Although siponimod had a “small benefit” on the primary end point, it did not reduce the time to three-month confirmed worsening of the T25FW, said the authors. “Worsening of the T25FW by 20%, as required in this trial, is a reliable measure of change and suggests clinical significance.”
The significant differences between the siponimod group and controls on the other secondary outcomes “might all reflect an effect on the inflammatory disease activity that characterizes relapsing-remitting MS, and this trial does not, in our opinion, provide convincing evidence that we have found a treatment that exerts its clinical effect through other mechanisms,” said Drs. Metz and Liu.
“Confidence in the treatment benefit of siponimod in progressive MS will … require confirmation in a second trial,” they continued. “Trials of other novel treatments that target noninflammatory mechanisms are still needed.”
—Erik Greb
Suggested Reading
Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 22 [Epub ahead of print].
Metz LM, Liu WQ. Effective treatment of progressive MS remains elusive. Lancet. 2018 Mar 22 [Epub ahead of print].