Multiple Sclerosis Drug Reduces Disease Activity, Disability Progression in Trials

Ocrelizumab (Ocrevus, Genentech) demonstrated significant reductions in disease activity and disability progression for patients with relapsing multiple sclerosis (RMS), according to data presented at the 70^th American Academy of Neurology (AAN) Annual Meeting.

The data is based on phase 3 studies evaluating the efficacy and safety of ocrelizumab compared with interferon beta-1a (Rebif) in 1656 individuals with relapsing forms of MS. According to a press release, the data showcase the efficacy of ocrelizumab through several measures of underlying disease activity and disability progression, including magnetic resonance imaging (MRI), cognitive function, and spinal fluid biomarkers of inflammation and neurodegeneration.

Ocrelizumab demonstrated a sustained reduction in underlying disease activity in RMS after 4 years of continuous treatment, according to the findings. Patients treated with ocrelizumab maintained low numbers of T1 gadolinium-enhancing lesions and new/enlarging T2 (N/ET2) lesions through year 2 of the open-label extension (OLE) phase. Patients who switched from interferon beta-1a to ocrelizumab at the start of the OLE period had a near-complete silencing of T1Gd+ lesions per scan at 1 and 2 years, as well as an 85% and 97% decrease in N/ET2 lesions per scan at years 1 and 2, respectively.

In a second 4-year analysis, patients who stayed on ocrelizumab through year 2 of the OLE period sustained low annualized relapse rates (ARR) and 24-week confirmed disability progression. Patients who switched from interferon beta-1a to ocrelizumab experienced a significant decline in ARR by year 1 that was maintained through year 2.

Ocrelizumab also showed benefit in reducing cognitive decline in patients with RMS, reducing the risk of 12- and 24-week confirmed cognitive decline by 38% and 39% during the 96-week period in patients with RMS, compared with interferon beta-1a. In a separate presentation of data, patients with RMS at an increased risk of progressive disease who were treated with ocrelizumab showed significant improvement in cognitive function compared with those taking interferon beta-1a through 96 weeks.

“These data, which show that Ocrevus not only delayed onset of documented cognitive decline, but may also improve cognitive function in people with multiple sclerosis, support a potential role for this therapy in addressing one of the most important, common, and challenging realities of multiple sclerosis-induced disability,” Stanley Cohan, MD, PhD, Medical Director of Providence Multiple Sclerosis Center, Portland, Oregon, said in the press release.

Based on an interim analysis of data from the new, phase 3 Ocrelizumab Biomarker Outcome Evaluation study, ocrelizumab reduced the presence of nerve damage and inflammation biomarkers in spinal fluid at 12 and 24 weeks. According to the press release, these findings add to evidence surrounding key MS biomarkers, which may be used in future research.

Across all trials, safety data remain consistent with ocrelizumab’s favorable benefit-risk profile in both relapsing and primary progressive multiple sclerosis.

“The Ocrevus data shared at AAN show the impact of this targeted B cell therapy on slowing disability progression in MS, and further support the approach of early treatment. In the extension studies, patients who received Ocrevus continuously experienced less disease progression than those who began treatment at a later time point,” Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies, said in the press release.

Reference

New OCREVUS (Ocrelizumab) Data at AAN Demonstrate Significant Reductions in Disease Activity and Disability Progression in Relapsing Multiple Sclerosis [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14714/2018-04-22/new-ocrevus-ocrelizumab-data-at-aan-demo. Accessed June 13, 2018.