21 results on '"Luis Perez de Llano"'
Number of results to display per page
Search Results
2. Comparative effectiveness of <scp>Anti‐IL5</scp> and <scp>Anti‐IgE</scp> biologic classes in patients with severe asthma eligible for both
- Author
-
Paul E. Pfeffer, Nasloon Ali, Ruth Murray, Charlotte Ulrik, Trung N. Tran, Jorge Maspero, Matthew Peters, George C. Christoff, Mohsen Sadatsafavi, Carlos A. Torres‐Duque, Alan Altraja, Lauri Lehtimäki, Nikolaos G. Papadopoulos, Sundeep Salvi, Richard W. Costello, Breda Cushen, Enrico Heffler, Takashi Iwanaga, Mona Al‐Ahmad, Désirée Larenas‐Linnemann, Piotr Kuna, João A. Fonseca, Riyad Al‐Lehebi, Chin Kook Rhee, Luis Perez‐de‐Llano, Diahn‐Warng Perng Steve, Bassam Mahboub, Eileen Wang, Celine Goh, Juntao Lyu, Anthony Newell, Marianna Alacqua, Andrey S. Belevskiy, Mohit Bhutani, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Anna von Bulow, John Busby, Giorgio Walter Canonica, Borja G. Cosio, Delbert R. Dorscheid, Mariana Muñoz‐Esquerre, J. Mark FitzGerald, Esther Garcia Gil, Peter G. Gibson, Liam G. Heaney, Mark Hew, Ole Hilberg, Flavia Hoyte, David J. Jackson, Mariko Siyue Koh, Hsin‐Kuo Bruce Ko, Jae Ha Lee, Sverre Lehmann, Cláudia Chaves Loureiro, Dóra Lúðvíksdóttir, Andrew N. Menzies‐Gow, Patrick Mitchell, Andriana I. Papaioannou, Todor A. Popov, Celeste M. Porsbjerg, Laila Salameh, Concetta Sirena, Camille Taillé, Christian Taube, Yuji Tohda, Michael E. Wechsler, David B. Price, Tampere University, Clinical Medicine, and Department of Respiratory medicine, Dermatology and Allergology
- Subjects
ISAR ,exacerbation ,real life ,Immunology ,Medizin ,Immunology and Allergy ,biologics ,oral corticosteroids ,3121 Internal medicine - Abstract
BackgroundPatients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of adult patients with severe asthma eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life.MethodsThis was a prospective cohort study that included adult patients with severe asthma from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance, and hospital admissions.ResultsIn the matched analysis (n = 350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p ConclusionsIn real life, both anti-IgE and anti-IL5/5R improve asthma outcomes in patients eligible for both biologic classes; however, anti-IL5/5R was superior in terms of reducing asthma exacerbations and LTOCS use. Background: Patients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of adult patients with severe asthma eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life. Methods: This was a prospective cohort study that included adult patients with severe asthma from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance, and hospital admissions. Results: In the matched analysis (n = 350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p < 0.001) and experienced a greater reduction in mean LTOCS dose than those treated with anti-IgE (37.44% vs. 20.55% reduction; p = 0.023). There was some evidence to suggest that patients treated with anti-IL5/5R experienced fewer asthma-related hospitalizations (IRR 0.64; 95% CI 0.38, 1.08), but not ER visits (IRR 0.94, 95% CI 0.61, 1.43). Conclusions: In real life, both anti-IgE and anti-IL5/5R improve asthma outcomes in patients eligible for both biologic classes; however, anti-IL5/5R was superior in terms of reducing asthma exacerbations and LTOCS use.
- Published
- 2023
- Full Text
- View/download PDF
3. Comparative effectiveness of Anti-IL5 and Anti-IgE biologic classes in severe asthma patients eligible for both
- Author
-
David Price, paul pfeffer, Nasloon Ali, Ruth Murray, Charlotte Ulrik, Trung Tran, Jorge Maspero, Matthew Peters, George Christoff, Mohsen Sadatsafavi, Carlos A. Torres-Duque, Alan Altraja, Lauri Lehtimäki, Nikolaos Papadopoulos, Sundeep Salvi, Richard W. Costello, Breda Cushen, Enrico Heffler, Takashi Iwanaga, Mona Al-Ahmad, Désirée Larenas-Linnemann, Piotr Kuna, João Fonseca, Riyad Al-Lehebi, Chin Kook Rhee, Luis Perez de Llano, Diahn-Wang Perng, Bassam Mahboub, Eileen Wang, Yun Yi Celine Goh, Juntao Lyu, Anthony Newell, Marianna Alacqua, Mohit Bhutani, Leif Bjermer, Unnur Steina Björnsdóttir, Arnaud Bourdin, Anna Von Bülow, John Busby, Walter Canonica, Borja G Cosio, Delbert Dorscheid, Mariana Muñoz Esquerre, Mark FitzGerald, Esther Garcia Gil, Peter Gerard Gibson, Liam Heaney, Mark Hew, Ole Hilberg, Flavia Hoyte, David Jackson, Mariko Koh, Hsin-Kuo Ko, Jae Ha Lee, Sverre Lehmann, Claudia Chaves Loureiro, Dora Ludviksdottir, Andrew Menzies-Gow, Patrick Mitchell, Andriana Papaioannou, Todor Popov, Celeste Porsbjerg, Laila Salameh, Concetta Sirena, Camille Taillé, Christian Taube, Yuji Tohda, and M. E. Wechsler
- Abstract
Background Patients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of severe adult asthma patients eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life. Methods This was a prospective cohort study that included adult severe asthma patients from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance and hospital admissions. Results In the matched analysis (n=350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p
- Published
- 2022
- Full Text
- View/download PDF
4. EAACI position paper on the clinical use of the bronchial allergen challenge: Unmet needs and research priorities
- Author
-
Ioana Agache, Dario Antolin‐Amerigo, Frederic Blay, Cristina Boccabella, Cristiano Caruso, Pascal Chanez, Mariana Couto, Ronina Covar, Serge Doan, Jean‐Luc Fauquert, Gail Gauvreau, Alina Gherasim, Ludger Klimek, Catherine Lemiere, Parameswaran Nair, Iñigo Ojanguren, David Peden, Luis Perez‐de‐Llano, Oliver Pfaar, Carmen Rondon, Maia Rukhazde, Joaquin Sastre, Johannes Schulze, Diana Silva, Susan Tarlo, Sanna Toppila‐Salmi, Jolanta Walusiak‐Skorupa, Stefan Zielen, Ibon Eguiluz‐Gracia, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), and Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
- Subjects
Research ,[SDV]Life Sciences [q-bio] ,Immunology ,Animals ,Humans ,Immunology and Allergy ,Antigens, Dermatophagoides ,Allergens ,Asthma ,Bronchial Provocation Tests - Abstract
