Abstract Details

Title No difference in radiologic outcomes for natalizumab patients on extended interval dosing compared with standard interval dosing in MS PATHS

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 210

Objective To compare the effectiveness of natalizumab extended interval dosing (EID) and every-4-week standard interval dosing (SID) using quantitative magnetic resonance imaging (MRI) metrics from standardized images in MS PATHS.

Background Independent real-world studies suggest that natalizumab effectiveness is maintained for patients who switch from natalizumab SID to EID. MS PATHS provides access to real-world clinical and MRI data collected using highly standardized acquisition protocols.

Design/Methods MRI segments were defined as 2 MRI acquisitions and the associated interval duration. MRI segments with average infusion cycles ≤35 days and >35 days were defined as SID and EID, respectively. For each MRI segment, new T2 lesions and changes in brain parenchymal fraction (BPF) and T2 lesion volume (T2LV) and were compared for SID and EID using inverse probability weighting (IPW) with logistic regression and robust linear regression. MRI outcomes in MS PATHS patients receiving natalizumab and matched patients receiving injectable platform disease-modifying therapies were compared.

Results For SID versus EID, IPW analysis included 596 and 85 MRI segments from 327 and 67 SID and EID patients, respectively. The comparator analysis included 654 and 108 MRI segments from 317 pooled SID+EID natalizumab and 70 platform patients, respectively. Proportions of patients with no new T2 lesions, BPF change, and adjusted T2LV change were similar in SID and EID patients (all P≥0.233). New T2 lesion development and annualized percentage decline in BPF were significantly lower for patients receiving natalizumab than platform therapies (all P<0.001). Between-group T2LV change was not significantly different (P=0.3).

Conclusions These real-world MRI outcomes in MS PATHS indicate that disease activity is low for both natalizumab SID and EID. New lesion development and brain atrophy is lower in those treated with natalizumab versus platform therapies. The ongoing phase 3b randomized NOVA trial (NCT03689972) will continue to evaluate the effectiveness of natalizumab EID.

Authors/Disclosures
Lana Zhovtis Ryerson, MD, FAAN (Jersey Shore University Medical Center) PRESENTER	Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi.
Robert T. Naismith, MD, FAAN (Washington University)	Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squib. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Naismith has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genzyme. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celltrion. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impaact-Bio. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Naismith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon. Dr. Naismith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NEJM Journal Watch.
Lauren B. Krupp, MD, FAAN (NYU Langone Medical Center)	Dr. krupp has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EBIX. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffman LaRoche. Dr. krupp has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for MMMK. Dr. krupp has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Patrick, Dolan, and Kaufman. Dr. krupp has received intellectual property interests from a discovery or technology relating to health care.
Leigh E. Charvet, PhD (NYU Langone)	Dr. Charvet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson & Johnson. Dr. Charvet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Springer Healthcare. Dr. Charvet has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for YBrain. Dr. Charvet has stock in Johnson&Johnson.
Shirley Liao	Shirley Liao has received personal compensation for serving as an employee of Biogen.
Elizabeth Fisher	Elizabeth Fisher has received personal compensation for serving as an employee of Biogen. Elizabeth Fisher has stock in Biogen. Elizabeth Fisher has received intellectual property interests from a discovery or technology relating to health care.
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.
James R. Williams III, PhD	Dr. Williams has received personal compensation for serving as an employee of Biogen. Dr. Williams has received stock or an ownership interest from Biogen.
Stephanie Licata	Stephanie Licata has received personal compensation for serving as an employee of Biogen. Stephanie Licata has received stock or an ownership interest from Biogen.
Nolan Campbell	Nolan Campbell has received personal compensation for serving as an employee of Biogen. Nolan Campbell has stock in Biogen.

��ɫ��

��ɫ��