Long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin 10%: a European post-authorization study.

IF 2.7 4区医学 Q3 IMMUNOLOGY

Immunotherapy Pub Date : 2024-01-01 Epub Date: 2024-06-18 DOI:10.1080/1750743X.2024.2354091

Pauline M Ellerbroek, Leif G Hanitsch, Torsten Witte, Vassilios Lougaris, P Martin van Hagen, Pieter van Paassen, Jie Chen, Katharina Fielhauer, Barbara McCoy, Andras Nagy, Leman Yel

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Abstract

Aim: To assess the long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in European routine clinical practice.Materials & methods: This prospective, noninterventional, open-label, post-authorization safety study (EUPAS5812) sourced data on adverse events, immunogenicity, treatment regimens and product administration for 106 adult patients prescribed fSCIG 10% across 17 sites in six European countries from July 2014 to February 2020.Results: In total, 1171 treatment-emergent adverse events were reported in 94 patients (88.7%); 25.5% of these events were considered related to fSCIG 10%. Positive binding antibody titers developed in three patients; no neutralizing antibodies to recombinant human hyaluronidase were detected.Conclusion: This real-world study of fSCIG 10% is the longest to date and confirms its long-term safety and tolerability in adults with antibody deficiency diseases.

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透明质酸酶促进皮下注射 10%免疫球蛋白的长期安全性：欧洲授权后研究。

目的：评估透明质酸酶促皮下免疫球蛋白（fSCIG）10% 在欧洲常规临床实践中的长期安全性。材料与方法：这项前瞻性、非干预性、开放标签、授权后安全性研究（EUPAS5812）收集了2014年7月至2020年2月期间欧洲6个国家17个研究机构106名处方fSCIG 10%的成年患者的不良事件、免疫原性、治疗方案和产品给药数据。研究结果94名患者（88.7%）共报告了1171例治疗突发不良事件，其中25.5%被认为与fSCIG 10%有关。三名患者的结合抗体滴度呈阳性；未检测到重组人透明质酸酶的中和抗体。结论这项关于 fSCIG 10% 的真实世界研究是迄今为止时间最长的研究，证实了它在成人抗体缺乏症患者中的长期安全性和耐受性。

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来源期刊

Immunotherapy 医学-免疫学

CiteScore

5.00

自引率

3.60%

发文量

113

审稿时长

6-12 weeks

期刊介绍： Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field. Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.