Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study

Andrew Menzies-Gow; Claire  McBrien; Bindhu Unni; Celeste M. Porsbjerg; Mona Al-Ahmad; Christopher Ambrose; Karin Dahl  Assing; Anna  von Bülow; John  Busby; Borja G. Cosio; J. Mark FitzGerald; Esther Garcia Gil; Susanne Hansen; Liam G Heaney; Mark Hew; David J Jackson; Maria Kallieri; Stelios Loukides; Njira Lugogo; Andriana I. Papaioannou; Désirée Larenas-Linnemann; Wendy C. Moore; Luis Perez de Llano; Linda M. Rasmussen; Johannes Schmidt; Salman Siddiqui; Marianna Alacqua; Trung N Tran; Charlotte  Suppli Ulrik; John W Upham; Wang Eileen; Lakmini Bulathsinhala; Victoria A  Carter; Isha Chaudhry; Nevaashni Eleangovan; Ruth B Murray; Chris Price; David Price

Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study

Andrew Menzies-Gow, Claire McBrien, Bindhu Unni, Celeste M. Porsbjerg, Mona Al-Ahmad, Christopher Ambrose, Karin Dahl Assing, Anna von Bülow, John Busby, Borja G. Cosio, J. Mark FitzGerald, Esther Garcia Gil, Susanne Hansen, Liam G Heaney, Mark Hew, David J Jackson, Maria Kallieri, Stelios Loukides, Njira Lugogo, Andriana I. PapaioannouDésirée Larenas-Linnemann, Wendy C. Moore, Luis Perez de Llano, Linda M. Rasmussen, Johannes Schmidt, Salman Siddiqui, Marianna Alacqua, Trung N Tran, Charlotte Suppli Ulrik, John W Upham, Wang Eileen, Lakmini Bulathsinhala, Victoria A Carter, Isha Chaudhry, Nevaashni Eleangovan, Ruth B Murray, Chris Price, David Price^* (Corresponding Author)

^*Corresponding author for this work

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Abstract

Introduction: International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors.

Methods: This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015-2020) or the CHRONICLE Study (2018-2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and (USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups.
Results: 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti–IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti–IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients who
stopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization.

Conclusion: The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching.

Original language	English
Pages (from-to)	63-78
Number of pages	16
Journal	Journal of Asthma and Allergy
Volume	15
Publication status	Published - 13 Jan 2022

Bibliographical note

Acknowledgements
We would like to acknowledge Dr. Ghislaine Scelo (PhD) and Dr. Nasloon Ali (PhD) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for their assistance in statistical data analysis, and Ms. Audrey Ang (BSc, Hons) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for editorial and formatting assistance that supported the development of this publication.

Funding
This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

Keywords

Severe asthma
biologics
prescribing
cohort study
management
international

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Menzies-Gow, A., McBrien, C., Unni, B., Porsbjerg, C. M., Al-Ahmad, M., Ambrose, C., Assing, K. D., von Bülow, A., Busby, J., Cosio, B. G., FitzGerald, J. M., Gil, E. G., Hansen, S., Heaney, L. G., Hew, M., Jackson, D. J., Kallieri, M., Loukides, S., Lugogo, N., ... Price, D. (2022). Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study. Journal of Asthma and Allergy, 15, 63-78.

Menzies-Gow, A, McBrien, C, Unni, B, Porsbjerg, CM, Al-Ahmad, M, Ambrose, C, Assing, KD, von Bülow, A, Busby, J, Cosio, BG, FitzGerald, JM, Gil, EG, Hansen, S, Heaney, LG, Hew, M, Jackson, DJ, Kallieri, M, Loukides, S, Lugogo, N, Papaioannou, AI, Larenas-Linnemann, D, Moore, WC, Perez de Llano, L, Rasmussen, LM, Schmidt, J, Siddiqui, S, Alacqua, M, Tran, TN, Suppli Ulrik, C, Upham, JW, Eileen, W, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Murray, RB, Price, C & Price, D 2022, 'Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study', Journal of Asthma and Allergy, vol. 15, pp. 63-78.

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title = "Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study",

abstract = "Introduction: International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors.Methods: This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015-2020) or the CHRONICLE Study (2018-2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and (USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups.Results: 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti–IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti–IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients whostopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization.Conclusion: The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching.",

keywords = "Severe asthma, biologics, prescribing, cohort study, management, international",

author = "Andrew Menzies-Gow and Claire McBrien and Bindhu Unni and Porsbjerg, {Celeste M.} and Mona Al-Ahmad and Christopher Ambrose and Assing, {Karin Dahl} and {von B{\"u}low}, Anna and John Busby and Cosio, {Borja G.} and FitzGerald, {J. Mark} and Gil, {Esther Garcia} and Susanne Hansen and Heaney, {Liam G} and Mark Hew and Jackson, {David J} and Maria Kallieri and Stelios Loukides and Njira Lugogo and Papaioannou, {Andriana I.} and D{\'e}sir{\'e}e Larenas-Linnemann and Moore, {Wendy C.} and {Perez de Llano}, Luis and Rasmussen, {Linda M.} and Johannes Schmidt and Salman Siddiqui and Marianna Alacqua and Tran, {Trung N} and {Suppli Ulrik}, Charlotte and Upham, {John W} and Wang Eileen and Lakmini Bulathsinhala and Carter, {Victoria A} and Isha Chaudhry and Nevaashni Eleangovan and Murray, {Ruth B} and Chris Price and David Price",

note = "Acknowledgements We would like to acknowledge Dr. Ghislaine Scelo (PhD) and Dr. Nasloon Ali (PhD) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for their assistance in statistical data analysis, and Ms. Audrey Ang (BSc, Hons) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for editorial and formatting assistance that supported the development of this publication. Funding This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution. ",

