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Improvements in Exacerbation Rate and Lung Function with Weight-Based Intravenous Reslizumab Dosing in Patients with Baseline High Body Weight
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A1356 - Improvements in Exacerbation Rate and Lung Function with Weight-Based Intravenous Reslizumab Dosing in Patients with Baseline High Body Weight
Author Block: K. R. Murphy1, M. McDonald2, M. C. Garin2; 1Allergy, Asthma, and Pulmonary Research, Boys Town National Research Hospital, Boys Town, NE, United States, 2Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: Reslizumab (RES) is a humanized anti-interleukin-5 monoclonal antibody that significantly reduced the risk of clinical asthma exacerbations (CAEs) and improved lung function in patients with uncontrolled eosinophilic asthma (EOS ≥400/µL) and ≥1 CAE in the prior 12 months (Castro et al., Lancet Respir Med. 2015). Dosing of IV RES is weight based, thus the aim of this analysis was to evaluate the RES therapeutic effect in a subgroup with high baseline body weight. Methods: This was a post-hoc analysis of the two duplicate, multicenter, randomized, 52-week, placebo (PBO)-controlled Phase 3 trials of RES (3 mg/kg IV Q4W) in adults and adolescents with eosinophilic asthma. Patients in the highest weight tertile were analyzed. CAEs and change in FEV1 and % predicted FEV1 at 52 weeks are reported. Results: The trials included 953 patients (RES 477; PBO 476). The overall weight range was 33.9 to 142.3kg. The high weight tertile included patients between 81 to 142.3kg, n=319 (RES 157; PBO 162). The annual CAE rate for RES was 0.69 vs PBO 1.40 (RR 0.50, reduction over 52 weeks of 50%, [95% CI: 0.34, 0.74] p-value=0.0005). Mean baseline FEV1 was 2205mL for RES and 2160mL for PBO, with mean change of 219mL with RES and 71mL with PBO at 52 weeks (treatment difference 129mL [95% CI: 28, 229mL] p-value=0.0123). Mean baseline % predicted FEV1 was 66% for both treatment arms, and mean change was 7.1% for RES and 2.7% for PBO at 52 weeks (treatment difference 4.0% [95% CI: 1.0, 7.0%] p-value=0.0095). Conclusions: RES was effective in producing substantial improvements in CAE rate and FEV1 in the subgroup with the highest baseline body weight in two large, multicenter Phase 3 trials. This finding supports the value of weight-based dosing in a severe, uncontrolled eosinophilic asthma population.
Author Block: K. R. Murphy1, M. McDonald2, M. C. Garin2; 1Allergy, Asthma, and Pulmonary Research, Boys Town National Research Hospital, Boys Town, NE, United States, 2Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: Reslizumab (RES) is a humanized anti-interleukin-5 monoclonal antibody that significantly reduced the risk of clinical asthma exacerbations (CAEs) and improved lung function in patients with uncontrolled eosinophilic asthma (EOS ≥400/µL) and ≥1 CAE in the prior 12 months (Castro et al., Lancet Respir Med. 2015). Dosing of IV RES is weight based, thus the aim of this analysis was to evaluate the RES therapeutic effect in a subgroup with high baseline body weight. Methods: This was a post-hoc analysis of the two duplicate, multicenter, randomized, 52-week, placebo (PBO)-controlled Phase 3 trials of RES (3 mg/kg IV Q4W) in adults and adolescents with eosinophilic asthma. Patients in the highest weight tertile were analyzed. CAEs and change in FEV1 and % predicted FEV1 at 52 weeks are reported. Results: The trials included 953 patients (RES 477; PBO 476). The overall weight range was 33.9 to 142.3kg. The high weight tertile included patients between 81 to 142.3kg, n=319 (RES 157; PBO 162). The annual CAE rate for RES was 0.69 vs PBO 1.40 (RR 0.50, reduction over 52 weeks of 50%, [95% CI: 0.34, 0.74] p-value=0.0005). Mean baseline FEV1 was 2205mL for RES and 2160mL for PBO, with mean change of 219mL with RES and 71mL with PBO at 52 weeks (treatment difference 129mL [95% CI: 28, 229mL] p-value=0.0123). Mean baseline % predicted FEV1 was 66% for both treatment arms, and mean change was 7.1% for RES and 2.7% for PBO at 52 weeks (treatment difference 4.0% [95% CI: 1.0, 7.0%] p-value=0.0095). Conclusions: RES was effective in producing substantial improvements in CAE rate and FEV1 in the subgroup with the highest baseline body weight in two large, multicenter Phase 3 trials. This finding supports the value of weight-based dosing in a severe, uncontrolled eosinophilic asthma population.
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