Updated Analysis of Ocrelizumab’s Safety

Among patients with primary progressive MS, the rate per 100 patient-years of serious infections remained stable (2.74) as of January 20, 2016, compared with the rate at the primary analysis cutoff date (2.97). The most common serious infection reported was pneumonia. No infections were identified as opportunistic in nature.

Malignancies

In the MS clinical trial program, an imbalance in the crude incidence of malignancies was observed between the ocrelizumab- and comparator-treated patients, which was associated with a cluster of breast cancer events in the ocrelizumab group. Over time, the crude incidence rate of malignancy per 100 patient-years in the ocrelizumab all-exposure population fluctuated but remained within the epidemiologic range of patients with MS. An observed change in the crude incidence rate of malignancy from June to September is attributed to the crude incidence rate of non-melanoma skin cancer, which increased from 0.090 at the primary analysis cutoff date to 0.145 at the September 15, 2016, data cutoff, due to six new cases of basal cell carcinoma. The crude incidence rate of breast cancer remained stable through the September 15, 2016, data cutoff.

More Recent Developments

In late May 2017, Genentech, the maker of ocrelizumab, notified physicians of the first case of progressive multifocal leukoencephalopathy (PML) in a patient taking ocrelizumab. The case occurred in a JCV-positive patient in Germany who stopped taking natalizumab in February after being on the drug for three years, and received the first dose of ocrelizumab in April. It is unclear whether the PML stemmed from the prior natalizumab treatment or if the switch to ocrelizumab played a role.

—Glenn S. Williams