Abstract Details

Title Early Impact of Natalizumab Switch to Moderate Versus High Efficacy Disease Modifying Therapy in Clinical Practice

Topic Multiple Sclerosis

Presentation(s) S6 - MS and CNS Inflammatory Disease: Clinical Considerations I (1:55 PM-2:06 PM)

Poster/Presentation
Number 006

Background NTZ is a highly effective DMT for relapsing MS. Long-term use is limited by potential safety risks that can be reduced by switching to an alternative DMT. However, discontinuation of NTZ may trigger rebound disease. Real-world studies are needed to investigate the impact of NTZ switch to moderate vs. high efficacy DMT on early disease activity.

Objective Assess early impact of switching from natalizumab (NTZ) to moderate vs. high efficacy disease modifying therapy (DMT) in multiple sclerosis (MS) patients.

Design/Methods Patients discontinuing NTZ at Cleveland Clinic (n=556) were identified. Patients who switched to moderate (dimethyl fumarate, fingolimod) or high efficacy (ocrelizumab, rituximab, alemtuzumab) DMT were assessed using descriptive statistics, chi-square, and two-sample t tests at 6-month follow-up. Propensity score adjusted analyses will be presented, adjusting for wash-out duration (≤ 3 months).

Results In our cohort, 49.3% switched to moderate efficacy DMT (dimethyl fumarate, n=133; fingolimod, n=141) vs. 23.1% who switched to high efficacy DMT (ocrelizumab, n=104; rituximab, n=17; alemtuzumab, n=7). There were no differences in baseline demographics and disease characteristics: mean age 47.2 years, 68.0% female, 77.5% Caucasian, mean disease duration 14.4 years, 95.4% relapsing remitting MS, relapses 42.6%, gadolinium-enhancing lesions 40.3%, and new T2 lesions 37.1%. Reasons for NTZ discontinuation included PML risk (54.9%), breakthrough disease (15.3%), and adverse effects (17.3%). NTZ switchers due to PML risk transitioned more commonly to high vs. moderate efficacy DMT (72.7% vs. 60.1%; p=0.01). Mean washout was comparable (2.57 vs. 2.34 months, p=0.34). Six-month disease activity measures on post-NTZ DMT (moderate vs. high efficacy DMT): relapse (10.6% vs. 5.6%, p=0.158), gadolinium-enhancing lesions (17.4% vs. 10.4%, p=0.22), and new T2 lesions (22.5% vs. 11.5%, p=0.05).

Conclusions In our cohort, early clinical disease activity remained low when transitioning from NTZ to moderate and high efficacy DMT. There was higher risk of MRI activity with transition to moderate efficacy therapies.

Authors/Disclosures
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health) PRESENTER	Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech_GN41791. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb . Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Hersh has received research support from Biogen. The institution of Dr. Hersh has received research support from Novartis. The institution of Dr. Hersh has received research support from Genentech_GN41791. The institution of Dr. Hersh has received research support from PCORI. The institution of Dr. Hersh has received research support from Bristol Myers Squibb.
Haleigh C. Harris	No disclosure on file
Devon Conway, MD	Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharmaceuticals. Dr. Conway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AstraZeneca. Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Conway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Conway has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Conway has received research support from Novartis. The institution of Dr. Conway has received research support from BMS. The institution of Dr. Conway has received research support from Biogen.
Le Hua, MD, FAAN (Cleveland Clinic)	Dr. Hua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genzyme. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hua 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. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapuetics. The institution of Dr. Hua has received research support from Genentech.

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