| アブストラクト | TNFalpha modulation has been reported to be either beneficial or detrimental in amyotrophic lateral sclerosis (ALS) and therefore appears as a key issue. We analysed the relationship between TNFalpha inhibitor (TNFi) exposure and ALS. We performed descriptive analysis of ALS reports in patients treated with TNFi, registered in the French Pharmacovigilance Database (FPvD) and disproportionality analyses by the 'case'/'non-case' method in FPvD and worldwide database (Vigibase((R)) ). The 8 retrieved ALS cases from the FPvD were 5 with limb-onset and 3 with bulbar-onset forms, in patients aged 43-75 years old, mainly treated for inflammatory rheumatism. The time to onset of the first symptoms ranged from 12 to 108 months, and the cumulative TNFi exposure before the diagnosis ranged from 12 to 120 months. TNFi was discontinued and thereafter survival ranged between 12 and 20 months. Disproportionality analyses showed significant associations between TNFi exposure and ALS in the FPvD and Vigibase((R)) (160 ALS cases), regardless comparators. A putative association between TNFi and ALS must be interpreted cautiously, but TNFi could act as a predisposing or risk factor. TNFi should therefore be avoided in patients with a known risk of ALS and discontinued in the case of neurological signs of ALS. |
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| 投稿者 | Petitpain, Nadine; Devos, David; Bagheri, Haleh; Rocher, Fanny; Gouraud, Aurore; Masmoudi, Kamel; Coquerel, Antoine |
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| 組織名 | Regional Pharmacovigilance Centre of Nancy, University Hospital Centre of Nancy,;Nancy, France.;Department of Medical Pharmacology, University Hospital Centre of Lille, Lille,;France.;Department of Neurology, ALS Centre Lille University, Inserm UMRS_1171, LICEND;COEN Centre, Lille, France.;Department of Medical and Clinical Pharmacology, Regional Pharmacovigilance and;Pharmacoepidemiology Centre, INSERM, UMR 1027, University Hospital Centre of;Toulouse, Toulouse, France.;Regional Pharmacovigilance Centre of Nice, University Hospital Centre of Nice,;Nice, France.;Regional Pharmacovigilance Centre of Lyon, University Hospital Centre of Lyon,;Lyon, France.;Regional Pharmacovigilance Centre of Amiens, University Hospital Centre of;Amiens, Amiens, France.;Regional Pharmacovigilance Centre of Caen, University Hospital Centre of Caen,;UMR, UMR University of Caen Normandie/Inserm U1075, Caen, France. |
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