Safety and efficacy of rituximab as first- and second line treatment in multiple sclerosis - A cohort study
| Autor: | Lars Bø, Stig Wergeland, Øivind Torkildsen, Jan Harald Aarseth, Hilde Marie Torgauten, Kjell-Morten Myhr |
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| Rok vydání: | 2020 |
| Předmět: |
Oncology
Treatment response medicine.medical_specialty efficacy multiple sclerosis 03 medical and health sciences Cellular and Molecular Neuroscience 0302 clinical medicine disease modifying therapies Internal medicine medicine Original Research Article Adverse effect 030203 arthritis & rheumatology Second line treatment business.industry Multiple sclerosis treatment response medicine.disease adverse effects Rituximab Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug Cohort study |
| Zdroj: | Multiple Sclerosis Journal-Experimental, Translational and Clinical Multiple Sclerosis Journal, Experimental, Translational and Clinical |
| ISSN: | 2055-2173 |
| Popis: | Background Rituximab is increasingly used as off-label therapy in multiple sclerosis (MS). More data are needed on safety and efficacy of rituximab, particularly in cohorts of de novo patients and patients in early therapy escalation. Objective To investigate the safety and efficacy of off-label treatment with rituximab in an MS-cohort of predominantly de novo patients or as therapy escalation. Methods We retrieved safety and efficacy data from the Norwegian MS-registry and biobank for all MS-patients treated with rituximab at Haukeland University Hospital, Bergen, Norway, during a four year period. Results In the 365 MS-patients (320 relapsing-remitting MS (RRMS), 23 secondary progressive MS (SPMS), and 22 primary progressive MS (PPMS)), the overall annualized relapse rate (ARR) was 0.03 and annualized drug discontinuation rate (ADDR) was 0.05. NEDA-3 was achived in 79% of patients with available data (n=351). Sixty-one patients experienced infusion-related adverse events of which two were serious (CTCAE grade 3–4). Eighteen patients experienced serious non-infusion related adverse events, of which 16 were infections. Infections (n = 34; 9.3%, CTCAE grade 2-5), hypogammaglobulinemia (n = 19, 5.2%) and neutropenia (n = 16; 4.4%) were the most common non-infusion-related adverse events. Conclusion Rituximab was a safe and highly efficient disease modifying therapy in this cohort of MS-patients; however, infections and neutropenia need to be monitored. |
| Databáze: | OpenAIRE |
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