Observational Studies Poster Presentation

P0915 - Safety and effectiveness of ocrelizumab in multiple sclerosis: a real-world study from Spain (ID 1026)

Speakers
  • A. Sempere
Authors
  • A. Sempere
  • L. Berenguer-Ruiz
  • A. Burgos-San Jose
  • M. Aragones
  • M. Navarro-Lopez
Presentation Number
P0915
Presentation Topic
Observational Studies

Abstract

Background

Although phase 3 clinical trials have demonstrated the efficacy and safety of ocrelizumab in patients with multiple sclerosis, real-world data are scarce.

Objectives

The aim of this study was to describe the effectiveness and safety of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.

Methods

In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. The main inclusion criteria was a history of initiation of ocrelizumab. Patients involved in any ocrelizumab trial were excluded. No evidence of disease activity (NEDA) outcome was assessed in RMS patients who were followed for at least one year.

Results

The cohort included 71 patients (43 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients’ mean age was 47.1 years in the PPMS group and 39.4 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 12.6 months (range 2 to 32). The median number of treatment cycles was 3. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 58% of the patients; by the first MRI control at 4-6 months, all patients except one were free of T1 Gd-enhancing lesions (63/64, 98.4% P<0.001). The proportion of patients with NEDA was 93.3% in the group of RMS patients who were followed for at least one year. Only two patients (2.8%) discontinued ocrelizumab; one due to pregnancy and the other one because of lack of efficacy, but none did so due to safety issues. Ocrelizumab was generally well tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.

Conclusions

Our data confirm the short-term effectiveness, tolerability, and safety of ocrelizumab in real-world clinical practice. Further studies are needed to assess patient outcomes with longer follow-up periods.

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