Clinical Remission in Severe Asthma: A Pooled Post hoc Analysis of the Patient Journey with Benralizumab

Andrew Menzies-Gow; Flavia L.  Hoyte; David Price; David Cohen; Peter Barker; James  Kreindler; Maria  Jison; Christopher L.  Brooks; Peggy  Papeleu; Rohit  Katial

doi:10.1007/s12325-022-02098-1

Clinical Remission in Severe Asthma: A Pooled Post hoc Analysis of the Patient Journey with Benralizumab

Andrew Menzies-Gow^* (Corresponding Author), Flavia L. Hoyte, David Price, David Cohen, Peter Barker, James Kreindler, Maria Jison, Christopher L. Brooks, Peggy Papeleu, Rohit Katial

^*Corresponding author for this work

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

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Abstract

Introduction: Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an IL-5 receptor α–directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.
Methods: In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting β2-agonists. This post hoc analysis included patients randomized to the approved benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS ≤12.5 mg per day (ZONDA). Individual remission components were zero exacerbations; zero OCS use; ACQ 6 score <1.5 or ≤0.75; and pre-bronchodilator forced expiratory volume in 1 sec (FEV1) increase ≥100 mL; clinical remission incorporated zero exacerbations, zero OCS use, ACQ-6 score ≤0.75, and pre-bronchodilator FEV1 increase ≥100 mL after 6- or 12-months.
Results: Overall, 609 patients (N=301 and N=308) and 586 patients (N=293 and N=293) receiving benralizumab in SIROCCO and CALIMA were included at 6- and 12-months, respectively; 40 ZONDA patients were included after 6-months. In SIROCCO/CALIMA, similar to 6-month findings, ~83% and ~49% receiving benralizumab, and 77% and 37% on placebo achieved ≥2 and ≥3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12-months. Among ZONDA
40 patients, 75% and ~48% on benralizumab and 35% and 20% on placebo achieved ≥2 and ≥3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.
Conclusions: This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma

Original language	English
Pages (from-to)	2065–2084
Number of pages	20
Journal	Advances in Therapy
Volume	39
Issue number	5
Early online date	14 Mar 2022
DOIs	https://doi.org/10.1007/s12325-022-02098-1
Publication status	Published - 1 May 2022

Bibliographical note

Funding
This study, the Rapid Service Fee, and the Open Access Fee were funded by AstraZeneca (Gaithersburg, MD, USA).

Data Availability Statement

Data underlying the findings described in this manuscript may be requested in accordance with AstraZeneca’s data-sharing policy described at https://astrazenecagroup-dt.pharmacm.com/DT/Home.

Keywords

Benralizumab
Biologic therapies
Oral corticosteroids (OCS)
Precision medicine
Remission
Severe eosinophilic asthma
Super-response
Treat-to-target

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@article{12da78b496d24771ac5c2ef3e3efba56,

title = "Clinical Remission in Severe Asthma: A Pooled Post hoc Analysis of the Patient Journey with Benralizumab ",

abstract = "Introduction: Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an IL-5 receptor α–directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.Methods: In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting β2-agonists. This post hoc analysis included patients randomized to the approved benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS ≤12.5 mg per day (ZONDA). Individual remission components were zero exacerbations; zero OCS use; ACQ 6 score <1.5 or ≤0.75; and pre-bronchodilator forced expiratory volume in 1 sec (FEV1) increase ≥100 mL; clinical remission incorporated zero exacerbations, zero OCS use, ACQ-6 score ≤0.75, and pre-bronchodilator FEV1 increase ≥100 mL after 6- or 12-months.Results: Overall, 609 patients (N=301 and N=308) and 586 patients (N=293 and N=293) receiving benralizumab in SIROCCO and CALIMA were included at 6- and 12-months, respectively; 40 ZONDA patients were included after 6-months. In SIROCCO/CALIMA, similar to 6-month findings, ~83% and ~49% receiving benralizumab, and 77% and 37% on placebo achieved ≥2 and ≥3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12-months. Among ZONDA40 patients, 75% and ~48% on benralizumab and 35% and 20% on placebo achieved ≥2 and ≥3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.Conclusions: This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma",

keywords = "Benralizumab, Biologic therapies, Oral corticosteroids (OCS), Precision medicine, Remission, Severe eosinophilic asthma, Super-response, Treat-to-target",

author = "Andrew Menzies-Gow and Hoyte, {Flavia L.} and David Price and David Cohen and Peter Barker and James Kreindler and Maria Jison and Brooks, {Christopher L.} and Peggy Papeleu and Rohit Katial",

note = "Funding This study, the Rapid Service Fee, and the Open Access Fee were funded by AstraZeneca (Gaithersburg, MD, USA). ",

year = "2022",

month = may,

day = "1",

doi = "10.1007/s12325-022-02098-1",

language = "English",

volume = "39",

pages = "2065–2084",

journal = "Advances in Therapy",

issn = "0741-238X",

publisher = "Springer ",

number = "5",

}

TY - JOUR

T1 - Clinical Remission in Severe Asthma

T2 - A Pooled Post hoc Analysis of the Patient Journey with Benralizumab

AU - Menzies-Gow, Andrew

AU - Hoyte, Flavia L.

