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Assessment of Early Responder Characteristics to Mepolizumab in Steroid-Dependent Eosinophilic Asthma
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A1363 - Assessment of Early Responder Characteristics to Mepolizumab in Steroid-Dependent Eosinophilic Asthma
Author Block: J. Kavanagh, L. Green, M. Fernandes, M. Bolton, G. d'Ancona, C. Roxas, B. Kent, D. Jackson; Guy's Severe Asthma Centre, Guys and St Thomas' NHS Trust, London, United Kingdom.
Rationale: Mepolizumab is an anti-IL-5 monoclonal antibody licensed for severe eosinophilic asthma. In several large multicentre studies it has been shown to significantly reduce exacerbations and requirement for maintenance oral corticosteroids (OCS). It remains unknown whether there are any early clinical or inflammatory characteristics at 4 weeks that can predict efficacy. It is also unknown what magnitude of OCS reduction is achievable in a real-life clinical setting as early as 12 weeks.
Methods: A retrospective review of patients in a single tertiary asthma centre with severe eosinophilic asthma requiring maintenance OCS who had received a minimum of 12 weeks mepolizumab therapy was carried out to identify whether any clinical or inflammatory characteristics at 4 weeks could predict response at 12 weeks. Response was defined as a reduction in OCS dose of ≥50%. OCS dose, blood eosinophil (Eos) count, FEV1, fractional exhaled nitric oxide (FeNO), exacerbation history and Asthma Control Questionnaire 7 (ACQ7) was recorded at baseline, 4 weeks and 12 weeks.
Results: Thirty-five patients (48.6% female, mean age 55.8±10.6) were included in this analysis. Overall the mean reduction in OCS dose was 52.9±27.6%. 27 patients (77%) achieved ≥50% reduction in OCS (classified as ‘responder’) by 12 weeks with a mean dose reduction of 64.7±16.4%. This compared to 11.6±17.0% in the ‘non-responder’ group. Comparing data at baseline, 4 and 12 weeks between responder with non-responder groups, there was no statistically significant differences in either absolute numbers or % change in FEV1, FeNO and blood eosinophil counts. In the responder group 64% had undetectable blood eosinophils at 4 weeks compared to 37.5% in the non-responder group with a trend towards statistical significance (P= 0.187). There was a significant improvement in ACQ7 at 12 weeks in the responder group (mean change -0.88±1.28) compared to the non-responder group (0.10±0.78), P=0.015.
Conclusion: Mepolizumab treatment in severe OCS-dependent eosinophilic asthma led to a 53% reduction in OCS dose by 12 weeks. Using 50% OCS reduction as a marker of mepolizumab efficacy, clinical and inflammatory characteristics at 4 weeks did not reliably predict who might achieve this degree of response. Patients who achieved at least a 50% reduction in OCS dose also experienced a significant improvement in asthma control by 12 weeks. Additional research is required in larger cohorts to explore whether there are indeed any early responder characteristics to mepolizumab treatment.
Author Block: J. Kavanagh, L. Green, M. Fernandes, M. Bolton, G. d'Ancona, C. Roxas, B. Kent, D. Jackson; Guy's Severe Asthma Centre, Guys and St Thomas' NHS Trust, London, United Kingdom.
Rationale: Mepolizumab is an anti-IL-5 monoclonal antibody licensed for severe eosinophilic asthma. In several large multicentre studies it has been shown to significantly reduce exacerbations and requirement for maintenance oral corticosteroids (OCS). It remains unknown whether there are any early clinical or inflammatory characteristics at 4 weeks that can predict efficacy. It is also unknown what magnitude of OCS reduction is achievable in a real-life clinical setting as early as 12 weeks.
Methods: A retrospective review of patients in a single tertiary asthma centre with severe eosinophilic asthma requiring maintenance OCS who had received a minimum of 12 weeks mepolizumab therapy was carried out to identify whether any clinical or inflammatory characteristics at 4 weeks could predict response at 12 weeks. Response was defined as a reduction in OCS dose of ≥50%. OCS dose, blood eosinophil (Eos) count, FEV1, fractional exhaled nitric oxide (FeNO), exacerbation history and Asthma Control Questionnaire 7 (ACQ7) was recorded at baseline, 4 weeks and 12 weeks.
Results: Thirty-five patients (48.6% female, mean age 55.8±10.6) were included in this analysis. Overall the mean reduction in OCS dose was 52.9±27.6%. 27 patients (77%) achieved ≥50% reduction in OCS (classified as ‘responder’) by 12 weeks with a mean dose reduction of 64.7±16.4%. This compared to 11.6±17.0% in the ‘non-responder’ group. Comparing data at baseline, 4 and 12 weeks between responder with non-responder groups, there was no statistically significant differences in either absolute numbers or % change in FEV1, FeNO and blood eosinophil counts. In the responder group 64% had undetectable blood eosinophils at 4 weeks compared to 37.5% in the non-responder group with a trend towards statistical significance (P= 0.187). There was a significant improvement in ACQ7 at 12 weeks in the responder group (mean change -0.88±1.28) compared to the non-responder group (0.10±0.78), P=0.015.
Conclusion: Mepolizumab treatment in severe OCS-dependent eosinophilic asthma led to a 53% reduction in OCS dose by 12 weeks. Using 50% OCS reduction as a marker of mepolizumab efficacy, clinical and inflammatory characteristics at 4 weeks did not reliably predict who might achieve this degree of response. Patients who achieved at least a 50% reduction in OCS dose also experienced a significant improvement in asthma control by 12 weeks. Additional research is required in larger cohorts to explore whether there are indeed any early responder characteristics to mepolizumab treatment.
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