Impact of Initiating Biologics in Patients With Severe Asthma on Long-Term Oral Corticosteroids or Frequent Rescue Steroids (GLITTER): Data From the International Severe Asthma Registry.


Journal

The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220

Informations de publication

Date de publication:
09 2023
Historique:
received: 20 09 2022
revised: 29 05 2023
accepted: 30 05 2023
medline: 11 9 2023
pubmed: 11 6 2023
entrez: 10 6 2023
Statut: ppublish

Résumé

Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS) nor been compared with effectiveness of continuing with HOCS alone. To examine the effectiveness of initiating biologics in a large, real-world cohort of adult patients with severe asthma and HOCS. This was a propensity score-matched, prospective cohort study using data from the International Severe Asthma Registry. Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCSs for ≥1 year or ≥4 courses of rescue OCSs within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with noninitiators. The impact of biologic initiation on asthma outcomes was assessed using generalized linear models. We identified 996 matched pairs of patients. Both groups improved over the 12-month follow-up period, but improvement was greater for biologic initiators. Biologic initiation was associated with a 72.9% reduction in the average number of exacerbations per year versus noninitiators (0.64 vs 2.06; rate ratio, 0.27 [95% CI, 0.10-0.71]). Biologic initiators were 2.2 times more likely than noninitiators to take a daily long-term OCS dose of less than 5 mg (risk probability, 49.6% vs 22.5%; P = .002) and had a lower risk of asthma-related emergency department visits (relative risk, 0.35 [95% CI, 0.21-0.58]; rate ratio, 0.26 [0.14-0.48]) and hospitalizations (relative risk, 0.31 [95% CI, 0.18-0.52]; rate ratio, 0.25 [0.13-0.48]). In a real-world setting, including patients with severe asthma and HOCS from 19 countries, and within an environment of clinical improvement, initiation of biologics was associated with further improvements across multiple asthma outcomes, including exacerbation rate, OCS exposure, and health care resource utilization.

Sections du résumé

BACKGROUND
Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS) nor been compared with effectiveness of continuing with HOCS alone.
OBJECTIVE
To examine the effectiveness of initiating biologics in a large, real-world cohort of adult patients with severe asthma and HOCS.
METHODS
This was a propensity score-matched, prospective cohort study using data from the International Severe Asthma Registry. Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCSs for ≥1 year or ≥4 courses of rescue OCSs within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with noninitiators. The impact of biologic initiation on asthma outcomes was assessed using generalized linear models.
RESULTS
We identified 996 matched pairs of patients. Both groups improved over the 12-month follow-up period, but improvement was greater for biologic initiators. Biologic initiation was associated with a 72.9% reduction in the average number of exacerbations per year versus noninitiators (0.64 vs 2.06; rate ratio, 0.27 [95% CI, 0.10-0.71]). Biologic initiators were 2.2 times more likely than noninitiators to take a daily long-term OCS dose of less than 5 mg (risk probability, 49.6% vs 22.5%; P = .002) and had a lower risk of asthma-related emergency department visits (relative risk, 0.35 [95% CI, 0.21-0.58]; rate ratio, 0.26 [0.14-0.48]) and hospitalizations (relative risk, 0.31 [95% CI, 0.18-0.52]; rate ratio, 0.25 [0.13-0.48]).
CONCLUSIONS
In a real-world setting, including patients with severe asthma and HOCS from 19 countries, and within an environment of clinical improvement, initiation of biologics was associated with further improvements across multiple asthma outcomes, including exacerbation rate, OCS exposure, and health care resource utilization.

Identifiants

pubmed: 37301430
pii: S2213-2198(23)00643-8
doi: 10.1016/j.jaip.2023.05.044
pii:
doi:

Substances chimiques

Adrenal Cortex Hormones 0
Steroids 0
Biological Products 0
Anti-Asthmatic Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2732-2747

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Wenjia Chen (W)

Saw Swee Hock School of Public Health, National University of Singapore, Singapore.

Trung N Tran (TN)

AstraZeneca, Gaithersburg, Md.

Mohsen Sadatsafavi (M)

Respiratory Evaluation Sciences Program, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada.

Ruth Murray (R)

Optimum Patient Care Global, Cambridge, United Kingdom.

Nigel Chong Boon Wong (NCB)

Saw Swee Hock School of Public Health, National University of Singapore, Singapore.

Nasloon Ali (N)

Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore.

Con Ariti (C)

Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore.

Lakmini Bulathsinhala (L)

Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore.

Esther Garcia Gil (EG)

AstraZeneca, Barcelona, Spain.

J Mark FitzGerald (JM)

Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.

Marianna Alacqua (M)

AstraZeneca, Cambridge, United Kingdom.

Mona Al-Ahmad (M)

Microbiology Department, Faculty of Medicine, Kuwait University, Al-Rashed Allergy Center, Ministry of Health, Kuwait City, Kuwait.

Alan Altraja (A)

Department of Pulmonology, University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia.

Riyad Al-Lehebi (R)

Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia; College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Mohit Bhutani (M)

Division of Pulmonary Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.

Leif Bjermer (L)

Respiratory Medicine and Allergology, Department of Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.

Anne-Sofie Bjerrum (AS)

Department of Respiratory Medicine and Allergy, Aarhus University Hospital, Aarhus, Denmark.

Arnaud Bourdin (A)

PhyMedExp, Univ Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France.

Anna von Bülow (A)

Respiratory Research Unit, Bispebjerg University Hospital, Copenhagen, Denmark.

John Busby (J)

Centre for Public Health, Queen's University Belfast, Belfast, Northern Ireland.

Giorgio Walter Canonica (GW)

Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Victoria Carter (V)

Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore.

