Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry

Wenjia Chen; Trung N Tran; Mohsen Sadatsafavi; Ruth Murray; Nigel Chong Boon Wong; Nasloon Ali; Con Ariti; Lakmini Bulathsinhala; Esther Garcia Gil; J Mark FitzGerald; Marianna Alacqua; Mona Al-Ahmad; Alan Altraja; Riyad Al-Lehebi; Mohit Bhutani; Leif Bjermer; Anne-Sofie Bjerrum; Arnaud Bourdin; Anna von Bülow; John Busby; Giorgio Walter Canonica; Victoria Carter; George C Christoff; Borja G Cosio; Richard W Costello; João A Fonseca; Peter G Gibson; Kwang-Ha Yoo; Liam G Heaney; Enrico Heffler; Mark Hew; Ole Hilberg; Flavia Hoyte; Takashi Iwanaga; Rupert C Jones; Mariko Siyue Koh; Piotr Kuna; Désirée Larenas-Linnemann; Sverre Lehmann; Lauri Lehtimäki; Juntao Lyu; Bassam Mahboub; Jorge Maspero; Andrew N Menzies-Gow; Anthony Newell; Concetta Sirena; Nikolaos G Papadopoulos; Andriana I Papaioannou; Luis Perez-de-Llano; Diahn-Warng Perng Steve; 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 Ulrik; Seung-Won Ra; Eileen Wang; Michael E Wechsler; David B Price

doi:10.1016/j.jaip.2023.05.044

Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry

Wenjia Chen, Trung N Tran, Mohsen Sadatsafavi, Ruth Murray, Nigel Chong Boon Wong, Nasloon Ali, Con Ariti, Lakmini Bulathsinhala, Esther Garcia Gil, J Mark FitzGerald, Marianna Alacqua, Mona Al-Ahmad, Alan Altraja, Riyad Al-Lehebi, Mohit Bhutani, Leif Bjermer, Anne-Sofie Bjerrum, Arnaud Bourdin, Anna von Bülow, John BusbyGiorgio Walter Canonica, Victoria Carter, George C Christoff, Borja G Cosio, Richard W Costello, João A Fonseca, Peter G Gibson, Kwang-Ha Yoo, Liam G Heaney, Enrico Heffler, Mark Hew, Ole Hilberg, Flavia Hoyte, Takashi Iwanaga, Rupert C Jones, Mariko Siyue Koh, Piotr Kuna, Désirée Larenas-Linnemann, Sverre Lehmann, Lauri Lehtimäki, Juntao Lyu, Bassam Mahboub, Jorge Maspero, Andrew N Menzies-Gow, Anthony Newell, Concetta Sirena, Nikolaos G Papadopoulos, Andriana I Papaioannou, Luis Perez-de-Llano, Diahn-Warng Perng Steve, 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 Ulrik, Seung-Won Ra, Eileen Wang, Michael E Wechsler, David B Price

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Abstract

BACKGROUND: Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS), nor been compared to 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 (http://isaregistries.org/). Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCS ≥1 year or ≥4 courses of rescue OCS within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with non-initiators. The impact of biologic initiation on asthma outcomes were 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/year versus non-initiators (0.64 vs 2.06, rate ratio: 0.27 [95%CI, 0.10, 0.71]). Biologic initiators were 2.2 times more likely than non-initiators to take a daily long-term OCS dose <5mg (probability: 49.6% vs 22.5%; p=0.002) 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 healthcare resource utilization.

Original language	English
Journal	Journal of Allergy and Clinical Immunology: In Practice
Early online date	08 Jun 2023
DOIs	https://doi.org/10.1016/j.jaip.2023.05.044
Publication status	Early online date - 08 Jun 2023

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Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry
Copyright 2023 Elsevier. This manuscript is distributed under a Creative Commons Attribution-NonCommercial-NoDerivs License (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits distribution and reproduction for non-commercial purposes, provided the author and source are cited.
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Chen, W., Tran, T. N., Sadatsafavi, M., Murray, R., Wong, N. C. B., Ali, N., Ariti, C., Bulathsinhala, L., Gil, E. G., FitzGerald, J. M., Alacqua, M., Al-Ahmad, M., Altraja, A., Al-Lehebi, R., Bhutani, M., Bjermer, L., Bjerrum, A.-S., Bourdin, A., von Bülow, A., ... Price, D. B. (2023). Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry. Journal of Allergy and Clinical Immunology: In Practice. Advance online publication. https://doi.org/10.1016/j.jaip.2023.05.044

@article{bca60b5cfa684735abaeae37fcf28efb,

title = "Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry",

abstract = "BACKGROUND: Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS), nor been compared to 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 (http://isaregistries.org/). Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCS ≥1 year or ≥4 courses of rescue OCS within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with non-initiators. The impact of biologic initiation on asthma outcomes were 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/year versus non-initiators (0.64 vs 2.06, rate ratio: 0.27 [95%CI, 0.10, 0.71]). Biologic initiators were 2.2 times more likely than non-initiators to take a daily long-term OCS dose <5mg (probability: 49.6% vs 22.5%; p=0.002) 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 healthcare resource utilization.",

