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Study shows anemia drug is safe, effective for patients with kidney disease

Issue: December 2018

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Francesco Locatelli

SAN DIEGO — A look at the cardiovascular safety and efficacy of methoxy polyethylene glycol-epoetin beta in the treatment of anemia in patients with chronic kidney disease showed no differences compared to a control group, according to findings presented at ASN Kidney Week 2018.

As part of the MIRCERA Post-Approval Safety Study, Francesco Locatelli, MD, and an international team of researchers compared cardiovascular outcomes and all-cause mortality for methoxy polyethylene glycol-epoetin beta (continuous erythropoietin receptor activator, known as CERA), administered monthly, to those of reference erythropoiesis-stimulating agents epoetin alfa/beta and darbepoetin alfa.

Patients with CKD with anemia were randomized either to start or switch to CERA or to a reference ESA, which was administered more frequently than the monthly CERA dosing. The primary endpoint was the composite of all-cause mortality and non-fatal myocardial infarction or stroke.

Of the 2,825 patients randomized between December 2008 and November 2011 to receive CERA or another anemia treatment, 2,818 were treated for a median of 3.4 years (maximum 8.5 years).

“We found no differences in the occurrence of (myocardial infarction), stroke or mortality when comparing the reference ESAs to CERA,” Locatelli said during his presentation. “Hemoglobins were steady throughout the study, with levels around 10 to 12 hgb. Serum iron levels were comparable, and the overall safety profile was consistent.”

Secondary analyses also showed no significant differences between treatment groups for patients with or without diabetes. Gastrointestinal bleeding and thromboembolic events were similar between treatment groups, and no patient developed antibody-mediated pure red cell aplasia. – by Mark E. Neumann

Reference:

Locatelli F, et al. Abstract FR-OR145. Presented at: ASN Kidney Week; Oct. 23-28, 2018; San Diego.

Disclosure: Locatelli reports that this study was funded by Hoffman LaRoche, manufacturers of CERA.