Ten-Year Data Demonstrate Ocrevus Treatment Reduced Disability in Individuals with Multiple Sclerosis

04/12/2024

According to long-term study results, earlier treatment with Ocrevus (ocrelizumab; Genentech, South San Francisco, CA) resulted in greater reductions in disability progression over 10 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) compared with those who delayed treatment or who were taking interferon β-1a or a placebo. After 10 years of treatment, 92% of individuals with RMS receiving Ocrevus treatment did not require a walking aid and 80% of those with PPMS did not need a wheelchair. The results were presented at the American Academy of Neurology (AAN) 2024 Annual Meeting.

The open-label extension (OLE) studies included participants from the OPERA I/II trials (NCT01247324/NCT01412333) originally randomized to receive either Ocrevus or a comparator (interferon β-1a) and participants from the ORATORIO trial (NCT01194570) originally randomized to receive Ocrevus or placebo. Participant either continued Ocrevus or switched to Ocrevus upon entering the OLE studies. Data related to disability accumulation, defined as time to 48-week confirmed disability progression (48W-CDP) on the Expanded Disability Status Scale (EDSS) and composite CDP (cCDP), or ≥20% increases in the Timed 25-Foot Walk or Nine-Hole Peg Test, were analyzed up to week 528.

  • 76.6% of individuals with RMS on continuous Ocrevus (those who received Ocrevus treatment versus comparator or placebo at the beginning of the clinical trial) were free from 48W-CDP on the EDSS events.
  • Individuals with RMS on continuous Ocrevus had a lower risk of reaching 48W-CDP on the EDSS (hazard ratio [HR], 0.77; 95% CI, 0.61 to 0.96; P=.0183) and a reduced need for a walking aid (HR, 0.58; 95% CI, 0.41 to 0.84; P=.003).
  • 36.4% of individuals with PPMS on continuous Ocrevus were free from 48W-CDP on the EDSS events, 18.6% were free from 48W-cCDP events, and 80.4% did not need a wheelchair.
  • Individuals with PPMS on continuous Ocrevus had a lower risk of reaching both 48W-CDP on the EDSS events (HR, 0.74; 95% CI, 0.61 to 0.91; P=.0041), and 48W-cCDP events (HR, 0.78; 95% CI, 0.65 to 0.93; P=.0064), and a reduced need for a wheelchair (HR, 0.70; 95% CI, 0.48 to 1.03; P=.0708).
  • Serious infection rates were low and stable, and malignancy rates remained within epidemiologic background throughout the 10-year study period.
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