Observational Studies Poster Presentation

P0837 - Assessing the real-world effectiveness of ocrelizumab in patients with multiple sclerosis – CONFIDENCE one-year interim analysis (ID 1133)

Speakers
  • M. Buttmann
Authors
  • M. Buttmann
  • S. Meuth
  • M. Weber
  • P. Dirks
  • J. Eggebrecht
  • S. Hieke-Schulz
  • J. Leemhuis
  • T. Ziemssen
Presentation Number
P0837
Presentation Topic
Observational Studies

Abstract

Background

Multiple sclerosis (MS) is a chronic inflammatory neurological disease that requires life-long treatment, and new therapies must be safe and effective over a long treatment duration. Ocrelizumab is a humanized antibody that selectively targets CD20+ B cells and has been shown to be efficacious for the treatment of both relapsing MS (RMS) and primary progressive MS (PPMS). Effectiveness data in large, real-world populations are needed for better informed clinical treatment.

Objectives

CONFIDENCE (ML39632, EUPAS22951) evaluates the safety and effectiveness of ocrelizumab in patients with RMS & PPMS in a real-world setting. Here, we present the first analysis of one-year effectiveness data from patients newly treated with ocrelizumab.

Methods

CONFIDENCE is a non-interventional study in patients with RMS or PPMS newly treated (up to 30 days prior or 60 days after enrolment) with ocrelizumab or other selected disease modifying therapies (DMTs) during the course of their disease. Data will be collected for 3000 ocrelizumab-treated patients and 1500 patients treated with other DMTs according to label at ~250 centers in Germany for up to 10 years. Here, we analyze effectiveness outcomes for patients treated with ocrelizumab for the first year, including treatment success (the proportion of patients with no relapse, progression or treatment discontinuation due to an adverse event) and change in Expanded Disability Status Scale (EDSS) from baseline. In addition, we will present patient-reported outcomes. Safety assessments are presented separately.

Results

As of 30 June 2020, 2,129 patients have been recruited for ocrelizumab treatment. The interim analysis is expected to include data from approximately 559 patients newly treated with ocrelizumab that had one year of follow up. Of these patients, ~82% had RMS and ~18% had PPMS. Mean (standard deviation [SD]) baseline EDSS was 3.3 (1.9) for patients with RMS and 4.5 (1.7) for patients with PPMS. Preliminary data show that 64% of patients were female (66% female RMS; 55% female PPMS). Over an observational period of one year, 83.6% of RMS and 93.2% of PPMS patients experienced treatment success. About 85.3% of patients with RMS experienced no relapses. The mean (SD) change in EDSS from baseline after one year of treatment was 0.0 [0.6] for patients with RMS and 0.1 [0.6] for patients with PPMS.

Conclusions

This analysis of one-year interim data in the CONFIDENCE study shows the effectiveness of ocrelizumab in a real-world setting.

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