Benralizumab, a monoclonal antibody targeting the IL-5 receptor, has demonstrated sustained efficacy in patients with severe eosinophilic asthma, according to a recent study conducted in Mexico City. The research, which evaluated 21 patients over a 12-month period, showed significant reductions in inhaled corticosteroid (ICS) dosage, improvements in respiratory function, and enhanced disease control. These findings underscore benralizumab's potential to improve the management of severe asthma and reduce patients' reliance on traditional therapies.
Study Design and Methods
The ambispective, longitudinal study, conducted at the Regional Hospital “General Ignacio Zaragoza,” included patients aged 18 years or older with severe uncontrolled eosinophilic asthma. Participants received subcutaneous benralizumab 30 mg every 8 weeks. The primary outcomes assessed were the reduction in ICS-LABA utilization, improvements in lung function (FEV1), and decreased serum eosinophil counts. Secondary outcomes included Asthma Control Test (ACT) scores, Asthma Control Questionnaire (ACQ) scores, and fractional exhaled nitric oxide (FeNO) levels. Statistical analysis was performed using a paired-sample t-test to compare baseline measurements with those at 6 and 12 months.
Key Findings
The study population consisted of 13 women (61.9%) and 8 men (38.1%), with an age range of 37 to 70 years. Key results include:
- FEV1 Improvement: A statistically significant increase of 241.43 mL (±461.43) after 6 months and 369.44 mL (±519.28) at 12 months.
- Eosinophil Reduction: A substantial depletion of 612.78 cells/μL (± 549.11) at 12 months.
- FeNO Reduction: An average decrease of 39.77 ppm (±50.12) at 6 months.
- Improved Disease Control: At 6 months, 90.5% of patients achieved disease control according to the ACT, and 62% achieved good control per the ACQ-5. At 12 months, 71% had good disease control.
- ICS Reduction: 95.2% of patients were on a lower dosage of ICS or had suspended treatment at 12 months.
Clinical Implications
The findings align with previous clinical trials, such as SIROCCO and CALIMA, which demonstrated benralizumab's ability to reduce asthma exacerbation rates and improve symptom control. The present study extends these observations by showing that benralizumab allows for significant reductions in ICS-LABA utilization, potentially decreasing adverse effects associated with these treatments. As the study highlights, 95.2% of patients were able to reduce ICS dosage by 12 months of treatment including 5 patients (23.8%) who were able to suspend ICS-LABA management.
Comparison to Existing Literature
The results are consistent with the SHAMAL study, which found that 92% of patients with severe eosinophilic asthma were able to reduce their ICS-LABA dosage without losing clinical control. Similarly, the ADNHI in practice study showed a reduction in inhaled therapies, including ICS-LABA, in patients treated with benralizumab. These studies, along with the current research, support the efficacy of benralizumab in controlling severe eosinophilic asthma and reducing the need for high doses of inhaled corticosteroids.
Safety and Tolerability
No patients reported adverse events while using benralizumab during the follow-up period. Only three patients experienced an exacerbation secondary to an infectious disease, indicating that benralizumab is a well-tolerated treatment option for severe eosinophilic asthma.
Study Limitations
The study's limitations include a small sample size and the absence of a placebo control. However, the consistency of the findings with previous research and the significant changes in biomarkers and clinical outcomes suggest that benralizumab is indeed effective in inducing remission in patients with uncontrolled severe eosinophilic asthma.
Conclusion
This study provides further evidence that benralizumab is an effective treatment option for patients with severe eosinophilic asthma. By reducing eosinophil counts, improving respiratory function, and enhancing disease control, benralizumab allows for a significant reduction in ICS-LABA utilization, leading to improved patient outcomes and a potential reduction in healthcare costs. The key to successful management with benralizumab lies in adequate patient selection, considering the predominant phenotype and the presence of basal factors that can help clinicians discern the patient group that will benefit fully from treatment selection.
