期刊
NEUROLOGY
卷 76, 期 15, 页码 1310-1315出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e3182152881
关键词
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资金
- Verein Therapieforschung fur Multiple Sklerose Kranke
- Krankheitsbezogenes Kompetenznetzwerk Multiple Sklerose (BMBF, KKNMS)
- DFG [SFB571]
- Merck Serono
- Merz Pharmaceuticals
- LLC
- Biogen Idec
- Bayer Schering Pharma
- Novartis
- sanofi-aventis
- Teva Pharmaceutical Industries Ltd.
- Roche
- metanomics GmbH
- Protagen AG
- Deutsche Forschungsgemeinschaft
- Bundesministerium fur Bildung und Forschung
- Hertie Foundation
- Braun Melsungen
- Auris Medical
Background: Neuromyelitis optica (NMO) is a severe autoimmune disease targeting optic nerves and spinal cord. The monoclonal anti-CD20 B-cell antibody rituximab is an emerging therapeutic option in NMO. However, neither long-term efficacy or safety of rituximab, nor the correlation between B-cell counts, B-cell fostering cytokines, aquaporin-4 antibodies (AQP4-ab), and disease activity in NMO, have been investigated prospectively. Methods: We performed a prospective long-term cohort study of 10 patients with NMO who were treated up to 5 times with rituximab as a second-line therapy. Clinical examinations, B-cell counts, and serum concentrations of BAFF (B-cell activating factor of the TNF family; also called TNFSF13b), APRIL (a proliferation-inducing ligand; also called TNFSF13), AQP4-ab, and immunoglobulin levels were measured every 3 months. Results: Repeated treatment with rituximab led to sustained clinical stabilization in most patients with NMO. Disease activity correlated with B-cell depletion, but not clearly with AQP4-ab or levels of APRIL. BAFF levels increased after application of rituximab and indicated persisting efficacy of the drug but did not correlate with disease activity. Overall, rituximab was well-tolerated even after up to 5 consecutive treatment courses; however, we observed several severe adverse reactions. Conclusion: Our data indicate that long-term therapy with rituximab is effective in NMO as a second-line therapy and has an acceptable safety profile. Retreatment with rituximab should be applied before reappearance of circulating B cells. Classification of evidence: This study provides Class IV evidence that repeated doses of rituximab result in stabilization in most patients. Neurology (R) 2011;76:1310-1315
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