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pages = "63--78",

journal = "Journal of Asthma and Allergy",

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TY - JOUR

T1 - Real world biologic use and switch patterns in severe asthma

T2 - data from the International Severe Asthma Registry and the US CHRONICLE Study

AU - Menzies-Gow, Andrew

AU - McBrien, Claire

AU - Unni, Bindhu

AU - Porsbjerg, Celeste M.

AU - Al-Ahmad, Mona

AU - Ambrose, Christopher

AU - Assing, Karin Dahl

AU - von Bülow, Anna

AU - Busby, John

AU - Cosio, Borja G.

AU - FitzGerald, J. Mark

AU - Gil, Esther Garcia

AU - Hansen, Susanne

AU - Heaney, Liam G

AU - Hew, Mark

AU - Jackson, David J

AU - Kallieri, Maria

AU - Loukides, Stelios

AU - Lugogo, Njira

AU - Papaioannou, Andriana I.

AU - Larenas-Linnemann, Désirée

AU - Moore, Wendy C.

AU - Perez de Llano, Luis

AU - Rasmussen, Linda M.

AU - Schmidt, Johannes

AU - Siddiqui, Salman

AU - Alacqua, Marianna

AU - Tran, Trung N

AU - Suppli Ulrik, Charlotte

AU - Upham, John W

AU - Eileen, Wang

AU - Bulathsinhala, Lakmini

AU - Carter, Victoria A

AU - Chaudhry, Isha

AU - Eleangovan, Nevaashni

AU - Murray, Ruth B

AU - Price, Chris

AU - Price, David

N1 - Acknowledgements We would like to acknowledge Dr. Ghislaine Scelo (PhD) and Dr. Nasloon Ali (PhD) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for their assistance in statistical data analysis, and Ms. Audrey Ang (BSc, Hons) of the Observational and Pragmatic Research Institute (OPRI), Singapore, for editorial and formatting assistance that supported the development of this publication. Funding This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

PY - 2022/1/13

Y1 - 2022/1/13

N2 - Introduction: International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors.Methods: This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015-2020) or the CHRONICLE Study (2018-2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and (USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups.Results: 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti–IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti–IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients whostopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization.Conclusion: The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching.

AB - Introduction: International registries provide opportunities to describe use of biologics for treating severe asthma in current clinical practice. Our aims were to describe real-life global patterns of biologic use (continuation, switches, and discontinuations) for severe asthma, elucidate reasons underlying these patterns, and examine associated patient-level factors.Methods: This was a historical cohort study including adults with severe asthma enrolled into the International Severe Asthma Registry (ISAR; http://isaregistries.org, 2015-2020) or the CHRONICLE Study (2018-2020) and treated with a biologic. Eleven countries were included (Bulgaria, Canada, Denmark, Greece, Italy, Japan, Kuwait, South Korea, Spain, UK, and (USA). Biologic utilization patterns were defined: 1) continuing initial biologic; 2) stopping biologic treatment; or 3) switching to another biologic. Reasons for discontinuation/switching were recorded and comparisons drawn between groups.Results: 3531 patients were included. Omalizumab was the most common initial biologic in 2015 (88.2%) and benralizumab in 2019 (29.6%). Most patients (79%; 2791/3531) continued their first biologic; 10.2% (356/3531) stopped; 10.8% (384/3531) switched. The most frequent first switch was from omalizumab to an anti–IL-5/5R (49.6%; 187/377). The most common subsequent switch was from one anti–IL-5/5R to another (44.4%; 20/45). Insufficient efficacy and/or adverse effects were the most frequent reasons for stopping/switching. Patients whostopped/switched were more likely to have a higher baseline blood eosinophil count and exacerbation rate, lower lung function, and greater health care resource utilization.Conclusion: The description of real-life patterns of continuing, stopping, or switching biologics enhances our understanding of global biologic use. Prospective studies involving structured switching criteria could ascertain optimal strategies to identify patients who may benefit from switching.

KW - Severe asthma

KW - biologics

KW - prescribing

KW - cohort study

KW - management

KW - international

M3 - Article

SN - 1178-6965

VL - 15

SP - 63

EP - 78

JO - Journal of Asthma and Allergy

JF - Journal of Asthma and Allergy

ER -

Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study

Abstract

Bibliographical note

Keywords

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