MS Drug Reduces Risk of Disability Progression in Phase 3 Study

June 13, 2018

Long-term treatment of patients with secondary progressive multiple sclerosis (SPMS) with siponimod may reduce the risk of disability progression, according to findings of the phase 3 EXPAND study.

Long-term treatment of patients with secondary progressive multiple sclerosis (SPMS) with siponimod may reduce the risk of disability progression, according to findings of the phase 3 EXPAND study.

The study compared the results of a 3-year treatment with once daily oral siponimod (2 mg) versus placebo. The results, presented at the 70th American Academy of Neurology (AAN) Annual Meeting, revealed that siponimod treatment resulted in significant risk reduction in disability progression, which was sustained for 3 to 6 months.

"Siponimod's beneficial effect on preventing disability progression, independent from its reduction in relapse frequency, demonstrates that patients with secondary progressive MS could benefit from this treatment," said Bruce Cree, MD, PhD, MAS, clinical research director and associate professor, School of Medicine, University of California San Francisco.

The estimated risk reduction for disability progression sustained at 3 months ranged from 14% to 20% compared with the placebo for nonrelapsing patients. Also, for disability sustained at 6 months, the estimated risk reduction ranged from 29% to 33%.

"This is very exciting because many people diagnosed with relapsing-remitting MS [multiple sclerosis], the most common form of the disease, will ultimately transition to SPMS, where without effective new therapies, they experience gradual worsening of disability despite infrequent relapses," Cree said in a statement.

Siponimod was also beneficial for cognitive processing speed—the key cognitive function affected by MS, according to the research. In the analysis, siponimod’s effect was measured by the Symbol Digit Modalities Test (SDMT), the Paced Auditory Serial Addition Test (PASAT), and the Brief Visuospatial Memory Test-Revised (BVMT-R).

The results demonstrated that from baseline to month 24, treatment with siponimod had a significant benefit on cognitive processing speed compared with placebo, for all patients. Also, those who had relapsed within 2 years before starting the trial and those who did not also exemplified a cognitive benefit. Siponimod treatment, however, did not result in any significant differences in memory, according to the study.

"A decline in the ability to rapidly process information affects more than half of MS patients and is more severe in secondary progressive MS than relapsing-remitting MS. These data show that siponimod could have a meaningful impact on these patients' daily lives," said Danny Bar-Zohar, global head of Neuroscience Development, Novartis. "Furthermore, the advanced models used in the new analyses help us to better understand the relationship between relapses and disability and the effect of siponimod on these parameters,”

Reference

Kappos L, Bar-Or A, Cree BAC; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6.