Allergic asthma (AA) is a common asthma phenotype, and its diagnosis requires both the demonstration of IgE-sensitization to aeroallergens and the causative role of this sensitization as a major driver of asthma symptoms. Therefore, a bronchial allergen challenge (BAC) would be occasionally required to identify AA patients among atopic asthmatics. Nevertheless, BAC is usually considered a research tool only, with existing protocols being tailored to mild asthmatics and research needs (eg long washout period for inhaled corticosteroids). Consequently, existing BAC protocols are not designed to be performed in moderate-to-severe asthmatics or in clinical practice. The correct diagnosis of AA might help select patients for immunomodulatory therapies. Allergen sublingual immunotherapy is now registered and recommended for controlled or partially controlled patients with house dust mite-driven AA and with FEV1 ≥ 70%. Allergen avoidance is costly and difficult to implement for the management of AA, so the proper selection of patients is also beneficial. In this position paper, the EAACI Task Force proposes a methodology for clinical BAC that would need to be validated in future studies. The clinical implementation of BAC could ultimately translate into a better phenotyping of asthmatics in real life, and into a more accurate selection of patients for long-term and costly management pathways.
- Published
- 2022
- Full Text
- View/download PDF
5. Defining a Severe Asthma Super-Responder: Findings from a Delphi Process
- Author
-
Liang-Wen Hang, Karrinda Kenny, Louis-Philippe Boulet, Jane Duke, Désirée Larenas-Linnemann, Claude S. Farah, Mónica De Gennaro, Peter A. B. Wark, Hubertus Jersmann, Maria Teresa Costantino, Dermot Ryan, Mark Hew, Vanessa M. McDonald, Mohammad Hashim Khan, Pin-Kuei Fu, Mitesh Patel, Majdy Idrees, David A. Jackson, Violina Vasileva, Constance H. Katelaris, Matthew Masoli, Nunzio Crimi, Celeste Porsbjerg, Janet Rimmer, Veronica Lawriwskyj, Ying-Chun Chien, Norma Linaker, Sally E. Wenzel, Alan Altraja, Ricardo Campos, Carlos Torres-Duque, Manlio Milanese, Enrico Heffler, Eleftherios Zervas, Andréanne Côté, Guy Brusselle, Alan James, Luis Perez-de-Llano, Jorge Maspero, David Langton, Francesca Puggioni, Mona Al-Ahmad, Riyard Al-Lehebi, Adel H. Mansur, Tom Brown, José Luis Miguel, Chris Corrigan, Arnaud Bourdin, James Fingleton, Brian J. Lipworth, Shrikant Pawar, Paula Kauppi, Philip G. Bardin, Alexandra Nanzer-Kelly, Carlos Andrés Celis-Preciado, Santus Pierachille, David Price, George Christoff, Pauline Hughes, Hitashi Rupani, João Fonseca, Nikolaos G. Papadopoulos, Naghmeh Radhakrishna, Lauri Lehtimäki, Rekha Chaudhuri, Anne-Maree Cheffins, Tara Mackenzie, Christian Taube, Kenneth R. Chapman, Charlotte Suppli Ulrik, Giorgio Walter Canonica, Mariko Koh Siyue, Maria Elisabetta Conte, Giovanna Elisiana Carpagnano, Chantal E. Le Lievre, Mohsen Sadatsafavi, Unnur S. Bjornsdottir, Praveen Akuthota, Mark FitzGerald, Andrew Menzies-Gow, Jaideep Dhariwal, Stelios Loukides, Michael E. Wechsler, Paul E Pfeffer, Matthew J. Peters, Giuseppe Guida, Zinta Harrington, Konstantinos Kostikas, Ian Clifton, Tze Lee Tan, Andriana I. Papaioannou, Li Ping Chung, John W. Upham, Parameswaran Nair, John Harrington, Aikaterini Detoraki, Liam G Heaney, Roberta Parente, Paul M. O'Byrne, Jo A Douglass, Kanok Pipatvech, Ming-Ju Tsai, Caterina Bucca, Vibeke Backer, Peter Middleton, Patrick Mitchell, Paddy Dennison, Luisa Ricciardi, Njira L Lugogo, Job F M van Boven, Flavia C.L. Hoyte, Stephen J. Fowler, Gregory Katsoulotos, Bassam Mahboub, Rovira Francisco, Nicola A. Hanania, John Corless, Mona-Rita Yacoub, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
- Subjects
medicine.medical_specialty ,Exacerbation ,[SDV]Life Sciences [q-bio] ,Delphi method ,Biologics ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Randomized controlled trial ,law ,medicine ,Immunology and Allergy ,Asthma ,Asthma treatment ,Consensus ,Delphi Technique ,Humans ,Surveys and Questionnaires ,Quality of Life ,030212 general & internal medicine ,Intensive care medicine ,ComputingMilieux_MISCELLANEOUS ,business.industry ,Minimal clinically important difference ,medicine.disease ,3. Good health ,030228 respiratory system ,Asthma Control Questionnaire ,Allergists ,business - Abstract
Background Clinicians are increasingly recognizing severe asthma patients in whom biologics and other add-on therapies lead to dramatic improvement. Currently, there is no agreed-upon super-responder (SR) definition. Objective To survey severe asthma experts using a modified Delphi process, to develop an international consensus-based definition of a severe asthma SR. Methods The Delphi panel was composed of 81 participants (94% specialist pulmonologists or allergists) from 24 countries and consisted of three iterative online voting rounds. Consensus on individual items, whether acceptance or rejection, required at least 70% agreement by panel members. Results Consensus was achieved that the SR definition should be based on improvement across three or more domains assessed over 12 months. Major SR criteria included exacerbation elimination, a large improvement in asthma control (two or more times the minimal clinically important difference), and cessation of maintenance of oral steroids (or weaning to adrenal insufficiency). Minor SR criteria were composed of a 75% exacerbation reduction, having well-controlled asthma, and 500 mL or greater improvement in FEV1. The SR definition requires improvement in at least two major criteria. In the future, the SR definition should be expanded to incorporate quality of life measures, although current tools can be difficult to implement in a clinical setting and further research is needed. Conclusions This international consensus-based definition of severe asthma SRs is an important prerequisite for better understanding SR prevalence, predictive factors, and the mechanisms involved. Further research is needed to understand the patient's perspective and to measure quality of life more precisely in SRs.