AU - Price, David

AU - Cohen, David

AU - Barker, Peter

AU - Kreindler, James

AU - Jison, Maria

AU - Brooks, Christopher L.

AU - Papeleu, Peggy

AU - Katial, Rohit

N1 - Funding This study, the Rapid Service Fee, and the Open Access Fee were funded by AstraZeneca (Gaithersburg, MD, USA).

PY - 2022/5/1

Y1 - 2022/5/1

N2 - Introduction: Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an IL-5 receptor α–directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.Methods: In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting β2-agonists. This post hoc analysis included patients randomized to the approved benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS ≤12.5 mg per day (ZONDA). Individual remission components were zero exacerbations; zero OCS use; ACQ 6 score <1.5 or ≤0.75; and pre-bronchodilator forced expiratory volume in 1 sec (FEV1) increase ≥100 mL; clinical remission incorporated zero exacerbations, zero OCS use, ACQ-6 score ≤0.75, and pre-bronchodilator FEV1 increase ≥100 mL after 6- or 12-months.Results: Overall, 609 patients (N=301 and N=308) and 586 patients (N=293 and N=293) receiving benralizumab in SIROCCO and CALIMA were included at 6- and 12-months, respectively; 40 ZONDA patients were included after 6-months. In SIROCCO/CALIMA, similar to 6-month findings, ~83% and ~49% receiving benralizumab, and 77% and 37% on placebo achieved ≥2 and ≥3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12-months. Among ZONDA40 patients, 75% and ~48% on benralizumab and 35% and 20% on placebo achieved ≥2 and ≥3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.Conclusions: This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma

AB - Introduction: Consensus definitions for clinical remission and super-response were recently established for severe asthma. Benralizumab is an IL-5 receptor α–directed monoclonal antibody for severe, uncontrolled asthma; efficacy and safety were demonstrated in previous pivotal phase 3 trials (SIROCCO, CALIMA, ZONDA). This analysis applied a composite remission definition to characterize individual responses to benralizumab after 6 and 12 months.Methods: In previous phase 3 studies, eligible patients were those with severe, uncontrolled asthma receiving medium- or high-dosage inhaled corticosteroids plus long-acting β2-agonists. This post hoc analysis included patients randomized to the approved benralizumab dose and not receiving oral corticosteroids (OCS) at baseline (SIROCCO/CALIMA) or OCS ≤12.5 mg per day (ZONDA). Individual remission components were zero exacerbations; zero OCS use; ACQ 6 score <1.5 or ≤0.75; and pre-bronchodilator forced expiratory volume in 1 sec (FEV1) increase ≥100 mL; clinical remission incorporated zero exacerbations, zero OCS use, ACQ-6 score ≤0.75, and pre-bronchodilator FEV1 increase ≥100 mL after 6- or 12-months.Results: Overall, 609 patients (N=301 and N=308) and 586 patients (N=293 and N=293) receiving benralizumab in SIROCCO and CALIMA were included at 6- and 12-months, respectively; 40 ZONDA patients were included after 6-months. In SIROCCO/CALIMA, similar to 6-month findings, ~83% and ~49% receiving benralizumab, and 77% and 37% on placebo achieved ≥2 and ≥3 remission components after 12 months; 14.5% (85/586) on benralizumab and 7.7% (48/620) on placebo achieved clinical remission at 12-months. Among ZONDA40 patients, 75% and ~48% on benralizumab and 35% and 20% on placebo achieved ≥2 and ≥3 remission components at 6 months, respectively; 22.5% (9/40) on benralizumab and 7.5% on placebo achieved clinical remission.Conclusions: This analysis demonstrates clinical remission is achievable by targeting the underlying drivers of inflammation. Precision medicines can help shift treatment paradigms toward treat-to-target, with clinical remission as the ultimate therapeutic goal in severe asthma

KW - Benralizumab

KW - Biologic therapies

KW - Oral corticosteroids (OCS)

KW - Precision medicine

KW - Remission

KW - Severe eosinophilic asthma

KW - Super-response

KW - Treat-to-target

U2 - 10.1007/s12325-022-02098-1

DO - 10.1007/s12325-022-02098-1

M3 - Article

C2 - 35287231

SN - 0741-238X

VL - 39

SP - 2065

EP - 2084

JO - Advances in Therapy

JF - Advances in Therapy

IS - 5

ER -

Clinical Remission in Severe Asthma: A Pooled Post hoc Analysis of the Patient Journey with Benralizumab

Abstract

Bibliographical note

Data Availability Statement

Keywords

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