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Safety of ocrelizumab in multiple sclerosis: Updated analysis in patients with relapsing and primary progressive multiple sclerosis
Multiple Sclerosis Journal ; 27(2 SUPPL):607-608, 2021.
Article in English | EMBASE | ID: covidwho-1495999
ABSTRACT

Introduction:

Ongoing consistent safety reporting is crucial to understand the long-term benefit-risk profile of ocrelizumab (OCR) in patients with multiple sclerosis (MS), in both clinical trials and globally, in the post-marketing (PM) setting. 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 patients with relapsing-remitting MS, relapsing MS (RMS) and primary progressive MS (PPMS). It is important to understand the longterm safety profile of OCR independent of any impact of COVID- 19 infections.

Aims:

To maintain continuity in the safety update by reporting longer-term safety evaluations from OCR clinical trials and OLE periods up to November 2020 and selected PM data, excluding COVID-19 cases;the latter will be communicated in a separate late-breaking abstract.

Methods:

Safety outcomes, excluding COVID-19, are reported for the OCR all-exposure population in Phase II/III trials and associated OLEs plus ongoing Phase IIIb trials in MS (VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO and CONSONANCE). To account for different exposure lengths, rates per 100 patient years (PY) are presented. The number of postmarketing OCR-treated patients is based on estimated number of vials sold and US claims data.

Results:

In clinical trials, 5,688 patients with MS received OCR (21,675 PY of exposure;Nov 2020). Reported rates per 100 PY (95% confidence interval) were Adverse events (AEs), 238 (236- 240);infections, 71.8 (70.7-73.0);serious AEs, 7.05 (6.71-7.42);serious infections, 2.0 (1.82-2.20);malignancies, 0.42 (0.34- 0.52);and AEs leading to discontinuation, 0.96 (0.83-1.10). As of December 2020, over 200,000 patients with MS initiated OCR globally in the PM setting. Data remain generally consistent with those observed in clinical trials.

Conclusions:

AE rates in the OCR all-exposure population and PM settings, excluding COVID-19 infections, remain generally consistent with the controlled treatment period in RMS/PPMS populations. Serious infection and malignancy rates remain within the range reported for patients with MS in real-world registries. In patients with RMS and PPMS, OCR demonstrates a consistent and favourable safety profile;these longer-term data are in accordance with the safety outcomes initially observed during the controlled treatment periods. Regular reporting of longer-term safety data will continue.

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Prognostic study Language: English Journal: Multiple Sclerosis Journal Year: 2021 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Prognostic study Language: English Journal: Multiple Sclerosis Journal Year: 2021 Document Type: Article