Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS
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 ...
Source: Neurology Neuroimmunology and Neuroinflammation - Category: Neurology Authors: de Stefano, N., Barkhof, F., Montalban, X., Achiron, A., Derfuss, T., Chan, A., Hodgkinson, S., Prat, A., Leocani, L., Schmierer, K., Sellebjerg, F., Vermersch, P., Wiendl, H., Keller, B., Roy, S., MAGNIFY-MS Study Group Tags: MRI, Class IV, Multiple sclerosis RESEARCH Article Source Type: research