Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping

Ippazio Cosimo Antonazzo, Emanuel Raschi, Luca Vignatelli, Elisa Baldin, Trond Riise, Roberto D’Alessandro, Fabrizio De Ponti and Elisabetta Poluzzi ()
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Ippazio Cosimo Antonazzo: Alma Mater Studiorum, University of Bologna
Emanuel Raschi: Alma Mater Studiorum, University of Bologna
Luca Vignatelli: IRCCS—Institute of Neurological Sciences of Bologna, Epidemiology and Biostatistics Service
Elisa Baldin: IRCCS—Institute of Neurological Sciences of Bologna, Epidemiology and Biostatistics Service
Trond Riise: University of Bergen
Roberto D’Alessandro: IRCCS—Institute of Neurological Sciences of Bologna, Epidemiology and Biostatistics Service
Fabrizio De Ponti: Alma Mater Studiorum, University of Bologna
Elisabetta Poluzzi: Alma Mater Studiorum, University of Bologna

Drug Safety, 2017, vol. 40, issue 9, No 8, 823-834

Abstract: Abstract Introduction The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. Objective The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. Methods A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS. The Newcastle-Ottawa Scale and appropriate guidelines from the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) were used to assess the quality of included studies. Results After screening 832 articles, 58 were selected (of which 14 were found by checking the reference lists of reviews): 30 case reports and case series, 24 longitudinal studies and four randomized controlled trials. Seven longitudinal studies had good (at least 7 out of 9) quality scores, whereas case reports/case series presented several limitations. Half of included articles focused on immunomodulatory drugs (etanercept, infliximab and adalimumab), especially in case reports/series, suggesting an association with MS occurrence. Contraceptives and antibacterials were investigated in some population-based studies, without definite results. Conclusion A heterogeneous pharmacological profile of identified classes emerged. Low strength of evidence and conflicting results highlighted the difficulties in addressing the possible contribution of drugs in MS occurrence. Methodological advances are needed, especially to control the confounding role of underlying disease for specific drug classes.

Date: 2017
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DOI: 10.1007/s40264-017-0551-0

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