Ocrelizumab treatment in multiple sclerosis: A Danish population-based cohort study
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Ocrelizumab treatment in multiple sclerosis : A Danish population-based cohort study. / 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.
In: European Journal of Neurology, Vol. 29, No. 2, 2022, p. 496-504.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Ocrelizumab treatment in multiple sclerosis
T2 - A Danish population-based cohort study
AU - Pontieri, Luigi
AU - Blinkenberg, Morten
AU - Bramow, Stephan
AU - Papp, Viktoria
AU - Rasmussen, Peter V.
AU - Kant, Matthias
AU - Schäfer, Jakob
AU - Mathiesen, Henrik K.
AU - Jensen, Michael B.
AU - Sirakov, Georgi
AU - Berg, Jonas M.
AU - Kopp, Tine I.
AU - Joensen, Hanna
AU - Sellebjerg, Finn
AU - Magyari, Melinda
N1 - Publisher Copyright: © 2021 European Academy of Neurology
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1111/ene.15142
DO - 10.1111/ene.15142
M3 - Journal article
C2 - 34644452
AN - SCOPUS:85118118854
VL - 29
SP - 496
EP - 504
JO - European Journal of Neurology
JF - European Journal of Neurology
SN - 1351-5101
IS - 2
ER -
ID: 305422192