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 journalArticlepeer-review

63 Citations (Scopus)
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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 languageEnglish
Pages (from-to)2065–2084
Number of pages20
JournalAdvances in Therapy
Volume39
Issue number5
Early online date14 Mar 2022
DOIs
Publication statusPublished - 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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