Viborg regional hospital
Department of Neurology

Author Of 1 Presentation

Observational Studies Poster Presentation

P0868 - Early experience with ocrelizumab in Denmark. A population-based registry study (ID 804)

Abstract

Background

Ocrelizumab (OCR) is a humanized monoclonal antibody targeting CD20-positive B cells. In Denmark, OCR treatment is recommended for patients with highly active relapsing-remitting multiple sclerosis (RRMS) or with early active primary progressive MS (PPMS) and moderate disability.

Objectives

To describe the real-world experience of patients initiating OCR by characterizing baseline demographic and disease attributes, as well as treatment outcomes, of an unselected adult MS population.

Methods

Observational cohort study with prospectively enrolled cases from January 2018 to April 2020 using data from the near complete nationwide population-based Danish Multiple Sclerosis Registry.

Results

Of the 851 patients initiating OCR treatment, 735 (86%) had RRMS, 61 (7%) had secondary progressive MS (SPMS) and 55 (7%) had PPMS. Of all patients, 131 were treatment naïve and, of these, 41 were PPMS. Median disease duration in years was 10.1 for RRMS (IQR 4.4-16.7), 17.8 for SPMS (13.3-24) and 3.9 for PPMS (2.5-7.8). Median baseline Expanded Disability Status Scale (EDSS) score was 3 for RRMS (IQR 2-4), 6 for SPMS (4.5-6.5) and 3.5 for PPMS (2.5-4.5). In the year prior to OCR initiation, 50% of the RRMS population had at least one relapse on another disease-modifying therapy (DMT); of these, 58% were on high efficacy DMT. Compared to RRMS, SPMS patients were older, had higher EDSS, and 34% had at least one relapse in the two years prior to OCR start. Fifty-five (90%) were previously treated with DMT, and 69% were on DMT in the year before OCR start.

The median OCR therapy duration was 0.9 years. During follow-up, 93% of all patients were relapse-free, and five patients reported more than one relapse. Out of 18 treatment discontinuations that occurred, two were due to disease breakthrough and nine were due to adverse events. Of the 383 patients with an EDSS score between 6 and 12 months, 80 (21%) showed EDSS improvement, 266 (69%) remained stable, and 37 (10%) experienced worsening. Of the 63 reported adverse events, the most common were upper respiratory tract infections (15), allergic reactions (7), and herpes simplex infections (6).

Conclusions

In this nationwide study, we present all Danish patients receiving OCR therapy in a real-world setting. Patient characteristics differed for RRMS, PPMS and particularly the SPMS group. With reservations for the short follow-up time, 93% of all patients were relapse-free and only 10% experienced disability worsening.

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