Ippazio Cosimo Antonazzo1, Emanuel Raschi1, Emanuele Forcesi1, Trond Riise2,3, Kjetil Bjornevik2,3,4, Elisa Baldin5,6, Fabrizio De Ponti1, Elisabetta Poluzzi1. 1. a Department of Medical and Surgical Sciences , Alma Mater Studiorum, University of Bologna , Bologna , Italy. 2. b Department of Global Public Health and Primary Care , University of Bergen , Bergen , Norway. 3. c The Norwegian Multiple Sclerosis Competence Center, Department of Neurology , Haukeland University Hospital , Norway. 4. d Department of Nutrition , Harvard T.H. School of Public Health , Boston , MA , USA. 5. e Epidemiology and Biostatistics Service , IRCCS-Institute of Neurological Sciences of Bologna , Bologna , BO , Italy. 6. f Department of Biomedical and Surgical Sciences , University of Ferrara , Ferrara , Italy.
Abstract
BACKGROUND: Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs). RESEARCH DESIGN AND METHODS: We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period. Reporting odds ratio (ROR) for MS was calculated for each single substance. Disproportionality signals were considered when at least 10 cases were retrieved with a lower limit of the 95% confidence interval (CI) >1. RESULTS: After a customized data-mining process, 3,226 reports of MS were retrieved. 'Antineoplastic and immunomodulating drugs' (33% of total reports) were the most frequently reported, with 10 disproportionality signals, including etanercept (445 cases; ROR: 2.48; 95% Cl: 2.24-2.74), adalimumab (329; 2.05; 1.83-2.30), and infliximab (119; 2.25; 1.87-2.70). We also observed signals for drugs acting on hormone balance, bone density, and central nervous system. CONCLUSION: Our findings suggest that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk.
BACKGROUND: Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs). RESEARCH DESIGN AND METHODS: We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period. Reporting odds ratio (ROR) for MS was calculated for each single substance. Disproportionality signals were considered when at least 10 cases were retrieved with a lower limit of the 95% confidence interval (CI) >1. RESULTS: After a customized data-mining process, 3,226 reports of MS were retrieved. 'Antineoplastic and immunomodulating drugs' (33% of total reports) were the most frequently reported, with 10 disproportionality signals, including etanercept (445 cases; ROR: 2.48; 95% Cl: 2.24-2.74), adalimumab (329; 2.05; 1.83-2.30), and infliximab (119; 2.25; 1.87-2.70). We also observed signals for drugs acting on hormone balance, bone density, and central nervous system. CONCLUSION: Our findings suggest that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk.
Authors: Xiaoying Kang; Alexander Ploner; Nancy L Pedersen; Sara Bandres-Ciga; Alastair J Noyce; Karin Wirdefeldt; Dylan M Williams Journal: Neurology Date: 2021-02-19 Impact factor: 9.910
Authors: Irini Papazian; Eleni Tsoukala; Athena Boutou; Maria Karamita; Konstantinos Kambas; Lida Iliopoulou; Roman Fischer; Roland E Kontermann; Maria C Denis; George Kollias; Hans Lassmann; Lesley Probert Journal: J Neuroinflammation Date: 2021-09-26 Impact factor: 8.322