Schönfeld N, Barkane L, Davoliene I, Danilovits M, Miliauskas S, Ader F, Kon O M, Lange C, Duvignaud A, Heiss-Neumann M, Hittel N, Lazarević N, Knebel I, Martin A, Eschenbach B, van Heumen E, George V
Helios Klinikum Emil von Behring, Berlin, Germany.
Riga East University Hospital, Riga, Latvia.
IJTLD Open. 2024 Jun 1;1(6):274-278. doi: 10.5588/ijtldopen.24.0113. eCollection 2024 Jun.
A post-authorisation safety study (PASS) on delamanid (DLM) was conducted as part of a post-approval commitment to the European Medicines Agency. The aim of this study was to evaluate the use of DLM in a real-life setting, its safety, and treatment outcomes in patients with multidrug-resistant TB (MDR-TB).
This was a prospective, multicentric, non-interventional study conducted in the European Union. MDR-TB Regimen selection and patient monitoring were conducted in accordance with existing medical practices. Data on the use of DLM, related adverse events, and treatment outcomes were collected for up to 30 months after the first DLM dose. Descriptive summary statistics were used for continuous and categorical variables.
Out of 86 patients, one had extrapulmonary TB. Two-thirds of the patients were treated with DLM for more than 24 weeks. The most frequent adverse drug reaction to DLM was QT interval prolongation. Resistance to DLM was detected in one patient during treatment. The treatment success rate was 77%.
No new safety concerns were revealed, including in patients treated with DLM for more than 24 weeks. QT interval prolongations were well managed and did not lead to any clinically significant cardiac effects. The treatment outcomes were in line with the WHO target for Europe.
作为对欧洲药品管理局批准后承诺的一部分，开展了一项关于地拉米定（DLM）的上市后安全性研究（PASS）。本研究的目的是评估DLM在实际临床环境中的使用情况、安全性以及耐多药结核病（MDR-TB）患者的治疗效果。
这是一项在欧盟开展的前瞻性、多中心、非干预性研究。MDR-TB治疗方案的选择和患者监测按照现有医疗实践进行。收集首次服用DLM剂量后长达30个月的DLM使用数据、相关不良事件及治疗效果。连续变量和分类变量采用描述性汇总统计。
86例患者中，1例患有肺外结核。三分之二的患者接受DLM治疗超过24周。DLM最常见的药物不良反应是QT间期延长。治疗期间在1例患者中检测到对DLM耐药。治疗成功率为77%。
未发现新的安全问题，包括接受DLM治疗超过24周的患者。QT间期延长得到妥善处理，未导致任何具有临床意义的心脏影响。治疗效果符合世界卫生组织针对欧洲设定的目标。
