Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial

Analysis (n=544) found that compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6.5 study years of follow-up.

SPS commentary:

Time to onset of disability progression was confirmed at 24 weeks with four measures: increase in EDSS score, ≥20% increase in time to complete the 9-Hole Peg Test ≥20% increase in time to perform the Timed 25-Foot Walk and composite progression defined as the first confirmed occurrence of any of these three individual measures), as was time to requiring a wheelchair (EDSS ≥7).

A commentary notes that although this analysis of the open-label extension yielded no unexpected findings, the results are valuable, in showing that efficacy persisted in participants treated continuously with ocrelizumab up to 6·5 study years, and improved in participants who switched from placebo to ocrelizumab compared with before the switch. It adds that several important questions remain, such as:

  • Can these these results be extrapolated in primary progressive multiple sclerosis to secondary progressive multiple sclerosis (a more common form of progressive multiple sclerosis, which occurs after a relapsing-remitting course)?
  • Are there rare or late adverse events that have not yet been seen?
  • What is the clinical significance of the decrease in immunoglobulin concentrations, and how should patients with low immunoglobulin concentrations be managed?

The Lancet Neurology

Resource links:

Commentary