Disability appears to mostly accumulate in people with relapsing forms of multiple sclerosis (MS) in a progressive manner — rather than being due to relapses, a pooled analysis of patients in two Ocrevus (ocrelizumab) clinical trials shows.
These findings, indicating that disease progression underlies relapsing MS as well, “challenge the current clinical distinction of relapsing and progressive forms of multiple sclerosis,” the researchers wrote.
“We provide evidence that, in a typical population with relapsing MS, 80% to 90% of overall disability accumulation occurred independently of relapses,” they wrote. “This observation, obtained in the setting of 2 state-of-the-art prospective phase 3 trials, challenges the current paradigm of a dichotomy” in disease course between these two MS forms.
The study, “Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials,” was published in the journal JAMA Neurology.
New symptoms in MS are considered to either occur in isolated attacks and build up in a stepwise manner (relapsing MS), or build up continuously over time, independent of relapses, as a consequence of progressive disease.
Relapsing and progressive MS are generally regarded as distinct clinical entities, with patients accumulating disability through different mechanisms. But increasing evidence supports relapsing MS patients also worsening over time, even when relapses are well under control.
Researchers in five countries set out to investigate how relapse-associated worsening (RAW) and steady progression independent of relapse activity (PIRA) contribute to overall disability accumulation in relapsing MS.
Pooled data from two identical and randomized Phase 3 trials — OPERA I (NCT01247324) and OPERA II (NCT01412333) — investigating Ocrevus against Rebif (interferon beta-1a) were used. These data used were collected between August 2011 and April 2015, and analyses took place between July 2015 and February 2020.
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