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- W4281641263 abstract "Background Ongoing safety reporting is crucial to understanding the long-term benefit-risk profile of ocrelizumab in multiple sclerosis (MS). Safety/efficacy of ocrelizumab have been characterised in Phase II ( NCT00676715 ) and III ( NCT01247324 /NCT01412333/ NCT01194570 ) trials in relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). Here, we report safety evaluations from ocrelizumab clinical trials and open-label extensions up to January 2019, and selected post-marketing data. Methods Safety outcomes are reported for the ocrelizumab all-exposure population in Phase II/III and ongoing Phase IIIb trials. To account for different exposure lengths, rates per 100 patient years (PY) are presented. Results In clinical trials, 4,611 patients with MS received ocrelizumab (14,329 PY exposure). 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). Updated ocrelizumab all-exposure population data and selected post-marketing data will be presented. Conclusions Reported event rates in the ocrelizumab all-exposure clinical trial population and post-mar- keting settings remain generally consistent with the controlled treatment period in RMS/PPMS populations. Regular reporting of long-term safety data will continue. k.schmierer@qmul.ac.uk" @default.
- W4281641263 created "2022-06-13" @default.
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- W4281641263 date "2022-05-27" @default.
- W4281641263 modified "2023-09-27" @default.
- W4281641263 title "034 Updated safety analysis of ocrelizumab in multiple sclerosis" @default.
- W4281641263 doi "https://doi.org/10.1136/jnnp-2022-abn.73" @default.
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