Asthma · Biologics for severe asthma
Mepolizumab treatment in patients with severe eosinophilic asthma
| Design | Randomised, double-blind, double-dummy, placebo-controlled trial |
|---|---|
| Treatment | Mepolizumab 75 mg intravenously or 100 mg subcutaneously every 4 weeks |
| Control | Placebo |
| Population | 576 patients with severe eosinophilic asthma and recurrent exacerbations despite high-dose inhaled glucocorticoids |
| Follow-up | 32 weeks |
| Primary endpoint | Rate of exacerbations |
| Result | Exacerbations fell by 47% (95% CI 29 to 61) with intravenous mepolizumab and 53% (37 to 65) with subcutaneous mepolizumab versus placebo (p<0.001 for both). Exacerbations needing an emergency visit or admission fell by 32% and 61% respectively. At week 32 mean FEV1 increase from baseline was 100 mL greater with intravenous mepolizumab than placebo. |
| Secondary endpoints | Exacerbations requiring emergency care, FEV1, asthma control questionnaire, quality of life |
Mepolizumab administered either intravenously or subcutaneously significantly reduced asthma exacerbations and was associated with improvements in markers of asthma control.
The trial authors, in the published abstract
The trial that established anti-IL-5 therapy and, with it, the eosinophil as a treatment target rather than a curiosity. Everything that followed — SWIFT with six-monthly dosing, BOREAS and MATINEE in COPD — descends from it. Modest FEV1 gain: this is an exacerbation drug, not a bronchodilator.
Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014 Sep 25;371(13):1198-207.