Demyelinating Disease in Patients Treated with TNF Antagonists in Rheumatology: Data from BIOBADASER, a Pharmacovigilance Database, and a Systematic Review

被引:34
作者
Cruz Fernandez-Espartero, Maria [2 ]
Perez-Zafrilla, Beatriz [3 ,4 ]
Naranjo, Antonio [5 ]
Esteban, Carmen [6 ]
Ortiz, Ana M. [7 ]
Gomez-Reino, Juan J.
Carmona, Loreto [1 ,8 ]
机构
[1] Univ Camilo Jose Cela, Sch Hlth Sci, Madrid 28692, Spain
[2] Hosp Univ Mostoles, Dept Rheumatol, Mostoles, Spain
[3] Res Unit, Madrid, Spain
[4] Complejo Hosp Univ Albacete, Clin Res Unit, Albacete, Spain
[5] Hosp Gran Canaria Dr Negrin, Dept Rheumatol, Las Palmas Gran Canaria, Spain
[6] Pharmacovigilance Ctr, Madrid, Spain
[7] Hosp Univ Princesa, Dept Rheumatol, Madrid, Spain
[8] Hosp Univ Santiago, Dept Rheumatol, Dept Med, USC, Santiago, Spain
关键词
demyelinating disease; TNF antagonists; demyelination; optic neuritis; multiple sclerosis; TUMOR-NECROSIS-FACTOR; MULTIFOCAL MOTOR NEUROPATHY; MULTIPLE-SCLEROSIS; FACTOR-ALPHA; OPTIC NEURITIS; PSORIATIC-ARTHRITIS; ETANERCEPT THERAPY; INFLIXIMAB THERAPY; CNS DEMYELINATION; GUILLAIN-BARRE;
D O I
10.1016/j.semarthrit.2011.05.003
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives: To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. Methods: All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95% CI). 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: It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. (C) 2011 Published by Elsevier Inc. Semin Arthritis Rheum 41:524-533
引用
收藏
页码:524 / 533
页数:10
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