American College of Cardiology

American College of Cardiology

Source:

Ridker PM, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).

Disclosures: The study was funded by Novo Nordisk. Ridker reports he received investigator-initiated research grants and served as a consultant to multiple pharmaceutical companies.
May 25, 2021
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Ziltivekimab reduces inflammatory biomarkers tied to atherosclerosis

Source:

Ridker PM, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; May 15-17, 2021 (virtual meeting).

Disclosures: The study was funded by Novo Nordisk. Ridker reports he received investigator-initiated research grants and served as a consultant to multiple pharmaceutical companies.
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Ziltivekimab, a novel interleukin-6 ligand inhibitor, significantly reduced multiple inflammatory and thrombotic biomarkers associated with atherosclerosis, according to data presented at the American College Cardiology Scientific Session.

“Ziltivekimab (Novo Nordisk) ... markedly reduced multiple biomarkers of systemic inflammation and thrombosis known to promote the atherothrombotic process, including high-sensitivity C-reactive protein, fibrinogen, serum amyloid A, secretory phospholipase A2 and lipoprotein(a),” Paul M. Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention and the Eugene Braunwald Professor of Medicine at Harvard Medical School, said during a presentation on the RESCUE trial.

Paul M. Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention and the Eugene Braunwald Professor of Medicine at Harvard Medical School.

“The magnitude of change with ziltivekimab on hsCRP was nearly twice as large in RESCUE as that observed in the CANTOS trial of canakinumab, where cardiovascular event rates were reduced by 15% to 20%,” Ridker said.

For the RESCUE trial, simultaneously published in The Lancet, the researchers analyzed 264 participants, (median age, 68 years; 49% women) with stage 3 to 5 chronic kidney disease, diabetes and atherosclerotic CVD.

Researchers found that among the patients who received placebo, there was a 4% reduction in median hsCRP at 12 weeks, whereas the reductions in the ziltivekimab groups were 77% for the 7.5 mg group, 88% for the 15 mg group and 92% for the 30 mg group (P < .0001 for all).

According to the researchers, by comparison, the median differences in percentage change in hsCRP between the ziltivekimab and placebo groups, after aligning for strata, were –66.2% for the 7.5 mg group, –77.7% for the 15 mg group and –87.8% for the 30 mg group (P < .001 for all).

“Dose-dependent effects of ziltivekimab on high-sensitivity CRP were observed over time in terms of both absolute levels and median percentage change, though formal statistical testing across doses was not prespecified in the protocol,” the researchers wrote in The Lancet. “Compared with placebo, ziltivekimab was associated with similar significant dose-dependent reductions for the secondary biomarker endpoints of fibrinogen and serum amyloid A, and the exploratory endpoints of secretory phospholipase A2 and haptoglobin.”

“We believe these phase 2 data suggest that ziltivekimab may be unique among currently available IL-6 inhibitors and strongly support its use in future cardiovascular outcome trials,” Ridker said during his presentation.

Ridker said during the presentation that a large-scale CV outcomes trial, ZEUS, will be conducted among 6,200 patients with known ASCVD, chronic kidney disease stages 3 to 4 and hsCRP greater than 2 ml/L.

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