Patients with Severe Eosinophilic Asthma, CRSwNP More Likely to Achieve Remission with Benralizumab

Renaud Louis, MD, PhD

Credit: LinkedIn

Up to half of all patients receiving benralizumab were able to achieve clinical remission of severe eosinophilic asthma and concomitant chronic rhinosinusitis with nasal polyps (CRSwNP) at 12 months, according to data from a pooled analysis.¹

In new post hoc research presented at the American Thoracic Society (ATS) 2023 International Conference in Washington, DC, this week, a multinational team of investigators observed outcomes from a quintet of clinical trials that would indicate the interleukin 5 (IL-5) inhibitor benralizumab as a viable option to treat patients with severe asthma and concomitant CRSwNP.

Led by Renaud Louis, MD, PhD, of the University of Liege department of pneumology, investigated conducted analysis of patients with severe eosinophilic asthma treated with benralizumab in prior clinical trials to interpret rates of clinical remission between those with and without concomitant CRSwNP.

Among the earliest US Food and Drug Administration-approved add-on biologics for severe eosinophil asthma in November 2017,² benralizumab’s mechanism of action against eosinophils has altered standards for potential disease resolution.

“Biologic therapies, which target key drivers of the underlying pathophysiology of asthma, have made clinical remission an achievable treatment goal in severe asthma,” Louis and colleagues wrote.

What’s more, the common concomitant condition CRSwNP among patients with severe eosinophilic asthma has become better understood as a predictor of enhanced response to benralizumab in some patient subpopulations. Investigators sought the prevalence of clinical remission in patients treated with the IL-5 inhibitor based on 3 components:

• No asthma exacerbations
• No oral corticosteroid use for exacerbations nor long-term asthma control
• Asthma Control Questionnaire 6-Item (ACQ-6) score of <1.5

The post hoc analysis featured patients with uncontrolled, severe eosinophilic asthma treated with benralizumab from each of the following studies:

• SIROCCO, a phase 3, 48-week, double-blind, parallel-group, placebo-controlled trial including patients aged 12 – 75 years old
• CALIMA, a phase 3, 56-week, double-blind, parallel-group, placebo-controlled trial including patients aged 12 – 75 years old
• ZONDA, a phase 3, 28-week, double-blind, parallel-group, placebo-controlled trial including patients aged ≥18 years old
• ANDHI, a phase 3b, 23-week, randomized, double-blind, placebo-controlled trial including patients aged 12 – 75 years old
• PONENTE, a phase 3b, 56-week open-label trial including patients aged 12 – 75 years old

Louis and colleagues assessed patient baseline characteristics, and 6- and 12-month clinical remission rates. The final analysis included 1559 overall patients with severe eosinophilic asthma, as well as 386 with concomitant CRSwNP, from the 5 trials.

The team observed a more than two-fold increased rate of clinical remission among patients with severe eosinophilic asthma plus CRSwNP (47.5%) treated with benralizumab than among those with lone severe asthma (21.8%).

Among the 5 clinical trials, patients from ZONDA with severe eosinophilic asthma plus CRSwNP were the most likely to achieve clinical remission with benralizumab (61.5%) at 6 months. In the open-label PONENTE trial, just 21.8% of overall treated patients and 21.9% of patients with concomitant CRSwNP achieved clinical remission.

Among the 3 clinical trials to reach 12-month data, benralizumab-treated patients with concomitant CRSwNP were again more likely to achieve clinical remission than those with lone severe eosinophilic asthma. In the CALIMA trial, 58.1% of patients with concomitant CRSwNP achieved clinical remission at 12 months, versus just 36.2% of those without CRSwNP.

“Across 5 clinical trials of benralizumab, rates of clinical remission were generally higher in patients with SEA and concomitant CRSwNP than in the overall population, reinforcing the presence of CRSwNP with enhanced asthma outcomes with benralizumab treatment,” investigators concluded.

References

1. ^{Lous RE, Harrison T, Shavit A, Kwiatek J, et al. Approaching Clinical Remission in Severe Asthma: An Analysis of Patients With Comorbid Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Treated With Benralizumab Across Five Clinical Trials. Paper presented at: American Thoracic Society (ATS) 2023 International Conference. Washington, DC. May 18 – 24, 2023.}
2. ^{Castles T. FDA Approves Benralizumab for Severe Eosinophilic Asthma. HCPLive. Published November 15, 2017. Accessed May 24, 2023. https://www.hcplive.com/view/fda-approves-benralizumab-for-severe-eosinophilic-asthma}