- Published
- 2021
- Full Text
- View/download PDF
6. COVID-19-vaccination in patients receiving allergen immunotherapy (AIT) or biologics - EAACI recommendations
- Author
-
Hans Jürgen Hoffmann, Andrea Matucci, Anna Kosowska, Aslı Gelincik, Luis Perez de Llano, Oliver Pfaar, Mario Cazzola, Kari Nadeau, Milena Sokolowska, Alessandra Vultaggio, Eva Untersmayr, Oscar Palomares, Jean-Christoph Roger J-P Caubet, Anna Sediva, Isabel Skypala, Rosan Meyer, Davide Firinu, Montserrat Fernandez-Rivas, Sevim Bavbek, Ronald van Ree, Thomas Eiwegger, Domingo Barber Hernández, Alexia Chatzipetrou, Jonathan Corren, Elizabeth Palmer, Musa Khaitov, Mohamed H. Shamji, Vera Mahler, Oliver Price, Vibeke Backer, Magdalena Zemelka-Wiacek, Cezmi A. Akdis, Florin-Dan Popescu, Margitta Worm, Victoria Del Pozo, Alberto Alvarez-Perea, Annick Barbaud, Sylwia Smolinska, Karin Hoffmann-Sommergruber, Job van Boven, Audrey DunnGalvin, Motohiro Ebisawa, Tomas Chivato, Gunter J. Sturm, André Moreira, Mubeccel Akdis, Barbara Rogala, Ludger Klimek, Ioana Agache, María José Torres, Marek Jutel, Matteo Bonini, Radoslaw Gawlik, Jolanta Walusiak-Skorupa, Marina Atanaskovic-Markovic, Montserrat Alvaro, Stefan Vieths, Stefano Del Giacco, Sarita Patil, Alexandra F. Santos, A. Cianferoni, Charlotte G. Mortz, Antonino Romano, Giorgio Walter Canonica, Sergio Bonini, Antti Lauerma, Hideaki Morita, Knut Brockow, and Frédéric De Blay
- Subjects
Allergen immunotherapy ,medicine.medical_specialty ,Allergy ,biology ,business.industry ,Immunoglobulin E ,medicine.disease ,Vaccination ,Immune system ,Pandemic ,biology.protein ,medicine ,In patient ,Intensive care medicine ,business ,Asthma - Abstract
Immune modulation is a key therapeutic tool for allergic diseases and asthma. It can be achieved in an antigen-specific way via allergen immunotherapy (AIT) or in endotype-driven approach using biologicals that target the major pathways of the type 2 (T2) immune response: IgE, IL-5 and IL-4/IL-13. COVID-19 vaccine provides an excellent opportunity to tackle the global pandemics and is currently being applied in an accelerated rhythm worldwide. It works as well through immune modulation. Thus, as there is an obvious interference between these treatment modalities recommendations on how they should be applied in sequence are expected. The European Academy of Allergy and Clinical Immunology (EAACI) gathered an outstanding expert panel under its Research and Outreach Committee (ROC). This expert panel was called to evaluate the evidence and formulate recommendation on the administration of COVID-19 vaccine in patients with allergic diseases and asthma receiving AIT or biologicals. The panel also formulated recommendations for COVID-19 vaccine in association with biologicals targeting the type 1 or type 3 immune response. In formulating recommendations, the panel evaluated the mechanisms of COVID-19 infection, of COVID-19 vaccine, of AIT and of biologicals and considered the data published for other anti-infectious vaccines administered concurrently with AIT or biologicals.
