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Abstract Details

Blood Biomarker Dynamics in Highly Active Relapsing Multiple Sclerosis Patients Treated With Cladribine Tablets: Results of the 2-Year MAGNIFY-MS Study
Multiple Sclerosis
S16 - MS Clinical Trials and Therapeutics (2:00 PM-2:12 PM)
006
To describe blood biomarker (BB) dynamics over 2 years of treatment with cladribine tablets 3.5mg/kg (CladT), including immune cell subsets, serum proteins, and intracellular cytokines.
MAGNIFY-MS (NCT03364036) BB analysis was designed to characterize the effect of CladT on BB in patients with highly active relapsing multiple sclerosis.
Blood samples were collected at baseline and Months (M) 3, 6, 12, 15, 18, and 24 for immune cell characterization and serum protein analysis. Intracellular cytokine analyses were performed for a subset of patients in the BB sub-study.

A total of 270 patients enrolled in the main study were analyzed (BB sub-study, n=57). Quantitative immune cell changes were observed following each yearly treatment course. Median percentage change from baseline at M24: regulatory (+1.62%), transitional (+6.3%), naïve (+10.85%), memory (-89.29%) B-cells; total plasma cells: -62.47%; T cells remained below baseline levels (CD4+, -57.51%; CD8+, -45.93%). Increased levels above baseline from M12 onwards were detected for CD16lowCD56bright (M24, +17.21%) and NKp46 cells (M24, +77.7%). IgM and IgG levels remained within reference ranges. Compared with baseline, serum neurofilament levels were reduced at M12 (-25.22%) and M24 (-23.23%).

In the BB sub-study, reductions in pro-inflammatory cytokine-producing B-cells (IL-6) and CD4+ and CD8+ T-cells (GMCSF, TNFα, INFg), and increases in anti-inflammatory cytokine-producing CD19+ and memory B-cells (IL-10) and CD4+ and CD8+ T-cells (IL-4), were observed.
Multifaceted immune changes were detected over a 2-year observation period following CladT treatment. Most dynamic changes were observed in the peripheral B-cell compartment (persistent reduction of B-memory cells), while IgM and IgG levels remained within reference ranges, helping to interpret efficacy and safety data in conjunction with changes in immune cells, serum proteins, clinical and MRI parameters.
Authors/Disclosures
Heinz Wiendl, MD, FAAN (University of Freiburg)
PRESENTER 		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 Lundbeck. 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 $500-$4,999 for serving as a Consultant for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for INmune Bio_Syneos Health. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Muna Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Myrobalan Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSL Group. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Red Nucleus. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Swiss Multiple Sclerosis Society. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teladoc Health. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Toleranzia . Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. 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 $5,000-$9,999 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 Uniqure. 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 Biocryst. 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 Galapagos. 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. Dr. Wiendl has received publishing royalties from a publication relating to health care.
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.
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.
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 Pharmaceuticals. 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. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIAL PD. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVoice. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung Biosys. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas BioPharma. 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 Pharmaceuticals. 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 Pharmaceuticals. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Anat Achiron, MD, PhD, FAAN (Sheba Medical Center, Tel-Hashomer) Dr. Achiron has nothing to disclose.
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.
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.
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.
Alexandre Prat, MD (CHUM Hopital Norte Dame/ Dept of Neurology) The institution of Dr. Prat has received research support from CIHR and MSSC.
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.
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.
Patrick Vermersch (CHR de Lille) 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.
No disclosure on file
Elina Jarvinen Elina Jarvinen has received personal compensation for serving as an employee of Merck Oy, Espoo, Finland, an affiliate of Merck KGaA.
No disclosure on file
Lidia Gardner, PhD, EMBA (Novartis Pharmaceutical Corporation) Dr. Gardner has stock in EMD Serono.