Rationale, Patient Characteristics, and First Interim Insights from NeofiLos – A Prospective Data Collection to Evaluate Utility and Added Value of Serum NfL in MS
Katja Akgün1, Ulf Schulze-Topphoff2, Katrin Schuh2, Inessa Schwab Sauerbeck2, Tjalf Ziemssen1
1University Clinic Dresden, Center of Clinical Neuroscience, 2Novartis Germany IMI
Objective:
NeofiLos enables office-based centers to access sNfL testing aiming to investigate utility of serial measurements in clinical routine in Germany.
Background:

Neuroaxonal damage results in release of neurofilaments such as neurofilament light chain (NfL) with elevated NfL potentially indicating RMS disease activity[1][2][3].

Elevated NfL levels may reveal "subclinical" disease before lesions or clinical symptoms appear[4]. Measuring sNfL may help elucidate subclinical disease activity with prognostic value for future disease activity and potentially contribute to optimized decision making. 


[1]Thebault S et al. Mult Scler. 2022;28(10):1491-1497.

[2]Dietmann AS et al. J Neurol. 2023;270(3):1416-1429.

[3]Kuhle J et al. Mult Scler. 2020;26(13):1691-1699.

[4]Akgün K et al. Neurol Neuroimmunol Neuroinflamm. 2019;6(3):e555.

Design/Methods:

NeofiLos is an ongoing prospective data collection at ~80 office-based neurologists assessing utility of sNfL from physician’s perspective in ~500 RMS patients treated with ofatumumab or other approved first-line disease modifying therapies. sNfL will be measured at baseline followed by quarterly interval up to 5x per patient. Values embedded into scientific context using patient demographics are reported to neurologists evaluating value and implementation of sNfL into clinical routine.

Results:
First interim results will depict patient demographics including age, gender and body-mass-index of patient collective, diagnosis and therapy decisions made by treating neurologists at baseline. Data will provide insights on general perception of sNfL including benefits and gaps based on current knowledge and experience with sNfL. Analysis of questionnaires will shed light on sNfL value from physicians perspective for future patient care including practical aspects of how, under which conditions, and with what frequency sNfL shall be used. Data will depict details on accessibility and reimbursement as prerequisites for implementation in daily practice.
Conclusions:

This pilot project for sNfL in routine medical care setting is highlighting importance and benefit of sNfL as additional parameter in MS patient management defining actual gaps and optimizing future patient care. =

10.1212/WNL.0000000000206114