- Published
- 2021
- Full Text
- View/download PDF
7. Biomarker Relatability in the International Severe Asthma Registry
- Author
-
Lakmini Bulathsinhala, Isha Chaudry, David Price, G.W. Canonica, Mark FitzGerald, Guy Brusselle, Luis Perez-de-Llano, Trung N. Tran, Eve Denton, Chin Kook Rhee, Ruth Murray, George Christoff, Anna Quinton, Mohsen Sadatsafavi, Andrew Menzies-Gow, Mark Hew, Njira L Lugogo, Victoria Carter, and Charlotte Suppli Ulrik
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,Internal medicine ,Severe asthma ,medicine ,Biomarker (medicine) ,business - Published
- 2020
- Full Text
- View/download PDF
8. Biologic Utilization Patterns: Data from the International Severe Asthma Registry (ISAR)
- Author
-
Liam G Heaney, Naeimeh Hosseini, Luis Perez-de-Llano, David A. Jackson, JM FitzGerald, T.S. Cheng, Désirée Larenas-Linnemann, Mona Al-Ahmad, Johannes Schmid, Andrew Menzies-Gow, M.-A. Rowlands, Eileen Wang, Trung N. Tran, Lakmini Bulathsinhala, Maria Kallieri, Mark Hew, L.M. Rasmussen, Ruth Murray, John W. Upham, Borja G. Cosío, Marianna Alacqua, Celeste Porsbjerg, Njira L Lugogo, Isha Chaudhry, Andriana I. Papaioannou, David Price, Charlotte Suppli Ulrik, Victoria Carter, Stylianos Loukides, and Nevaashni Eleangovan
- Subjects
Inverse synthetic aperture radar ,medicine.medical_specialty ,business.industry ,Severe asthma ,Emergency medicine ,Medicine ,business - Published
- 2020
- Full Text
- View/download PDF
9. A Global Survey of Blood Eosinophil Distribution in Severe Asthma Patients: Data from the International Severe Asthma Registry (ISAR)
- Author
-
Liam G Heaney, Michael E. Wechsler, Lakmini Bulathsinhala, Victoria Carter, Chin Kook Rhee, John Busby, Borja G. Cosío, David Price, Mohsen Sadatsafavi, Andrew Menzies-Gow, JM FitzGerald, T.A. Popov, Paul E Pfeffer, Mona Al-Ahmad, Luis Perez-de-Llano, David A. Jackson, Richard W. Costello, N.G. Papadopolous, Eileen Wang, Christopher P. Price, Marianna Alacqua, Trung N. Tran, G.W. Canonica, Andriana I. Papaioannou, Ruth Murray, George Christoff, Takashi Iwanaga, Isha Chaudhry, Marjan Kerkhof, Enrico Heffler, James Zangrilli, and Yuji Tohda
- Subjects
Inverse synthetic aperture radar ,medicine.medical_specialty ,business.industry ,Internal medicine ,Severe asthma ,medicine ,Distribution (pharmacology) ,business ,Blood eosinophil - Published
- 2020
- Full Text
- View/download PDF
10. Global Access for Biologics in the Treatment of Severe Asthma: A Challenge to Personalized Medicine
- Author
-
Isha Chaudhry, Borja G. Cosío, Charlotte Suppli Ulrik, Mona Al-Ahmad, Naeimeh Hosseini, Luis Perez-de-Llano, A. Tan, Victoria Carter, Maria Kallieri, Stylianos Loukides, Eileen Wang, M.-A. Rowlands, Liam G Heaney, Andriana I. Papaioannou, Trung N. Tran, Lakmini Bulathsinhala, L.M. Rasmussen, David Price, JM FitzGerald, Désirée Larenas-Linnemann, Celeste Porsbjerg, Nevaashni Eleangovan, Marianna Alacqua, David A. Jackson, Njira L Lugogo, John W. Upham, Johannes Schmid, Ruth Murray, Job F M van Boven, Mark Hew, and Andrew Menzies-Gow
- Subjects
medicine.medical_specialty ,business.industry ,Severe asthma ,medicine ,Personalized medicine ,Intensive care medicine ,business - Published
- 2020
- Full Text
- View/download PDF
11. Eosinophilic and Noneosinophilic Asthma
- Author
-
Liam G. Heaney, Luis Perez de Llano, Mona Al-Ahmad, Vibeke Backer, John Busby, G. Walter Canonica, George C. Christoff, Borja G. Cosio, J. Mark FitzGerald, Enrico Heffler, Takashi Iwanaga, David J. Jackson, Andrew N. Menzies-Gow, Nikos G. Papadopoulos, Andriana I. Papaioannou, Paul E. Pfeffer, Todor A. Popov, Celeste M. Porsbjerg, Chin Kook Rhee, Mohsen Sadatsafavi, Yuji Tohda, Eileen Wang, Michael E. Wechsler, Marianna Alacqua, Alan Altraja, Leif Bjermer, Unnur S. Björnsdóttir, Arnaud Bourdin, G.G.O. (Guy) Brusselle, Roland Buhl, Richard W. Costello, Mark Hew, Mariko Siyue Koh, Sverre Lehmann, Lauri Lehtimäki, Matthew Peters, Camille Taillé, Christian Taube, Trung N. Tran, James Zangrilli, Lakmini Bulathsinhala, Victoria A. Carter, Isha Chaudhry, Neva Eleangovan, Naeimeh Hosseini, Marjan Kerkhof, Ruth Murray, Chris A. Price, David B. Price, Liam G. Heaney, Luis Perez de Llano, Mona Al-Ahmad, Vibeke Backer, John Busby, G. Walter Canonica, George C. Christoff, Borja G. Cosio, J. Mark FitzGerald, Enrico Heffler, Takashi Iwanaga, David J. Jackson, Andrew N. Menzies-Gow, Nikos G. Papadopoulos, Andriana I. Papaioannou, Paul E. Pfeffer, Todor A. Popov, Celeste M. Porsbjerg, Chin Kook Rhee, Mohsen Sadatsafavi, Yuji Tohda, Eileen Wang, Michael E. Wechsler, Marianna Alacqua, Alan Altraja, Leif Bjermer, Unnur S. Björnsdóttir, Arnaud Bourdin, G.G.O. (Guy) Brusselle, Roland Buhl, Richard W. Costello, Mark Hew, Mariko Siyue Koh, Sverre Lehmann, Lauri Lehtimäki, Matthew Peters, Camille Taillé, Christian Taube, Trung N. Tran, James Zangrilli, Lakmini Bulathsinhala, Victoria A. Carter, Isha Chaudhry, Neva Eleangovan, Naeimeh Hosseini, Marjan Kerkhof, Ruth Murray, Chris A. Price, and David B. Price
- 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 yea
- Published
- 2021
- Full Text
- View/download PDF
12. International severe asthma registry (ISAR): protocol for a global registry
- Author
-
