Efficacy and safety of ocrelizumab in patients with relapsing multiple sclerosis: Real-world experience of two Swiss multiple sclerosis centers

• Published in: Multiple sclerosis and related disorders Vol. 86; p. 105570
• Main Authors: Diem, L, Ovchinnikov, A, Friedli, C, Hammer, H, Kamber, N, Chan, A, Salmen, A, Findling, O, Hoepner, R
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-06-2024
• Subjects: Immunotherapy; Multiple sclerosis; Ocrelizumab; Relapsing multiple sclerosis; Relapsing multiple sclerosis; Multiple sclerosis; Ocrelizumab; Immunotherapy
• ISSN: 2211-0348; 2211-0356; 2211-0356
• DOI: 10.1016/j.msard.2024.105570

•High efficacy of OCR in patients with RMS.•Tolerability of OCR was in general good.•Infection rates highlight the need for pharmacovigilance for OCR treatment.•Correlation between hypogammaglobulinemia and infection rates.
Ocrelizumab (OCR) is a humanized monoclonal antibody directed against CD-20 positive lymphocytes, mainly B-lymphocytes. OCR is approved for treatment of primary progressive (PPMS) and relapsing multiple sclerosis (RMS). This study aims to provide real-world safety and efficacy data of people with RMS treated with OCR in two Swiss Multiple Sclerosis (MS) centers.
We have conducted a retrospective data analysis using the patient cohorts from the Cantonal Hospital Aarau and Bern University Hospital (RMS: n = 235). Statistical analyses were performed with Mann–Whitney U-Test, Chi-squared test and Spearman-Rho-Correlation. Adjustment for multiple testing was performed by Bonferroni procedure.
After initiation of OCR, there was a decrease in disease activity in RMS patients. In our study, 152/190 (80.0 %) RMS patients fulfilled the criteria for NEDA-3 12 months and 88/104 (84.6 %) showed NEDA-3 24 months after OCR initiation. The most frequent adverse events (AEs) in our study were infections, taking place in 78/235 (33.2 %) RMS patients. COVID-19 was the most common infection, followed by urinary infections and other respiratory infections and infectious adverse events occurred significantly more frequent in patients with reduced IgG serum concentration.
Our real-world study showed OCR being associated with low rates of any type of MS disease activity as indicated by NEDA-3. The adverse event profile is comparable to the known events especially infections and an association between infections and reduced IgG serum concentration was found.