A longitudinal follow-up of severe asthma patients receiving reslizumab

Introduction: In two duplicate multicentre placebo-controlled Phase 3 (BREATH) studies, reslizumab (RES) reduced exacerbations and improved lung function and quality of life (QOL) in adult patients (pts) with uncontrolled severe eosinophilic asthma (Castro et al Lancet Respir Med 2015:3:355-66). Aims/Objectives: To report a long-term (up to 2 yrs) single centre experience (France) evaluating the efficacy and safety of RES in pts who participated in a phase 3 placebo-controlled trial (PCT) and entered the open-label extension study (OLE). Methods: Pts (≥18 yrs) who completed a PCT with IV RES 3 mg/kg Q4W (52 wks) entered an OLE and received open-label IV RES 3 mg/kg Q4W for up to 2 yrs. Changes in lung function (FEV₁), asthma symptoms and control (ASUI; ACQ7), and QOL (AQLQ) were assessed from baseline of PCT to the end of the OLE. Results: Of the 10 pts, 60% were female (median age: 57.5 yrs [range: 36.0–73.0]; median BMI: 24.7 kg/m² [19.0–33.8]). Median duration of RES exposure was 367 days (289–708). Most pts (60%) had improved FEV₁. The median change in FEV₁ was 105 mL (–230 to 600, or –15.5% to +54.0% of baseline). The median improvements in ASUI, ACQ7, and AQLQ versus baseline were 0.30 (–0.10 to 0.5), –1.29 (0 to –2.7), and 1.3 (–0.1 to 2.3), respectively (exceeding the minimally important differences). Ovarian and prostate cancers were reported during the OLE (n=1 each); neither was considered related to study drug by the investigator. The overall safety profile in this cohort was similar to that of the pivotal phase 3 trials (Castro 2015). Conclusions: Patients treated with long-term reslizumab maintained clinically significant improvements in FEV₁, asthma symptoms, asthma control and quality of life.