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Abstract Details

Early Onset of Action and Sustained Efficacy of MRI Outcomes During Cladribine Tablets Treatment in Highly Active Relapsing Multiple Sclerosis: Results of the 2-year MAGNIFY-MS Study
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-018
MAGNIFY-MS used frequent MRI to increase understanding of the onset of action and sustained efficacy of cladribine tablets (CladT) 3.5 mg/kg cumulative dose over 2 years in patients with highly active relapsing multiple sclerosis. 
To report the 2-year, follow-up magnetic resonance imaging (MRI), clinical, and safety results from the MAGNIFY-MS study (NCT03364036).
MRI was performed at screening, baseline, and at Months (M)1, 2, 3, 6, 12, 15, 18, and 24 following CladT initiation. Combined unique active (CUA), T1 Gd+, and new or enlarging T2 lesion count changes were compared exploratively between baseline and post-baseline visits using a mixed-effects linear model for repeated measures. Poisson regression estimated annualized relapse rate (ARR). Safety endpoints are summarized descriptively.
Overall, 270 patients received treatment (mean age 37.7 years; 66.7% female). Among evaluable patients (n=265), mean CUA lesion counts reduced significantly from M2 onwards
(-3.52 lesions/year; 95% confidence interval [CI]: -4.60, -2.43; p<0.0001). The maximum mean change was reached at M6 (-5.99 lesions/year; 95%CI: -6.18, -5.80; p<0.0001) and maintained until M24 (-5.91 lesions/year; 95%CI: -6.15, -5.67; p<0.0001). Annualized mean T1 Gd+ and new/enlarging T2 lesion counts decreased similarly. ARR was 0.11 (95%CI: 0.09, 0.15). Expanded Disability Status Scale score remained stable for most patients. Overall, 227 patients (84.1%) had ≥1 treatment-emergent adverse event (TEAE); 14 patients (5.2%) had ≥1 serious TEAE. Most post-baseline reports of lymphopenia were Grade 1-2; 66/270 patients (24.4%) experienced Grade 3 and (2/270 patients (0.7%) experienced Grade 4 lymphopenia. TEAEs leading to temporary discontinuation of study treatment occurred in 4 patients (1.5%). Six patients (7.7%) withdrew due to progressive disease.
CladT shows an early onset of action from M2 onwards with sustained reductions in MRI lesion counts over 2 years. The benefit:risk profile of CladT remained unchanged and in line with previous observations.
Authors/Disclosures
Patrick Vermersch (CHR de Lille)
PRESENTER
Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS-Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ad Scientiam. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi.
Nicola De Stefano, MD (University of Siena) Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Healthcare KGaA. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharma AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Serono S.p.A. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche S.p.A.. The institution of Dr. De Stefano has received research support from Italian MS Society. The institution of Dr. De Stefano has received research support from Merck Healthcare KGaA.
Anat Achiron, MD, PhD, FAAN (Sheba Medical Center, Tel-Hashomer) Dr. Achiron has nothing to disclose.
Frederik Barkhof, MD, PhD (Image Analysis Center) Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Frederik Barkhof has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Combinostics. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IXICO. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EISAI.
Andrew Chan The institution of Andrew Chan has received research support from UCB. The institution of Andrew Chan has received research support from Biogen. The institution of Andrew Chan has received research support from Sanofi Genzyme.
Tobias Derfuss An immediate family member of Tobias Derfuss has received personal compensation for serving as an employee of Novartis. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GeNeuro. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MedDay. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Merck. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Roche. An immediate family member of Tobias Derfuss has received stock or an ownership interest from Novartis. The institution of Tobias Derfuss has received research support from Roche. The institution of Tobias Derfuss has received research support from Biogen.
Suzanne J. Hodgkinson, MD, MBBS, PhD, FRACP The institution of Dr. Hodgkinson has received research support from MERCK. The institution of Dr. Hodgkinson has received research support from Atara. The institution of Dr. Hodgkinson has received research support from Biogen . The institution of Dr. Hodgkinson has received research support from Genzyme. The institution of Dr. Hodgkinson has received research support from ROCHE. The institution of Dr. Hodgkinson has received research support from Novartis.
Letizia M. Leocani, MD (University Vita-Salute San Raffaele, INSPE) Dr. Leocani has received personal compensation in the range of $0-$499 for serving as a Consultant for Roche . Dr. Leocani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Leocani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Leocani has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Med-ex learning.
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia) The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen. Dr. Montalban 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. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban 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. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Alexandre Prat, MD (CHUM Hopital Norte Dame/ Dept of Neurology) The institution of Dr. Prat has received research support from CIHR and MSSC.
Klaus Schmierer, MD, PhD (The Blizard Institute, Centre for Neuroscience, Surgery & Trauma) Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AXDEV. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MedScape. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDiem. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurology Academy. Dr. Schmierer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck KGaA. Dr. Schmierer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merck KGaA. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for F. Hoffmann-La Roche AG. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. Schmierer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva.
Finn Sellebjerg, MD (Copenhagen University Hospital Rigshospitalet) Dr. Sellebjerg has received personal compensation for serving as an employee of Danish Multiple Sclerosis Society. Dr. Sellebjerg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Sellebjerg 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. Sellebjerg 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. Sellebjerg 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. Dr. Sellebjerg 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. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Gangsted Foundation. Dr. Sellebjerg has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Warwara Larsen Foundation. The institution of Dr. Sellebjerg has received research support from Biogen. The institution of Dr. Sellebjerg has received research support from Merck. The institution of Dr. Sellebjerg has received research support from Novartis. The institution of Dr. Sellebjerg has received research support from Sanofi Genzyme. Dr. Sellebjerg has received publishing royalties from a publication relating to health care.
Heinz Wiendl, MD, FAAN (University of Muenster) Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NexGen. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Worldwide Clinical Trials. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gossamer Bio. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LTS. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl 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. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz-Hexal. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cellerys. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Toleranzia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care.
Birgit Keller Birgit Keller has received personal compensation for serving as an employee of Merck Healthcare KGaA.
Andrzej Smyk Andrzej Smyk has received personal compensation for serving as an employee of Merck KGaA.
Lidia Gardner, PhD, EMBA (Novartis Pharmaceutical Corporation) Dr. Gardner has stock in EMD Serono.