To report ongoing safety evaluations from ocrelizumab clinical trials and open-label extension (OLE) periods up to July 2018, and report updated post-marketing data.

Ongoing safety reporting is crucial to understanding the long-term benefit–risk profile of ocrelizumab in patients with multiple sclerosis (MS). The safety and efficacy of ocrelizumab have been characterized in one Phase II study in relapsing-remitting MS (NCT00676715), two identical Phase III trials in relapsing MS (RMS; OPERA I/II [NCT01247324]/[NCT01412333]) and the Phase III trial in primary progressive MS (PPMS; ORATORIO [NCT01194570]) and their extensions.

Safety outcomes were reported for all patients who received ocrelizumab during the controlled treatment and associated OLE periods of the Phase II and Phase III MS clinical trials, plus the Phase IIIb trials VELOCE, CHORDS/CASTING and OBOE (ocrelizumab all-exposure population; updated data-cut to include ENSEMBLE). The number of post-marketing patients exposed to ocrelizumab is based on estimated total number of vials sold, as well as US claims data. To account for the different exposure lengths, the rate per 100 patient years (PY) is presented. Adverse events (AEs) were classified according to the Medical Dictionary for Regulatory Activities.

In clinical trials, 3,811 patients with MS received ocrelizumab, resulting in 10,919 PY of exposure, as of February 2018. Reported rates per 100 PY (95% confidence interval) were as follows: AEs, 242 (239-245); serious AEs, 7.23 (6.73-7.75); infections, 74.5 (72.9-76.1); serious infections, 2.00 (1.74-2.28); and malignancy 0.45 (0.33-0.60). Updated cross-trial information and post-marketing data using a July 2018 data-cut will be presented at the conference.

The reported rates of events per 100 PY in the ocrelizumab MS all-exposure population continue to be generally consistent with those seen during the controlled treatment period in the RMS and PPMS populations. Long-term safety data will continue to be reported on a regular basis.