Nicola De Stefano,1 Patrick Vermersch,2 Heinz Wiendl,3 Frederik Barkhof,4,5 Xavier Montalban,6,7 Anat Achiron,8,9 Tobias Derfuss,10 Andrew Chan,11 Alexandre Prat,12 Letizia Leocani,13,14,15 Klaus Schmierer,16,17 Finn Sellebjerg,18,19 Annette Lehn,20 Andrzej Smyk,20 Axel Nolting,20 Ralf Koelbach,21 Suzanne Hodgkinson22
1 Department of Medicine, Surgery and Neuroscience, University ofSiena, Siena, Italy
2 Univ. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France
3 Department of Neurology, Institute ofTranslational Neurology, University of Münster, Münster, Germany;
4 Department of Radiology and Nuclear Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands;
5 Queen Square Institute of Neurology and Centre for Medical Image Computing, University College London, London, United Kingdom
6 Division ofNeurology, St Michael’s Hospital, University of Toronto, Toronto, Canada
7 Department of Neurology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain
8 Multiple Sclerosis Center, Sheba Academic Medical Center, Ramat Gan, Israel
9 Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
10 Department of Neurology, University Hospital Basel, Basel, Switzerland
11 Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland;
12 Department of Neurosciences, Université de Montréal, Montréal, Canada
13 University Vita-Salute San Raffaele, Milan, Italy
14 Scientific Institute IRCCS San Raffaele, Milan, Italy
15 Department of Neurorehabilitation Science, Casa di Cura Igea, Milan, Italy
16 The Blizard Institute, Centre for Neuroscience, Surgery and Trauma, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, London, United Kingdom
17 Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, United Kingdom
18 Danish MS Center, Department of Neurology, Copenhagen University Hospital – Rigshospitalet, Glostrup, Denmark
19 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
20 The healthcare business of Merck KGaA, Darmstadt, Germany
21 Cytel, Inc., Berlin, Germany
22 Ingham Institute for Applied Medical Research, University of New South Wales Medicine and Liverpool Hospital, Sydney, Australia
MAGNIFY-MS (NCT03364036) was a 2-year, phase IV study in which eligible patients (n=270) with highly active relapsing multiple sclerosis received cladribine tablets (CladT). MAGNIFY-MS Extension is a 2-year follow-up study that aimed to evaluate the long-term effectiveness of CladT up to 4 years after the initial dose. 219 patients entered the MAGNIFY-MS extension study (females, 64.8%; mean age, 40.4 years; treatment-naïve, 40.6%; MRI lesions [Baseline Period]: T1 Gd+, 50.2%; active T2, 42.9%). During the extension period, the Kaplan-Meier estimated NEDA-3 rate (95% confidence interval [CI]) was 78.6% (72.5, 83.5) in Year 3 and 79.2% (72.3, 84.6) in Year 4. The annualized qualified relapse rate (ARR, 95% CI) for the parent study was 0.09 (0.06, 0.12) and for the extension period was 0.08 (0.06, 0.11). The ARR was 0.09 (0.07, 0.11) over 4 years. There were 142 patients (64.8%) with ≥1 adverse event (AE) during the extension study, 13 (5.9%) ≥1 serious AE, and 3 (1.4%) had ≥1 any serious treatment-related AEs. No new safety signals were seen. The findings from MAGNIFY-MS Extension confirm the long-term (4-year) high efficacy of CladT. The long-term safety profile of CladT was consistent with earlier safety data.
