CHEST Guidelines-Reslizumab-for-Inadequately-Controlled-Asthma-With

Reslizumab-for-Inadequately-Controlled-Asthma-With

Pdf Summary

This study investigated the efficacy and safety of reslizumab, a humanized anti-IL-5 monoclonal antibody, in patients aged 12 to 75 with inadequately controlled asthma and elevated blood eosinophil levels. Conducted as a randomized, double-blind, placebo-controlled phase 3 trial, it involved administration of reslizumab at doses of 0.3 mg/kg or 3.0 mg/kg, or placebo, every four weeks over 16 weeks. The primary endpoint was change in pre-bronchodilator FEV1, with secondary endpoints including FVC, asthma symptom control, and blood eosinophil levels.<br /><br />The results showed that reslizumab significantly improved FEV1, with the 3.0 mg/kg dose providing greater improvements than the 0.3 mg/kg dose. Clinically meaningful increases in lung function parameters such as FVC and FEF25%-75% were noted, particularly with the higher dose. Additionally, reslizumab improved patient-reported asthma control and quality of life scores. Adverse events, such as headache and nasopharyngitis, were mostly mild to moderate. The safety profile was comparable between the two reslizumab doses.<br /><br />The study concluded that reslizumab, particularly at 3.0 mg/kg, was effective in improving lung function, asthma control, and quality of life in patients with inadequately controlled asthma and elevated eosinophil levels. The results support the use of elevated blood eosinophil counts as a biomarker for identifying responders to reslizumab therapy. The treatment was well tolerated, with the greater clinical benefits from the 3.0 mg/kg dose not associated with increased safety risks. Overall, this trial supports reslizumab as a valuable addition to asthma therapy for a specific subset of patients.

Keywords

reslizumab

asthma

eosinophil

monoclonal antibody

FEV1

FVC

randomized trial

lung function

asthma control

biomarker