Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study
Autor: | Maya Zeineddine, Nabil K. El-Ayoubi, Johny Nicolas, Bassem Yamout, Samia J. Khoury, Yehya El Kouzi |
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Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Adult
Male lcsh:Immunologic diseases. Allergy medicine.medical_specialty Multiple Sclerosis Article Subject Immunology Cohort Studies 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Immunology and Allergy Humans Immunologic Factors 030212 general & internal medicine Lebanon Adverse effect Retrospective Studies Expanded Disability Status Scale business.industry Multiple sclerosis Progressive multifocal leukoencephalopathy Brain Retrospective cohort study General Medicine Off-Label Use Middle Aged medicine.disease Antigens CD20 Magnetic Resonance Imaging Injection Site Reaction Cohort Disease Progression Rituximab Female business lcsh:RC581-607 030217 neurology & neurosurgery Cohort study medicine.drug Research Article Follow-Up Studies |
Zdroj: | Journal of Immunology Research, Vol 2018 (2018) Journal of Immunology Research |
ISSN: | 2314-7156 2314-8861 |
Popis: | Objective. To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting. Methods. Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity. Results. A total of 89 rituximab-treated patients were included: 59 relapsing-remitting MS (RRMS) and 30 progressive MS (PMS). Patients were treated with 1000 or 2000 mg rituximab IV every 6–12 months for a mean duration of 22.2 ± 24.8 months. The subjects were 65.2% females with a mean age of 40.5 ± 12.3 years and a mean disease duration of 7.9 ± 6.2 years. During treatment, the ARR decreased from 1.07 at baseline to 0.11 in RRMS (p<0.0001) and from 0.25 to 0.16 in PMS patients (p=0.593). The mean Expanded Disability Status Scale (EDSS) remained unchanged in both RRMS and PMS patients. Between baseline and the last follow-up, the percent of patients free from any new MRI lesions increased from 18.6% to 92.6% in the RRMS group and from 43.3% to 82% in the PMS group. No evidence of disease activity (NEDA) was achieved in 74% of patients at 1 year of treatment. A total of 64 adverse events (AEs) (71.9%) were recorded with the most common being infusion-related reactions in 25.8% of patients, all mild in nature. Two of our rituximab-treated patients experienced serious AEs requiring surgical interventions: pyoderma gangrenosum vaginalis with perianal abscess and fistula and an increase in the size of a meningioma. No case of progressive multifocal leukoencephalopathy (PML) was detected. Conclusion. In our real-world cohort, rituximab was well-tolerated and effective in reducing relapse rate and disability progression in relapsing-remitting and progressive MS patients. |
Databáze: | OpenAIRE |
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