Real‐world experience of ocrelizumab in multiple sclerosis in a Spanish population

Abstract

Objective Pivotal trial have shown that patients with multiple sclerosis (MS) receiving ocrelizumab had better outcomes. However, data on ocrelizumab in clinical practice are limited. The aim of this study was to evaluate the preliminary safety profile and effectiveness of ocrelizumab treatment for multiple sclerosis (MS) in a real‐world clinical setting. Methods We conducted a retrospective study including consecutive patients from nine public hospitals in south‐eastern Spain who received ocrelizumab after it was approved. Results A total of 228 MS patients were included (144 with relapsing–remitting MS [RRMS], 25 secondary progressive MS [SPMS], and 59 primary progressive MS [PPMS]). Median follow‐up period was 12 months (range, 1‐32). No evidence of disease activity (NEDA) status at year 1 was achieved in 91.2% of the relapsing MS (RMS) population, while disability progression was detected in 37.5% of the PPMS patients (median follow‐up period, 19 months). The most common adverse events reported were infusion‐related reactions and infections, with the most common infections being urinary tract infections followed by upper respiratory infections and COVID‐19. Interpretation The preliminary results in our real‐world setting show that ocrelizumab presented excellent results in suppressing disease activity with a favorable and consistent safety profile.

Real-world evidence of ocrelizumab in Chilean patients with multiple sclerosis

“…It is noteworthy, that only three patients (1%) discontinued treatment indefinitely during the follow-up period, with only one case due to a serious infection, reducing attrition bias. This is consistent with other studies that report low discontinuation rates, both in real-world settings 9,10,12 and in the extensions of pivotal trials. 27 In our study, the rate may be slightly lower as temporary suspensions due to pregnancy were not included.…”

“…active MRI/inactive MRI PIRA events, or increases in serum neurofilament light chain assessments) was out of the scope of this study. CDI has been less reported in RWE studies, ranging from 17% to 20%, 9,10 mostly in RRMS patients during the first year of treatment, similar to our findings.…”

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

“…A markedly decreasing risk of MRI activity over time during ocrelizumab treatment was also found, in line with the results of the OPERA trials [2] and the two real‐world studies from Spain [5,6]. Our data suggest that ocrelizumab reduces MRI activity not only in younger patients with well‐defined relapse frequencies at baseline (OPERA I and II) but also in a less strictly selected patient population.…”

“…The clinical effectiveness and safety data in our cohort are generally in line with those reported in the pivotal phase 3 clinical trials and in the few real-world studies conducted so far [2,3,[5][6][7][8][9].…”

Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study

“…The clinical effectiveness data in our cohort are generally in line with those reported in the pivotal phase 3 clinical trials and in the few real-world studies conducted so far [2,3,[8][9][10][11][12].…”