Treatment with Ocrevus (ocrelizumab) slows disability progression in primary progressive multiple sclerosis (PPMS) in ways that may be of considerable importance to patients — including the possibility of delaying the need for a wheelchair by up to seven years, according to new data from a Phase 3 study.
Genentech, which developed and markets Ocrevus, will detail this and other latest clinical data in a series of oral and poster presentations at the 4th Congress of the European Academy of Neurology (EAN), running in Lisbon from June 16 to 19.
New analysis of data collected during the extended period of the Phase 3 ORATORIO study (NCT01194570) continue to demonstrate its benefits in PPMS patients, the presentations show.
Of note, researchers found that Ocrevus-treated patients, compared to a placebo group, had a 46% lesser risk of progressing to a wheelchair, based on data using 24-week confirmed disability progression (as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater, or EDSS≥7).
Data extrapolation suggested that treatment with Ocrevus could delay the need for a wheelchair by seven years compared to placebo, with the median time-to-wheelchair estimated to be 19.2 years for Ocrevus-treated PPMS patients and 12.1 years for the placebo group.
In general, the disability progression rate for placebo patients in the ORATORIO trial was of 12.1 years (median time of reaching EDSS≥7 and possibly being reliant on a wheelchair). The rate is similar to the median 12.4 years reported in untreated PPMS patients in the real-world MSBase registry.
“To a person living with primary progressive MS, for whom disability accumulates twice as fast as in relapsing MS, seven more years without the need for a wheelchair could extend the time they can live independently in their home, continue working or looking after their families,” Helmut Butzkueven, professor and chair of MS and Neuroimmunology Research at Central Clinical School, Monash University, said in a press release.
Safety data, covering 3,778 relapsing MS and PPMS patients and representing 9,474 patient years of exposure to Ocrevus, were also consistent with finding in Phase 3 clinical trials, the study noted.
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