Krämer J, Tenberg JG, Kleiter I, Gaissmaier W, Ruck T, Heesen C, Meuth SGBACKGROUND: Progressive multifocal Leukoencephalopathy (PML) is one of the major risks of natalizumab therapy. Despite introduction of the currently employed PML risk stratification algorithm, the incidence of natalizumab-associated PML cases is not decreasing. OBJECTIVES: We addressed the following questions: How do natalizumab-treated multiple sclerosis patients and their treating physicians assess and deal with PML risk? Is PML rist the real reason for natalizumab discontinuation? METHODS: 699 natalizumab-treated multiple sclerosis patients and 99 physicians were included in this prospective observational study. Questonnaires were completed at 5 different time points. Patients were stratified into 5 subgroups according to the presence of PML risk factors (prior immunosuppression, anti-JCV antibody status, treatment duration). Patients with prior immunosuppression (n = 30, treated by n = 7 physicians) were excluded from analyses, because patient numbers were too small. Patients’ anti-JCV antibody index was not considered because data recruitment ended in 2014. Using Bayesian network and regression analysis,we examined the relationship between different patient- and physician-factors and patients’ discontinuation of natalizumab.
PLoS One. 2017 Apr 13;12(4):e0174858
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