Author Of 1 Presentation

Observational Studies Poster Presentation

P0916 - Safety and tolerability in patients with multiple sclerosis receiving ocrelizumab in a real-world setting – CONFIDENCE one-year interim analysis (ID 1136)

Speakers
Presentation Number
P0916
Presentation Topic
Observational Studies

Abstract

Background

As of April 2020, >160,000 patients with relapsing forms of multiple sclerosis (RMS) or primary progressive MS (PPMS) worldwide had started treatment with ocrelizumab (OCR), a humanized monoclonal antibody selectively targeting CD20+ B-cells.

Pivotal studies established the risk-benefit profile of OCR under controlled trial conditions.

Objectives

Real-world data are needed to further characterise the safety of OCR in clinical practice. Here we present 1-year, real-world safety data for patients receiving OCR.

Methods

CONFIDENCE (ML39632, EUPAS22951), a non-interventional, post-authorization safety study, aims to enrol 3,000 patients with RMS or PPMS newly treated (up to 30 days prior or 60 days after enrolment) with OCR and 1,500 patients newly treated with other selected DMTs according to label at ~250 German neurological practices. Each patient is followed for 7.5–10 years. Study visits, documented circa every 6 months, follow routine clinical practice. The primary outcome is the incidence and type of uncommon adverse events (AEs) (incidence of 0.1% to 1% [1 to 10 out of 1000 patients] or less). Statistical analyses are mainly descriptive and exploratory. Assessments of effectiveness (secondary objectives) are presented separately.

Results

As of 30 June 2020, 2,129 patients treated with OCR had been recruited. The interim analysis is expected to include approximately 559 OCR-treated patients, ~82% with RMS and ~18% with PPMS, with 1-year follow-up data (mean baseline age [SD], 45.5 [11.4] years; 64.4% female; mean baseline EDSS [SD] RMS 3.3 [1.9], PPMS 4.5 [1.7]). Preliminary data showed that ~63.0% of patients had ≥1 AE during OCR treatment; ~26.8% had treatment-related AEs (TRAEs). The most common AEs were infections and infestations (~31.5%), nervous system disorders (~14.7%), and general disorders and administration site conditions (~12.3%). The incidence of serious AEs was ~14.0%, most frequently infections and infestations (~3.6%; RMS, ~3.9% [n=18]; PPMS, ~1.9% [n=2]), nervous system disorders (~3.2%), and injury, poisoning and procedural complications (~2.1). The most frequent serious infections were urinary tract infections (~1.3% [n=7]) and pneumonia (~0.5% [n=3]). Seven patients overall (1.3%) had treatment-related serious infections.

Conclusions

The safety profile of OCR in this first interim analysis of the CONFIDENCE study, representing a real-world population currently treated with OCR in Germany, was consistent with controlled clinical trials.

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