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Abstract Details

Natalizumab extended interval dosing (EID) is associated with a reduced risk of progressive multifocal leukoencephalopathy (PML) than every-4-week (Q4W) dosing: Updated analysis of the TOUCH® Prescribing Program database
Multiple Sclerosis
P5 - Poster Session 5 (8:00 AM-9:00 AM)
9-022
Update the assessment of PML risk with natalizumab EID compared with Q4W dosing using TOUCH data as of June 1, 2019.
Natalizumab treatment is associated with PML risk. Previous analyses of patient data in the TOUCH database have demonstrated that EID is associated with lower risk of PML than Q4W dosing.
TOUCH data were used to determine whether EID is associated with lower PML risk compared with Q4W dosing in anti–JC virus antibody positive patients using 3 preplanned analyses specified for the 2017 study: a primary analysis (EID defined by the last 18 months of exposure), secondary analysis (EID defined as any prolonged period of EID in exposure history at any time), and tertiary analysis (EID defined as a dosing history consisting primarily of EID). Patients with average dosing intervals <3 or >12 weeks were excluded. Hazard ratios (HRs) of PML with EID and Q4W dosing were compared using adjusted Cox regression models and Kaplan-Meier estimates.
The updated analyses included more patients than the original 2017 study (primary: 2639 EID [32.7% increase] and 15,159 Q4W [15.4% increase]; secondary: 4237 EID [27.2% increase] and 17,493 Q4W [13.4% increase]; tertiary: 1048 EID [28.6% increase] and 26,540 Q4W [14.6% increase]). For all analyses, the mean number of natalizumab infusions and mean treatment duration were greater with EID than with Q4W dosing. Average dosing intervals were unchanged from 2017. The PML HR (95% confidence interval) was 0.11 (0.05–0.28; P<0.0001) for the primary analysis and 0.20 (0.11?0.40; P<0.0001) for the secondary analysis, both favoring EID. As in previous TOUCH analyses, no EID PML cases were observed in the tertiary analysis (Kaplan-Meier log-rank test P=0.006).

This updated analysis of TOUCH patient data continues to demonstrate that natalizumab EID is associated with a significantly lower PML risk than Q4W dosing.

 
Authors/Disclosures
Lana Zhovtis Ryerson, MD, FÂ鶹´«Ã½Ó³»­ (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.
John F. Foley, MD, FÂ鶹´«Ã½Ó³»­ (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.
Ih Chang Ih Chang has received personal compensation for serving as an employee of Cerevel. Ih Chang has received stock or an ownership interest from Cerevel Therapeutics.
Ilya Kister, MD, FÂ鶹´«Ã½Ó³»­ (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 R. Cutter, PhD (University of Alabama At Birmingham) Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 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 No disclosure on file
Xiaochun Li 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.
Karen Smirnakis No disclosure on file
Zheng Ren Zheng Ren has received personal compensation for serving as an employee of Biogen.
Christophe Hotermans, MD, PhD (Alexion) No disclosure on file
Pei-Ran Ho No disclosure on file
Nolan Campbell Nolan Campbell has received personal compensation for serving as an employee of Biogen. Nolan Campbell has stock in Biogen.