Having recently concluded an ORATORIO phase III clinical trial of primary progressive multiple sclerosis (PPMS) patients, Genentech’s Ocrevus (ocrelizumab) increased the number of patients found to have no experienced progression (NEP) when taking the drug.
The evaluation of NEP – a combined measure of three disability assessments – was a secondary exploratory endpoint of the clinical trial. Researchers presented the findings at ACTRIMS 2017 in Orlando, Florida.
A total of 732 patients – 230 placebo and 461 Ocrevus – were randomised to receive 600mg of Ocrevus as two 300mg intravenous infusions 14 days apart, or placebo every 24 weeks for 120 weeks until a pre-specified number of confirmed disability progression (CDP) events had occurred. CDP was measured by the Expanded Disability Status Scale score.
Patients with no evidence of progression (NEP) were also found to have no confirmed disability progression (CDP) at 12 weeks. In addition, they had no CDP at 20 per cent on the timed 25-foot walk test and on the nine-hole peg test. These tests cover the patient’s overall disability, including arm function and ambulation. Patients continued evaluations until the end of the study or until researchers recorded a pre-specified number of progressions.
At 120 weeks, 42.7 per cent of Ocrevus-treated patients reached NEP, compared to only 29.1 per cent among those receiving placebo. The difference represents a 47 per cent relative increase in the Ocrevus group.
Researchers also assessed the components of NEP in pairs. They found that more patients treated with Ocrevus did not experience progression on EDSS in combination with the 25-foot walk test (44.7 percent versus 31.3 percent in the placebo group).
Combining the 25-foot walk test and the 9-hole peg test also revealed a greater proportion in the Ocrevus group (48.4 per cent) than in the placebo group (36.1 per cent). The smallest change was seen when researchers analysed EDSS and the nine-hole peg test together; for these parameters, there was only a 15 per cent relative increase among Ocrevus-treated (61.4 per cent) compared to those receiving placebo (53.5 per cent).
The U.S. Food and Drug Administration (FDA) is currently reviewing the Biologics License Approval for Ocrevus in the United States.
Source: MS-Uk (10/03/17)