Sandi Dániel, Kokas Zsófia, Kincses Zsigmond Tamás, Füvesi Judit, Fricska-Nagy Zsanett, Vörös Erika, Biernacki Tamás, Vécsei László, Klivényi Péter, Bencsik Krisztina
Department of Neurology, Albert Szent-Györgyi Clinical Center and Faculty of Medicine, University of Szeged, Szeged, Hungary.
Department of Radiology, Albert Szent-Györgyi Clinical Center and Faculty of Medicine, University of Szeged, Szeged, Hungary.
Heliyon. 2024 Oct 18;10(20):e39536. doi: 10.1016/j.heliyon.2024.e39536. eCollection 2024 Oct 30.
Natalizumab (NAT), a highly effective disease modifying therapy (DMT) in relapsing-remitting multiple sclerosis (RRMS), was approved for clinical use in Hungary on February 1, 2010. In this study we aimed to assess its effectiveness in view of the concept of "No Evidence of Disease Activity" (NEDA-3), furthermore evaluate its effect on limb function, pathopsychological symptoms (cognition, fatigue, depression) and quality of life (QoL).
From February 1, 2010, to December 1, 2022, 121 eligible patients were consecutively enrolled from the MS center of the University of Szeged, Hungary. Here, we report data on 6-years of follow-up. First, we evaluated the proportion of patients reaching the NEDA-3 state and any possible influencing factors. Then, we assessed the change of upper and lower limb functions via the 9-hole-peg test (9HPT) and the 25-feet walk test (TW25F). Finally, we assessed the change of pathopsychological symptoms (cognition, fatigue, depression) and QoL via the BICAMS, FIS, BDI-II and MSQoL-54 questionnaires, and the possible influencing factors behind it.
Cumulatively, 97 patients (80.2 %) achieved NEDA-3 throughout the follow-up period. On a year-by-year basis, the proportion changed from 95.9 % in the 1st year to 84.3 %, 81.3 %, 76.4 %, 74.5 % and 78.9 % in the 2, 3rd, 4, 5 and 6 year respectively (p<0.001). Baseline EDSS scores and the type of preceding DMT affected this outcome. Both the upper and the lower limb functions remained stable. Cognitive functions improved (p<0.001), fatigue and depression scores remained stable during the follow-up period. QoL remained stable or improved in all subscales of MSQoL-54 questionnaire.
Our 6-years long detailed follow-up study demonstrates that NAT not only reduces disease activity and progression. It effectively protects from the worsening of limb function, cognitive and other psychological impairments, and stabilizes the patients' quality of life in basically every measurable aspect.
那他珠单抗（NAT）是一种用于复发缓解型多发性硬化症（RRMS）的高效疾病修正疗法（DMT），于2010年2月1日在匈牙利获批用于临床。在本研究中，我们旨在根据“无疾病活动证据”（NEDA-3）的概念评估其有效性，并进一步评估其对肢体功能、病理心理症状（认知、疲劳、抑郁）和生活质量（QoL）的影响。
从2010年2月1日至2022年12月1日，连续从匈牙利塞格德大学的MS中心招募了121名符合条件的患者。在此，我们报告6年随访的数据。首先，我们评估达到NEDA-3状态的患者比例以及任何可能的影响因素。然后，我们通过9孔插钉试验（9HPT）和25英尺步行试验（TW25F）评估上肢和下肢功能的变化。最后，我们通过BICAMS、FIS、BDI-II和MSQoL-54问卷评估病理心理症状（认知、疲劳、抑郁）和QoL的变化及其背后可能的影响因素。
在整个随访期间，累计有97名患者（80.2%）达到NEDA-3。逐年来看，这一比例从第1年的95.9%分别变为第2、3、4、5和6年的84.3%、81.3%、76.4%、74.5%和78.9%（p<0.001）。基线EDSS评分和先前DMT的类型影响了这一结果。上肢和下肢功能均保持稳定。认知功能有所改善（p<0.001），随访期间疲劳和抑郁评分保持稳定。MSQoL-54问卷的所有子量表中，QoL保持稳定或有所改善。
我们长达6年的详细随访研究表明，NAT不仅能降低疾病活动度和疾病进展。它还能有效防止肢体功能、认知及其他心理障碍恶化，并在几乎每个可测量的方面稳定患者的生活质量。
