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 (P14-3.011)

<h3>Objective:</h3> To update the assessment of PML risk with natalizumab EID in comparison with Q4W dosing using TOUCH data as of June 30, 2022. <h3>Background:</h3> 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. <h3>Design/Methods:</h3> TOUCH data were used to estimate PML risk for EID compared with Q4W dosing in anti-JCV antibody-positive patients using 3 pre specified 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. <h3>Results:</h3> 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), <i>P</i>&lt;0.0001]; secondary: 80% [HR=0.202 (0.113–0.361), <i>P</i>&lt;0.0001]; tertiary: 96% [HR=0.040 (0.007–0.218)], <i>P</i>=0.0002). <h3>Conclusions:</h3> 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. <b>Disclosure:</b> 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. The institution of Dr. Zhovtis Ryerson has received research support from Biogen. The institution of Dr. Zhovtis Ryerson has received research support from Genentech. 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. Dr. Kister has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech-Roche. The institution of Dr. Kister has received research support from Genentech. Dr. Kister has received publishing royalties from a publication relating to health care. 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. An immediate family member of Dr. Metzger has received personal compensation for serving as an employee of Ascendis. 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 Biogen. An immediate family member of Dr. Metzger has stock in Rhythm. 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 has nothing to disclose. 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 has received personal compensation for serving as an employee of Biogen. Karen Smirnakis has received stock or an ownership interest from Biogen. Dr. DSILVA has received stock or an ownership interest from BIOGEN. Mrs. Sinks has received personal compensation for serving as an employee of Biogen . Nolan Campbell has received personal compensation for serving as an employee of Biogen. Nolan Campbell has stock in Biogen. Tyler Lasky has received personal compensation for serving as an employee of Biogen. Tyler Lasky has stock in Biogen. Karthik Bodhinathan has nothing to disclose.

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.