Multiple Forms of MS Progression Reduced by Ocrelizumab
Data presented this weekend at the 3rd Congress of the European Academy of Neurology will show its varied efficacy in MS progression prevention.
New data show ocrelizumab significantly reduces multiple measures of disease progression in both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
The data, from a post-hoc analysis of the OCREVUS (ocrelizumab) Phase III clinical trial program, will be presented this weekend at the 3rd Congress of the European Academy of Neurology (EAN) in Amsterdam, Netherlands.
The monoclonal antibody treatment — approved by the US Food and Drug Administration (FDA) in March 2017 as the first treatment for PPMS — reported a significantly reduced disease activity and disability progression in both RMS and PPMS patients. The conditions of patients were measured by novel MS composite endpoint No Evidence of Progression or Active Disease (NEPAD).
The clinical endpoint significance of NEPAD is in the combination of capabilities MS patients are able to maintain. It signifies a patient who has had no relapses, no confirmed disability progression — as measured by the Expanded Disability Status Scale (EDSS) — and no progression equal to or above 20% on the timed 25-foot walk (T25-FW) and the 9-hole peg test (9-HPT).
NEPAD is also a metric for lesions, signifying an MS patient with no gadolinium-enhancing T1 MRI lesions, and no new or enlarging T2 MRI lesions.
Though the treatment is approved for PPMS treatment, it reported a significant rate increase in RMS patients able to maintain NEPAD conditions (82%) versus Rebif (interferon beta-1a) at 96 weeks in the Phase III OPERA I and II trials.
Ocrelizumab additionally tripled the proportion of PPMS patients who maintained NEPAD versus placebo at 120 weeks (29.9% versus 9.4%, respectively) in the ORATORIO study. In a post-hoc analysis of the same study, ocrelizumab reduced the risk of 12- and 24-week confirmed disability progression (CDP) than traditionally assess in PPMS patients.
Ludwig Kappos, MD, Department of Neurology Chair at the University Hospital in Basel, Switzerland, said the results prove the effects of ocrelizumab on disability progression are “clinically meaningful.”
“Slowing disability progression, or preventing people with MS from having to use a cane or wheelchair, makes a great difference to their daily lives,” Kappos said. “It is particularly exciting to see these benefits in people with PPMS, a disabling form of MS without approved treatments in Europe.”
In all Phase III studies, the most common side effects associated with the treatment were mild-to-moderate infusion reactions and upper respiratory tract infections.
Researcher will also present interim results from the FLOODLIGHT sensor-based digital monitoring study, which is intended to determine adherence and correlation with in-clinic testing in people with and without MS, at the congress.
There will be supplemental outcome analysis in ocrelizumab’s effect on pregnant female patients.
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