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Ocrelizumab treatment in multiple sclerosis: A Danish population‐based cohort study
Author(s) -
Pontieri Luigi,
Blinkenberg Morten,
Bramow Stephan,
Papp Viktoria,
Rasmussen Peter V.,
Kant Matthias,
Schäfer Jakob,
Mathiesen Henrik K.,
Jensen Michael B.,
Sirakov Georgi,
Berg Jonas M.,
Kopp Tine I.,
Joensen Hanna,
Sellebjerg Finn,
Magyari Melinda
Publication year - 2022
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.15142
Subject(s) - ocrelizumab , medicine , multiple sclerosis , cohort , population , expanded disability status scale , magnetic resonance imaging , physical therapy , radiology , rituximab , immunology , environmental health , lymphoma
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.