Produced by GlaxoSmithKline, 100 mg mepolizumab used in conjunction with maximal guideline-recommended therapy, showed a consistent 18% to 20% reduction.
Mepolizumab, a monoclonal antibody, showed a reduction in the annual rate of moderate and severe exacerbations for patients with chronic obstructive pulmonary disease (COPD), according to the results of the METREX and METREO phase 3 studies.
Produced by GlaxoSmithKline, 100 mg mepolizumab used in conjunction with maximal guideline-recommended therapy, showed a consistent 18% to 20% reduction in exacerbations for COPD patients with blood eosinophil counts of >150 cells/µL at study entry or >300 cells/µL within the past year.
Moderate exacerbations were defined as those requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations were considered those requiring hospitalization or resulted in death.
“We believe the data published today in the New England Journal of Medicine demonstrate the benefits of a personalized medicine approach in the treatment of COPD with mepolizumab, using blood eosinophils as a biomarker,” Steve Yancey, the vice president and medicine development lead for mepolizumab at GlaxoSmithKline said in a statement. “Based on the clinically meaningful reductions in exacerbations shown in these studies, we plan to progress regulatory filings this year.”
In the METREX study, the frequency of exacerbations was a statistically significant 18% (p=0.036), while METREO’s results, a 20% reduction (p=0.068) was not found to be statistically significant.
METREX examined 117106 patients, randomizing them to either 100 mg mepolizumab or placebo, stratifying the subjects into 2 groups: higher eosinophil (count of >150 cells/µL at study entry or >300 cells/µL within the past year), and lower eosinophil (<150 cells/µL at study entry and no evidence of >300 cells/µL within the past year).
METREO enrolled 117113 patients to the same groups, and compared mepolizumab in 100 mg and 300 mg doses and placebo. The 100-mg group saw a 20% reduction, while the 300-mg group saw a 14% reduction, both considered not statistically significant.
Analysis of the studies showed that the rates of exacerbation reduction increased simultaneously with blood eosinophil counts, which signified blood eosinophils as a biomarker for identifying the patients with COPD that are most likely to respond to mepolizumab treatment.
“For people living with COPD, a sudden worsening of their symptoms, known as an exacerbation, causes them to struggle to breathe despite receiving the available guideline recommended treatment," Ian Pavord, FMedSci, FRCP, of the University of Oxford, said. "For these patients, there are currently no other treatment options. When considering the challenges these patients face, the exacerbation reduction shown in the METREX and METREO studies is a clinically important outcome.”
The results were presented at the European Respiratory Society (ERS) International Congress 2017, and simultaneously published in the New England Journal of Medicine.