P89\u2005Real-world 1 year effectiveness of benralizumab in severe eosinophilic asthma

Abstract

Introduction Benralizumab is an anti-IL5R monoclonal antibody licensed for patients with severe eosinophilic asthma (SEA). Phase 3 clinical trials demonstrated significant reductions in exacerbation rates and in maintenance oral corticosteroid (mOCS) use. However, relatively low exacerbation rates in placebo treated subjects post-baseline highlight that many subjects were likely to have moderate rather than severe asthma once adherence to inhaled therapy and other factors were corrected. There is currently a paucity of real-world data in SEA confirming the effectiveness of benralizumab. Methods We performed a retrospective review of all SEA patients in a regional severe asthma centre who had received a minimum of 12 months benralizumab treatment. All participants had blood eosinophils of ³0.4x109 despite adequate adherence to ICS/LABA. At each benralizumab dose blood eosinophils, fraction exhaled nitric oxide (FeNO), spirometry, asthma control questionnaire (ACQ6), mini-asthma quality of life questionnaire (mini-AQLQ) and exacerbations were recorded. Results Forty-three patients were included in this analysis (65% female, age 50.95±13.82, BMI 30.67±7.17). The median annual exacerbation rate fell by 75% from 4.0 (IQR 3.0–6.0) to 1.0 (IQR 0.0–2.0), p<0.01. ACQ6 improved by 0.90 from 3.20±1.45 to 2.30±1.31, p0.001. Mini-AQLQ improved by 0.93 from 3.19±1.49 to 4.12±1.50, p<0.001, both exceeding the MCID of 0.5. FEV1 and FeNO did not significantly change. Seventy percent of patients required mOCS at baseline. Of these, just over half (53.6%) were able to discontinue mOCS entirely by one year. The median dose of prednisolone fell from 10 mg (IQR 5–15 mg) at baseline to 0 mg (0–5 mg) at one year (p<0.001) representing a 100% reduction. Conclusion In the largest real-world effectiveness dataset to date of benralizumab in a SEA we report a 75% reduction in exacerbations and a median reduction of 100% in mOCS use at 1 year. Our cohort appeared more severe than the asthma cohort recruited to the phase 3 benralizumab program with a higher proportion on mOCS, higher baseline exacerbation rate and higher ACQ scores despite confirmed adherence to background treatment.Abstract P89 Table 1 N= 43 Baseline 1 year P value Age (years) 50.95 ± 13.82 Female subjects 28 (65.1%) Weight (kg) 83.23 ± 18.83 BMI (kg/m2) 30.67 ± 7.17 Atopy 34 (79.1%) Adult onset disease (≥ 18 years) 22 (51.2%) Nasal polyposis 10 (23.3%) Smoking history (n=40)Never smokerEx-smokerCurrent smoker 30 (75%)10 (25%)0 (0%) Co-morbid COPD 4 (9.3%) Peak blood eosinophil count in the year preceding anti-IL5/R (x109) 1.0 (0–0.8) Blood eosinophil count (x109) 0.1 (0.1–0.3) 0.0 (0.0–0.0) 0.023 FeNO (ppb) 48.0 (25.5–78.0) 46 (35.8–75.8) 0.202 Annual exacerbation rate 4 (3–6) 1 (0–2) <0.001 Median prednisolone dose in patients on mOCS at baseline (mg/day) 10 (5–15) 0 (0–5) <0.001 FEV1 (% predicted) 61.76 ± 20.43 63.05 ± 24.94 0.496 ACQ-6 3.20 ± 1.45 2.30 ± 1.31 0.001 Mini-AQLQ 3.19 ± 1.49 4.12 ± 1.50 <0.001 ABBREVIATIONS: ACQ6 = Asthma Control Questionnaire 6; BMI = Body Mass Index; mOCS = maintenance Oral Corticosteroid; Mini-AQLQ = Mini Asthma Quality of Life Questionnaire; ppb = parts per billion Values quoted are a mean when normally distributed (± standard distribution) or median when data is non-parametric (interquartile range, IQR).