SP558
24-MONTH SAFETY OUTCOMES OF BIOSIMILAR EPOETIN ALFA IN THE EUROPEAN MONITOR-CKD5 PHARMACOEPIDEMIOLOGICAL STUDY OF ANAEMIA IN HAEMODIALYSIS

Introduction and Aims: MONITOR-CKD5 is a European study examining the effectiveness and safety outcomes of biosimilar epoetin alfa (Binocrit^®/Sandoz) in haemodialysis patients in real-world practice. We report safety data accrued over 24 months.

Methods: Prospective 24-month pharmacoepidemiological study of CKD5 patients (pts) with renal anaemia started on Binocrit^® treatment de novo or by conversion in 10 European countries. We report data on adverse drug reactions (ADR) and (serious) adverse events (S/AE).

Results: Mean+SD age in this mainly male (59.3%) cohort was 64.8±14.95y. Most pts (82.5%) were converted from a prior erythropoiesis-stimulating agent (ESA). Primary CKD5 aetiologies included diabetic nephropathy (22.5%), chronic glomerulonephritis (18.1%), and renal vascular disease (14.6%). Most common comorbidities included hypertension (81.0%), coronary disease (35.1%), and type 2 diabetes (30.2%). In the evaluable sample (n=2023) 291 (14.4%) pts experienced a thrombo-embolic event (TEE), mainly shunt thrombosis (164/8.1%), myocardial ischaemia/infarction (68/3.4%), and cerebrovascular accident (34/1.7%) (all other TEEs ≤1.0%). Other clinical events (≥1.0%) observed were infection requiring treatment (681/33.7%), surgery excl. transplant (315/15.6%), bleeding with significant blood loss (172/8.5%), and red blood cell transfusion (RBCTx) for reasons other than renal anaemia (107/5.3%). Whereas 2.8% of pts had received RBCTx prior to visit 1, for visits 2 through 24 RBCTx rates since-prior-visit ranged from 0.3% (V22) to 1.2% (V3). In total, 345 (17.1%) pts were hospitalized during the study, mainly once (193/9.5%) or twice (59/2.9%); and (per MedDRA coding) mainly for surgical/medical procedures (135/6.7%), infections and infestations (83/4.1%), or injury, poisoning, and procedural complications (77/3.8%). In the safety sample (n=2086), 140 pts (6.7%) were reported to have experienced an AE or SAE, including 16 (0.8%) stated to be related. Of these 140 patients, 108 (5.2%) were reported to have experienced an SAE, including 11 (0.5%) stated to be related.

Conclusions: MONITOR-CKD5 confirms that the real-world safety profile of Binocrit^®, a biosimilar epoetin alfa, is consistent with the profile of originator epoetin alfa. Our findings are the first two-year evidence of the safety of Binocrit^® in daily clinical practice.