Ziltivekimab targets IL-6 to effectively treat anemia patients with CKD stage 3-5, finds study
Anemia affects about 15% of CKD patients and is linked to increased morbidity, mortality, and reduced quality of life. In 30-50% of dialysis patients with kidney failure, high biomarkers of inflammation such as IL-6 and hsCRP are present. Elevated hsCRP (high-sensitivity C-reactive protein) levels are also associated with anemia onset in early CKD stages. Reducing inflammation (indicated by hsCRP decline) may improve CKD patient outcomes.
Pablo E Pergola et al. and colleagues, in a recent study published in the Journal of the American Society of Nephrology, said that Anti-inflammatory therapy with ziltivekimab improved anaemia and iron homeostasis markers in stage 3-5 CKD patients with systemic inflammation, suggesting a possible role in anaemia management.
In the phase 2 RESCUE trial, ziltivekimab reduced inflammation biomarkers compared to placebo in CKD patients with systemic inflammation (hs-CRP ≥2 mg/L). This subanalysis assessed ziltivekimab's effect on Hb and iron homeostasis in these patients.
This study analyzed exploratory endpoints from the RESCUE trial, which included 264 adults with CKD stages 3-5 and high-sensitivity C-reactive protein ≥2 mg/L. Participants were randomized to receive a placebo or subcutaneous ziltivekimab (7.5, 15, or 30 mg) once every four weeks for up to 24 weeks.
- There was a significant increase in Hb levels with ziltivekimab 7.5, 15, and 30 mg (treatment differences versus placebo: +0.57 g/dl, +1.05 g/dl, and +0.99 g/dl), respectively.
- From baseline to week 12, Ziltivekimab was associated with increased serum iron levels, total iron-binding capacity, and transferrin saturation.
- There were no major safety concerns reported.
- Anemia, sustained thrombocytopenia, sustained neutropenia, and iron deficiency anemia cases were infrequent and similar across all groups.
Due to COVID-19, the trial was terminated early, and 12-week data is presented in the study.
The levels of biomarkers related to iron metabolism increased with ziltivekimab compared to placebo, suggesting that anti-inflammatory therapy may be beneficial for treating anemia in CKD.
The decrease in hepcidin levels may have been physiologically meaningful, as it could explain the observed effects on iron metabolism and, ultimately, on Hb levels, they added.
Novo Nordisk A/S funded the study.
Reference:
Pergola PE et al. Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). J Am Soc Nephrol. 2023 Dec 13.
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