The multiple sclerosis medication fingolimod is showing promising effects.
In patients with relapsing-remitting multiple sclerosis (RRMS), fingolimod may protect against deep gray matter (dGM) and thalamus volume loss and may also lead to slower disability progression compared with placebo, according to an analysis published in Neurology.
The investigators analyzed pooled data from the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis FREEDOMS and FREEDOMS II phase 3 trials, using data from the fingolimod program. In the pooled analysis, a total of 2064 participants with RRMS received 0.5 mg fingolimod (n=783), 1.25 mg fingolimod, or placebo (n=773). At 12 and 24 months, the investigators evaluated baseline changes in dGM and thalamic volumes. White matter and ventricular volume changes were also evaluated.
Significant reductions in thalamus volume loss were also observed with fingolimod (49.7% [P<.001] and 26.1% [P =.006]). In addition, there was significantly less white matter loss and ventricular volume enlargement among those receiving fingolimod compared with placebo (all P<.001). Patients taking placebo who demonstrated a high dGM (hazard ratio 0.54; P =.0323) or thalamic (hazard ratio 0.58; P =.0663) volume at baseline were less likely to experience worsening of disability. Comparatively, participants who were treated with both doses of fingolimod experienced less overall progression of disability than those receiving placebo (P =.0457).
The investigators suggest a potential systematic bias in determining white matter and GM borders as well as the lesion-filling algorithm that was used in this study.
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