To report ongoing safety evaluations from ocrelizumab clinical trials and open-label extension (OLE) periods up to September 2019 and selected post-marketing data.

Ongoing safety reporting is crucial to understanding the long-term benefit–risk profile of ocrelizumab in patients with multiple sclerosis (MS). Safety/efficacy of ocrelizumab have been characterized in Phase II (NCT00676715) and Phase III (NCT01247324; NCT01412333; NCT01194570) trials in patients with relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS).

Safety outcomes are reported for the ocrelizumab all-exposure population in Phase II/III trials and associated OLEs plus ongoing Phase IIIb trials (VELOCE, CHORDS, CASTING, LIBERTO, OBOE, ENSEMBLE and ENSEMBLE PLUS). The number of post-marketing ocrelizumab-treated patients is based on estimated number of vials sold and US claims data. To account for different exposure lengths, rates per 100 patient years (PY) are presented.

In clinical trials, 4,611 patients with MS received ocrelizumab (14,329 PY of exposure) as of January 2019. Reported rates per 100 PY (95% confidence interval) were: adverse events (AEs), 252 (249–254); serious AEs, 7.33 (6.89–7.79); infections, 76.7 (75.3–78.2); serious infections, 1.99 (1.77–2.23); malignancies, 0.46 (0.35–0.58); and AEs leading to discontinuation, 1.08 (0.92–1.27). As of October 2019, over 125,000 patients with MS have initiated ocrelizumab globally in the post-marketing setting. Data remain generally consistent with those observed in clinical trials. Updated ocrelizumab all-exposure population data using a September 2019 cut-off and selected post-marketing data on infections, malignancies, fatalities and progressive multifocal leukoencephalopathy will be presented.

Reported rates of events in the ocrelizumab all-exposure clinical trial population and post-marketing settings remain generally consistent with the controlled treatment period in RMS/PPMS populations. Rates of serious infections and malignancies remain within the range reported for patients with MS in real-world registries. Regular reporting of long-term safety data will continue.