MiscellaneousDemyelinating Disease in Patients Treated with TNF Antagonists in Rheumatology: Data from BIOBADASER, a Pharmacovigilance Database, and a Systematic Review
Section snippets
Methods
The information presented herein was obtained from the following sources: (1) the Spanish Registry of adverse events of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic literature review on demyelinating diseases reported as an adverse event of TNF antagonists.
Cases of Demyelinating Diseases in the BIOBADASER Registry
Up to 1 September 2008, BIOBADASER contained information on 9256 patients receiving anti-TNF therapies, with a total exposure of 21,425 patient-years. Exposure of patients with rheumatoid arthritis (RA) was 13,075 patient-years, with ankylosing spondylitis (AS) 2870 patient-years, and with psoriatic arthritis (PsA) 2873 patient-years. Nine patients had a confirmed demyelinating disease—of which 1 was a case of Guillain Barre's syndrome and the other were unspecified lesions—4 had optic
Discussion
We have investigated the characteristics and incidence of demyelinating cases in patients with rheumatic diseases treated with TNF antagonists. Notably, the information obtained depended on the source: literature review, spontaneous pharmacovigilance system, or a biologics registry, reflecting the different nature of the safety system and ratifying the more pragmatic view of the registries. As an example, MS represents nearly half of the cases reported to FEDRA, but only 7% of the BIOBADASER
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This work was partially supported by the RETICS Program, RD08/0075 (RIER), Instituto de Salud Carlos III (ISCIII). BIOBADASER is supported by the Sociedad Española de Reumatología and the Spanish Agency of Medicines and Health care Products. Grants in approximately equal amounts (all under 25,000€/year) from Roche, Abbott, BMS, Schering, and Wyeth contribute to the support of the registry.