Eileen Wang, Trung N. Tran, Marianna Alacqua, Todor A. Popov, Ruth Murray, George Christoff, Lauri Lehtimäki, Chris A. Price, Mohsen Sadatsafavi, James Zangrilli, Naeimeh Hosseini, Andrew Menzies-Gow, John Busby, Luis Perez-de-Llano, Mariko Siyue Koh, Unnur S. Bjornsdottir, Guy Brusselle, Paul E Pfeffer, Vibeke Backer, Michael E. Wechsler, Mark Hew, Anke H. Maitland-van der Zee, Peter G. Gibson, Alan Altraja, Lakmini Bulathsinhala, Dora Ludviksdottir, Celeste Porsbjerg, Liam G Heaney, Richard W. Costello, Enrico Heffler, Rupert Jones, Leif Bjermer, Yuji Tohda, Borja G. Cosío, Nikolaos G. Papadopoulos, J. Mark FitzGerald, Giorgio Walter Canonica, Chin Kook Rhee, Victoria Carter, Neva Eleangovan, Takashi Iwanaga, Isha Chaudhry, You Sook Cho, Arnaud Bourdin, Matthew J. Peters, David Price, Thao Le, David A. Jackson, Epidemiology, Pulmonary Medicine, The Lung Centre Vancouver General Hospital, UBC Institute for Heart and Lung Health, Vancouver, BC, AstraZeneca, Gaithersburg, MD, USA, AstraZeneca, Luton, United Kingdom of Great Britain and Northern Ireland., Department of Pulmonary Medicine, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia, Center of Physical Activity Research, Rigshospitalet and Copenhagen University, Copenhagen, Denmark., Department of Respiratory Medicine & Allergology, Skåne University Hospital, Lund, Sweden, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Ghent University Hospital, Humanitas Clinical and Research Center [Rozzano, Milan, Italy], Queen's University [Belfast] (QUB), Dipartimento di Scienze Mediche, Università degli studi di Torino (UNITO), Department of Electrical and Computer Engineering [Houston], University of Houston, Royal Brompton Hospital, Lung Division, London, United Kingdom of Great Britain and Northern Ireland., MedScript Ltd, UPC Research Laboratories, Allergy Department, Institute for Nuclear Research and Nuclear Energy (INRNE), Académie des sciences de Bulgarie, Aberystwyth University, Division of Infection and Immunity, School of Medicine [Cardiff], Cardiff University-Institute of Medical Genetics [Cardiff]-Cardiff University-Institute of Medical Genetics [Cardiff], Tampere University, Department of Respiratory medicine, Dermatology and Allergology, Clinical Medicine, Pulmonology, Paediatric Pulmonology, AII - Inflammatory diseases, APH - Personalized Medicine, Læknadeild (HÍ), Faculty of Medicine (UI), Heilbrigðisvísindasvið (HÍ), School of Health Sciences (UI), Háskóli Íslands, and University of Iceland
- Subjects
Severe asthma ,Epidemiology ,[SDV]Life Sciences [q-bio] ,Delphi method ,Health informatics ,0302 clinical medicine ,DESIGN ,Health care ,Medicine and Health Sciences ,Protocol ,Registries ,030212 general & internal medicine ,ComputingMilieux_MISCELLANEOUS ,lcsh:R5-920 ,OUTCOMES ,education.field_of_study ,030503 health policy & services ,Pharmacoepidemiology ,Astmi ,3142 Public health care science, environmental and occupational health ,3. Good health ,SAFETY ,Medical emergency ,lcsh:Medicine (General) ,0305 other medical science ,Research Article ,Adult ,Adolescent ,Population ,PHENOTYPES ,Health Informatics ,03 medical and health sciences ,Disease registry ,Skráning gagna ,Pharmacovigilance ,medicine ,Humans ,education ,Disease burden ,TO-TREAT ASTHMA ,MEPOLIZUMAB ,business.industry ,medicine.disease ,Asthma ,EXACERBATIONS ,DEFINITION ,Real-world ,HEALTH-CARE ,business ,COSTS - Abstract
Publisher's version (útgefin grein), 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., The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts from AstraZeneca. AstraZeneca reviewed the draft before submission; however, decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
- Published
- 2020
- Full Text
- View/download PDF
13. Defining a severe asthma super-responder: findings from a Delphi process
- Author
-
Delphi panel: Adel Mansur, Aikaterini, Detoraki, Alan, Altraja, Alan, James, Alexandra, Nanzer-Kelly, Andréanne, Côté, Andrew, Menzies-Gow, Andriana, Papaioannou, Anne-Maree, Cheffins, Arnaud, Bourdin, Bassam, Mahboub, Brian, Lipworth, Carlos Andrés Celis-Preciado, Carlos, Torres-Duque, Caterina, Bucca, Celeste, Porsbjerg, Charlotte, Ulrik, Chris, Corrigan, Christian, Taube, Claude, Farah, Constance, Katelaris, David, Langton, Dermot, Ryan, Désirée, Larenas-Linnemann, Eleftherios, Zervas, Enrico, Heffler, Flavia, Hoyte, Francesca, Puggioni, George, Christoff, Giorgio Walter Canonica, Giovanna Elisiana Carpagnano, Giuseppe, Guida, Gregory, Katsoulotos, Guy, Brusselle, Hitashi, Rupani, Hubertus, Jersmann, Ian, Clifton, Jaideep, Dhariwal, James, Fingleton, Jane, Duke, Janet, Rimmer, Douglass, Jo, João, Fonseca, Job van Boven, John, Corless, John, Harrington, Jorge, Maspero, José Luis Miguel, Kanok, Pipatvech, Karrinda, Kenny, Kenneth, Chapman, Konstantinos, Kostikas, Lauri, Lehtimäki, Li Ping Chung, Liam, Heaney, Liang-Wen, Hang, Louis-Philippe, Boulet, Luis, Perez-de-Llano, Ricciardi, Luisa, Majdy, Idrees, Manlio, Milanese, Maria Elisabetta Conte, Maria Teresa Costantino, Mariko Koh Siyue, Mark, Fitzgerald, Mark, Hew, Matthew, Peters, Ming-Ju, Tsai, Mitesh, Patel, Mohammad Hashim Khan, Mohsen, Sadatsafavi, Mona, Al-Ahmad, Mona-Rita, Yacoub, Mónica De Gennaro, Naghmeh, Radhakrishna, Nicola Alexander Hanania, Nikolaos, Papadopoulos, Njira, Lugogo, Norma, Linaker, Nunzio, Crimi, Paddy, Dennison, Parameswaran, Nair, Patrick David Mitchell, Paul, O’Byrne, Paul, Pfeffer, Paula, Kauppi, Pauline, Hughes, Peter, Middleton, Peter, Wark, Philip, Bardin, Pin-Kuei, Fu, Praveen, Akuthota, Rekha, Chaudhuri, Ricardo, Campos, Riyard, Al-Lehebi, Roberta, Parente, Rovira, Francisco, Sally, Wenzel, Santus, Pierachille, Shrikant, Pawar, Stelios, Loukides, Stephen, Fowler, Tara, Mackenzie, Thomas, Brown, Tze Lee Tan, Unnur, Björnsdóttir, Vanessa, Mcdonald, Veronica, Lawriwskyj, Vibeke, Backer, Violina, Vasileva, Ying-Chun, Chien, and Zinta, Harrington.
