Primary Progressive MS
• ORATORIO trial (NEJM 376 Jan 2017)
• 732 patients, 488 active rx, 244 placebo
• 600mg infusion (300mg x2, 14 days apart), every 24 weeks for 120 weeks
• Primary end point – 12 weeks confirmed disability progression
o 32.9% vs 39.3% (Ocreliz vs placebo)
o HR 0.76 (CI 0.59-0.98)
o AbRR 6.4% NNT 15.6
• Less decline in 25 foot walk test on ocrelizumab
• No change in SF-36 physical component summary score
• The separation in the two groups appeared after first 12 weeks and then did not change.
• INFORMS Trial
o Reduced lesion progression but not atrophy or function – negative trial
•
Secondary Progressive MS
· ~150patients
· 12-15% of patients in treatment arm improved EDSS
· Mean overall EDSS improvement 0.1-0.2
· No side effects – except it interferes with thyroid assays
· ASCEND trial
o Lancet Neurology 2018
o 889 patients – randomised to Natalizumab vs placebo
o No difference in EDSS or 25ft walk test
o Improvement in 9 hole PEG test
o Overall no effect on combined sustained disability end point.
• EXPAND trial
• See other topic in MS treatments (MS treatment - preventative immunomodulatory)