title: Assessing PML risk under immunotherapy: if all you have is a hammer, everything looks like a nail.
abstract: Recently, three progressive multifocal leukoencephalopathy (PML) cases have been reported in multiple sclerosis (MS) patients, two treated with fingolimod (Gilenya, Novartis), the third with dimethyl fumarate (Tecfidera, Biogen). Because our immunotherapeutic arsenal in MS and other diseases is increasing, and because PML is a very serious health risk, it is of interest to the clinical community to show how we can assess this risk in a statistically sound way. The null-hypothesis for this analysis was that there is no elevated risk for PML in patients treated with one of these recent drugs, compared to the incidence in the general population. We conclude that the null hypothesis cannot be refuted.
authors.affiliation: Center for Neurosciences, Vrije Universiteit Brussel, Belgium jeroen.van.schependom@vub.ac.be.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Van Schependom
authors.affiliation: Center for Neurosciences, Vrije Universiteit Brussel, Belgium.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Gielen
authors.affiliation: Center for Neurosciences, Vrije Universiteit Brussel, Belgium.
authors.forename: Jorne
authors.initials: J
authors.lastname: Laton
authors.affiliation: Center for Neurosciences, Vrije Universiteit Brussel, Belgium/National Multiple Sclerosis Center, Melsbroek, Belgium.
authors.forename: Guy
authors.initials: G
authors.lastname: Nagels
mesh_terms: D000069462:Dimethyl Fumarate / Q000009:adverse effects; D000068876:Fingolimod Hydrochloride / Q000009:adverse effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D012306:Risk
chemical_list: D007166:Immunosuppressive Agents; D000069462:Dimethyl Fumarate; D000068876:Fingolimod Hydrochloride
keywords: Dimethyl fumarate; fingolimod; immunotherapy; progressive multifocal leukoencephalopathy