Ocrelizumab treatment in multiple sclerosis: A Danish population‐based cohort study
Background and purpose Real‐world evidence regarding the effectiveness and safety of ocrelizumab for the treatment of multiple sclerosis (MS) is limited. The aim was to evaluate the effectiveness and safety of ocrelizumab treatment for MS in a real‐world setting. Methods A nationwide population‐base...
Saved in:
| Published in: | European journal of neurology Vol. 29; no. 2; pp. 496 - 504 |
|---|---|
| Main Authors: | , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
John Wiley & Sons, Inc
01-02-2022
|
| Subjects: | |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | Background and purpose
Real‐world evidence regarding the effectiveness and safety of ocrelizumab for the treatment of multiple sclerosis (MS) is limited. The aim was to evaluate the effectiveness and safety of ocrelizumab treatment for MS in a real‐world setting.
Methods
A nationwide population‐based cohort study was conducted where clinical and magnetic resonance imaging data of MS patients enrolled prospectively in the Danish Multiple Sclerosis Registry who initiated ocrelizumab treatment between January 2018 and November 2020 were analyzed.
Results
A total of 1104 patients (85.7% relapsing–remitting MS [RRMS], 8.8% secondary progressive MS [SPMS], 5.5% primary progressive MS [PPMS]) were included, with a median follow‐up period of 1.3 years. At baseline, the mean age was 41.4 years in the RRMS group, 44.5 years in the PPMS group and 50.3 years in the SPMS group. Median Expanded Disability Status Scale score was 2.5, 3.5 and 5.5, respectively. Most RRMS and SPMS patients had received previous disease‐modifying therapies (87.5% and 91.8%, respectively), whereas PPMS patients were mostly treatment naïve (78.7%). After ocrelizumab initiation, 9.3% of the patients experienced a relapse and 8.7% a 24 weeks confirmed disability worsening. Conversely, 16.7% showed a 24 weeks confirmed disability improvement. After ~1 year of treatment, most patients (94.5%) were free of magnetic resonance imaging activity. Ocrelizumab was generally well tolerated, as side effects were only reported for 10% of patients, mostly consisting of infusion‐related reactions and infections.
Conclusions
It is shown that most MS patients treated with ocrelizumab are clinically stabilized and with an adverse event profile consistent with the experience from the pivotal clinical trials.
This real‐world, nationwide population‐based cohort study evaluated the effectiveness and safety of ocrelizumab for the treatment of multiple sclerosis using data from the Danish Multiple Sclerosis Registry of 1104 Danish patients who started ocrelizumab treatment between January 2018 and November 2020. After ocrelizumab initiation, only 9.3% of the patients experienced a relapse and 8.7% a 24 weeks confirmed disability worsening. Conversely, 16.7% showed a 24 weeks confirmed disability improvement and most patients (94.5%) were free of magnetic resonance imaging activity after ~1 year. Ocrelizumab was generally well tolerated, as side effects were only reported for 10% of patients. Our results indicate that most Danish patients treated with ocrelizumab are clinically stabilized, at least in the short term. |
|---|---|
| Bibliography: | Funding information This investigator sponsored study was funded by Roche. The funder had no influence on the study design, data analysis and interpretation ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| ISSN: | 1351-5101 1468-1331 |
| DOI: | 10.1111/ene.15142 |