- Published
- 2020
14. Asthma control conundrum in clinical practice – Data from a two-stage Delphi survey and literature review
- Author
-
Giorgio Walter Canonica, Antonio Spanevello, Luis Pérez de Llano, Christian Domingo Ribas, John D Blakey, Gabriel Garcia, Hiromasa Inoue, Margareth Dalcolmo, Dong Yang, Soniya Mokashi, Abhishek Kurne, and Aman Kapil Butta
- Subjects
Asthma expert recommendation ,Quantitative form ,Asthma communication ,Asthma consensus ,Screening questions ,Standard definitions in asthma ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Science (General) ,Q1-390 - Abstract
Definitions and measures of asthma control used in clinical trials and practice often vary, as highlighted in the manuscript, “Is asthma control more than just an absence of symptoms? An expert consensus statement”. Furthermore, the authors discussed differences between patients and healthcare professionals (HCPs) in terms of understanding and managing asthma. Given these disparities, there is a need for consensus regarding what constitutes well-controlled asthma and, especially, how best it can be measured and recorded. In the current work, we describe our data and provide more detail on the methodology from a two-stage Delphi survey and a structured literature review, which were designed to reach a consensus definition of asthma control and alleviate misalignments between patients and HCPs. Survey data were collected using a two-stage Delphi technique; a method used to collate expert opinions over a series of sequential questionnaires to reach a consensus. The collated Delphi survey data were compared with results from a comprehensive, structured literature review of 216 publications, to assess if there was a correlation between existing guidance and measures of asthma control used in clinical trials and standard clinical practice. In order to collate and interpret findings from the Delphi survey, responses from 82 panelists (73 HCPs and 9 authors) were qualitatively analyzed, quantitatively categorized, and presented as percentages or counts in Excel databases, which are detailed in the current work. Searches conducted using PubMed and Cochrane identified 664 manuscripts, and Embase was used to identify 89 congress abstracts. After applying a stringent screening method using predefined key words, the structured literature review consisted of 185 peer-reviewed manuscripts and 31 congress abstracts, and assessed existing guidance and measures of asthma control used in clinical trials. In this publication, we provide further insight into the predefined keywords, search strings, and strategy applied to identify manuscripts and congress abstracts for inclusion/exclusion, and detail methods for data extraction. Together, the data from the Delphi survey and structured literature review aimed to provide greater insights into challenges and approaches in achieving asthma control in clinical practice, with the potential for results to be used to guide a universally accepted definition and measure of asthma control that can be used and understood by patients, HCPs, and researchers. Qualitative and quantitative methodology and analysis from the Delphi survey and literature review search strategy can potentially be used to identify disparities and explore expert opinion and relevant literature in other therapeutic areas to guide a consensus where disparities exist.
- Published
- 2023
- Full Text
- View/download PDF
15. A New Therapeutic Approach Based on a Reinterpretation of Asthma Control
- Author
-
Luis Pérez de Llano, Luís Manuel Entrenas, M. Inés Carrascosa, Ignacio Dávila, Carlos Almonacid, Beatriz Abascal-Bolado, Francisco Javier Montoro, Ana Isabel Sogo, and Christian Domingo
- Subjects
Adherence. Asthma control. Inhaled corticosteroid. Inhaler device. Therapeutic index. ,Diseases of the respiratory system ,RC705-779 - Abstract
The concept of asthma control is fundamental because it establishes a target for treatment, but despite the diversity of definitions, a high proportion of patients fail to achieve it. In this article, we highlight the shortcomings of the current concept of control by discussing aspects such as the differences between patient- and physician-perceived control and the limitations of the tools used to assess it. We also comment on the drawbacks of the stepwise approach to achieve control recommended by guidelines: the absence of conclusive evidence on the exclusive use of as-needed budesonide/formoterol in mild asthma, the lack of consideration of the different pharmacological properties of the currently available inhaled corticosteroids (ICS) and ignoring the existence of different asthma endotypes, some of which are resistant to these drugs. Other aspects, such as adherence to medication, the use of rescue medication, the influence of the inhalation device, the particle size, the pharmacological characteristics, and the lung deposition of ICS, are also mentioned. As an alternative to the guidelines´ recommendations, we propose a more customized approach based on the identification of therapeutic goals and treatable traits.
