Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study.

IF 1.1 4区 医学 Q3 UROLOGY & NEPHROLOGY
Stavros Patsialas, Heather Fowler, Ruffy Guilatco, Stephanie Salts, Feng Richard Xia, Sonja Gomez Perez, Andreas Iwanowitsch, Matthias Kohnle
{"title":"Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study.","authors":"Stavros Patsialas,&nbsp;Heather Fowler,&nbsp;Ruffy Guilatco,&nbsp;Stephanie Salts,&nbsp;Feng Richard Xia,&nbsp;Sonja Gomez Perez,&nbsp;Andreas Iwanowitsch,&nbsp;Matthias Kohnle","doi":"10.5414/CN110825","DOIUrl":null,"url":null,"abstract":"<p><p>Epoetin has been used to treat patients with renal anemia since 1988. -Anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been associated with epoetin usage, and a PRCA incidence of 4.5 per 10,000 patient-years was observed for epoetin-α (Eprex) in 2002. The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. One PRCA in 1 (0.02%) patient in group R who tested positive for neutralizing antibodies was reported. Overall, 527 adverse events of special interest (AESI) including PRCA occurred in 418 (6.60%) patients, lack of efficacy occurred in 34 (0.54%), and thromboembolic events in 389 (6.14%) patients. 41 adverse drug reactions other than AESIs were reported in 28 (0.44%) patients. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"247-255"},"PeriodicalIF":1.1000,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10112001/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical nephrology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5414/CN110825","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Epoetin has been used to treat patients with renal anemia since 1988. -Anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been associated with epoetin usage, and a PRCA incidence of 4.5 per 10,000 patient-years was observed for epoetin-α (Eprex) in 2002. The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. One PRCA in 1 (0.02%) patient in group R who tested positive for neutralizing antibodies was reported. Overall, 527 adverse events of special interest (AESI) including PRCA occurred in 418 (6.60%) patients, lack of efficacy occurred in 34 (0.54%), and thromboembolic events in 389 (6.14%) patients. 41 adverse drug reactions other than AESIs were reported in 28 (0.44%) patients. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern.

Abstract Image

慢性肾性贫血患者皮下给药epoetin-zeta三年安全性观察:PASCO II研究结果
自1988年以来,促生成素已被用于治疗肾性贫血患者。抗红细胞生成素抗体介导的纯红细胞再生不全(PRCA)与生成素的使用有关,2002年观察到生成素-α (Eprex)的PRCA发病率为每10,000患者年4.5例。PASCO II研究(reacrit和皮下给药Silapo (epoetin-ζ)治疗肾性贫血的授权后安全性队列观察)随访了6346例患者(4501例reacrit (R组);1845 Silapo (S组)使用生物类似药epoetin-ζ进行长达3年的皮下治疗。R组1例(0.02%)中和抗体检测阳性的患者中有1例PRCA。总体而言,418例(6.60%)患者发生了527例特殊利益不良事件(AESI),包括PRCA, 34例(0.54%)患者发生了缺乏疗效,389例(6.14%)患者发生了血栓栓塞事件。28例(0.44%)患者发生非AESIs药物不良反应41例。经暴露调整后的PRCA发病率为0.84 / 10000患者年。这项现实世界的研究表明,在接受皮下给药生物仿制药epoetin-ζ的肾性贫血患者中,PRCA的发生率大大低于2002年Eprex观察到的风险,并且没有免疫原性问题或其他新的安全性问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Clinical nephrology
Clinical nephrology 医学-泌尿学与肾脏学
CiteScore
2.10
自引率
9.10%
发文量
138
审稿时长
4-8 weeks
期刊介绍: Clinical Nephrology appears monthly and publishes manuscripts containing original material with emphasis on the following topics: prophylaxis, pathophysiology, immunology, diagnosis, therapy, experimental approaches and dialysis and transplantation.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信