Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy

Wenjia  Chen; Mohsen Sadatsafavi; Trung N Tran; Ruth B Murray; Nigel Chong Boon  Wong; Nasloon  Ali; Cono  Ariti; Esther Garcia Gil; Anthony Patrick Newell; Marianna Alacqua; Mona Al-Ahmad; Harry  Altraja; Riyad  Al-Lehebi; Mohit  Bhutani; Leif Bjermer; Anne Sofie Bjerrum; Arnaud Bourdin; Lakmini Bulathsinhala; Anna  von Bülow; John  Busby; Giorgio Walter Canonica; Victoria Carter; George Christoff; Borja G. Cosio; Richard W  Costello; J. Mark FitzGerald; João A. Fonseca; Kwang Ha Yoo; Liam G Heaney; Enrico Heffler; Mark Hew; Ole   Hilberg; Flavia  Hoyte; Takashi Iwanaga; David J Jackson; Rupert C Jones; Mariko Koh  Siyue; Piotr Kuna; Désirée Larenas-Linnemann; Sverre  Lehmann; Lauri A.  Lehtimäki; Juntao  Lyu; Bassam Mahboub; Jorge F Maspero; Andrew Menzies-Gow; Concetta  Sirena; Nikolaos G Papadopoulos; Andriana I. Papaioannou; Luis Perez de Llano; Diahn Warng Perng; Matthew Peters; Paul E Pfeffer; Celeste M. Porsbjerg; Todor A Popov; Chin Kook Rhee; Sundeep Salvi; Camille  Taillé; Christian  Taube; Carlos A.  Torres-Duque; Charlotte  Suppli Ulrik; Seung Won  Ra; Wang Eileen; Michael E Wechsler; David Price

doi:10.2147/JAA.S377174

Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy

Wenjia Chen, Mohsen Sadatsafavi, Trung N Tran, Ruth B Murray, Nigel Chong Boon Wong, Nasloon Ali, Cono Ariti, Esther Garcia Gil, Anthony Patrick Newell, Marianna Alacqua, Mona Al-Ahmad, Harry Altraja, Riyad Al-Lehebi, Mohit Bhutani, Leif Bjermer, Anne Sofie Bjerrum, Arnaud Bourdin, Lakmini Bulathsinhala, Anna von Bülow, John BusbyGiorgio Walter Canonica, Victoria Carter, George Christoff, Borja G. Cosio, Richard W Costello, J. Mark FitzGerald, João A. Fonseca, Kwang Ha Yoo, Liam G Heaney, Enrico Heffler, Mark Hew, Ole Hilberg, Flavia Hoyte, Takashi Iwanaga, David J Jackson, Rupert C Jones, Mariko Koh Siyue, Piotr Kuna, Désirée Larenas-Linnemann, Sverre Lehmann, Lauri A. Lehtimäki, Juntao Lyu, Bassam Mahboub, Jorge F Maspero, Andrew Menzies-Gow, Concetta Sirena, Nikolaos G Papadopoulos, Andriana I. Papaioannou, Luis Perez de Llano, Diahn Warng Perng, Matthew Peters, Paul E Pfeffer, Celeste M. Porsbjerg, Todor A Popov, Chin Kook Rhee, Sundeep Salvi, Camille Taillé, Christian Taube, Carlos A. Torres-Duque, Charlotte Suppli Ulrik, Seung Won Ra, Wang Eileen, Michael E Wechsler, David Price^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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 anti106 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 1,412 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

Original language	English
Pages (from-to)	1491—1510
Number of pages	20
Journal	Journal of Asthma and Allergy
Volume	15
Issue number	15
Early online date	21 Oct 2022
DOIs	https://doi.org/10.2147/JAA.S377174
Publication status	Published - 21 Oct 2022