- Published
- 2023
- Full Text
- View/download PDF
16. Evaluation of real-world mepolizumab use in severe asthma across Europe: the SHARP experience with privacy-preserving federated analysis
- Author
-
Johannes A. Kroes, Rafael Alfonso-Cristancho, Aruna T. Bansal, Emmanuelle Berret, Kristina Bieksiene, Arnaud Bourdin, Luisa Brussino, Diogo Canhoto, Cristina Cardini, Gulfem Celik, Zsuzsanna Csoma, Barbro Dahlén, Ebru Damadoglu, Katrien Eger, Lisa Gauquelin, Bilun Gemicioglu, Ozlem Goksel, Sophie Graff, Enrico Heffler, Hendrik B. Hofstee, Peter Howarth, Rupert W. Jakes, Fabienne Jaun, Virginija Kalinauskaite-Zukauske, Peter Kopač, Namhee Kwon, Claudia C. Loureiro, Victor Lozoya García, Matthew Masoli, Mariana Paula Rezelj, Luis Pérez De Llano, Sanja Popović-Grle, David Ramos-Barbón, Ana Sà Sousa, Konstantinos Samitas, Florence Schleich, Concetta Sirena, Sabina Skrgat, Eleftherios Zervas, George Zichnalis, Elisabeth H. Bel, Jacob K. Sont, Simone Hashimoto, and Anneke Ten Brinke
- Subjects
Medicine - Abstract
Background An objective of the Severe Heterogeneous Asthma Registry, Patient-centered (SHARP) is to produce real-world evidence on a pan-European scale by linking nonstandardised, patient-level registry data. Mepolizumab has shown clinical efficacy in randomised controlled trials and prospective real-world studies and could therefore serve as a proof of principle for this novel approach. The aim of the present study was to harmonise data from 10 national severe asthma registries and characterise patients receiving mepolizumab, assess its effectiveness on annual exacerbations and maintenance oral glucocorticoid (OCS) use, and evaluate treatment patterns. Methods In this observational cohort study, registry data (5871 patients) were extracted for harmonisation. Where harmonisation was possible, patients who initiated mepolizumab between 1 January 2016 and 31 December 2021 were examined. Changes of a 12-month (range 11–18 months) period in frequent (two or more) exacerbations, maintenance OCS use and dose were analysed in a privacy-preserving manner using meta-analysis of generalised estimating equation parameters. Periods before and during the coronavirus disease 2019 pandemic were analysed separately. Results In 912 patients who fulfilled selection criteria, mepolizumab significantly reduced frequent exacerbations (OR 0.18, 95% CI 0.13–0.25), maintenance OCS use (OR 0.75, 95% CI 0.61–0.92) and dose (mean −3.93 mg·day−1, 95% CI −5.24–2.62 mg·day−1) in the pre-pandemic group, with similar trends in the pandemic group. Marked heterogeneity was observed between registries in patient characteristics and mepolizumab treatment patterns. Conclusions By harmonising patient-level registry data and applying federated analysis, SHARP demonstrated the real-world effectiveness of mepolizumab on asthma exacerbations and maintenance OCS use in severe asthma patients across Europe, consistent with previous evidence. This paves the way for future pan-European real-world severe asthma studies using patient-level data in a privacy-proof manner.
- Published
- 2023
- Full Text
- View/download PDF
17. Asthma–COPD overlap: identification and optimal treatment
- Author
-
Borja G. Cosío, David Dacal, and Luis Pérez de Llano
- Subjects
Diseases of the respiratory system ,RC705-779 - Abstract
Asthma and chronic obstructive pulmonary disease (COPD) are both highly prevalent conditions that can coexist in the same individual: the so-called ‘asthma -COPD overlap’ (ACO). Its prevalence and prognosis vary widely depending on how ACO is defined in each publication, the severity of bronchial obstruction of patients included and the treatment they are receiving. Although there is a lack of evidence about the biology of ACO, the overlap of both diseases should express a mixture of a Th1 inflammatory pattern (characteristic of COPD) and a Th2 signature (characteristic of asthma). In this review we support a novel algorithm for ACO diagnosis proposed by the Spanish Respiratory Society (SEPAR), based on a sequential evaluation that considers: (a) the presence of chronic airflow limitation in a smoker or ex-smoker patient ⩾35 years old; (b) a current diagnosis of asthma; and (c) the existence of a very positive bronchodilator test (PBT; ⩾15% and ⩾400 ml) or the presence of eosinophilia in blood (⩾300 eosinophils/μl). This algorithm can identify those patients who may benefit from a treatment with inhaled corticosteroids (ICSs) and maybe from biological drugs in a near future. In addition, it is easily applicable in clinical practice. The major disadvantage is that it groups patients with very different characteristics under the ACO’s umbrella. In view of this heterogeneity, we recommend a strategy of defining specific and measurable therapeutic objectives for every single patient and identifying the traits that can be treated to achieve those objectives.
