Real-world data on combination treatment with bedaquiline in patients with multidrug-resistant pulmonary tuberculosis in Japan: An interim analysis of post-marketing surveillance

IF 1.9 4区医学 Q3 INFECTIOUS DISEASES

Journal of Infection and Chemotherapy Pub Date : 2025-02-17 DOI:10.1016/j.jiac.2025.102661

Mako Nakaya , Manami Kamishima , Toshio Yamaoka , Hiroaki Tsuchiya , Tokiko Touma , Atsushi Saito , Yuki Saito , Hideaki Nagai

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引用次数: 0

Abstract

Background

An observational post-marketing surveillance (PMS) is being conducted to evaluate the long-term safety and effectiveness of bedaquiline as part of combination therapies in treating pulmonary multidrug-resistant tuberculosis (MDR-TB) in Japan.

Methods

This interim analysis includes patients with MDR-TB who started bedaquiline-containing anti-tuberculosis (TB) drugs in Japan between January 2018 and September 2022. Outcomes include the incidence of adverse drug reactions (ADRs) and negative sputum cultures.

Results

In total, 112 patients were included in the safety analysis. All patients were receiving anti-TB drugs in addition to bedaquiline at baseline; 96.4 % were receiving ≥3 drugs. The most commonly used concomitant anti-TB drugs were delamanid, cycloserine, linezolid, and levofloxacin hydrate. At 24 weeks after bedaquiline initiation, in the effectiveness analysis set, 19/20 (95.0 %) had negative sputum mycobacteria growth indicator tube cultures and 9/12 (75.0 %) have negative solid medium cultures. Patients received bedaquiline for a median of 186.0 days, during which 85 ADRs occurred in 45 patients (40.2 %). The top three ADRs were electrocardiogram QT prolonged (9.8 %), nausea (7.1 %), and hepatic function abnormal (4.5 %).

Conclusions

This interim analysis of a PMS supports the long-term safety and effectiveness of bedaquiline for MDR-TB in Japan. ADRs were consistent with previous reports and no new safety signals were detected. The final analysis of this ongoing PMS will be expected to confirm these findings.

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日本多药耐药肺结核患者联合贝达喹啉治疗的真实数据：上市后监测的中期分析

背景：日本正在进行一项观察性上市后监测（PMS），以评估贝达喹啉作为联合疗法治疗肺部耐多药结核病（MDR-TB）的长期安全性和有效性。方法：该中期分析包括2018年1月至2022年9月在日本开始使用含贝达喹啉抗结核（TB）药物的耐多药结核病患者。结果包括药物不良反应（adr）的发生率和痰培养阴性。结果：共有112例患者纳入安全性分析。所有患者在基线时均接受贝达喹啉以外的抗结核药物治疗；96.4%的患者接受≥3种药物治疗。最常用的联合抗结核药物是德拉马尼、环丝氨酸、利奈唑胺和水合左氧氟沙星。贝达喹啉起始治疗24周后，在疗效分析集中，19/20（95.0%）的痰分枝杆菌生长指示剂试管培养阴性，9/12（75.0%）的固体培养基培养阴性。患者接受贝达喹啉治疗的中位时间为186.0天，其间45例患者（40.2%）发生85例不良反应。不良反应前三位分别是心电图QT间期延长（9.8%）、恶心（7.1%）和肝功能异常（4.5%）。结论：该中期PMS分析支持贝达喹啉在日本治疗耐多药结核病的长期安全性和有效性。不良反应与以前的报告一致，没有发现新的安全信号。预计对正在进行的经前综合症的最终分析将证实这些发现。

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

Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY

CiteScore

4.10

自引率

4.50%

发文量

303

审稿时长

47 days

期刊介绍： The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.