Kim Su Hyun, Park Min Su, Kim Woojun, Huh So Young, Shin Hyun June, Hyun Jae Won, Kim Ho Jin
Department of Neurology, Research Institute and Hospital of National Cancer Center, Goyang, Korea.
Department of Neurology, College of Medicine, Yeungnam University, Gyeongsan, Korea.
J Clin Neurol. 2019 Jan;15(1):20-26. doi: 10.3988/jcn.2019.15.1.20. Epub 2018 Oct 26.
This study assessed the long-term outcomes of disease-modifying therapies (DMTs) in Korean multiple sclerosis (MS) patients treated in real-world clinical settings in Korea.
We retrospectively evaluated the medical records of 160 patients with an initial diagnosis of clinically isolated syndrome or relapsing-remitting MS who were treated for at least 2 years. A status of 3 for no evidence of disease activity (NEDA3) was defined as no relapse, disability progression, or active lesions in annual magnetic resonance imaging (MRI) evaluations.
Patients who were initially treated with interferon β (=152), glatiramer acetate (=6), or teriflunomide (=2) were included. The mean disease duration was 8.2 years. Compared to pretreatment, annualized relapse rates were significantly reduced after treatment [from 1.0±0.8 to 0.2±0.4 (mean±standard deviation), <0.001]. At the follow-up, 79 patients (49%) had changed their treatment regimen due to lack of efficacy (33%), side effects (14%), or other reasons (2%). Disability progression was observed in 18% of the patients over a mean treatment duration of 5.7 years. After 2 years, NEDA3 was observed in 38% of the patients. Loss of NEDA3 at 2 years was associated with long-term disability progression [odds ratio (OR)=17.975, =0.003]. Poor response to first-line treatment was independently associated with a delay in treatment from disease onset (OR=1.238, =0.049) and 10 or more brain lesions in the initial MRI (OR=3.648, =0.047).
This study has provided real-world evidence that DMTs are effective in reducing disease activity and disability progression in Korean MS patients.
本研究评估了在韩国实际临床环境中接受治疗的韩国多发性硬化症（MS）患者使用疾病修正疗法（DMTs）的长期疗效。
我们回顾性评估了160例最初诊断为临床孤立综合征或复发缓解型MS且接受治疗至少2年的患者的病历。无疾病活动证据3（NEDA3）状态定义为在年度磁共振成像（MRI）评估中无复发、残疾进展或活动性病变。
纳入了最初接受干扰素β（=152例）、醋酸格拉替雷（=6例）或特立氟胺（=2例）治疗的患者。平均病程为8.2年。与治疗前相比，治疗后年化复发率显著降低[从1.0±0.8降至0.2±0.4（均值±标准差），<0.001]。随访时，79例患者（49%）因疗效不佳（33%）、副作用（14%）或其他原因（2%）改变了治疗方案。在平均5.7年的治疗期间，18%的患者出现了残疾进展。2年后，38%的患者达到NEDA3状态。2年时NEDA3状态的丧失与长期残疾进展相关[比值比（OR）=17.975，=0.003]。对一线治疗反应不佳与疾病发作后治疗延迟（OR=1.238，=0.049）和初始MRI中有10个或更多脑病变（OR=3.648，=0.047）独立相关。
本研究提供了真实世界的证据，表明DMTs在降低韩国MS患者的疾病活动和残疾进展方面是有效的。
