Real-World Safety and Effectiveness of Infliximab in 255 Patients with Intestinal, Neurological, and Vascular Behçet’s Disease: A Post-Marketing Surveillance

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-10-16 DOI:10.1007/s12325-024-02993-9

Toshifumi Hibi, Shunsei Hirohata, Tadakazu Hisamatsu, Hirotoshi Kikuchi, Mitsuhiro Takeno, Noriko Sato, Naomi Mizuno, Mayumi Tashiro, Yutaka Susuta, Yoshiaki Ishigatsubo

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引用次数: 0

Abstract

Introduction

Behçet’s disease (BD) with intestinal, neurological (NBD), and vascular (VBD) manifestations often leads to poor outcomes. Infliximab is approved for the treatment of intestinal BD, NBD, and VBD in Japan; however, evidence regarding its safety and effectiveness in these patients is limited. We conducted a 2-year post-marketing surveillance to evaluate the safety and effectiveness of infliximab in patients with intestinal BD, NBD, and VBD in Japan.

Methods

This 2-year, multicenter, prospective, observational study included all patients with intestinal BD, NBD, or VBD, who had experienced an insufficient response to conventional therapies (e.g., glucocorticoids and immunosuppressants/immunomodulators), and initiated infliximab for the first time at participating medical institutions. The safety endpoints included adverse events and adverse drug reactions (ADRs), and the effectiveness endpoints included global improvement, and for patients with acute NBD, acute attacks.

Results

Between October 2015 and August 2018, 255 patients (171 intestinal BD, 49 NBD, and 51 VBD; including 16 with two disease types) were enrolled from 133 medical centers and treated with infliximab. Adverse events, ADRs, and serious ADRs occurred in 100 (39.2%), 72 (28.2%), and 38 (14.9%) patients, respectively; incidences were generally similar across intestinal BD, NBD, and VBD groups. No new safety concerns were identified. At the final evaluation, 68.8% of patients with intestinal BD showed improvement, most patients with chronic progressive NBD and VBD had not worsened (100% and 91.7%, respectively), and 93.3% of patients with acute NBD had no new acute attacks during the observation period.

Conclusion

These results confirmed the safety and effectiveness of infliximab in clinical practice in 255 patients with intestinal BD, NBD, and VBD. There were no new safety concerns.

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英夫利西单抗对 255 例肠道、神经和血管性白塞氏病患者的实际安全性和有效性：上市后监测

简介：伴有肠道、神经（NBD）和血管（VBD）表现的贝赫切特病（BD）往往疗效不佳。在日本，英夫利西单抗被批准用于治疗肠道白塞氏病、NBD和VBD；然而，有关其对这些患者的安全性和有效性的证据却很有限。我们开展了一项为期两年的上市后监测，以评估英夫利昔单抗在日本肠道BD、NBD和VBD患者中的安全性和有效性：这项为期 2 年的多中心前瞻性观察研究纳入了所有对常规疗法（如糖皮质激素和免疫抑制剂/免疫调节剂）反应不佳，并在参与研究的医疗机构首次使用英夫利西单抗的肠道 BD、NBD 或 VBD 患者。安全性终点包括不良事件和药物不良反应（ADRs），有效性终点包括总体改善，对于急性NBD患者，有效性终点包括急性发作：2015年10月至2018年8月期间，来自133个医疗中心的255名患者（171名肠道BD患者、49名NBD患者和51名VBD患者；包括16名患有两种疾病类型的患者）接受了英夫利西单抗治疗。发生不良事件、不良反应和严重不良反应的患者分别为 100 例（39.2%）、72 例（28.2%）和 38 例（14.9%）；肠道 BD、NBD 和 VBD 组的发生率基本相似。未发现新的安全问题。在最终评估中，68.8%的肠道BD患者病情有所改善，大多数慢性进行性NBD和VBD患者病情没有恶化（分别为100%和91.7%），93.3%的急性NBD患者在观察期间没有新的急性发作：这些结果证实了英夫利西单抗在255例肠道BD、NBD和VBD患者的临床实践中的安全性和有效性。结论：这些结果证实了英夫利昔单抗在255例肠道BD、NBD和VBD患者临床实践中的安全性和有效性，没有新的安全问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.