Abstract Details

Title Rationale, Patient Characteristics, and First Interim Insights from NeofiLos – A Prospective Data Collection to Evaluate Utility and Added Value of Serum NfL in MS

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (11:45 AM-12:45 PM)

Poster/Presentation
Number 6-016

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. =

Authors/Disclosures
Philipp Kulozik PRESENTER	No disclosure on file
Katja Akgün	Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS.
Ulf Schulze Topphoff (Novartis Pharma)	Ulf Schulze Topphoff has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Katrin Schuh (Novartis Pharma)	Katrin Schuh has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Inessa Schwab Sauerbeck (Novartis Germany IMI)	Inessa Schwab Sauerbeck has received personal compensation for serving as an employee of Novartis Pharma GmbH.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden)	Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.

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