D. Maitland-Van Der Zee, A.H. Menzies-Gow, A. Murray, R.B. Papadopoulos, N.G. Perez-De-Llano, L. Peters, M. Pfeffer, P.E. Popov, T.A. Porsbjerg, C.M. Price, C.A. Rhee, C.K. Sadatsafavi, M. Tohda, Y. Wang, E. Wechsler, M.E. Zangrilli, J. Price, D.B.
Abstract: Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally. © 2020 The Author(s).
Published: 2020

47. International severe asthma registry (ISAR): protocol for a global registry

Author: FitzGerald, J.M. (J Mark), Tran, T.N. (Trung N.), Alacqua, M. (Marianna), Altraja, A. (Alan), Backer, V. (Vibeke), Bjermer, L. (Leif), Bjornsdottir, U. (Unnur), Bourdin, A. (Arnaud), Brusselle, G.G. (Guy), Bulathsinhala, L. (Lakmini), Busby, J. (John), Canonica, G. (Gwalter), Carter, V. (Victoria), Chaudhry, I. (Isha), Cho, Y.S. (You Sook), Christoff, G. (George), Cosio, B.G. (Borja G.), Costello, A. (Anthony), Eleangovan, N. (Neva), Gibson, P.G., Heaney, L.G. (Liam G.), Heffler, E. (E.), Hew, M. (Mark), Hosseini, N. (Naeimeh), Iwanaga, T. (Takashi), Jackson, D.J. (David J.), Jones, R. (Rupert), Koh, M.S. (Mariko S.), Le, T. (Thao), Lehtimäki, L. (Lauri), Ludviksdottir, D. (Dora), Maitland-van der Zee, A-H. (Anke-Hilse), Menzies-Gow, A. (Andrew), Murray, R.B. (Ruth B.), Papadopoulos, N., Perez-de-Llano, L. (Luis), Peters, M. (Matthew), Pfeffer, P.E. (Paul E.), Popov, T.A., Porsbjerg, C. (Celeste), Price, C.A. (Chris A.), Rhee, C.K. (Chin K.), Sadatsafavi, M. (Mohsen), Tohda, Y. (Yuji), Wang, E. (Eileen), Wechsler, M.E. (Michael E.), Zangrilli, J. (James), Price, D. (David), FitzGerald, J.M. (J Mark), Tran, T.N. (Trung N.), Alacqua, M. (Marianna), Altraja, A. (Alan), Backer, V. (Vibeke), Bjermer, L. (Leif), Bjornsdottir, U. (Unnur), Bourdin, A. (Arnaud), Brusselle, G.G. (Guy), Bulathsinhala, L. (Lakmini), Busby, J. (John), Canonica, G. (Gwalter), Carter, V. (Victoria), Chaudhry, I. (Isha), Cho, Y.S. (You Sook), Christoff, G. (George), Cosio, B.G. (Borja G.), Costello, A. (Anthony), Eleangovan, N. (Neva), Gibson, P.G., Heaney, L.G. (Liam G.), Heffler, E. (E.), Hew, M. (Mark), Hosseini, N. (Naeimeh), Iwanaga, T. (Takashi), Jackson, D.J. (David J.), Jones, R. (Rupert), Koh, M.S. (Mariko S.), Le, T. (Thao), Lehtimäki, L. (Lauri), Ludviksdottir, D. (Dora), Maitland-van der Zee, A-H. (Anke-Hilse), Menzies-Gow, A. (Andrew), Murray, R.B. (Ruth B.), Papadopoulos, N., Perez-de-Llano, L. (Luis), Peters, M. (Matthew), Pfeffer, P.E. (Paul E.), Popov, T.A., Porsbjerg, C. (Celeste), Price, C.A. (Chris A.), Rhee, C.K. (Chin K.), Sadatsafavi, M. (Mohsen), Tohda, Y. (Yuji), Wang, E. (Eileen), Wechsler, M.E. (Michael E.), Zangrilli, J. (James), and Price, D. (David)
Abstract: BACKGROUND: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. METHODS: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide acces
Published: 2020
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48. International severe asthma registry (ISAR): protocol for a global registry

