Categorical change in T2 lesion volume and clinical outcomes in the Phase III FREEDOMS and its extension study, evaluating Gilenya (fingolimod) in patients with relapsing-remitting multiple sclerosis: STUDY

Background/objective

Clinical evidence in relapsing-remitting multiple sclerosis (RRMS) suggests an association between changes in T2 lesion volume (LV) and confirmed disability progression (CDP). Here, we investigated the clinical outcomes in the FREEDOMS study and its' extension, by categorical change in T2LV.

Design/methods

Post-hoc analyses were performed in the overall fingolimod 0.5 mg, and placebo groups in patients with baseline and M24 evaluations for T2LV (1057/1272 patients overall; 372/425 fingolimod 0.5 mg; 342/418 placebo). Categorical subgroups were defined based on change in T2LV from baseline to M24: decreased (500 mm3). Clinical outcomes included M3 and M6 CDP measured by mean change in Expanded Disability Status Scale (EDSS) score and Multiple Sclerosis Functional Composite (MSFC) z-scores. Additional analyses assessed the relationship between LV change in the first two years and disability through M48.

Results

At M24 the proportions with decreased, stable and increased T2LV were 15.5% (164/1057), 59.9% (633/1057), and 24.6% (260/1057), respectively. More fingolimod 0.5 mg patients showed decreased or stable LV versus placebo (% [fingolimod/placebo]: decreased [17.7%/5.8%]; stable [67.5%/50.3%]; increased [14.8%/40.3%]). Compared to stable or decreased LV, increased LV was associated with worsening disability at M24 (LV [decreased/stable/increased], all patients): change in EDSS [−0.01/−0.01/0.14] and MSFC [0.08/0.01/−0.08] scores; proportion with M3 [16.4%/17.4%/21.7%] and M6 CDP [11.3%/14.0%/19.0%]. Results within fingolimod and placebo groups were consistent with this overall pattern, and LV in the first two years was similarly associated with disability by M48.

Conclusion

Two year categorical T2LV change was related to disability over 24 and 48 months in RRMS patients. Patients with increased T2LV exhibited higher mean changes in EDSS and MSFC and more 3- and 6-M CDP/shorter time to CDP. Fewer fingolimod treated patients had increased T2LV while higher proportions demonstrated stable or decreased LV than placebo.

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