Ocrevus Lowers Multiple Sclerosis Disease Activity in Late-Stage Trials

Exploratory analyses reinforced findings from three phase 3 studies of ocrelizumab (Ocrevus) in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

The findings revealed a 75% higher proportion of RMS patients achieved No Evidence of Disease Activity (NEDA) with Ocrevus, compared with interferon beta-1a (Rebif). Furthermore, a 47% higher proportion of PPMS patients achieved NEP with Ocrevus compared with placebo.

In separate post-hoc analyses, Ocrevus increased disease control in RMS and PPMS patients. The analyses had 2 composite endpoints that measured disease control using a combination of MRI and clinical outcomes: NEDA in RMS patients and NEP in PPMS patients.

For the NEDA analysis, data was pooled together from the OPERA 1 and OPERA 2 studies, which compared NEDA during different time periods of the course of 2 years. NEDA was defined as a patient with no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions, and no new or enlarging MRI lesions.

The results of the analysis showed that Ocrevus significantly increased the proportion of RMS patients who achieved NEDA by 75% compared with Rebif over 96 weeks (0-96 weeks, p<0.0001).

In comparison with Rebif, Ocrevus treatment significantly increased the relative proportion of patients who achieved NEDA by 33% in weeks zero to 24, and by 72% in weeks 24 to 96 (both p<0.0001). The study showed that most of the participants were able to achieve NEDA in the first 24 weeks of treatment with Ocrevus (60.8%), with this proportion increasing during weeks 24 to 96 of the study to 72.2%.

“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS,” said Gavin Giovannoni, Scientific Steering Committee Member of OPERA 1 and 2 studies. “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.”

For the ORATORIO study of PPMS patients, the new post-hoc analyses measuring NEP, which included 3 measurers of physical disability, reflected no evidence of worsening disability. Those who achieved NEP had no evidence of confirmed disability progression sustained for at least 12 weeks, and less than 20% worsening of performance on the timed 25-foot walk and 9-hole peg test.

Ocrevus was found to significantly increase the proportion of PPMS patients with NEP by 47% at week 120, compared with placebo (p=0.0006).

“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said researcher Xavier Montalban, MD, PhD. “Ocrevus significantly impacted 3 key disability measurements, which further highlight its clinical significance in people with primary progressive MS.”

The findings from the analyses will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London, England.