Abstract Details

Title Serum Neurofilament Light (sNfL) Levels in Patients with Relapsing-remitting Multiple Sclerosis (RRMS) Switching from Natalizumab Every-4-week (Q4W) Dosing to Extended Interval Dosing (EID)

Topic Multiple Sclerosis

Presentation(s) S10 - Multiple Sclerosis: Biomarkers and Outcome Measures (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Objective

Evaluate sNfL levels in RRMS patients who switched from natalizumab Q4W dosing to EID compared to those who remained on Q4W dosing in a real-world setting.

Background Natalizumab EID is associated with a lower risk of progressive multifocal leukoencephalopathy compared to Q4W dosing in anti-JC virus (JCV) antibody positive patients. Previous studies indicate no increased clinical or radiological disease activity in patients receiving EID vs Q4W dosing. sNfL is a proposed biomarker of MS disease activity in patients with RRMS.

Design/Methods RRMS patients stable on natalizumab Q4W dosing for 2.5 years were switched to EID (average dosing interval ≥35 days) or remained on Q4W dosing for ≥6 additional infusions. sNfL levels were measured in samples collected before switch and after reaching presumptive steady-state (≥6 months) post-switch to EID using the Simoa NF-light^® Advantage Kit. sNfL differences on Q4W vs EID were assessed after adjustment for baseline covariates (age, sex, height, weight, and anti–JCV antibody serostatus) using (1) parallel analyses in patients who stayed on Q4W dosing or switched to EID;(2) analyses pre- and post- switch from Q4W to EID, and (3) modeled robust linear regression analyses in patients with complete pre- and post-switch sNfL data additionally adjusted for Q4W sNfL levels.

Results Sixty patients switched to EID and 79 remained on Q4W dosing. After covariate adjustment, sNfL levels were not significantly different in EID vs Q4W groups using parallel (P=0.60) and pre/post (P=0.10) analyses.Modeled robust regression analysis (complete data set n=99) did not show any statistically significant differences between Q4W and EID (P=0.80).

Conclusions These results, while limited by small sample size and potential selection bias, indicate that patients in real-world clinical practice who switched from natalizumab Q4W to EID showed no increase in sNfL levels, supporting previous reports that EID is not associated with increased disease activity.

Authors/Disclosures
John F. Foley, MD, FAAN (Rocky Mountain MS Clinic) PRESENTER	The institution of Dr. Foley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Foley has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Dr. Foley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics . The institution of Dr. Foley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon Therapeutics. The institution of Dr. Foley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Dr. Foley has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Foley has stock in InterPRO Bioscience. The institution of Dr. Foley has received research support from Biogen. The institution of Dr. Foley has received research support from Novartis. The institution of Dr. Foley has received research support from Octave. The institution of Dr. Foley has received research support from Genentech. The institution of Dr. Foley has received research support from Imstem. The institution of Dr. Foley has received research support from Aegir.
	No disclosure on file
Tamara Hoyt (Rocky Mountain MS Research Group)	Ms. Hoyt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono.
	No disclosure on file
Evan Riddle, PhD	Dr. Riddle has received personal compensation for serving as an employee of Biogen. Dr. Riddle has received stock or an ownership interest from Biogen.
Carl DeMoor	Carl DeMoor has received personal compensation for serving as an employee of Biogen. Carl DeMoor has received stock or an ownership interest from Biogen. An immediate family member of Carl DeMoor has received personal compensation in the range of $100,000-$499,999 for serving as a Program Director with NIH.
Nolan Campbell	Nolan Campbell has received personal compensation for serving as an employee of Biogen. Nolan Campbell has stock in Biogen.
Tatiana Plavina, PhD	No disclosure on file

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