The MUSCA Trial

DREAMPhase II/III dose ranging efficacy and safety study

Primary endpoint: Quality of Life, measured by SGRQ score

Key secondary endpoint: Lung function, measured by FEV1

a form of the disease in which people with asthma struggle to control their symptoms and may continue to have asthma attacks even when they take high doses of medicine

References

Severe asthma patients with an eosinophilic phenotype (N = 551)

Trial visits every 4 weeks for 24 weeks

Randomised, double-blind

Nucala (mepolizumab) 100mg subcutaneous injection every 4 weeks, added to standard of care (N = 274)

Placebo subcutaneous injection every 4 weeks, added to standard of care (N = 277)

St George’s Respiratory Questionnaire (SGRQ) score: patient-reported outcome measure, used to understand how severe asthma affects a person’s quality of life

Eosinophils are a type of white blood cell that in some severe asthma patients contribute to inflammation in the lungs, making breathing difficult and increasing the risk of an asthma attack. It is estimated that 2% to 5% of patients with asthma have an eosinophilic phenotype.

125hospitals/research centres

FEV1:measure of how much air a person can forcefully blow out of their lungs, used to assess how a patient’s breathing is improving

MENSAPhase III exacerbation study

SIRIUSPhase III oral corticosteroid sparing study

COSMOSPhase III long-term efficacy and safety study

DREAM:Pavord I, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380:651-659.MENSA:Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P. Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma. N Engl J Med. 2014;371:1198-207.SIRIUS:Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID, for the SIRIUS Investigators. Oral corticosteroid-sparing effect of mepolizumab in severe eosinophilic asthma. N Engl J Med. 2014;371:1189-97.COSMOS:Lugogo N, Domingo Ribas C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma: a multi-center open-label, phase IIIb study. Clin Ther. 2016;38:2058-2070.

The Nucala® (mepolizumab) MUSCA Trial(Mepolizumab adjUnctive therapy in subjects with Severe eosinophiliC Asthma)

Eosinophilic phenotype:

19 countries

Severe asthma:

Normal airways Inflamed airways

Phase III study