Results from the Phase III ORATORIO-HAND study show that ocrelizumab, an antibody drug already prescribed to some patients with multiple sclerosis (MS), could benefit a much larger patient population, including those who are older or at more advanced stages of the disease. Published today in The Lancet, these findings could change the way clinicians understand and manage MS.
“Our study suggests we should think differently about what successful treatment looks like in advanced MS and that we shouldn’t assume a lack of benefit in certain groups,” said Gavin Giovannoni, MD, PhD, professor of neurology at Queen Mary University of London. “These findings show that treatment can make a meaningful difference to people with more advanced forms of MS and can help preserve hand and arm function, which is important for maintaining independence, daily activities and quality of life.”
The clinical trial recruited over 1,000 patients with primary progressive multiple sclerosis (PPMS), a form of MS where disability worsens over time that affects about 10–15% of people diagnosed with the autoimmune condition. Ocrelizumab is currently available to patients early on in their PPMS with lower levels of disability, delivered as an infusion every six months to reduce disability progression. However, those with advanced disease, including patients who need a wheelchair to move around, are not eligible for this treatment and currently have limited options available to them.
Compared to a placebo, ocrelizumab significantly reduced the risk of disability progression by 30%, with stronger effects in patients showing signs of inflammatory activity on MRI scans, for whom the drug reduced this risk by 55%. The treatment also reduced the worsening of hand and arm function by 41% after 12 weeks and lowered the need for a wheelchair by 52% among patients who were already unable to walk freely at the start.
These results settle a longstanding debate over whether more advanced forms of multiple sclerosis can still benefit from treatment. In contrast with previous studies, which often excluded patients over 55 and those with advanced disability, this clinical trial recruited participants up to 65 years old and those with substantial mobility impairment.
In addition to assessing walking ability, the study focused on assessing hand and arm function. This decision was based on a separate survey conducted by Giovannoni’s team in which patients with worsening multiple sclerosis reported prioritizing upper-limb function due to its importance for their independence, including their ability for cleaning and grooming themselves.
“MS can be debilitating, exhausting and unpredictable, and hand and arm function is essential for helping people to remain independent,” said Catherine Godbold, PhD, senior research communications manager at the MS Society. “Many previous trials have focused solely on walking ability as a measure of whether a drug is effective. But trials like this are vital in helping us find treatments for everyone.”
“Ocrelizumab is already used as a treatment for active relapsing MS and early primary progressive MS,” she added. “These results could mean it is made available for more people with primary progressive MS, who don’t currently have access to any treatment options. The key now is how we work together to see these findings translated into clinical practice.”