Keywords

severe asthma
biologics
real-world
treatment pattern
patient characteristics

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Chen, W., Sadatsafavi, M., Tran, T. N., Murray, R. B., Wong, N. C. B., Ali, N., Ariti, C., Gil, E. G., Newell, A. P., Alacqua, M., Al-Ahmad, M., Altraja, H., Al-Lehebi, R., Bhutani, M., Bjermer, L., Bjerrum, A. S., Bourdin, A., Bulathsinhala, L., von Bülow, A., ... Price, D. (2022). Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy. Journal of Asthma and Allergy, 15(15), 1491—1510. https://doi.org/10.2147/JAA.S377174

Chen, W, Sadatsafavi, M, Tran, TN, Murray, RB, Wong, NCB, Ali, N, Ariti, C, Gil, EG, Newell, AP, Alacqua, M, Al-Ahmad, M, Altraja, H, Al-Lehebi, R, Bhutani, M, Bjermer, L, Bjerrum, AS, Bourdin, A, Bulathsinhala, L, von Bülow, A, Busby, J, Canonica, GW, Carter, V, Christoff, G, 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, Siyue, MK, Kuna, P, Larenas-Linnemann, D, Lehmann, S, Lehtimäki, LA, Lyu, J, Mahboub, B, Maspero, JF, Menzies-Gow, A, Sirena, C, Papadopoulos, NG, Papaioannou, AI, Perez de Llano, L, Perng, DW, Peters, M, Pfeffer, PE, Porsbjerg, CM, Popov, TA, Rhee, CK, Salvi, S, Taillé, C, Taube, C, Torres-Duque, CA, Suppli Ulrik, C, Ra, SW, Eileen, W, Wechsler, ME & Price, D 2022, 'Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy', Journal of Asthma and Allergy, vol. 15, no. 15, pp. 1491—1510. https://doi.org/10.2147/JAA.S377174

@article{1bf588e49873452b843c8e7b0ca3992e,

title = "Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy",

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 anti106 IL4R), were described at the time of biologic initiation or registry enrolment. Statistical relationships were tested using Pearson{\textquoteright}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 1,412 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",

author = "Wenjia Chen and Mohsen Sadatsafavi and Tran, {Trung N} and Murray, {Ruth B} and Wong, {Nigel Chong Boon} and Nasloon Ali and Cono Ariti and Gil, {Esther Garcia} and Newell, {Anthony Patrick} and Marianna Alacqua and Mona Al-Ahmad and Harry Altraja and Riyad Al-Lehebi and Mohit Bhutani and Leif Bjermer and Bjerrum, {Anne Sofie} and Arnaud Bourdin and Lakmini Bulathsinhala and {von B{\"u}low}, Anna and John Busby and Canonica, {Giorgio Walter} and Victoria Carter and George Christoff and Cosio, {Borja G.} and Costello, {Richard W} and FitzGerald, {J. Mark} and Fonseca, {Jo{\~a}o A.} and Yoo, {Kwang Ha} and Heaney, {Liam G} and Enrico Heffler and Mark Hew and Ole Hilberg and Flavia Hoyte and Takashi Iwanaga and Jackson, {David J} and Jones, {Rupert C} and Siyue, {Mariko Koh} and Piotr Kuna and D{\'e}sir{\'e}e Larenas-Linnemann and Sverre Lehmann and Lehtim{\"a}ki, {Lauri A.} and Juntao Lyu and Bassam Mahboub and Maspero, {Jorge F} and Andrew Menzies-Gow and Concetta Sirena and Papadopoulos, {Nikolaos G} and Papaioannou, {Andriana I.} and {Perez de Llano}, Luis and Perng, {Diahn Warng} and Matthew Peters and Pfeffer, {Paul E} and Porsbjerg, {Celeste M.} and Popov, {Todor A} and Rhee, {Chin Kook} and Sundeep Salvi and Camille Taill{\'e} and Christian Taube and Torres-Duque, {Carlos A.} and {Suppli Ulrik}, Charlotte and Ra, {Seung Won} and Wang Eileen and Wechsler, {Michael E} and David Price",