Author: FitzGerald, JM, Tran, TN, Alacqua, M, Altraja, A, Backer, V, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, G, Bulathsinhala, L, Busby, J, Canonica, GW, Carter, V, Chaudhry, I, Cho, YS, Christoff, G, Cosio, BG, Costello, RW, Eleangovan, N, Gibson, PG, Heaney, LG, Heffler, E, Hew, M, Hosseini, N, Iwanaga, T, Jackson, DJ, Jones, R, Koh, MS, Le, T, Lehtimaki, L, Ludviksdottir, D, Maitland-van der Zee, AH, Menzies-Gow, A, Murray, RB, Papadopoulos, NG, Perez-de-Llano, L, Peters, M, Pfeffer, PE, Popov, TA, Porsbjerg, CM, Price, CA, Rhee, CK, Sadatsafavi, M, Tohda, Y, Wang, E, Wechsler, ME, Zangrilli, J, Price, DB, FitzGerald, JM, Tran, TN, Alacqua, M, Altraja, A, Backer, V, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, G, Bulathsinhala, L, Busby, J, Canonica, GW, Carter, V, Chaudhry, I, Cho, YS, Christoff, G, Cosio, BG, Costello, RW, Eleangovan, N, Gibson, PG, Heaney, LG, Heffler, E, Hew, M, Hosseini, N, Iwanaga, T, Jackson, DJ, Jones, R, Koh, MS, Le, T, Lehtimaki, L, Ludviksdottir, D, Maitland-van der Zee, AH, Menzies-Gow, A, Murray, RB, Papadopoulos, NG, Perez-de-Llano, L, Peters, M, Pfeffer, PE, Popov, TA, Porsbjerg, CM, Price, CA, Rhee, CK, Sadatsafavi, M, Tohda, Y, Wang, E, Wechsler, ME, Zangrilli, J, and Price, DB
Abstract: BACKGROUND: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. METHODS: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. CONCLUSIONS: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medi
Published: 2020

49. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry.

Author: Wang, E, Wechsler, ME, Tran, TN, Heaney, LG, Jones, RC, Menzies-Gow, AN, Busby, J, Jackson, DJ, Pfeffer, PE, Rhee, CK, Cho, YS, Canonica, GW, Heffler, E, Gibson, PG, Hew, M, Peters, M, Harvey, ES, Alacqua, M, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Murray, RB, Price, DB, Wang, E, Wechsler, ME, Tran, TN, Heaney, LG, Jones, RC, Menzies-Gow, AN, Busby, J, Jackson, DJ, Pfeffer, PE, Rhee, CK, Cho, YS, Canonica, GW, Heffler, E, Gibson, PG, Hew, M, Peters, M, Harvey, ES, Alacqua, M, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Murray, RB, and Price, DB
Abstract: BACKGROUND: Clinical characteristics of the international population with severe asthma are unknown. Intercountry comparisons are hindered by variable data collection within regional and national severe asthma registries. We aimed to describe demographic and clinical characteristics of patients treated in severe asthma services in the United States, Europe, and the Asia-Pacific region. METHODS: The International Severe Asthma Registry retrospectively and prospectively collected data in patients with severe asthma (≥ 18 years old), receiving Global Initiative for Asthma (GINA) Step 5 treatment or with severe asthma remaining uncontrolled at GINA Step 4. Baseline demographic and clinical data were collected from the United States, United Kingdom, South Korea, Italy, and the Severe Asthma Web-based Database registry (including Australia, Singapore, and New Zealand) from December 2014 to December 2017. RESULTS: We included 4,990 patients. Mean (SD) age was 55.0 (15.9) years, and mean (SD) age at asthma onset was 30.7 (17.7) years. Patients were predominantly female (59.3%) and white (72.6%), had never smoked (60.5%), and were overweight or obese (70.4%); 34.9% were at GINA Step 5; and 57.2% had poorly controlled disease. A total of 51.1% of patients were receiving regular intermittent oral corticosteroids, and 25.4% were receiving biologics (72.6% for those at GINA Step 5). Mean (SD) exacerbation rate was 1.7 (2.7) per year. Intercountry variation was observed in clinical characteristics, prescribed treatments, and biomarker profiles. CONCLUSIONS: Using a common data set and definitions, this study describes severe asthma characteristics of a large patient cohort included in multiple severe asthma registries and identifies country differences. Whether these are related to underlying epidemiological factors, environmental factors, phenotypes, asthma management systems, treatment access, and/or cultural factors requires further study.
Published: 2020

