Uher Tomas, Havrdova Eva, Sobisek Lukas, Krasensky Jan, Vaneckova Manuela, Seidl Zdenek, Tyblova Michaela, Ramasamy Deepa, Zivadinov Robert, Horakova Dana
Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine and General University Hospital, Charles University in Prague, Prague, Czech Republic.
Department of Statistics and Probability, University of Economics in Prague, Prague, Czech Republic.
Mult Scler. 2017 Feb;23(2):242-252. doi: 10.1177/1352458516650525. Epub 2016 Jul 11.
No evidence of disease activity (NEDA) has been proposed as a new treatment goal in multiple sclerosis (MS). NEDA-3 status is defined as the absence of magnetic resonance imaging (MRI; new/enlarging/enhancing lesions and increased whole brain volume loss in NEDA-4) and clinical disease activity.
To investigate the persistence of NEDA status over long-term follow-up in MS patients treated with weekly intramuscular interferon beta-1a.
We included 192 patients after the first demyelinating event suggestive of MS, that is, clinically isolated syndrome (CIS) and 162 relapsing-remitting MS (RRMS) patients.
NEDA-3 status was observed in 40.1% of CIS and 20.4% of RRMS patients after 1 year. After 4 years, 10.1% of CIS patients had NEDA-3 status. After 10 years, none of the RRMS patients had NEDA-3 status. Only 4.6% of CIS and 1.0% of RRMS patients maintained NEDA-4 status after 4 years. Loss of NEDA-3 status after the first year was associated with a higher risk of disability progression (hazard ratio (HR) = 2.3-4.0; p = 0.005-0.03) over 6 years.
Despite intramuscular interferon beta-1a treatment, loss of NEDA status occurred in the vast majority of individuals. Loss of NEDA status during the first year was associated with disability progression over long-term follow-up; however, specificity for individual patient was low.
无疾病活动证据（NEDA）已被提议作为多发性硬化症（MS）的新治疗目标。NEDA-3状态定义为无磁共振成像（MRI；NEDA-4中为新出现/扩大/强化病灶及全脑体积丢失增加）及临床疾病活动。
调查接受每周一次肌肉注射干扰素β-1a治疗的MS患者长期随访中NEDA状态的持续性。
我们纳入了192例首次出现提示MS的脱髓鞘事件后即临床孤立综合征（CIS）的患者以及162例复发缓解型MS（RRMS）患者。
1年后，40.1%的CIS患者和20.4%的RRMS患者达到NEDA-3状态。4年后，10.1%的CIS患者处于NEDA-3状态。10年后，无RRMS患者处于NEDA-3状态。4年后，仅4.6%的CIS患者和1.0%的RRMS患者维持NEDA-4状态。第1年后NEDA-3状态的丧失与6年中残疾进展风险较高相关（风险比（HR）=2.3 - 4.0；p = 0.005 - 0.03）。
尽管采用了肌肉注射干扰素β-1a治疗，但绝大多数个体出现了NEDA状态的丧失。第1年中NEDA状态的丧失与长期随访中的残疾进展相关；然而，对个体患者的特异性较低。
