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Up to Four Years of Longitudinal Follow-Up for Patients with Severe Eosinophilic Asthma Receiving Reslizumab
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A1376 - Up to Four Years of Longitudinal Follow-Up for Patients with Severe Eosinophilic Asthma Receiving Reslizumab
Author Block: L. Pahus1, A. Bourdin2, M. McDonald3, P. Meizlik3, P. Chanez1; 1Aix Marseille University, Marseille, France, 2Montpellier University Hospital, Montpellier, France, 3Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: The Phase 3 BREATH trials demonstrated that reslizumab improved FEV1, reduced clinical asthma exacerbations (CAEs), and maintained a favorable safety profile (Castro et al, Lancet Resp Med. 2015). The aim of this analysis is to present safety and efficacy data from a cohort in France with the longest (up to 4 years) clinical trial exposure to IV reslizumab (RES). Methods: 7 patients with uncontrolled eosinophilic asthma (blood eosinophils ≥400/µL, ≥1 CAE in 12 months prior to enrollment) who completed a 52-week placebo controlled trial (PCT) entered a RES (3mg/kg [IV] Q4W) open-label extension (OLE) study (≤2 years) followed by an additional, consecutive open-label safety (OLS) study (2 years) at a single center in France. This post-hoc analysis evaluated exposure time, CAEs, and adverse events (AE) during each study. Results: The mean age was 56.7 years (range: 36-73). 1 patient was randomized to and received RES in the PCT prior to enrolling in the two open-label studies. The mean total RES exposure across all 3 studies is 40.4 months (range: 37.7 to 49.6 months) with a mean exposure of 348 days (range: 303 to 400 days) in the OLE and 733 days (range: 726 to 757 days) in the OLS. The 1 RES-treated patient in the PCT had 358 days of exposure in that study. At PCT baseline, patients had a mean 2.4 CAE/year. CAE rate during the treatment period of the PCT was 4.0 CAE/year (PBO) versus 1.0 CAE/year (RES). The subsequent CAE rates during the OLE and OLS, respectively, were 1.5 CAE/year and 1.4 CAE/year. The most frequent AE in the PCT, OLE, and OLS was asthma (n=7, n=6, n=7 patients, respectively). No patients discontinued RES due to AE. Conclusions: Up to 4 years of longitudinal clinical trial data supports that extended long-term use of reslizumab is safe and well-tolerated with maintained reduction in CAEs.
Author Block: L. Pahus1, A. Bourdin2, M. McDonald3, P. Meizlik3, P. Chanez1; 1Aix Marseille University, Marseille, France, 2Montpellier University Hospital, Montpellier, France, 3Teva Pharmaceuticals, Malvern, PA, United States.
Rationale: The Phase 3 BREATH trials demonstrated that reslizumab improved FEV1, reduced clinical asthma exacerbations (CAEs), and maintained a favorable safety profile (Castro et al, Lancet Resp Med. 2015). The aim of this analysis is to present safety and efficacy data from a cohort in France with the longest (up to 4 years) clinical trial exposure to IV reslizumab (RES). Methods: 7 patients with uncontrolled eosinophilic asthma (blood eosinophils ≥400/µL, ≥1 CAE in 12 months prior to enrollment) who completed a 52-week placebo controlled trial (PCT) entered a RES (3mg/kg [IV] Q4W) open-label extension (OLE) study (≤2 years) followed by an additional, consecutive open-label safety (OLS) study (2 years) at a single center in France. This post-hoc analysis evaluated exposure time, CAEs, and adverse events (AE) during each study. Results: The mean age was 56.7 years (range: 36-73). 1 patient was randomized to and received RES in the PCT prior to enrolling in the two open-label studies. The mean total RES exposure across all 3 studies is 40.4 months (range: 37.7 to 49.6 months) with a mean exposure of 348 days (range: 303 to 400 days) in the OLE and 733 days (range: 726 to 757 days) in the OLS. The 1 RES-treated patient in the PCT had 358 days of exposure in that study. At PCT baseline, patients had a mean 2.4 CAE/year. CAE rate during the treatment period of the PCT was 4.0 CAE/year (PBO) versus 1.0 CAE/year (RES). The subsequent CAE rates during the OLE and OLS, respectively, were 1.5 CAE/year and 1.4 CAE/year. The most frequent AE in the PCT, OLE, and OLS was asthma (n=7, n=6, n=7 patients, respectively). No patients discontinued RES due to AE. Conclusions: Up to 4 years of longitudinal clinical trial data supports that extended long-term use of reslizumab is safe and well-tolerated with maintained reduction in CAEs.
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