Ocrelizumab treatment in multiple sclerosis: A Danish population‐based cohort study

Abstract

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.

Ocrelizumab: A Review in Multiple Sclerosis

“…Early analyses of data from the international MSBase Registry [ 28 ] and Danish Multiple Sclerosis Registry [ 30 ] also indicate that ocrelizumab is an effective treatment for MS. In MSOCR-R, a prospective MSBase cohort study of patients with RRMS newly treated with ocrelizumab ( n = 800 eligible as of April 2021), most ocrelizumab recipients (91%) remained free from relapse after 2 years [ 28 ].…”

“…Patients had a median exposure to ocrelizumab of 1.8 years [ 28 ]. In an observational cohort study with prospectively enrolled cases ( n = 1104 initiating treatment with ocrelizumab; 946, 97 and 61 with RRMS, SPMS and PPMS, respectively) using data from the nationwide population-based Danish Multiple Sclerosis Registry, 9.3% of the total cohort experienced relapses during ocrelizumab treatment (median time to first relapse 4.2 months) [ 30 ]. The mean ARR was 0.09 after initiation of ocrelizumab versus 0.58 in the year prior to initiation.…”

“…Most patients (94.5%) were free of MRI disease activity after ≈ 1 year of treatment. The median duration of follow-up was 16 months [ 30 ].…”

“…[ 10 , 11 , 14 – 16 , 33 , 34 ]) and in a real-world setting (e.g. [ 30 , 35 , 36 ]). In the pooled OPERA I and II safety populations, the proportion of patients reporting adverse events (AEs) was the same with ocrelizumab as with interferon β-1a (83.3%) [ 10 ].…”

“…The effectiveness of ocrelizumab in the treatment of patients with MS in a real-world clinical setting has been investigated in several large studies (n > 300) [25][26][27][28][29][30][31][32], the early results of which appear to confirm the therapeutic benefits demonstrated in clinical trials.…”