- Published
- 2018
- Full Text
- View/download PDF
18. Characterization of Eosinophilic and Non-Eosinophilic Severe Asthma Phenotypes and Proportion of Patients with These Phenotypes in the International Severe Asthma Registry (ISAR)
- Author
-
Mona Al-Ahmad, Paul E Pfeffer, Lakmini Bulathsinhala, John Busby, Luis Perez-de-Llano, James Zangrilli, Borja G. Cosío, Marjan Kerkhof, Trung N. Tran, Ruth Murray, George Christoff, Enrico Heffler, A.L. Papaioannou, Liam G Heaney, G.W. Canonica, Eileen Wang, Yuji Tohda, Chris A. Price, Chin Kook Rhee, JM FitzGerald, Nikolaos G. Papadopoulos, Marianna Alacqua, T.A. Popov, Mohsen Sadatsafavi, David A. Jackson, Andrew Menzies-Gow, Takashi Iwanaga, Isha Chaudhry, Michael E. Wechsler, Victoria Carter, David Price, and Richard W. Costello
- Subjects
business.industry ,Severe asthma ,Immunology ,Eosinophilic ,Medicine ,business ,Phenotype
19. Association between pre-biologic T2-biomarker combinations and response to biologics in patients with severe asthma
- Author
-
Celeste M. Porsbjerg, John Townend, Celine Bergeron, George C. Christoff, Gregory P. Katsoulotos, Désirée Larenas-Linnemann, Trung N. Tran, Riyad Al-Lehebi, Sinthia Z. Bosnic-Anticevich, John Busby, Mark Hew, Konstantinos Kostikas, Nikolaos G. Papadopoulos, Paul E. Pfeffer, Todor A. Popov, Chin Kook Rhee, Mohsen Sadatsafavi, Ming-Ju Tsai, Charlotte Suppli Ulrik, Mona Al-Ahmad, Alan Altraja, Aaron Beastall, Lakmini Bulathsinhala, Victoria Carter, Borja G. Cosio, Kirsty Fletton, Susanne Hansen, Liam G. Heaney, Richard B. Hubbard, Piotr Kuna, Ruth B. Murray, Tatsuya Nagano, Laura Pini, Diana Jimena Cano Rosales, Florence Schleich, Michael E. Wechsler, Rita Amaral, Arnaud Bourdin, Guy G. Brusselle, Wenjia Chen, Li Ping Chung, Eve Denton, Joao A. Fonseca, Flavia Hoyte, David J. Jackson, Rohit Katial, Bruce J. Kirenga, Mariko Siyue Koh, Agnieszka Ławkiedraj, Lauri Lehtimäki, Mei Fong Liew, Bassam Mahboub, Neil Martin, Andrew N. Menzies-Gow, Pee Hwee Pang, Andriana I. Papaioannou, Pujan H. Patel, Luis Perez-De-Llano, Matthew J. Peters, Luisa Ricciardi, Bellanid Rodríguez-Cáceres, Ivan Solarte, Tunn Ren Tay, Carlos A. Torres-Duque, Eileen Wang, Martina Zappa, John Abisheganaden, Karin Dahl Assing, Richard W. Costello, Peter G. Gibson, Enrico Heffler, Jorge Máspero, Stefania Nicola, Diahn-Warng Perng (Steve), Francesca Puggioni, Sundeep Salvi, Chau-Chyun Sheu, Concetta Sirena, Camille Taillé, Tze Lee Tan, Leif Bjermer, Giorgio Walter Canonica, Takashi Iwanaga, Libardo Jiménez-Maldonado, Christian Taube, Luisa Brussino, and David B. Price
- Subjects
severe asthma ,biomarkers ,eosinophil (EOS) ,FeNO (Fraction of exhaled Nitric Oxide) ,biologics ,FEV1 ,Immunologic diseases. Allergy ,RC581-607 - Abstract
BackgroundTo date, studies investigating the association between pre-biologic biomarker levels and post-biologic outcomes have been limited to single biomarkers and assessment of biologic efficacy from structured clinical trials.AimTo elucidate the associations of pre-biologic individual biomarker levels or their combinations with pre-to-post biologic changes in asthma outcomes in real-life.MethodsThis was a registry-based, cohort study using data from 23 countries, which shared data with the International Severe Asthma Registry (May 2017-February 2023). The investigated biomarkers (highest pre-biologic levels) were immunoglobulin E (IgE), blood eosinophil count (BEC) and fractional exhaled nitric oxide (FeNO). Pre- to approximately 12-month post-biologic change for each of three asthma outcome domains (i.e. exacerbation rate, symptom control and lung function), and the association of this change with pre-biologic biomarkers was investigated for individual and combined biomarkers.ResultsOverall, 3751 patients initiated biologics and were included in the analysis. No association was found between pre-biologic BEC and pre-to-post biologic change in exacerbation rate for any biologic class. However, higher pre-biologic BEC and FeNO were both associated with greater post-biologic improvement in FEV1 for both anti-IgE and anti-IL5/5R, with a trend for anti-IL4Rα. Mean FEV1 improved by 27-178 mL post-anti-IgE as pre-biologic BEC increased (250 to 1000 cells/µL), and by 43-216 mL and 129-250 mL post-anti-IL5/5R and -anti-IL4Rα, respectively along the same BEC gradient. Corresponding improvements along a FeNO gradient (25-100 ppb) were 41-274 mL, 69-207 mL and 148-224 mL for anti-IgE, anti-IL5/5R, and anti-IL4Rα, respectively. Higher baseline BEC was also associated with lower probability of uncontrolled asthma (OR 0.392; p=0.001) post-biologic for anti-IL5/5R. Pre-biologic IgE was a poor predictor of subsequent pre-to-post-biologic change for all outcomes assessed for all biologics. The combination of BEC + FeNO marginally improved the prediction of post-biologic FEV1 increase (adjusted R2: 0.751), compared to BEC (adjusted R2: 0.747) or FeNO alone (adjusted R2: 0.743) (p=0.005 and
- Published
- 2024
- Full Text
- View/download PDF
20. International severe asthma registry (ISAR): protocol for a global registry
- Author
-
J. Mark FitzGerald, Trung N. Tran, Marianna Alacqua, Alan Altraja, Vibeke Backer, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Guy Brusselle, Lakmini Bulathsinhala, John Busby, Giorgio W. Canonica, Victoria Carter, Isha Chaudhry, You Sook Cho, George Christoff, Borja G. Cosio, Richard W. Costello, Neva Eleangovan, Peter G. Gibson, Liam G. Heaney, Enrico Heffler, Mark Hew, Naeimeh Hosseini, Takashi Iwanaga, David J. Jackson, Rupert Jones, Mariko S. Koh, Thao Le, Lauri Lehtimäki, Dora Ludviksdottir, Anke H. Maitland-van der Zee, Andrew Menzies-Gow, Ruth B. Murray, Nikolaos G. Papadopoulos, Luis Perez-de-Llano, Matthew Peters, Paul E. Pfeffer, Todor A. Popov, Celeste M. Porsbjerg, Chris A. Price, Chin K. Rhee, Mohsen Sadatsafavi, Yuji Tohda, Eileen Wang, Michael E. Wechsler, James Zangrilli, and David B. Price
- Subjects
Disease registry ,Protocol ,Real-world ,Severe asthma ,Medicine (General) ,R5-920 - Abstract
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 medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.
- Published
- 2020
- Full Text
- View/download PDF
21. Prediction of Future Risk in Patients With Controlled Asthma
- Author
-
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Clinic of Barcelona, Hospital Galdakao-Usansolo, Complexo Hospitalario Universitario de A Coruña, and Luis Perez de Llano, MD, PhD.
- Published
- 2012
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.