2024 | David J. Jackson, Girolamo Pelaia, Benjamin Emmanuel, Trung N. Tran, David Cohen, Vivian H. Shih, Anat Shavit, Douglas Arbetter, Rohit Katial, Adrian Paul J. Rabe, Esther Garcia Gil, Marisa Pardal, Javier Nuevo, Michael Watt, Silvia Boarino, Sheena Kayaniyil, Cláudia Chaves Loureiro, Alicia Padilla-Galo and Parameswaran Nair
This large, multinational, retrospective, observational real-world study programme, XALOC-1, evaluated the effectiveness of benralizumab in patients with severe eosinophilic asthma (SEA). The study included 1002 patients from five countries: Canada, Italy, Portugal, Spain, and the UK. Key findings include:
1. **Clinical Outcomes**:
- **Annualized Exacerbation Rate (AER)**: Overall, AER reduced by 82.7% at week 48, with a 72.9% reduction in biologic-experienced patients.
- **Maintenance Oral Corticosteroid (mOCS) Use**: 47.4% of patients eliminated mOCS use by week 48, with a mean reduction in daily dose of 51.2%.
- **Asthma Symptom Control**: Clinically significant improvements were observed in asthma symptom control scores, with 67.8% of patients achieving or exceeding the minimal clinically important difference (MCID).
2. **Subgroup Analysis**:
- **Biologic Experience**: Biologic-experienced patients (380 out of 1002) showed notable improvements, with a 72.9% reduction in AER.
- **Key Clinical Characteristics**: Patients with higher baseline blood eosinophil count (BEC) and fractional exhaled nitric oxide (FENO) levels had more pronounced improvements in AER.
3. **Treatment Persistence**:
- 77.9% of patients continued benralizumab treatment at week 48, with a median treatment duration of 352 days.
- Discontinuation rates were higher in biologic-experienced patients, primarily due to lack of efficacy or adverse events.
4. ** responders**:
- Univariable and multivariable logistic regression analyses identified higher baseline AER and BEC as positive predictors of response.
5. **Discussion**:
- Benralizumab was effective in reducing AER and mOCS use, improving asthma control, and enhancing lung function in a diverse patient population.
- The study provides valuable insights into the real-world effectiveness of benralizumab, particularly in biologic-experienced patients, and supports its use in a broad group of patients suboptimally controlled on alternative biologic therapies.
6. **Limitations**:
- The retrospective design, lack of a control arm, and data limitations in patient-reported outcomes and lung function measurements are noted as potential limitations.
Overall, XALOC-1 demonstrates the broad therapeutic applicability of benralizumab in SEA, including in patients who have not adequately responded to anti-IgE and/or anti-IL-5 treatments.This large, multinational, retrospective, observational real-world study programme, XALOC-1, evaluated the effectiveness of benralizumab in patients with severe eosinophilic asthma (SEA). The study included 1002 patients from five countries: Canada, Italy, Portugal, Spain, and the UK. Key findings include:
1. **Clinical Outcomes**:
- **Annualized Exacerbation Rate (AER)**: Overall, AER reduced by 82.7% at week 48, with a 72.9% reduction in biologic-experienced patients.
- **Maintenance Oral Corticosteroid (mOCS) Use**: 47.4% of patients eliminated mOCS use by week 48, with a mean reduction in daily dose of 51.2%.
- **Asthma Symptom Control**: Clinically significant improvements were observed in asthma symptom control scores, with 67.8% of patients achieving or exceeding the minimal clinically important difference (MCID).
2. **Subgroup Analysis**:
- **Biologic Experience**: Biologic-experienced patients (380 out of 1002) showed notable improvements, with a 72.9% reduction in AER.
- **Key Clinical Characteristics**: Patients with higher baseline blood eosinophil count (BEC) and fractional exhaled nitric oxide (FENO) levels had more pronounced improvements in AER.
3. **Treatment Persistence**:
- 77.9% of patients continued benralizumab treatment at week 48, with a median treatment duration of 352 days.
- Discontinuation rates were higher in biologic-experienced patients, primarily due to lack of efficacy or adverse events.
4. ** responders**:
- Univariable and multivariable logistic regression analyses identified higher baseline AER and BEC as positive predictors of response.
5. **Discussion**:
- Benralizumab was effective in reducing AER and mOCS use, improving asthma control, and enhancing lung function in a diverse patient population.
- The study provides valuable insights into the real-world effectiveness of benralizumab, particularly in biologic-experienced patients, and supports its use in a broad group of patients suboptimally controlled on alternative biologic therapies.
6. **Limitations**:
- The retrospective design, lack of a control arm, and data limitations in patient-reported outcomes and lung function measurements are noted as potential limitations.
Overall, XALOC-1 demonstrates the broad therapeutic applicability of benralizumab in SEA, including in patients who have not adequately responded to anti-IgE and/or anti-IL-5 treatments.