Background Ongoing safety reporting is crucial to understanding the long-term benefit–risk profile of ocrelizumab in patients with multiple sclerosis (MS). The safety/efficacy of ocrelizumab have been characterised 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). We report ongoing safety evaluations from ocrelizumab clinical trials and open-label extension periods up to February 2018.
Methods Safety outcomes were reported for the ocrelizumab all-exposure population in Phase II/III and ongoing Phase IIIb MS trials. 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.
Results In clinical trials, 3,811 patients with MS received ocrelizumab (10,919 PY of exposure, as of February 2018). Reported rates per 100 PY (95% confidence interval) were: adverse events (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 post-marketing data will be presented.
Conclusions Reported rates of events in the ocrelizumab all-exposure population continue to be generally consistent with the controlled treatment period in RMS/PPMS populations. Regular reporting of long-term safety data will continue.
Disclosures Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK, and funded by F. Hoffmann-La Roche Ltd.
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