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 experience of ocrelizumab in multiple sclerosis in an Arab population

“…Most of the infections reported in two recent observational studies were classified as minor in 8 and 5% of the patients [ 28 , 29 ]. However, in our cohort, this proportion was higher (16%), even slightly higher than the one reported in the latest published study [ 30 ]. This might be explained by the longer follow-up interval in our series.…”

“…In our cohort, the most frequent comorbidities included cardiovascular risk factors, diabetes, and mental health conditions. All of them presented with a similar profile as described in previous studies [ 30 , 31 ] but with a lower frequency for all of them. Depression and anxiety are reported to be prevalent in patients with MS, with prevalence rates ranging from 20% to 50%.…”

“…Depression, anxiety, cardiovascular disease, epilepsy, metabolic disease, and autoimmune diseases are some of the most common conditions found in patients. Real-world studies offer crucial information about patients with different comorbidities and prior treatments, who are rarely included in clinical trials [ 30 ]. In our cohort, the most frequent comorbidities included cardiovascular risk factors, diabetes, and mental health conditions.…”

Severe outcomes of COVID-19 among patients with multiple sclerosis under anti-CD-20 therapies: A systematic review and meta-analysis

“…All selected articles were rigorously appraised by two authors according to a modified version of the Dutch Cochrane center critical review checklist proposed by MOOSE (Stroup et al, 2000). Key domains assessed by the MOOSE tool include: (I) Clear definition of study population; (II) Clear definition of outcomes and outcomes assessment; (III) Independent assessment of outcome parameters; (IV) Sufficient The presence of SARS-CoV2 antibodies in MS patients (Armstrong et al, 2021;Arrambide et al, 2021;Barzegar et al, 2020Barzegar et al, , 2021Bose and Galetta, 2021;Bsteh et al, 2021;Chaudhry et al, 2020;Ciampi et al, 2020;Conte, 2020;Czarnowska et al, 2021;D'Abramo et al, 2021;Devogelaere et al, 2020;Fernandez-Diaz et al, 2021;Fragoso et al, 2021;Garg et al, 2020;Hervas-Garcia, 2020;Loonstra et al, 2020;Louapre et al, 2020;Montero-Escribano et al, 2020;Olivares Gazca et al, 2020;Sahraian et al, 2020;Salter et al, 2021;Sen et al, 2021;Sormani et al, 2021b,a;Spelman et al, 2021;Stroup et al, 2000;Suwanwongse and Shabarek, 2020;Thornton and Harel, 2020 *Data provided by the authors but not published.…”

Predictors of Ocrelizumab Effectiveness in Patients with Multiple Sclerosis

“…Moreover, a recently published post hoc exploratory analysis provided effectiveness data of ocrelizumab in a subgroup of patients with advanced MS [9]. However, available observational studies regarding its use in the post-marketing setting are still sparse [10][11][12] and characterized by several limitations, including the retrospective nature, limited numbers of patients enrolled, short follow-up duration, lack of MRI, and/or immunological data. Complementing the results of phase III clinical trials with observational data referring to an "unselected cohort" is critical in order to achieve information that could be transferred to real-life scenarios.…”