50. Characteristics and treatment regimens across ERS SHARP severe asthma registries

Author: van Bragt, JJMH, Adcock, IM, Bel, EHD, Braunstahl, G-J, ten Brinke, A, Busby, J, Canonica, GW, Cao, H, Chung, KF, Csoma, Z, Dahlen, B, Davin, E, Hansen, S, Heffler, E, Horvath, I, Korn, S, Kots, M, Kuna, P, Kwon, N, Louis, R, Plaza, V, Porsbjerg, C, Ramos-Barbon, D, Richards, LB, Skrgat, S, Sont, JK, Vijverberg, SJH, Weersink, EJM, Yasinska, V, Wagers, SS, Djukanovic, R, Maitland-van der Zee, AH, Abenhardt, B, Adler, J, Alfonso, R, Ali, R, Alkameh, S, Almonacid Sanchez, C, Alvares, L, Anderson, G, Assing, K, Ayre, S, Becker, J, Bergmann, K, Bieksiene, K, Bjerring, N, Blasi, F, Bloemen, P, Blum, H, Boeing, S, Bonavia, M, Bossios, A, Bourdin, A, Brons, A, Brusselle, G, Buis, J, Caiaffa, M, Calabrese, C, Camiciottoli, G, Caruso, C, Castilla Martinez, M, Centanni, S, Cisneros Serrano, C, Corsico, A, Cosmi, L, Costantino, M, Costello, R, Crimi, N, Dahlen, S, D'Amato, M, Davies, D, Garcia-Cosio Piqueras, FDB, Decarlo, G, Deimling, A, Del Giacco, S, Diaz Campos, R, Djandji, M, Doberer, D, Dupont, L, Dyett, K, Edelbaher, N, Edelmann, M, Ehmann, R, Ekberg-Jansson, A, Farsi, A, Favero, E, Feimer, J, Fletcher, M, Foschino, B, Frankemolle, B, Gaga, M, Gappa, M, Garcia de Pedro, J, Garcia Rivero, J, Gasplmayr, M, Gebhardt, R, Geldmacher, H, Geltner, C, Gerstlauer, M, Gibson, T, Giuseppe, G, Gogoll, C, Grimm-Sachs, V, Grisle, I, Gruen, B, Gruenewaldt, A, Guarnieri, G, Gullon Blanco, J, Hamelmann, E, Hamerlijnck, D, Hammers-Reinhard, A, Hanon, S, Harzheim, D, Heaney, L, Hellmich, S, Herden, M, Hering, T, Herth, F, Hilberg, O, Howarth, P, Hubatsch, M, Humbert, M, Husemann, K, Idzko, M, Jackson, D, Jandl, M, Jaumont, X, Joos, G, Joest, M, Juech, M, Kabesch, M, Kaiser-Labusch, P, Kardos, P, Kaessner, F, Keeley, T, Kerr, W, Kirschner, J, Klimek, L, Koca, M, Koczulla, R, Koerner-Rettberg, C, Kopac, P, Kronsbein, J, Lipinska, IK, Langer, M, Langeveld, B, Lantz, A, Lazarinis, N, Lazic, Z, Lehtimaki, L, Leuppi, J, Lombardi, C, Lommatzsch, M, Lopez-Vina, A, Luca, R, Ludviksdottir, D, Luettecke-Hecht, C, Macchia, L, Magni, T, Martinez Rivera, C, Mastoridis, P, Mazza, F, Menzella, F, Menzies-Gow, A, Michils, A, Mihaltan, F, Milanese, M, Milger-Kneidinger, K, Molinska, J, Montagna, I, Montuschi, P, Muelleneisen, N, Munoz Esquerre, M, Nanzer-Kelly, A, Nenasheva, N, Neurohr, C, Nucera, E, Otker, J, Oud, K, Paggiaro, P, Parente, R, Parkinson, J, Passalacqua, G, Patberg, N, Patella, V, Patino, O, Paulsson, T, Peche, R, Pelaia, G, Peress, E, Perez de Llano, L, Pfeffer, P, Pfister, P, Pilette, C, Pinedo Sierra, C, Pini, L, Powitz, F, Ranger, T, Rasmussen, L, Rasmussen, K, Rezelj, M, Ricciardi, L, Ricciardolo, F, Ridolo, E, Rijssenbeek-Nouwens, L, Rolla, G, Romero Ribate, D, Ruediger, S, Safioti, G, Sandstrom, T, Santus, P, Sauer, R, Schauerte, G, Schipmann, R, Schleich, F, Schmid, J, Schmidt, F, Schmidt, O, Schmitz, M, Schrag, T, Schroeer, S, Schultz, K, Schulz, C, Scichilone, N, Sedlak, V, Selb, J, Senna, G, Sergejeva, S, Serrano