In the open-label extension of OPERA I and II trials (NCT01247324 and NCT01412333) fewer participants with relapsing MS who were treated with ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) for 6 years vs 4 years had confirmed disability progression (19% vs. 24%; p<0.05). Those who had 4 years of ocrelizumab treatment had 2 years of IFN treatment during the double-blind portion of OPERA.
Similarly, for individuals with primary progressive MS in the ORATORIO (NCT01194570) open-label study who received ocrelizumab for 6.5 years vs 2.5 years of placebo + 4 years ocreclizumab, had lower confirmed disability progression. (52% vs 65%; P = .002) and a 42% reduction in the risk of progressing to Expanding Disability State Score of 7 or more, which reflects needing a wheelchair (P = .0112). Individuals who received ocrelizumab for the full 6.5 years also had less upper limb disability progression, as measured with the 9-hole peg test (9-HPT)(31% vs 43%; P =.004).
Hideki Garren, MD, global head of Multiple Sclerosis and Neuroimmunology at Genentech said, “We understand how important preventing or reducing disability progression is to people who are living with MS, and are excited to have data showing that early treatment with Ocrevus may help them achieve this goal.”
Reduced infusion times for ocrelizumab were evaluated in the phase 3b CHORDS substudy and the SaROD study (NCT03606460 and NCT03606460), and individuals whose infusion times were completed in 2.5 hours vs the standard 3.5 hours had no increased risk of infusion-related reactions. Ocrelizumab infusions standardly are needed every 6 months.
Data from 267 women were also reviewed and did not suggest any increased risk of adverse pregnancy-related outcomes in case of accidental exposure to ocrelizumab within a year of conception or during pregnancy.
These data were presented at the European Committee on Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden September 11-13, 2019.