Effectiveness and safety of Rituximab in multiple sclerosis: an observational study from Southern Switzerland

Despite positive results from phase II and observational studies, Rituximab (RTX) is not currently approved for multiple sclerosis (MS) treatment and can only be used off-label. To characterize MS patients treated with RTX and investigate its effectiveness and safety in a clinical practice setting....

Full description

Saved in:
Bibliographic Details
Published in:PloS one Vol. 13; no. 5; p. e0197415
Main Authors: Scotti, Barbara, Disanto, Giulio, Sacco, Rosaria, Guigli, Marilu’, Zecca, Chiara, Gobbi, Claudio
Format: Journal Article
Language:English
Published: United States Public Library of Science 14.05.2018
Public Library of Science (PLoS)
Subjects:
Analysis
Autoimmune diseases
Biology and Life Sciences
Care and treatment
Data processing
Disease
Drug therapy
Females
Immunotherapy
Infections
Interferon
Laboratories
Magnetic resonance imaging
Medicine and Health Sciences
Monoclonal antibodies
Multiple sclerosis
Neurology
Observational studies
Patient outcomes
Patients
People and Places
Regression analysis
Research and Analysis Methods
Rheumatoid arthritis
Rituximab
Safety
Safety and security measures
Studies
Switzerland
Sweden
ISSN:1932-6203, 1932-6203
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Despite positive results from phase II and observational studies, Rituximab (RTX) is not currently approved for multiple sclerosis (MS) treatment and can only be used off-label. To characterize MS patients treated with RTX and investigate its effectiveness and safety in a clinical practice setting. Observational analysis of data collected from MS patients at the Neurocenter of Southern Switzerland. Relapses, EDSS worsening, MRI lesion accrual and "evidence of disease activity" (EDA) status were described by Cox regression. RTX and natalizumab treated patients were matched by propensity scores. Out of 453 MS patients, 82 were treated with RTX, 43 (52.4%) relapsing-remitting (RRMS) and 39 (47.6%) progressive MS (median age = 48 [40-54] years, females n = 60 [73.2%], EDSS = 4.0 [2.5-6.0], median follow-up = 1.5 [1.0-2.5] years). Three relapses occurred and 59 (75.6%) patients had not EDA at follow-up end. Time to EDA was similar in RTX and natalizumab treated RRMS patients (HR = 1.64, 95%CI = 0.46-5.85, p = 0.44). Twenty-four patients presented non infusion related adverse events (infections), requiring RTX discontinuation in 6 individuals. These results provide further evidence for RTX being effective in MS treatment, to a similar extent to natalizumab in RRMS. Clinicians must be vigilant for the potential occurrence of infections.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
content type line 23
ObjectType-Undefined-3
Competing Interests: The authors have declared that no competing interests exist.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0197415