Is rituximab noninferior to ocrelizumab for suppressing MRI-detected disease activity in newly diagnosed relapsing multiple sclerosis?
Does ocrelizumab delay disability progression — particularly loss of hand function — in a broad PPMS population that includes older patients and those with more advanced disability typically excluded from registration trials?
ORATORIO-HAND
Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study
Bottom Line: In a broad PPMS population including older patients and those with EDSS up to 8.0, ocrelizumab 600 mg IV every 24 weeks significantly delayed composite 12-week confirmed disability progression (9HPT or EDSS) by 30% versus placebo, with an even larger 55% risk reduction in the MRI-active subgroup, and an acceptable…