The subgroups were defined by baseline characteristics that are known to be potential modifiers of risk to conversion to clinically-definite multiple sclerosis, including age, gender, first classification of demyelinating event, presence of T1 Gd+ lesions, and number of active T2 lesions.
Bruce Hughes, MD
According to results of a post hoc analysis presented at the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), May 28­—June 1, in Seattle, Washington, the effect of cladribine tablets on the reduction of the mean number of T1 gadolinium-enhancing (Gd+) lesions, active T2 lesions, and combined unique active (CUA) lesions is consistent across subgroups of patients with a first demyelinating event who are at high risk of converting to multiple sclerosis.
Investigators, led by Bruce Hughes, MD, associate professor in neurology at the Des Moines University College of Medicine, and director of the Ruan Multiple Sclerosis Center at Mercy Ruan Neurology Clinic and Research Center, conducted the post hoc analysis of the phase 3 ORACLE-MS study to better understand the effect of cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years [CT3.5]) versus placebo on the mean number of T1 Gd+, active T2, and CUA lesions across subgroups of patients (N = 616).
The subgroups were defined by baseline characteristics that are known to be potential modifiers of risk to conversion to clinically-definite multiple sclerosis, including age (<30 or ≥30 years), gender, first classification of demyelinating event, presence of T1 Gd+ lesions, and number of active T2 lesions (<9 or ≥9).
Results of the analysis suggest that treatment with cladribine tablets 10 mg (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years [CT3.5 and CT5.25, respectively] significantly reduce the risk of the number of new or persisting T1 Gd+ lesions, active T2, and CUA lesions per patient per scan versus placebo regardless of baseline characteristics. The risk reduction reported in this study with CT3.5 and CT5.25 versus placebo was 89.3% and 90.0%, respectively, for T1 Gd+ lesions; 76.5% and 70.2% for active T2 lesions, and 84.7% and 84.8% for CUA lesions (all P <.0001).
The reduction in risk in lesion counts ranged from 60% to 89% for T1 Gd+ lesions, 49% to 80% for active T2 lesions, and 61% to 83% for CUA lesions, suggesting that the effect of cladribine tablets on reduction in the mean number of lesions is consistent across all studied subgroups.
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Leist T, Damian D, Hyvert Y, et al. The effects of cladribine tablets on reduction in magnetic resonance imaging lesions are consistent across subgroups in the ORACLE-MS study. Presented at: 2019 CMSC Annual Meeting. May 28—June 1, 2019; Seattle, WA. Abstract DXM05.