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

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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
Early online date14 Mar 2022
DOIs
Publication statusPublished - 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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