Pariente, J, Sichau, M, Simona, D, Singer, A, Skowasch, D, Smeenk, F, Smith, S, Solidoro, P, Spadaro, G, Spanevello, A, Stefansdottir, M, Steinmetz, K, Steiss, J, Stephan, M, Stieglitz, S, Suhling, H, Taube, C, Yavuz, ST, Tudoric, N, Ulrik, C, van de Ven, M, van den Elshout, F, Van Dyke, M, Van Nederveen-Bendien, S, van Veen, I, Vandenplas, O, Velthove, K, Vianello, A, Vogelberg, C, Wallen-Nielsen, E, Weersink, EJ, Wisskirchen, T, Yacoub, M, Yancey, S, Zappa, M, Zielen, S, Zimmermann, C, Zimmermann, R, van Bragt, JJMH, Adcock, IM, Bel, EHD, Braunstahl, G-J, ten Brinke, A, Busby, J, Canonica, GW, Cao, H, Chung, KF, Csoma, Z, Dahlen, B, Davin, E, Hansen, S, Heffler, E, Horvath, I, Korn, S, Kots, M, Kuna, P, Kwon, N, Louis, R, Plaza, V, Porsbjerg, C, Ramos-Barbon, D, Richards, LB, Skrgat, S, Sont, JK, Vijverberg, SJH, Weersink, EJM, Yasinska, V, Wagers, SS, Djukanovic, R, Maitland-van der Zee, AH, Abenhardt, B, Adler, J, Alfonso, R, Ali, R, Alkameh, S, Almonacid Sanchez, C, Alvares, L, Anderson, G, Assing, K, Ayre, S, Becker, J, Bergmann, K, Bieksiene, K, Bjerring, N, Blasi, F, Bloemen, P, Blum, H, Boeing, S, Bonavia, M, Bossios, A, Bourdin, A, Brons, A, Brusselle, G, Buis, J, Caiaffa, M, Calabrese, C, Camiciottoli, G, Caruso, C, Castilla Martinez, M, Centanni, S, Cisneros Serrano, C, Corsico, A, Cosmi, L, Costantino, M, Costello, R, Crimi, N, Dahlen, S, D'Amato, M, Davies, D, Garcia-Cosio Piqueras, FDB, Decarlo, G, Deimling, A, Del Giacco, S, Diaz Campos, R, Djandji, M, Doberer, D, Dupont, L, Dyett, K, Edelbaher, N, Edelmann, M, Ehmann, R, Ekberg-Jansson, A, Farsi, A, Favero, E, Feimer, J, Fletcher, M, Foschino, B, Frankemolle, B, Gaga, M, Gappa, M, Garcia de Pedro, J, Garcia Rivero, J, Gasplmayr, M, Gebhardt, R, Geldmacher, H, Geltner, C, Gerstlauer, M, Gibson, T, Giuseppe, G, Gogoll, C, Grimm-Sachs, V, Grisle, I, Gruen, B, Gruenewaldt, A, Guarnieri, G, Gullon Blanco, J, Hamelmann, E, Hamerlijnck, D, Hammers-Reinhard, A, Hanon, S, Harzheim, D, Heaney, L, Hellmich, S, Herden, M, Hering, T, 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Sierra, C, Pini, L, Powitz, F, Ranger, T, Rasmussen, L, Rasmussen, K, Rezelj, M, Ricciardi, L, Ricciardolo, F, Ridolo, E, Rijssenbeek-Nouwens, L, Rolla, G, Romero Ribate, D, Ruediger, S, Safioti, G, Sandstrom, T, Santus, P, Sauer, R, Schauerte, G, Schipmann, R, Schleich, F, Schmid, J, Schmidt, F, Schmidt, O, Schmitz, M, Schrag, T, Schroeer, S, Schultz, K, Schulz, C, Scichilone, N, Sedlak, V, Selb, J, Senna, G, Sergejeva, S, Serrano Pariente, J, Sichau, M, Simona, D, Singer, A, Skowasch, D, Smeenk, F, Smith, S, Solidoro, P, Spadaro, G, Spanevello, A, Stefansdottir, M, Steinmetz, K, Steiss, J, Stephan, M, Stieglitz, S, Suhling, H, Taube, C, Yavuz, ST, Tudoric, N, Ulrik, C, van de Ven, M, van den Elshout, F, Van Dyke, M, Van Nederveen-Bendien, S, van Veen, I, Vandenplas, O, Velthove, K, Vianello, A, Vogelberg, C, Wallen-Nielsen, E, Weersink, EJ, Wisskirchen, T, Yacoub, M, Yancey, S, Zappa, M, Zielen, S, Zimmermann, C, and Zimmermann, R
Abstract: Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.
Published: 2020

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