TY - JOUR T1 - A randomized phase 3 study of the efficacy and safety of reslizumab in subjects with asthma with elevated eosinophils JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P299 AU - Leif Bjermer AU - Catherine Lemiere AU - Jorge Maspero AU - Monika Ciesielska AU - Christopher O'Brien AU - James Zangrilli Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P299.abstract N2 - Introduction: Reslizumab (RES), a humanized anti-human interleukin-5, is under development for patients with moderate to severe, persistent asthma with elevated eosinophils (EOS).Objectives: To compare the efficacy and safety of RES vs placebo (PBO) in subjects with asthma and elevated EOS.Methods: This was a multicenter, PBO-controlled, double-blind, 16-week study (NCT01270464). Subjects (N=311) were 12-75 years of age with uncontrolled asthma on at least medium ICS, had an asthma control questionnaire (ACQ) score ≥1.5, and blood EOS level of ≥400/µL. Randomization was to intravenous RES 0.3 or 3.0 mg/kg or PBO once every 4 weeks. Efficacy variables included pre-dose, pre-bronchodilator pulmonary function (FEV1, primary variable) and ACQ scores.Results: Following 16 weeks of therapy, RES (0.3 and 3.0 mg/kg) significantly improved overall FEV1 (P≤0.024) and ACQ score (P≤0.033) vs PBO (treatment difference vs PBO: 115 and 160 mL, FEV1 and 0.238 and 0.359 ACQ, respectively); improvements for RES 3.0 mg/kg vs PBO were observed in both measures (153 mL, FEV1; -0.283, ACQ) as early as 4 weeks (P≤0.015) and maintained over the duration of the study. Clinically meaningful improvements in FVC (130 mL, P=0.017) and FEF25-75% (0.233 L/s; P=0.055) were noted only for the 3.0 mg/kg dose. The most commonly reported AEs in any treatment group were asthma, headache, nasopharyngitis, bronchitis, and upper respiratory tract infection.Conclusion: In subjects with elevated blood EOS, 4 monthly doses of RES were well tolerated and associated with improvements in pulmonary function and patient-reported asthma control on top of standard-of-care therapies. ER -