Novartis announced new data from the ACROSS study, which assessed 10-year disability outcomes in people with relapsing remitting multiple sclerosis (RRMS) treated with Gilenya® (fingolimod). These results provide supportive evidence of the long-term effectiveness of continuous Gilenya treatment on controlling disability progression. Full results are being presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in London, UK.
ACROSS is a single visit observational study of 175 individuals previously enrolled in the Phase II study of fingolimod in RRMS.The study met its primary endpoint of a significantly lower change from baseline at 10 years in patients’ Expanded disability Status Scale (EDSS) score with continuous versus non-continuous Gilenya treatment (0.55 versus 1.21, respectively; p=0.0155).Analyses of key secondary endpoints showed that after 10 years, the risk of progression to secondary progressive MS (SPMS) was reduced by 66.2% in patients who remained on Gilenya treatment for at least eight years, compared to those who did not.There was also a significant four-fold delay in the time to use of a wheelchair. Almost 60% (59.4%) of patients in ACROSS stayed on Gilenya at 10 years, demonstrating persistence of treatment over the long term.
“Multiple sclerosis is a debilitating, life-long disease, and greatly impacts how individuals are able to go about their daily lives,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “The ACROSS data add to our understanding of the long-term use of Gilenya as a highly-effective treatment option for people with relapsing remitting MS.”
MS is a chronic neurological disease, associated with worsening physical and cognitive (e.g. memory) disability over time that limits sufferers’ abilities to go about everyday tasks.Limiting disability progression as early on in the disease process as possible is an important treatment goal in MS and can help improve the long-term outcomes of people with the condition, as well as delaying progression to SPMS.