Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: Real-world effectiveness and safety in the MONITOR-CKD5 study

Gérard London, Johannes Mann, David Goldsmith, Christian Combe, Frank Dellanna, Philippe Zaoui, Nadja Hoebel, Andriy Krendyukov, Karen MacDonald, Ivo L Abraham

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Aims: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. Materials and methods: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). Results: Most (59.3%) patients were male, median age was 68 years. At enrollment, most (82.5%) had been treated with an erythropoiesis-stimulating agent, and 73.0% had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/ kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/ kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7%) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8%) were related to HX575 treatment, 148 (108 patients; 5.2%) were reported as serious, including 12 events in 11 patients (0.5%) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. Conclusions: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalClinical Nephrology
Volume89
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

Epoetin Alfa
Biosimilar Pharmaceuticals
Renal Dialysis
Anemia
Kidney
Safety
Hemoglobins
Therapeutics
Pure Red-Cell Aplasia
Hematinics
Patient Safety

Keywords

  • Biosimilar
  • Epoetin-α
  • Erythropoiesis stimulating agents
  • HX575
  • Renal anemia

ASJC Scopus subject areas

  • Nephrology

Cite this

Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia : Real-world effectiveness and safety in the MONITOR-CKD5 study. / London, Gérard; Mann, Johannes; Goldsmith, David; Combe, Christian; Dellanna, Frank; Zaoui, Philippe; Hoebel, Nadja; Krendyukov, Andriy; MacDonald, Karen; Abraham, Ivo L.

In: Clinical Nephrology, Vol. 89, No. 1, 01.01.2018, p. 1-9.

Research output: Contribution to journalArticle

London, Gérard ; Mann, Johannes ; Goldsmith, David ; Combe, Christian ; Dellanna, Frank ; Zaoui, Philippe ; Hoebel, Nadja ; Krendyukov, Andriy ; MacDonald, Karen ; Abraham, Ivo L. / Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia : Real-world effectiveness and safety in the MONITOR-CKD5 study. In: Clinical Nephrology. 2018 ; Vol. 89, No. 1. pp. 1-9.
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abstract = "Aims: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. Materials and methods: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). Results: Most (59.3{\%}) patients were male, median age was 68 years. At enrollment, most (82.5{\%}) had been treated with an erythropoiesis-stimulating agent, and 73.0{\%} had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/ kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/ kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7{\%}) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8{\%}) were related to HX575 treatment, 148 (108 patients; 5.2{\%}) were reported as serious, including 12 events in 11 patients (0.5{\%}) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. Conclusions: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.",
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AU - London, Gérard

AU - Mann, Johannes

AU - Goldsmith, David

AU - Combe, Christian

AU - Dellanna, Frank

AU - Zaoui, Philippe

AU - Hoebel, Nadja

AU - Krendyukov, Andriy

AU - MacDonald, Karen

AU - Abraham, Ivo L

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AB - Aims: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. Materials and methods: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). Results: Most (59.3%) patients were male, median age was 68 years. At enrollment, most (82.5%) had been treated with an erythropoiesis-stimulating agent, and 73.0% had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/ kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/ kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7%) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8%) were related to HX575 treatment, 148 (108 patients; 5.2%) were reported as serious, including 12 events in 11 patients (0.5%) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. Conclusions: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.

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KW - Renal anemia

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