Methodology in neuroanatomic measurement.

Abstract

<h3>Background</h3> Patients with high disease activity (HDA) relapsing-remitting MS are less likely to attain no evidence of disease activity (NEDA; no relapses, MRI activity or progression). <h3>Objective</h3> <i>Post-hoc</i> analysis to compare the proportion of patients with NEDA with cladribine tablets 3.5 mg/kg (CT3.5) vs placebo. <h3>Methods</h3> Patients from CLARITY were retrospectively stratified using 2 definitions of HDA based on relapse history, prior treatment, and MRI characteristics: HRA (n=261) and HRA plus disease activity on treatment (HRA+DAT) [n=289]). Data for patients treated with CT3.5 or placebo who fulfilled these criteria and achieved NEDA status were compared over the 2 years using odds ratios (OR) and 95% CI. <h3>Results</h3> HRA subgroup: 76% of CT3.5-treated patients were relapse-free and 84% were T1 Gd+ lesion free vs 49% and 31%, respectively, for placebo. HRA+DAT subgroup: 77% of CT3.5-treated were relapse-free and 85% were T1 Gd+ lesion free vs 50% and 32%, respectively, for placebo. In the HRA and HRA+DAT subgroups, 43.2% and 43.7%, respectively, of CT3.5-treated patients were disease activity free compared with 8.7%, (OR: 8.02; 95% CI: 3.93 to 16.35; p&lt;0.0001) and 9.0% (OR: 7.82; 95% CI: 4.03 to 15.19; p&lt;0.0001) respectively, for placebo. In the overall population, composite NEDA score favored CT over placebo (OR: 4.46; 95% CI: 3.18 to 6.26; p&lt;0.0001). <h3>Conclusions</h3> Treatment with CT3.5 significantly increased the proportion of HDA patients with NEDA vs placebo. <h3>Disclaimer</h3> http://medpub-poster.merckgroup.com/ABN2018DISC_NEDA.pdf