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Abstract Details

Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-Week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database
Multiple Sclerosis
P14 - Poster Session 14 (11:45 AM-12:45 PM)
3-011
Natalizumab treatment is associated with PML risk. Previous analyses of TOUCH data have demonstrated that natalizumab EID is associated with significantly lower PML risk than Q4W dosing in anti–JC virus (JCV) antibody-positive patients with multiple sclerosis.
To update the assessment of PML risk with natalizumab EID in comparison with Q4W dosing using TOUCH data as of June 30, 2022.
TOUCH data were used to estimate PML risk for EID compared with Q4W dosing in anti-JCV antibody-positive patients using 3 prespecified analyses: primary (EID defined by the last 18 months of treatment), secondary (EID defined as any prolonged period of EID at any time during treatment), and tertiary (EID defined as a dosing history consisting primarily of EID). Hazard ratios (HRs) of PML with EID versus Q4W dosing were estimated using adjusted Cox regression models.
Compared with the previous analyses, patient numbers increased for all 3 analyses (EID: 9.9%–16.6%; Q4W: 2.2%–3.4%). For all analyses (EID vs Q4W), the mean number of natalizumab infusions (primary: 64.9 vs 56.4; secondary: 61.9 vs 39.8; tertiary: 41.9 vs 41.6), mean treatment duration (in months: primary, 74.5 vs 55.0; secondary, 68.3 vs 38.2; tertiary, 55.9 vs 41.2), and mean dosing interval (in days: primary, 36.5 vs 30.1; secondary, 35.4 vs 29.9; tertiary, 42.5 vs 30.8) were numerically greater with EID than Q4W dosing. All 3 analyses showed reduced risks of PML with EID vs Q4W (primary: 86% [HR=0.139 (95% confidence interval [CI], 0.066–0.294), P<0.0001]; secondary: 80% [HR=0.202 (0.113–0.361), P<0.0001]; tertiary: 96% [HR=0.040 (0.007–0.218)], P=0.0002).
These results are consistent with all previous annual analyses of TOUCH patient data and demonstrate that natalizumab EID is associated with significantly lower PML risk than Q4W dosing. Continued follow-up will further quantify the amount of risk reduction with EID.
Authors/Disclosures
Lana Zhovtis Ryerson, MD (Jersey Shore University Medical Center)
PRESENTER
Dr. Zhovtis Ryerson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Zhovtis Ryerson 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. Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Zhovtis Ryerson 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. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Zhovtis Ryerson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Zhovtis Ryerson has received research support from Biogen. The institution of Dr. Zhovtis Ryerson has received research support from Genentech.
John F. Foley, MD, FAAN (Rocky Mountain MS Clinic) 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.
Ilya Kister, MD, FAAN (NYU School of Medicine) Dr. Kister has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech-Roche. Dr. Kister has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. The institution of Dr. Kister has received research support from Genentech. The institution of Dr. Kister has received research support from Novartis. Dr. Kister has received publishing royalties from a publication relating to health care.
Gary Raymond Cutter, PhD (University of Alabama At Birmingham) Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio, Medday, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, TG Therapeutics.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics, AI therapeutics, AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Horizon Pharmaceuticals, Immunic, Karuna Therapeutics, Mapi Pharmaceuticals LTD, Merck, Mitsubishi Tanabe Pharma Holdings, Opko Biologics,Prothena Biosciences, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, NHLBI (Protocol Review Committee), University of Texas Southwestern, University of Pennsylvania, Visioneering Technologies, Inc.. Dr. Cutter has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Ryan Metzger, PhD (RM Biosciences) An immediate family member of Dr. Metzger has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Metzger has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Interpro Bioscience. An immediate family member of Dr. Metzger has stock in Ascendis. An immediate family member of Dr. Metzger has stock in Neurocrine Biosciences.
Judith Goldberg The institution of Judith Goldberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amarin. The institution of Judith Goldberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Asieris. Judith Goldberg has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Statistical Science and Technology Associates, Inc..
Xiaochun Li Xiaochun Li has nothing to disclose.
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.
Karen Smirnakis Karen Smirnakis has received personal compensation for serving as an employee of Biogen. Karen Smirnakis has received stock or an ownership interest from Biogen.
Liesel DSilva, MD (BIOGEN) Dr. DSILVA has received stock or an ownership interest from BIOGEN.
Susie Sinks, PhD (Biogen) Mrs. Sinks has received personal compensation for serving as an employee of Biogen .
Nolan Campbell Nolan Campbell has received personal compensation for serving as an employee of Biogen. Nolan Campbell has stock in Biogen.
Tyler Lasky Tyler Lasky has received personal compensation for serving as an employee of Biogen. Tyler Lasky has stock in Biogen.
Karthik *Use 279959 Bodhinathan, PhD (Biogen) Dr. Bodhinathan has stock in BIOGEN.