Ippazio Cosimo Antonazzo1, Emanuel Raschi1, Luca Vignatelli2, Elisa Baldin2,3, Trond Riise4,5, Roberto D'Alessandro2, Fabrizio De Ponti1, Elisabetta Poluzzi6. 1. Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy. 2. IRCCS-Institute of Neurological Sciences of Bologna, Epidemiology and Biostatistics Service, Via Altura 3, 40139, Bologna, BO, Italy. 3. Gertrude H. Sergievsky Center, Columbia University, New York, NY, USA. 4. Department of Global Public Health and Primary Care, University of Bergen, Kalfarveien 31, 5020, Bergen, Norway. 5. The Norwegian Multiple Sclerosis Competence Center, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway. 6. Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy. elisabetta.poluzzi@unibo.it.
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.
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.
Authors: A-L Ponsonby; R M Lucas; I A van der Mei; K Dear; P C Valery; M P Pender; B V Taylor; T J Kilpatrick; A Coulthard; C Chapman; D Williams; A J McMichael; T Dwyer Journal: Neurology Date: 2012-03-07 Impact factor: 9.910
Authors: Vittorio Mantero; Andrea Rigamonti; Anna Fiumani; Luisa De Toni Franceschini; Ugo Pozzetti; Roberto Balgera; Andrea Salmaggi Journal: Neurol Sci Date: 2018-04-26 Impact factor: 3.307