Abstract: TH-PO888
Pegmolesatide for the Treatment of Anemia in Patients with CKD Undergoing Dialysis: Insights from a Randomized Active-Controlled Phase 3 Study
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Chen, Jianghua, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
- Zhou, Linghui, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
- Guo, Minghao, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
- Zheng, Hongguang, General Hospital of Northern Theater Command, Shenyang, Liaoning, China
- Xie, Deqiong, Second People's Hospital of Yibin, Yibin, Sichuan, China
- Hu, Zhizhen, Jiangsu Hansoh Pharmaceutical Co Ltd, Lianyungang, Jiangsu, China
- Luo, Weili, Jiangsu Hansoh Pharmaceutical Co Ltd, Lianyungang, Jiangsu, China
Background
Pegmolesatide, a novel long-acting pegylated erythropoietin mimetic peptide, has proved comparable efficacy and safety with epoetin alfa based on a randomized, multicenter, open-label, non-inferiority phase 3 study (NCT03902691). This post-hoc analysis aims to explore further benefits of pegmolesatide for the treatment of anemia patients on dialysis.
Methods
A total of 372 chronic kidney disease (CKD) patients undergoing dialysis were randomized (2:1) to receive pegmolesatide or epoetin alfa for 52 weeks. Post-hoc analysis was conducted to assess the proportions of patients across various hemoglobin (Hb) ranges during the efficacy evaluation period.
Results
A larger proportion of patients on pegmolesatide achieved mean Hb≥11 g/dL compared to those on epoetin alfa (63.9% vs. 44.7%, P=0.0003). More patients receiving pegmolesatide maintained their Hb levels within the target ranges of 11-12 g/dL (35.2% vs. 22.8%, P=0.0164) and 11-13 g/dL (57.5% vs. 36.8%, P=0.0002) compared to those receiving epoetin alfa. In subgroups of baseline characteristics with age ≤65 yrs., primary hypertension, stage 5 CKD≥12 months, CRP≤11.5 mg/L, serum ferritin between 100-500 ng/mL, and transferrin saturation≥20%, pegmolesatide also showed greater effect in maintaining Hb levels between 11-12 g/dL (Figure). Similar findings were observed in these subgroups for the target range of 11-13 g/dL. The incidences of treatment related adverse events of particular interest, including hypertension (4.5% vs. 6.5%), hepatotoxicity (0.8% vs. 2.4%) and hyperkalaemia (2.4% vs. 4.0%), were numerically lower in the pegmolesatide group.
Conclusion
Pegmolesatide demonstrated a stronger likelihood of maintaining Hb levels within guideline-recommended ranges and potentially provided a more favorable safety profile compared to epoetin alfa.
Funding
- Commercial Support – Jiangsu Hansoh Pharmaceutical Co Ltd