NEDA-state, psychological symptoms and quality of life are stable in natalizumab-treated multiple sclerosis patients: An up to 6-years long follow-up study.

Introduction: 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).

Patients And Methods: 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.

Results: 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.

Conclusion: 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.