Ocrelizumab treatment in multiple sclerosis: A Danish population-based cohort study
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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.
|Tidsskrift||European Journal of Neurology|
|Status||Udgivet - 2022|
L. Pontieri reports no disclosures. M. Blinkenberg reports personal fees from Sanofi Genzyme, Biogen, Merck, Novartis, Bristol‐Myers Squibb, Roche and non‐financial support from Biogen, Roche and Sanofi Genzyme. S. Bramow has received financial support for congress participation and consultancy honoraria from Biogen. V. Papp has received support for scientific meetings from Merck and Sanofi Genzyme and honoraria for lecturing from Alexion. P.V. Rasmussen has served on scientific advisory boards for Biogen, Sanofi, Roche, Novartis, Merck, Alexion and has received honoraria for lecturing from Biogen, Merck, Novartis, Roche, and support for congress participation from Merck, Sanofi and Roche. M. Kant reports no disclosures. J. Schäfer has received support for congress participation from Merck, Roche, Sanofi Genzyme, Biogen and Teva. H. K. Mathiesen has received support for congress participation from Teva, Merck Serono, Bayer Schering, Biogen and Sanofi. M. B. Jensen has served on scientific advisory boards, served as a consultant, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche, Sanofi Genzyme and Teva. G. Sirakov has received support for congress participation from Biogen, Sanofi Genzyme, Roche, Merck. J. M. Berg reports no disclosures. T. I. Kopp has received honoraria for participating in advisory boards from Novartis and support for congress participation from Biogen. H. Joensen has received honoraria for participating in advisory boards from Biogen. F. Sellebjerg has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche and Sanofi Genzyme. M. Magyari has served on scientific advisory boards for Biogen, Sanofi, Teva, Roche, Novartis, Merck, Abbvie, and has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi, Genzyme, and support for congress participation from Biogen, Genzyme, Teva, Roche, research grants from Sanofi, Novartis, Merck.
This investigator sponsored study was funded by Roche. The funder had no influence on the study design, data analysis and interpretation
© 2021 European Academy of Neurology