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Multiple Sclerosis Drug Reduces Disease Activity, Prevents Progression

Ocrevus (ocrelizumab) effective in patients with relapsing and primary progressive multiple sclerosis.
 
Published Online: Sep 20,2016
Laurie Toich, Assistant Editor
Genentech recently announced positive results from analyses of 3 clinical trials of Ocrevus (ocrelizumab) in patients with relapsing, and primary progressive multiple sclerosis.

Findings were announced at the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis. Increased disease control was seen in both patients with relapsing multiple sclerosis and primary progressive multiple sclerosis who received Ocrevus.

In separate post-hoc analyses, 2 composite endpoints were determined through clinical and MRI outcomes, according to Genentech. No Evidence of Disease Activity (NEDA) analyzed outcomes for patients with relapsing multiple sclerosis, and No Evidence of Progression (NEP) analyzed outcomes for patients with primary progressive multiple sclerosis.

The NEDA analysis examined data from the OPERA 1 and OPERA II phase 3 studies, and compared no evidence of disease activity over a period 2 years. No evidence of disease activity is defined as no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions, or no new enlarging MRI lesions, according to Genentech.

This analysis found that the number of patients with relapsing multiple sclerosis (MS) who achieved no evidence of disease activity increased by 75% with Ocrevus, compared with beta-1a over a period of 96 weeks.

Ocrevus also increased the amount of patients achieving no evidence of disease activity by 33% within the first 24 weeks of treatment, and 72% in weeks 24 to 96 compared with inferno beta-1a, Genentech reported. Approximately 60.8% and 72.2% of patients achieved no evidence of disease activity within the first 24 weeks, and weeks 24 to 96, respectively.

“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS,” said Professor Gavin Giovannoni, Scientific Steering Committee Member of the OPERA I and II studies and Chair of Neurology at Barts and The London School of Medicine and Dentistry. “These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

Post-hoc analyses of ONTORIO clinical trial in patients with primary progressive multiple sclerosis evaluated evidence of progression through measures of physical disability, such as confirmed disability progression, walking speed and upper extremity function.

The analyses discovered no evidence of worsening of patient physical disability. Patients who achieved this had no evidence of confirmed disability progression for at least 12 weeks, and less than 20% worsening of performance on the 25-foot walk and 9-hole peg test, according to Genentech.

Treatment with Ocrevus increased the amount of patients with primary progressive multiple sclerosis showing no evidence of progression by 47% at 120 weeks, compared with placebo.

“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said Xavier Montalban, MD, PhD, Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “Ocrevus significantly impacted three key disability measurements, which further highlight its clinical significance in people with primary progressive MS.”