Real-world safety and treatment patterns of subcutaneous IgPro20 for chronic inflammatory demyelinating polyneuropathy: Post-marketing surveillance in Japan

Q4 Immunology and Microbiology

Clinical and Experimental Neuroimmunology Pub Date : 2024-10-03 DOI:10.1111/cen3.12816

Naoki Terasaka, Takanori Mizushima, Yuki Niwa, Tetsushi Akasaki, Hideo Usui

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Abstract

Objectives

IgPro20, a subcutaneous immunoglobulin replacement therapy, is approved in Japan for chronic inflammatory demyelinating polyneuropathy (CIDP). This post-marketing surveillance study characterized real-world treatment patterns and safety profile of injection site reactions associated with IgPro20 treatment in Japanese patients with CIDP.

Methods

Patients with CIDP initiating IgPro20 between October 2019 and September 2022 at medical institutions in Japan were followed for 6 months. The primary outcome was the incidence of injection site reactions. Other outcomes included patient clinicodemographic characteristics, IgPro20 treatment status, CIDP-related concomitant medications and any concurrent therapies.

Results

The analysis included 108 patients from 38 sites. CIDP subtypes were typical (61.1%), multifocal acquired demyelinating sensory and motor neuropathy (multifocal; 19.4%), others (14.8%) or unknown (4.6%). Approximately one-fifth (21.3%) of patients commenced IgPro20 at a dosage of <200 mg/kg, 27.8% at ≥200 to ≤300 mg/kg, 37.0% at >300 to ≤400 mg/kg and 11.1% at >400 mg/kg. Most doses (82.7%) were given at home: 62.0% self-administered, 11.7% with caregiver and 8.9% with healthcare professional assistance. A total of 55 patients used CIDP-related concomitant medications, including corticosteroids (35.2%), immunosuppressants (19.4%) or intravenous immunoglobulin G (7.4%). The data also showed that various treatment patterns were used for these combinations. A total of 40 patients (37.0%) experienced injection site reactions, most frequently injection site erythema (21.3%) and injection site swelling (17.6%); one case of ulcer occurred (0.9%). No significant relationship between injection dosage/speed and the incidence of injection site reactions was observed.

Conclusions

This study of the use of subcutaneous IgPro20 for CIDP in Japan showed a real-world safety profile consistent with phase III trial data.

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皮下注射IgPro20治疗慢性炎症性脱髓鞘性多神经病变的实际安全性和治疗模式：日本上市后监测

IgPro20是一种皮下免疫球蛋白替代疗法，在日本被批准用于慢性炎症性脱髓鞘性多神经病变（CIDP）。这项上市后监测研究描述了日本CIDP患者与IgPro20治疗相关的真实治疗模式和注射部位反应的安全性。方法对2019年10月至2022年9月在日本医疗机构接受IgPro20治疗的CIDP患者进行为期6个月的随访。主要观察指标是注射部位反应的发生率。其他结果包括患者的临床人口学特征、IgPro20治疗状态、与cidp相关的伴随药物和任何同期治疗。结果纳入38个部位108例患者。cdp亚型典型（61.1%），多灶性获得性脱髓鞘感觉和运动神经病变(多灶性；19.4%)，其他（14.8%）或未知（4.6%）。大约五分之一（21.3%）的患者开始服用IgPro20时剂量为200 mg/kg， 27.8%为≥200至≤300 mg/kg， 37.0%为300至≤400 mg/kg， 11.1%为400 mg/kg。大多数剂量（82.7%）在家中给药：62.0%自行给药，11.7%由护理人员给药，8.9%由医疗保健专业人员协助给药。共有55例患者使用了与cidp相关的伴随药物，包括皮质类固醇（35.2%）、免疫抑制剂（19.4%）或静脉注射免疫球蛋白G（7.4%）。数据还显示，这些组合使用了不同的治疗模式。共有40例（37.0%）患者出现注射部位反应，最常见的是注射部位红斑（21.3%）和注射部位肿胀（17.6%）；溃疡1例（0.9%）。注射剂量/注射速度与注射部位反应发生率无显著关系。结论：在日本进行的使用皮下IgPro20治疗CIDP的研究显示出与III期试验数据一致的真实安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Experimental Neuroimmunology Immunology and Microbiology-Immunology and Microbiology (miscellaneous)

CiteScore

1.60

自引率

0.00%

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