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

note = "Copyright {\textcopyright} 2023. Published by Elsevier Inc.",

year = "2023",

month = jun,

day = "8",

doi = "10.1016/j.jaip.2023.05.044",

language = "English",

journal = "Journal of Allergy and Clinical Immunology: In Practice",

issn = "2213-2198",

publisher = "American Academy of Allergy, Asthma and Immunology",

}

Chen, W, Tran, TN, Sadatsafavi, M, Murray, R, Wong, NCB, Ali, N, Ariti, C, Bulathsinhala, L, Gil, EG, FitzGerald, JM, Alacqua, M, Al-Ahmad, M, Altraja, A, Al-Lehebi, R, Bhutani, M, Bjermer, L, Bjerrum, A-S, Bourdin, A, von Bülow, A, Busby, J, Walter Canonica, G, Carter, V, Christoff, GC, Cosio, BG, Costello, RW, Fonseca, JA, Gibson, PG, Yoo, K-H, Heaney, LG, Heffler, E, Hew, M, Hilberg, O, Hoyte, F, Iwanaga, T, Jones, RC, Koh, MS, Kuna, P, Larenas-Linnemann, D, Lehmann, S, Lehtimäki, L, Lyu, J, Mahboub, B, Maspero, J, Menzies-Gow, AN, Newell, A, Sirena, C, Papadopoulos, NG, Papaioannou, AI, Perez-de-Llano, L, Perng Steve, D-W, Peters, M, Pfeffer, PE, Porsbjerg, CM, Popov, TA, Rhee, CK, Salvi, S, Taillé, C, Taube, C, Torres-Duque, CA, Ulrik, C, Ra, S-W, Wang, E, Wechsler, ME & Price, DB 2023, 'Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry', Journal of Allergy and Clinical Immunology: In Practice. https://doi.org/10.1016/j.jaip.2023.05.044

TY - JOUR

T1 - Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry

AU - Chen, Wenjia

AU - Tran, Trung N

AU - Sadatsafavi, Mohsen

AU - Murray, Ruth

AU - Wong, Nigel Chong Boon

AU - Ali, Nasloon

AU - Ariti, Con

AU - Bulathsinhala, Lakmini

AU - Gil, Esther Garcia

AU - FitzGerald, J Mark

AU - Alacqua, Marianna

AU - Al-Ahmad, Mona

AU - Altraja, Alan

AU - Al-Lehebi, Riyad

AU - Bhutani, Mohit

AU - Bjermer, Leif

AU - Bjerrum, Anne-Sofie

AU - Bourdin, Arnaud

AU - von Bülow, Anna

AU - Busby, John

AU - Walter Canonica, Giorgio

AU - Carter, Victoria

AU - Christoff, George C

AU - Cosio, Borja G

AU - Costello, Richard W

AU - Fonseca, João A

AU - Gibson, Peter G

AU - Yoo, Kwang-Ha

AU - Heaney, Liam G

AU - Heffler, Enrico

AU - Hew, Mark

AU - Hilberg, Ole

AU - Hoyte, Flavia

AU - Iwanaga, Takashi

AU - Jones, Rupert C

AU - Koh, Mariko Siyue

AU - Kuna, Piotr

AU - Larenas-Linnemann, Désirée

AU - Lehmann, Sverre

AU - Lehtimäki, Lauri

AU - Lyu, Juntao

AU - Mahboub, Bassam

AU - Maspero, Jorge

AU - Menzies-Gow, Andrew N

AU - Newell, Anthony

AU - Sirena, Concetta

AU - Papadopoulos, Nikolaos G

AU - Papaioannou, Andriana I

AU - Perez-de-Llano, Luis

AU - Perng Steve, 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 - Ulrik, Charlotte

AU - Ra, Seung-Won

AU - Wang, Eileen

AU - Wechsler, Michael E

AU - Price, David B

PY - 2023/6/8

Y1 - 2023/6/8

N2 - BACKGROUND: Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS), nor been compared to 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 (http://isaregistries.org/). Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCS ≥1 year or ≥4 courses of rescue OCS within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with non-initiators. The impact of biologic initiation on asthma outcomes were 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/year versus non-initiators (0.64 vs 2.06, rate ratio: 0.27 [95%CI, 0.10, 0.71]). Biologic initiators were 2.2 times more likely than non-initiators to take a daily long-term OCS dose <5mg (probability: 49.6% vs 22.5%; p=0.002) 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 healthcare resource utilization.

AB - BACKGROUND: Effectiveness of biologics has neither been established in patients with high oral corticosteroid exposure (HOCS), nor been compared to 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 (http://isaregistries.org/). Between January 2015 and February 2021, patients with severe asthma and HOCS (long-term OCS ≥1 year or ≥4 courses of rescue OCS within a 12-month period) were identified. Biologic initiators were identified and, using propensity scores, matched 1:1 with non-initiators. The impact of biologic initiation on asthma outcomes were 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/year versus non-initiators (0.64 vs 2.06, rate ratio: 0.27 [95%CI, 0.10, 0.71]). Biologic initiators were 2.2 times more likely than non-initiators to take a daily long-term OCS dose <5mg (probability: 49.6% vs 22.5%; p=0.002) 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 healthcare resource utilization.

U2 - 10.1016/j.jaip.2023.05.044

DO - 10.1016/j.jaip.2023.05.044

M3 - Article

C2 - 37301430

SN - 2213-2198

JO - Journal of Allergy and Clinical Immunology: In Practice

JF - Journal of Allergy and Clinical Immunology: In Practice

ER -

Impact of initiatinG bioLogics In patients with severe asThma on long-Term OCS or frEquent Rescue steroids (GLITTER): data from the International Severe Asthma Registry

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