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Abstract Details

Efficacy and Safety of Tolebrutinib in Patients With Highly Active Relapsing MS: Subgroup Analysis of the Phase 2b Study
Multiple Sclerosis
S25 - MS and CNS Inflammatory Disease: Emerging Therapeutics and Biomarkers (4:32 PM-4:40 PM)
004
Describe efficacy and safety in patients with relapsing MS (RMS) who had highly active disease (HAD) at baseline in the phase 2b trial of tolebrutinib (NCT03889639).
Tolebrutinib is a covalent, irreversible, central nervous system (CNS)–penetrant Bruton’s tyrosine kinase inhibitor targeting B lymphocytes and myeloid cells (eg, macrophages and microglia), modulating immunity in the periphery and CNS. Phase 2b trial results demonstrated tolebrutinib was well tolerated and identified a dose-dependent reduction in new/enlarging MRI lesions.
The phase 2b study was a randomized, double-blind, placebo-controlled, cross-over, dose-ranging trial. HAD was defined as 1 relapse in the year prior to screening and ≥1 gadolinium (Gd)-enhancing lesion on MRI performed within 6 months prior to screening, or ≥9 T2 lesions at baseline or ≥2 relapses in the year prior to screening.
Of 130 enrolled participants, 61 (47%) met HAD criteria at baseline. Patients with HAD composed 44% of the placebo cohort (29/66) who later crossed over to tolebrutinib treatment. HAD patients were distributed across each tolebrutinib dose arm (12/33 [36%], 19/32 [59%], 16/33 [48%], and 14/32 [44%] in the 5, 15, 30, and 60 mg arms, respectively). After 4 weeks of placebo treatment, the HAD subgroup had mean 0.89 Gd-enhancing lesions and 1.44 new/enlarging T2 lesions. After 12 weeks of tolebrutinib treatment, mean numbers of new Gd-enhancing lesions in the HAD subgroups were 0.82 (5 mg), 0.5 (15 mg), 0.38 (30 mg), and 0.08 (60 mg). Respective numbers of new/enlarging T2 lesions were 1.09 (5 mg), 0.89 (15 mg), 0.75 (30 mg), and 0.15 (60 mg). Tolebrutinib was well tolerated over 12 weeks.
This subgroup analysis shows that 12-week treatment with tolebrutinib 60 mg effectively reduced new Gd-enhancing and new/enlarging T2 lesions in RMS patients with HAD, consistent with its previously reported effects in the overall study population.
Authors/Disclosures
Anthony Traboulsee, MD (University of British Columbia)
PRESENTER 		Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Genzyme. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.
Sana Syed, MD (Sanofi Genzyme) Dr. Syed has received personal compensation for serving as an employee of Sanofi US.
Nicole L. Yonkers, PhD (Sanofi Genzyme) Dr. Yonkers has received personal compensation for serving as an employee of Sanofi Genzyme.
Christopher C. LaGanke, MD (North Central Neurology Associates, PC) Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for GSK. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Serono EMD. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. LaGanke has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. LaGanke has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics.
William D. Honeycutt, MD (Neurology Associates, P.A.) Dr. Honeycutt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Honeycutt has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Honeycutt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Viela Bio. Dr. Honeycutt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Honeycutt has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Honeycutt has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Honeycutt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Honeycutt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Celegene.
Daniel R. Wynn, MD (Consultants in Neurology, Ltd.) Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mylan. Dr. Wynn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wynn has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Wynn has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Wynn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Banner Life. Dr. Wynn has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Biogen. The institution of Dr. Wynn has received research support from Novartis. The institution of Dr. Wynn has received research support from Sanofi. The institution of Dr. Wynn has received research support from Adamas Pharmaceutics. The institution of Dr. Wynn has received research support from EMD Serono. The institution of Dr. Wynn has received research support from Roche. Dr. Wynn has a non-compensated relationship as a Director, Consultants in Neurology Comprehensive Care Center with National MS Society that is relevant to AAN interests or activities.
Sibyl E. Wray, MD (Hope Neurology) Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb/Celgene. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche/Genentech. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi/Genzyme. The institution of Dr. Wray has received research support from Biogen. The institution of Dr. Wray has received research support from Atara Biotherapeutics. The institution of Dr. Wray has received research support from Bristol Myers Squibb/Celgene. The institution of Dr. Wray has received research support from Novartis. The institution of Dr. Wray has received research support from Roche/Genentech. The institution of Dr. Wray has received research support from Sanofi/Genzyme. The institution of Dr. Wray has received research support from TG Therapeutics. The institution of Dr. Wray has received research support from EMD Serono. The institution of Dr. Wray has received research support from Pharmaceuticals Corp..
No disclosure on file
Deborah Dukovic No disclosure on file
Timothy J. Turner Timothy J. Turner has received personal compensation for serving as an employee of Sanofi. Timothy J. Turner has stock in Sanofi. Timothy J. Turner has received intellectual property interests from a discovery or technology relating to health care.