Table 1.
Studies of reslizumab in asthma
Study | Study design | Number of patients | Population | Regimen | Main findings |
---|---|---|---|---|---|
Kips et al21 | Randomized, double blind | 32 | Symptomatic severe persistent asthmatics despite using high-dose inhaled or oral corticosteroids | Single dose of reslizumab IV at doses ranging from 0.03 to 1.0 mg/kg or placebo | No biological activity seen at doses below 0.03 mg/kg. Dose of 1.0 mg/kg produced a significant reduction in eosinophil counts. No improvement in pulmonary function or symptom scores |
Castro et al22 | Multicenter, randomized, double blind, placebo controlled | 106 | Poorly controlled asthmatics with airway reactivity, on high-dose ICS+ to a second controller, and sputum eosinophils ≥3% | Reslizumab 3.0 mg/kg IV or placebo at baseline and at weeks 4, 8, and 12 | A trend toward improved ACQ scores, with patients with nasal polyps with a more substantial response. A trend toward improvement in exacerbation rates (8% vs 19%). Eosinophils significantly decreased in sputum |
Castro et al26 | Two replicate trials, multicenter, randomized, double blind, placebo controlled | 953 | Poorly controlled asthmatics despite using at least medium-dose ICS with or without a controller and a blood eosinophil count of ≥400 cells per µL | Reslizumab 3 mg/kg IV or placebo every 4 weeks × 13 doses | Reduction in rates of asthma exacerbations and improvement in FEV1 and asthma control |
Corren et al27 | Multicenter, randomized, double blind, placebo controlled | 496 | Poorly controlled asthmatics despite using at least medium-dose ICS with or without a controller without preselection eosinophil count criteria | Reslizumab 3.0 mg/kg IV or placebo every 4 weeks × 4 doses | No difference in FEV1 in both study groups. Subgroup analysis in subjects with blood eosinophil count of ≥400 cells per µL had improvements in FEV1, ACQ scores, and rescue inhaler use |
Bjermer et al28 | Multicenter, randomized, double blind, placebo controlled | 315 | Poorly controlled asthmatics despite using at least medium-dose ICS with or without a controller and a blood eosinophil count of ≥400 cells per µL | Reslizumab 0.3 or 3.0 mg/kg IV or placebo every 4 weeks × 4 doses | The 3.0 mg/kg dose had improvement in pulmonary function and self-reported asthma control and quality of life |
Abbreviations: ACQ, asthma control questionnaire; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; IV, intravenous.