Abstract: PO0484
IL-6 Inhibitor Ziltivekimab Increases Serum Hemoglobin and Iron Biomarkers in Patients with CKD Stage 3–5: A RESCUE Trial Analysis
Session Information
- Anemia: Therapies and Iron Metabolism
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
- Davidson, Michael, University of Chicago, Chicago, Illinois, United States
- Devalaraja, Matt, Nipuna Therapeutics, Wilmington, Delaware, United States
- Ivkovic, Milana, Novo Nordisk A/S, Søborg, Denmark
- Johansen, Nicklas Järvelä, Novo Nordisk A/S, Søborg, Denmark
- Raj, Dominic S., George Washington University School of Medicine, Washington, Washington, United States
- Sode, Birgitte Fischer, Novo Nordisk A/S, Søborg, Denmark
- Tuttle, Katherine R., University of Washington and Providence Health Care, Spokane, Washington, United States
- Perkovic, Vlado, UNSW Sydney, Sydney, New South Wales, Australia
Background
Interleukin-6 (IL-6)-mediated inflammation causes functional iron deficiency and anemia in patients (pts) with chronic kidney disease (CKD). IL-6 inhibitor, ziltivekimab, reduced inflammation markers (RESCUE trial; NCT03926117) and improved anemia and serum albumin in hemodialysis pts (NCT02868229). We examined the effect of ziltivekimab on serum hemoglobin (Hb) and iron homeostasis in pts with CKD stage 3–5 in the RESCUE trial.
Methods
Changes in anemia markers from baseline (BL) to Week 12 were assessed in pts (CKD stage 3–5, high-sensitivity C-reactive protein ≥2 mg/L) treated with ziltivekimab 7.5, 15 or 30 mg vs placebo (PBO). The intention-to-treat population was analyzed using a mixed model for repeated measurements (no adjustment for multiplicity). Analysis by BL Hb level (<11 or ≥11 g/dL) was conducted.
Results
In the RESCUE trial overall, mean age was 66 years, median Hb 12.5 g/dL at BL (N=198, ziltivekimab; N=66, PBO). Ziltivekimab increased Hb from BL to Week 12 vs PBO (p<0.001 for each dose; Figure/Table), with numerically greater increases with ziltivekimab vs PBO in pts with BL Hb <11 g/dL than pts with BL Hb ≥11 g/dL (Table). Ziltivekimab increased serum iron levels (p<0.0001), total iron-binding capacity and transferrin saturation (both p<0.01) vs PBO. No major safety concerns were reported.
Conclusion
Ziltivekimab improved levels of Hb, serum iron and other iron biomarkers vs PBO in pts with CKD stage 3–5. By reducing inflammation and improving functional iron deficiency, ziltivekimab may improve anemia in pts with CKD.
Funding
- Commercial Support –