New data for Roche’s Ocrevus show benefit in disability progression and cognitive decline in secondary progressive and primary progressive multiple sclerosis

Roche yesterday announced new Ocrevus (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting 02-07 April, 2022 in Seattle. Consonance data will be presented virtually at AAN 24-26 April 2022, Roche said in a statement.

According to the statement, treatment with Ocrevus resulted in a majority of patients experiencing no disease progression in a one-year analysis of Consonance, a first-of-its-kind open-label phase-III (b) trial to evaluate the effect of Ocrevus in SPMS and PPMS patients. After one year, 75 per cent of Ocrevus-treated patients with SPMS and PPMS achieved No Evidence of Progression (NEP; no evidence of confirmed disability progression as measured by an increase in Expanded Disability Status Score sustained for at least 24 weeks, and less than 20 per cent worsening of performance on the timed 25-foot walk [T25-FW] and Nine-Hole Peg Test [9-HPT]).

Additionally, 59 per cent of Ocrevus-treated patients in the trial achieved No Evidence of Progression or Active Disease (NEPAD; NEP plus no protocol-defined relapses, new and/or enlarging T2 lesions or T1 gadolinium-enhancing lesions) over one year. NEPAD is another novel composite endpoint and reflects no evidence of clinical or MRI disease activity or worsening of a person’s physical disability. Progression was primarily driven by T25-FW (16 per cent of patients) and activity of new and/or enlarging T2 lesions (19 per cent of patients), detected almost exclusively within the first six months of the trial, the statement added.

The analysis also demonstrated the positive effects of Ocrevus on cognition, with 70 per cent of patients having stable or improved cognition over one year, as measured with the Symbol Digit Modalities Test (SDMT). Clinically meaningful improvement (increase of ≥4 points on the SDMT) was observed in 34 per cent of patients treated with Ocrevus and worsening (decrease of ≥4 points) in 30 per cent of patients treated with Ocrevus. At enrollment, patients had moderate-to-severe dysfunction in information processing speed and visuospatial memory, which was stable or improved in a majority of patients after Ocrevus treatment, the statement further said.

It also mentioned that after one year of participating in the trial, 75 per cent of patients had one or more adverse events (AEs) and seven per cent experienced at least one serious AE. The interim analysis included 629 patients, and longer-term evaluation of Ocrevus will continue for four years with a target of 900 patients with PPMS or SPMS (in a 1:1 ratio) across 26 countries.

The statement stated that the current treatment guidelines recommend the initiation of high-efficacy Disease-Modifying Therapies (DMTs) for patients with highly active disease, as frequently seen with Black and Hispanic populations. However, a recent analysis of a the US commercial claims database found that only 30 per cent of non-Hispanic Black, and 20 per cent of Hispanic patients initiated any high-efficacy DMTs, in comparison to 39 per cent of non-Hispanic white patients in the first two years after diagnosis.

These insights further support Roche’s phase-IV ‘Characterization of ocrelizumab in Minorities with Multiple Sclerosis’ (CHIMES) trial in Black/African-American and Hispanic/Latino patients with relapsing MS (RMS). The results are expected to improve the current understanding of MS disease biology and treatment response to Ocrevus among these populations with MS, to improve the standard of care in traditionally underserved communities and improve inclusivity in clinical research, as per the statement.

Ocrevus is the first and only therapy approved for relapsing MS (RMS; including relapsing-remitting MS [RRMS] and active SPMS, in addition to clinically isolated syndrome [CIS] in the US) and PPMS. It is approved in 100 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the UK and the EU, the statement concluded.