Abstract | OBJECTIVES: METHODS: RESULTS: In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF antagonists in BIOBADASER was 0.65 per 1000 patient-years (95%CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95%CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. CONCLUSIONS:
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Authors | María Cruz Fernández-Espartero, Beatriz Pérez-Zafrilla, Antonio Naranjo, Carmen Esteban, Ana M Ortiz, Juan J Gómez-Reino, Loreto Carmona, BIOBADASER Study Group |
Journal | Seminars in arthritis and rheumatism
(Semin Arthritis Rheum)
Vol. 40
Issue 4
Pg. 330-7
(Feb 2011)
ISSN: 1532-866X [Electronic] United States |
PMID | 20864146
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review, Systematic Review)
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Copyright | Copyright © 2011 Elsevier Inc. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Antirheumatic Agents
- Tumor Necrosis Factor-alpha
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(adverse effects)
- Antirheumatic Agents
(adverse effects)
- Databases, Factual
- Demyelinating Diseases
(etiology)
- Female
- Humans
- Male
- Middle Aged
- Rheumatic Diseases
(therapy)
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors, therapeutic use)
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