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Background <p>Serum neurofilament light chain (sNfL) is an established biomarker of disease activity and progression in persons with multiple sclerosis (PwMS), with studies showing elevated sNfL levels during relapses and positive associations with disability scores.</p> Objective <p>&#xa0;To assess sNfL levels in PwMS receiving different disease-modifying therapies (DMTs), with a particular focus on extended-interval dosing (EID) regimens in real-world clinical practice.</p> Methods <p>In this two-center cross-sectional study, 172 PwMS without relapses in the preceding three months were included (University Hospital Cologne, n = 125; University Hospital Mainz, n = 47). Patients were categorized into the following groups: (1) low-efficacy DMT (leDMT; n = 8), (2) natalizumab standard-interval dosing (SID; every 4&#xa0;weeks; n = 7), (3) natalizumab EID (every 6–8&#xa0;weeks; n = 53), (4) ofatumumab (n = 17), (5) ocrelizumab SID (every 6&#xa0;months; n = 48), (6) ocrelizumab EID (every 9&#xa0;months; n = 17), and (7) no DMT (n = 19). sNfL levels were measured once in a cross-sectional design using an electrochemiluminescence immunoassay.</p> Results <p>&#xa0;No significant differences in sNfL levels were observed across DMT subgroups in the ANCOVA analysis after adjusting for age and the presence of new T2 lesions on the most recent cranial MRI. However, PwMS receiving DMTs showed lower sNfL levels compared with untreated patients. Notably EID of ocrelizumab (every 9&#xa0;months; 1.56&#xa0;pg/mL, 95% CI 1.26–1.85) and natalizumab (every 8&#xa0;weeks; 1.46&#xa0;pg/mL, 95% CI 1.29–1.64) was not associated with higher sNfL levels compared to standard interval dosing (SID) of ocrelizumab (1.45&#xa0;pg/mL, 95% CI 1.27–1.63) or natalizumab (1.13&#xa0;pg/mL, 95% CI 0.68–1.58).</p> Conclusion <p>&#xa0;EID regimens were not associated with increased sNfL levels, suggesting that they may effectively limit neuroaxonal damage. Larger studies that assess the added value sNfL monitoring for safely personalizing treatment intervals in PwMS with initially active disease are needed.</p>

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Serum neurofilament light chain as a biomarker of disease control in multiple sclerosis: a real-world cross-sectional analysis of therapeutic regimens

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  • 发表日期：

    2025年12月19日

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  • Agni M. Konitsioti,
  • Finja Schweitzer,
  • Wibke Johannis,
  • Falk Steffen,
  • Stefan Bittner,
  • Gereon R. Fink,
  • Michael Schroeter,
  • Clemens Warnke

摘要

Background

Serum neurofilament light chain (sNfL) is an established biomarker of disease activity and progression in persons with multiple sclerosis (PwMS), with studies showing elevated sNfL levels during relapses and positive associations with disability scores.

Objective

 To assess sNfL levels in PwMS receiving different disease-modifying therapies (DMTs), with a particular focus on extended-interval dosing (EID) regimens in real-world clinical practice.

Methods

In this two-center cross-sectional study, 172 PwMS without relapses in the preceding three months were included (University Hospital Cologne, n = 125; University Hospital Mainz, n = 47). Patients were categorized into the following groups: (1) low-efficacy DMT (leDMT; n = 8), (2) natalizumab standard-interval dosing (SID; every 4 weeks; n = 7), (3) natalizumab EID (every 6–8 weeks; n = 53), (4) ofatumumab (n = 17), (5) ocrelizumab SID (every 6 months; n = 48), (6) ocrelizumab EID (every 9 months; n = 17), and (7) no DMT (n = 19). sNfL levels were measured once in a cross-sectional design using an electrochemiluminescence immunoassay.

Results

 No significant differences in sNfL levels were observed across DMT subgroups in the ANCOVA analysis after adjusting for age and the presence of new T2 lesions on the most recent cranial MRI. However, PwMS receiving DMTs showed lower sNfL levels compared with untreated patients. Notably EID of ocrelizumab (every 9 months; 1.56 pg/mL, 95% CI 1.26–1.85) and natalizumab (every 8 weeks; 1.46 pg/mL, 95% CI 1.29–1.64) was not associated with higher sNfL levels compared to standard interval dosing (SID) of ocrelizumab (1.45 pg/mL, 95% CI 1.27–1.63) or natalizumab (1.13 pg/mL, 95% CI 0.68–1.58).

Conclusion

 EID regimens were not associated with increased sNfL levels, suggesting that they may effectively limit neuroaxonal damage. Larger studies that assess the added value sNfL monitoring for safely personalizing treatment intervals in PwMS with initially active disease are needed.