Siponimod cuts risk of disability progression in multiple sclerosis
Ludwig Kappos, M.D., from the University of Basel in Switzerland, and colleagues conducted a phase 3 trial at 292 hospital clinics and specialized multiple sclerosis centers in 31 countries. Patients with SPMS and an Expanded Disability Status Scale score of 3.0 to 6.5 were randomized in a 2:1 ratio to once-daily oral siponimod 2 mg or placebo. A total of 1,645 patients were included in the analyses: 1,099 to the siponimod group and 546 to the placebo group; 903 and 424 patients completed the study, respectively.
The researchers found that 26 and 32 percent of patients receiving siponimod and placebo had three-month confirmed disability progression events (hazard ratio, 0.79; relative risk reduction, 21 percent). Adverse events occurred in 89 and 82 percent of patients taking siponimod and placebo, respectively; serious adverse events were reported for 18 and 15 percent, respectively.
"Siponimod reduced the risk of disability progression with a safety profile similar to that of other S1P modulators and is likely to be a useful treatment for SPMS," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which manufactures siponimod and funded the study.
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