note = "Acknowledgments The authors would like to acknowledge Dr. James Zangrilli and Dr. Alex de Giorgio-Miller for their instrumental contributions to the study concept, Mr. Joash Tan (BSc, Hons) of the Observational and Pragmatic Research Institute (OPRI), 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.",

year = "2022",

month = oct,

day = "21",

doi = "10.2147/JAA.S377174",

language = "English",

volume = "15",

pages = "1491—1510",

journal = "Journal of Asthma and Allergy",

issn = "1178-6965",

publisher = "Dove Medical Press Ltd.",

number = "15",

}

TY - JOUR

T1 - Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy

AU - Chen, Wenjia

AU - Sadatsafavi, Mohsen

AU - Tran, Trung N

AU - Murray, Ruth B

AU - Wong, Nigel Chong Boon

AU - Ali, Nasloon

AU - Ariti, Cono

AU - Gil, Esther Garcia

AU - Newell, Anthony Patrick

AU - Alacqua, Marianna

AU - Al-Ahmad, Mona

AU - Altraja, Harry

AU - Al-Lehebi, Riyad

AU - Bhutani, Mohit

AU - Bjermer, Leif

AU - Bjerrum, Anne Sofie

AU - Bourdin, Arnaud

AU - Bulathsinhala, Lakmini

AU - von Bülow, Anna

AU - Busby, John

AU - Canonica, Giorgio Walter

AU - Carter, Victoria

AU - Christoff, George

AU - Cosio, Borja G.

AU - Costello, Richard W

AU - FitzGerald, J. Mark

AU - Fonseca, João A.

AU - Yoo, Kwang Ha

AU - Heaney, Liam G

AU - Heffler, Enrico

AU - Hew, Mark

AU - Hilberg, Ole

AU - Hoyte, Flavia

AU - Iwanaga, Takashi

AU - Jackson, David J

AU - Jones, Rupert C

AU - Siyue, Mariko Koh

AU - Kuna, Piotr

AU - Larenas-Linnemann, Désirée

AU - Lehmann, Sverre

AU - Lehtimäki, Lauri A.

AU - Lyu, Juntao

AU - Mahboub, Bassam

AU - Maspero, Jorge F

AU - Menzies-Gow, Andrew

AU - Sirena, Concetta

AU - Papadopoulos, Nikolaos G

AU - Papaioannou, Andriana I.

AU - Perez de Llano, Luis

AU - Perng, Diahn Warng

AU - Peters, Matthew

AU - Pfeffer, Paul E

AU - Porsbjerg, Celeste M.

AU - Popov, Todor A

AU - Rhee, Chin Kook

AU - Salvi, Sundeep

AU - Taillé, Camille

AU - Taube, Christian

AU - Torres-Duque, Carlos A.

AU - Suppli Ulrik, Charlotte

AU - Ra, Seung Won

AU - Eileen, Wang

AU - Wechsler, Michael E

AU - Price, David

N1 - Acknowledgments The authors would like to acknowledge Dr. James Zangrilli and Dr. Alex de Giorgio-Miller for their instrumental contributions to the study concept, Mr. Joash Tan (BSc, Hons) of the Observational and Pragmatic Research Institute (OPRI), 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 - 2022/10/21

Y1 - 2022/10/21

N2 - 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 anti106 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 1,412 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

AB - 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 anti106 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 1,412 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

KW - severe asthma

KW - biologics

KW - real-world

KW - treatment pattern

KW - patient characteristics

U2 - 10.2147/JAA.S377174

DO - 10.2147/JAA.S377174

M3 - Article

C2 - 36303891

VL - 15

SP - 1491—1510

JO - Journal of Asthma and Allergy

JF - Journal of Asthma and Allergy

SN - 1178-6965

IS - 15

ER -

Characterization of patients in the International Severe Asthma Registry with high steroid exposure who did or did not initiate biologic therapy

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