George C Christoff (GC)

Faculty of Public Health, Medical University-Sofia, Sofia, Bulgaria.

Borja G Cosio (BG)

Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain.

Richard W Costello (RW)

Department of Respiratory Medicine, RCSI Clinical Research Centre, Smurfit Building Beaumont Hospital, Dublin, Ireland.

João A Fonseca (JA)

Health Information and Decision Sciences Department (MEDCIDS) & Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine of University of Porto, Porto, Portugal.

Peter G Gibson (PG)

Australian Severe Asthma Network, Priority Research Centre for Healthy Lungs, University of Newcastle, Newcastle, New South Wales, Australia; Department of Respiratory and Sleep Medicine, Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.

Kwang-Ha Yoo (KH)

KonKuk University School of Medicine, Seoul, Korea.

Liam G Heaney (LG)

Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.

Enrico Heffler (E)

Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Mark Hew (M)

Allergy, Asthma & Clinical Immunology Service, Alfred Health, Melbourne, Victoria, Australia; Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.

Ole Hilberg (O)

Medical Department, Vejle University Hospital, Vejle, Denmark.

Flavia Hoyte (F)

Division of Allergy & Clinical Immunology, Department of Medicine, National Jewish Health, Denver, Colo; Division of Allergy & Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.

Takashi Iwanaga (T)

Center for General Medical Education and Clinical Training, Kindai University Hospital, Osakasayama, Japan.

David J Jackson (DJ)

UK Severe Asthma Network and National Registry, Guy's and St Thomas' NHS Trust, London, United Kingdom; School of Immunology & Microbial Sciences, King's College London, London, United Kingdom.

Rupert C Jones (RC)

Research and Knowledge Exchange, Plymouth Marjon University, Plymouth, United Kingdom.

Mariko Siyue Koh (MS)

Respiratory & Critical Care Medicine, Singapore General Hospital, Singapore; SingHealth Duke-NUS Lung Centre, Singapore.

Piotr Kuna (P)

Division of Internal Medicine, Asthma and Allergy Medical University of Łódź, Łódź, Poland.

Désirée Larenas-Linnemann (D)

Centro de Excelencia en Asma y Alergia, Hospital Médica Sur, Mexico City, Mexico.

Sverre Lehmann (S)

Section of Thoracic Medicine, Department of Clinical Science, University of Bergen, Bergen, Norway.

Lauri Lehtimäki (L)

Allergy Centre, Tampere University Hospital, Tampere, Finland; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.

Juntao Lyu (J)

Observational and Pragmatic Research Institute, Singapore; Optimum Patient Care, Brisbane, Queensland, Australia.

Bassam Mahboub (B)

College of Medicine, University of Sharjah, Sharjah, United Arab Emirates; Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates.

Jorge Maspero (J)

Clinical Research for Allergy and Respiratory Medicine, CIDEA Foundation, Buenos Aires, Argentina; University Career of Specialists in Allergy and Clinical Immunology at the Buenos Aires University School of Medicine, Buenos Aires, Argentina.

Andrew N Menzies-Gow (AN)

Royal Brompton & Harefield Hospitals, London, United Kingdom.

Anthony Newell (A)

Observational and Pragmatic Research Institute, Singapore; Optimum Patient Care, Brisbane, Queensland, Australia.

Concetta Sirena (C)

Severe Asthma Network in Italy (SANI), Milan, Italy.

Nikolaos G Papadopoulos (NG)

Division of Infection, Immunity & Respiratory Medicine, University of Manchester, Manchester, United Kingdom; Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.

Andriana I Papaioannou (AI)

2nd Respiratory Medicine Department, National and Kapodistrian University of Athens Medical School, Attikon University Hospital, Athens, Greece.

Luis Perez-de-Llano (L)

Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Monforte, Cervo, Lugo, Spain; Biodiscovery Research Group, Health Research Institute of Santiago de Compostela, Santiago de Compostela, Spain.

Diahn-Warng Perng Steve (DW)

Division of Clinical Respiratory Physiology, Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan; COPD Assembly of the Asian Pacific Society of Respirology, Tokyo, Japan.

Matthew Peters (M)

Department of Thoracic Medicine, Concord Hospital, Sydney, New South Wales, Australia.

Paul E Pfeffer (PE)

Department of Respiratory Medicine, Barts Health NHS Trust, London, United Kingdom; Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

Celeste M Porsbjerg (CM)

Respiratory Research Unit, Bispebjerg University Hospital, Copenhagen, Denmark.

Todor A Popov (TA)

University Hospital "Sv. Ivan Rilski," Sofia, Bulgaria.

Chin Kook Rhee (CK)

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Sundeep Salvi (S)

Pulmocare Research and Education Foundation, Pune, Maharashtra, India.

Camille Taillé (C)

Department of Respiratory Diseases, Bichat Hospital, AP-HP Nord-Université de Paris, Paris, France.

Christian Taube (C)

Department of Pulmonary Medicine, University Medical Center Essen-Ruhrlandklinik, Essen, Germany.

Carlos A Torres-Duque (CA)

CINEUMO, Respiratory Research Center, Fundación Neumológica Colombiana, Bogotá, Colombia.

Charlotte Ulrik (C)

Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark.

Seung-Won Ra (SW)

Division of Pulmonology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.

Eileen Wang (E)

Division of Allergy & Clinical Immunology, Department of Medicine, National Jewish Health, Denver, Colo; Division of Allergy & Clinical Immunology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colo.

Michael E Wechsler (ME)

NJH Cohen Family Asthma Institute, Department of Medicine, National Jewish Health, Denver, Colo.

David B Price (DB)

Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore; Division of Applied Health Sciences, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom. Electronic address: dprice@opri.sg.

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