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Safety of ocrelizumab in multiple sclerosis: Updated analysis in patients with relapsing and primary progressive multiple sclerosis
Multiple Sclerosis Journal ; 28(3 Supplement):354-355, 2022.
Article in English | EMBASE | ID: covidwho-2138866
ABSTRACT

Introduction:

The long-term benefit-risk profile of ocrelizumab (OCR) in patients (pts) with multiple sclerosis (MS) can be evaluated by regular safety reporting of clinical trial (CT) and post-marketing (PM) data. Safety/efficacy of OCR have been characterised in Phase II (NCT00676715) and Phase III (NCT01247324;NCT01412333;NCT01194570) trials and related open-label extension (OLE) periods, in relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). It is important to understand the long-term safety profile of OCR and consider the impact of COVID-19. Aim(s) To report the continuity in safety by reporting longer-term safety evaluations from OCR CT and OLE periods over a 9-year follow-up period (up to November 2021). Method(s) Safety outcomes, with and without COVID-19, are reported for the OCR all-exposure population from 11 ongoing CTs in MS. Rates per 100 patient years (PY) are presented. Result(s) Over more than 9 years of follow-up, 5,848 pts with MS received OCR treatment in 11 CTs (25,153 PY of exposure;November 2021). Reported rates per 100 PY (95% CI) were Adverse events (AEs), 232.71 (230.83-234.60), [excluding COVID-19 (EX COV) 230.12 (228.25-232.01)];infections, 69.89 (68.86-70.93), [EX COV 67.37 (66.36-68.39)];serious AEs, 7.61 (7.27-7.96), [EX COV 6.90 (6.58-7.23)];serious infections (SI), 2.74 (2.54-2.96), [EX COV 2.04 (1.87-2.22)];malignancies, 0.41 (0.34-0.50);SI leading to withdrawal, 0.12 (0.08-0.18), [EX COV 0.08 (0.05-0.13)];and AEs leading to discontinuation, 0.97 (0.85-1.10), [EX COV 0.93 (0.81-1.06)]. As of March 2022, over 250,000 pts with MS initiated OCR globally in the PM setting. Data remain generally consistent with those observed in CTs factoring in the impact of the COVID-19 pandemic. Conclusion(s) AE rates in the OCR all-exposure population remain generally consistent with the controlled treatment period in RMS/PPMS populations. Serious infection and malignancy rates remain within the range reported for pts with MS in realworld registries. COVID-19 did not lead to increased treatment withdrawal. Over a 9-year follow-up period, no new or unexpected safety signal was seen in pts treated with OCR in ongoing CTs. OCR continues to exhibit a stable and favourable safety profile. Regular reporting of longer-term safety data will continue.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Language: English Journal: Multiple Sclerosis Journal Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Language: English Journal: Multiple Sclerosis Journal Year: 2022 Document Type: Article