Sistema de Salut de Catalunya
Institut Català de la Salut
[de Stefano N] Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy. [Barkhof F] Department of Radiology, VU University Medical Center, Amsterdam, The Netherlands. UCL Institute of Neurology, London, UK. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Achiron A] Multiple Sclerosis Center, Sheba Academic Medical Center, Ramat Gan, Israel. [Derfuss T] Department of Neurology, University Hospital Basel, Basel, Switzerland. [Chan A] Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Vall d'Hebron Barcelona Hospital Campus
2022-09-12T08:25:22Z
2022-09-12T08:25:22Z
2022-07
Active Relapsing Multiple Sclerosis; MRI; Cladribine
Esclerosis Múltiple Recurrente Activa; Imagen por resonancia magnética; Cladribina
Esclerosi múltiple recurrent activa; Imatge per ressonància magnètica; Cladribina
Background and Objectives The onset of action for high-efficacy immunotherapies in multiple sclerosis (MS) is an important parameter. This study (MAGNIFY-MS) evaluates the onset of action of cladribine tablets by observing changes in combined unique active (CUA) MRI lesion counts during the first 6 months of treatment in patients with highly active relapsing MS. Methods MRI was performed at screening, baseline, and at months 1, 2, 3, and 6 after initiating treatment with cladribine tablets 3.5 mg/kg. CUA lesion counts, defined as the sum of T1 gadolinium-enhancing (Gd+) lesions and new or enlarging active T2 lesions (without T1 Gd+), were compared between postbaseline and the baseline period and standardized to the period length and the number of MRIs performed. Results Included in this analysis were 270 patients who received ≥1 dose of cladribine tablets. After treatment initiation, significant reductions in mean CUA lesion counts were observed from month 1 onward compared with the baseline period (−1.193 between month 1 and month 6, −1.500 between month 2 and month 6, and −1.692 between month 3 and month 6; all p < 0.0001). Mean T1 Gd+ lesion counts were decreased from month 2 onward compared with baseline (−0.857 at month 2, −1.355 at month 3, and −1.449 at month 6; all p < 0.0001), whereas the proportion of patients without any CUA lesions increased from 52.0% between month 1 and month 6 to 80.5% between month 3 and month 6. Discussion Findings suggest an early onset of action for cladribine tablets, with an increasing reduction in active MRI lesions over time. Trial Registration Information NCT03364036; Date registered: December 06, 2017.
This study was supported by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).
Article
Published version
English
Esclerosi múltiple - Imatgeria per ressonància magnètica; Immunoteràpia; Comprimits (Medicina) - Ús terapèutic; DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis; Other subheadings::Other subheadings::Other subheadings::/diagnostic imaging; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Magnetic Resonance Imaging; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple; Otros calificadores::Otros calificadores::Otros calificadores::/diagnóstico por imagen; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::diagnóstico por imagen::tomografía::imagen por resonancia magnética; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::inmunomodulación::inmunoterapia
Lippincott Williams & Wilkins
Neurology - Neuroimmunology & Neuroinflammation;9(4)
https://doi.org/10.1212/NXI.0000000000001187
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
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