PHILADELPHIA — Magnetic resonance imaging (MRI) data on patients with a first demyelinating event at high risk of converting to clinically definite multiple sclerosis (CDMS) suggest that the first year of treatment with cladribine tablets (CT) 10 mg (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years) has a rapid onset of action with beneficial effects on the number and volume of active lesions, with effects evident within 13 weeks, according to research presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10, 2019, in Philadelphia, Pennsylvania.
Researchers used data from the phase 3, randomized, placebo-controlled, 96-week ORACLE-MS trial (ClinicalTrials.gov identifier: NCT00725985) to assess the timing of effects of CT on MRI outcomes for 616 patients with a first demyelinating event at high risk of converting to multiple sclerosis. MRI scans were performed at baseline screening and at every 12 weeks for patients not converting to CDMS during the study.
Analysis of covariance and negative binomial models were used to analyze MRI-based end points, and the temporal effects of the first yearly course of CT and placebo on T1 gadolinium-enhancing (T1 Gd+), active T2, and combined unique active (CUA) lesions were presented graphically.
Compared with placebo, the reduction in mean T1 Gd+, active T2, or CUA lesion number per patient per scan with CT was nominally significantly greater (P <.0001). An early change from baseline at week 13 in Gd+ lesion volume was also found (CT, -155.73 mm³; placebo, -14.76 mm³). Compared with placebo, comparatively larger reductions in mean active T2 and CUA lesion numbers were seen at week 13 (active T2: CT, -1.25; placebo, -1.43; CUA: CT, -1.56; placebo, -2.41), with the mean number of T1 Gd+ lesions being 0.37 compared with 1.0 for placebo.
Study investigators conclude, “These MRI data from ORACLE-MS in subjects with a first demyelinating event at high risk of converting to CDMS suggest the first yearly treatment course of [CT] has a rapid onset of action, with beneficial treatment effects on active lesion number and volume evident within 13 weeks.”
Disclosure: Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Scarberry S, Damian D, Hyvert Y, Dangond F, Lebson L, Leist T. Cladribine tablets were associated with rapid onset of improvements in MRI outcomes in the ORACLE-MS trial. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. Abstract P3.2-061.