Patients with severe eosinophilic asthma see improvements 1 week after taking benralizumab
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Key takeaways:
- 58.2% of patients experienced a clinically important improvement by week 1.
- Patients with high chronic rhinosinusitis with nasal polyps and high eosinophil counts had the biggest improvements.
SAN ANTONIO — Patients with severe eosinophilic asthma experienced improvements in their symptoms within a week after taking benralizumab, according to data presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
“Clinical trials have demonstrated the early benefits of benralizumab (Fasenra, AstraZeneca) treatment in patients with severe eosinophilic asthma,” Erika Penz, MD, MSc, FRCPC, associate professor of respirology, critical care and sleep medicine at the University of Saskatchewan College of Medicine, said during her presentation. “However, there’s little real-world evidence on the benefits of this early response.”
The prospective, real-world XALOC-2 study examined 413 patients (median age [interquartile range (IQR)] = 58 [48-66]; 60% female) with severe eospinophilic asthma and a median age at asthma diagnosis .
At baseline, 27.4% of these patients also had chronic rhinosinusitis with nasal polyps (CRSwNP), and 60.5% were using maintenance oral corticosteroids. Median blood eosinophil count was 501 (IQR = 346-770) cells/µL, and patients experienced a median of (IQR = 1-4) exacerbations in the previous year as well.
“Asthma symptom control based on the Asthma Control Questionnaire ACQ-6 score was evaluated before and as early as 1 week after benralizumab treatment initiation overall and by baseline subgroups,” Penz said.
The researchers defined wellcontrolled asthma by ACQ-6 scores of less than 0.75, partly controlled asthma by ACQ-6 scores between 0.75 and 1.5 and asthma that was not wellcontrolled by ACQ-6 scores greater than 1.5.
“ACQ-6 scores showed the greatest improvement between baseline and week 1 after benralizumab treatment,” Penz said.
Specifically, 58.2% of patients experienced a clinically important improvement that exceeded the 0.5 minimally clinically important difference threshold by the end of the first week after the first dose of benralizumab.
“However, improvement was still observed up to week 8,” Penz said.
Percentages of patients exceeding this threshold increased to 64.9% at week 2 and week 4 and then to 69.9% at week 8.
Using a minimally clinically important difference threshold of 1.0, percentages of patients who experienced improvements included 34.1% at week 1, 43.5% at week 2, 49.6% at week 4 and 55.3% at week 8.
Percentages of patients with well-controlled asthma increased from 2.6% at baseline to 9.3% at week 1, 13% at week 2, 15.2% at week 4 and 20.8% at week 8.
Similarly, percentages of patients with partly controlled asthma increased from 6.4% at baseline to 15.1% at week 1, 18% at week 2 and 21.7% at week 4 before declining to 21.6% at week 8.
Conversely, the percentages of patients with poorly controlled asthma fell from 91% at baseline to 75.6% at week 1, 69% at week 2, 63% at week 4 and 57.6% at week 8.
Mean changes from baseline in ACQ-6 scores fell by 0.7 by week 1 and by 1.2 by week 8, with improvements across all subgroups as well.
“The greatest improvements were seen in patients with chronic rhinosinusitis with nasal polyps and in patients with eosinophil counts of at least 500 cells per microliter at baseline,” Penz said.
Based on these findings, the researchers said there was an association between targeting eosinophilic inflammation in severe eosinophilic asthma with benralizumab and meaningful responses in asthma symptom control across subgroups, regardless of baseline characteristics.
Perspective
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In this interim analysis, Dr. Penz et al reported data from a large, real-world study in four countries across two continents, evaluating clinical response to benralizumab in a mostly middle-aged population with severe eosinophilic asthma, with the majority (60.5%) being oral corticosteroid dependent.
This study showed that 1 week after starting benralizumab, 58.2% of patients had clinically meaningful improvement (defined as a decrease of 0.5 units or more in the six-item ACQ) that further improved over the course of the 8-week long study period.
This study is consistent with and builds on existing data from clinical trials, and it further supports the use of benralizumab in these patients. Additionally, the study found that the clinical benefit appeared larger in patients with concomitant chronic rhinosinusitis with nasal polyps and those with higher peripheral blood eosinophils.
This is a needed real-world study that provides valuable information for clinicians treating severe eosinophilic asthma. Further studies should aim to include a placebo arm, as it is known that patients in trials often report subjective improvement irrespective of treatment, in addition to evaluating other biologic therapies.
Finally, benralizumab is currently being evaluated in a randomized controlled trial for use in acute asthma exacerbations. This study showing rapid clinical improvement after initiation adds support to potentially using benralizumab for more indications in the future.
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Penz E, et al. Abstract 042. Presented at: AAAAI Annual Meeting; Feb. 24-27, 2023; San Antonio.
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