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切换至英夫利昔单抗生物类似药对荷兰结节病患者是安全且有效的。

Switching to an Infliximab Biosimilar Was Safe and Effective in Dutch Sarcoidosis Patients.

机构信息

Department of Clinical Pharmacy, St. Antonius Hospital, 3430 EM Nieuwegein, The Netherlands.

ILD Center of Excellence, St. Antonius Hospital, 3430 EM Nieuwegein, The Netherlands.

出版信息

Cells. 2021 Feb 19;10(2):441. doi: 10.3390/cells10020441.

Abstract

The effect of switching from originator infliximab to biosimilar infliximab in patients with sarcoidosis is unknown. The objective of this study is to investigate the effect of switching from Remicade or Inflectra to Flixabi in patients with severe refractory sarcoidosis. This single center retrospective cohort study was performed at St Antonius Hospital Nieuwegein, The Netherlands. All patients diagnosed with severe refractory sarcoidosis receiving Remicade or Inflectra switched to Flixabi. The primary outcome was infliximab discontinuation within 6 months of switching. Secondary endpoints included adverse events and loss of clinical, functional, or inflammatory response. Out of 86 patients who switched to Flixabi, 79 patients had complete data. None of the 79 patients discontinued infliximab during the first 6 months after switching. Five patients reported an adverse event related to Flixabi treatment. We found no change from baseline in FVC, FEV1, DLCOc, 6MWT, and infliximab trough levels 26 weeks after switching. An improvement in physical functioning of 7.3 ± 13.4 points ( = 0.002) with RAND/SF36 and in biomarker sIL-2R (-475.58 ± 1452.39; = 0.005) was observed. Switching from originator infliximab Remicade or biosimilar infliximab Inflectra to biosimilar infliximab Flixabi did not result in treatment discontinuation or loss of clinical/functional/inflammatory remission.

摘要

将英夫利昔单抗原研药转换为英夫利昔单抗生物类似药对结节病患者的影响尚不清楚。本研究的目的是研究将 Remicade 或 Inflectra 转换为 Flixabi 对严重难治性结节病患者的影响。这是一项在荷兰 St Antonius 医院 Nieuwegein 进行的单中心回顾性队列研究。所有诊断为严重难治性结节病、接受 Remicade 或 Inflectra 治疗的患者均转换为 Flixabi。主要结局是在转换后 6 个月内停止使用英夫利昔单抗。次要终点包括不良事件和临床、功能或炎症反应的丧失。在转换为 Flixabi 的 86 名患者中,有 79 名患者具有完整的数据。在转换后的前 6 个月内,没有 79 名患者停止使用英夫利昔单抗。有 5 名患者报告与 Flixabi 治疗相关的不良事件。我们发现转换后 26 周时 FVC、FEV1、DLCOc、6MWT 和英夫利昔单抗谷浓度与基线相比没有变化。RAND/SF36 中身体功能改善了 7.3 ± 13.4 分( = 0.002),生物标志物 sIL-2R 降低了 475.58 ± 1452.39( = 0.005)。将英夫利昔单抗原研药 Remicade 或生物类似药 Inflectra 转换为英夫利昔单抗生物类似药 Flixabi 不会导致治疗中断或临床/功能/炎症缓解丧失。

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