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
Early online date	14 Mar 2022
DOIs	https://doi.org/10.1007/s12325-022-02098-1
Publication status	Published - 1 May 2022

Keywords

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

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Cite this

@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 ",

}

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

VL - 39

SP - 2065

EP - 2084

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

ER -

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

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Keywords

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