Conference Coverage

Ocrelizumab safety update: Encouraging rates of serious infection, malignancy


Key clinical point: Follow-up and postmarketing surveillance show no new safety signals with ocrelizumab.

Major finding: The fatality rate was 0.28/100 patient-years as of March 2018.

Study details: Follow-up of patients with nearly 9,500 patient-years of experience with ocrelizumab and postmarketing surveillance in patients with more than 14,000 patient-years of experience.

Disclosures: This study was sponsored by F. Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Symbiotix, Annexon Biosciences, Bionure, Molecular Stethoscope, and for serving on the board of directors of Neurona Therapeutics.

Source: Hauser S et al. Neurology. 2018 Apr 9;(15 Suppl.):S36.001.



– No new safety signals have emerged in multiple sclerosis patients treated with ocrelizumab, according to ongoing follow-up and postmarketing surveillance.

As of September 2017, patients with relapsing or primary progressive MS who were part of the pivotal OPERA I and II and ORATORIO trials – including phases 2 and 3 and open-label extensions – as well as an all-exposure population that included patients from prior studies, had nearly 9,500 patient-years of exposure to ocrelizumab (Ocrevus), a humanized anti-CD20 monoclonal antibody. The all-exposure population contributed about 1,500 of those patient-years, Stephen Hauser, MD, reported at the annual meeting of the American Academy of Neurology.

multiple sclerosis solitude72/iStockphoto
The reported rates per 100 patient-years for serious infections and malignancy – the “questions that are most on our minds as treating physicians” – were as expected, compared with MS and cancer registry information, said Dr. Hauser, director of the Weill Institute for Neurosciences at the University of California, San Francisco.

Postmarketing experience in approximately 37,000 treated patients with an additional 14,000 patient-years shows a fatality rate of 0.28/100 patient-years (49 fatalities) as of March 2018, he said.

“If one compares this to at least two reports of epidemiologic mortality estimates in MS, this is in line with – and in fact a little bit lower than – those estimates that range between 0.37 and 0.9, compared with 0.28,” he said. “So ... the updated safety profile in this all-exposure ocrelizumab population was generally consistent with what was seen during the controlled treatment period, and rates of serious infections fluctuated over time without any sustained increase.”

Only one serious opportunistic infection (Pasteurella) occurred in the controlled trials, and three more (two varicella zoster, one herpes simplex) occurred during open-marketing experience.

The rate of malignancies has been very encouraging, as well, as it appears to continue to align with population expectations, Dr. Hauser said.

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