BACKGROUND: In order to reduce the risk of progressive multifocal leucoencephalopathy when using natalizumab for more than 12 months, a 6-month drug holiday has been discussed. However, the consequences on short term disease activity have been poorly assessed. OBJECTIVE: The aim of this study was to assess clinical and radiological disease activity within 6 months after stopping natalizumab in very active relapsing remitting Multiple Sclerosis (RRMS) patients. METHODS: In 8 hospitals from Western France, we retrospectively collected clinical and MRI data from consecutive RRMS patients treated with natalizumab for at least 6 months, and who stopped the drug for various reasons except therapeutic failure. Patients didn't receive any other disease modifying treatment after discontinuing natalizumab. RESULTS: A total of 27 patients with very active RRMS before natalizumab start (mean annualized relapse rate of 2.3, MRI activity in 21 of 27 patients) were studied. Within 6 months after discontinuing natalizumab, 18 patients (67%) experienced clinical relapse and 3 additional patients had radiological activity, without clinical relapse. Four patients (15%) experienced a rebound activity, with severe relapse and 20 or more gadolinium enhancing lesions on MRI. CONCLUSION: Such observational data didn't support the concept of drug holiday when using natalizumab in very active RRMS.
BACKGROUND: In order to reduce the risk of progressive multifocal leucoencephalopathy when using natalizumab for more than 12 months, a 6-month drug holiday has been discussed. However, the consequences on short term disease activity have been poorly assessed. OBJECTIVE: The aim of this study was to assess clinical and radiological disease activity within 6 months after stopping natalizumab in very active relapsing remitting Multiple Sclerosis (RRMS) patients. METHODS: In 8 hospitals from Western France, we retrospectively collected clinical and MRI data from consecutive RRMS patients treated with natalizumab for at least 6 months, and who stopped the drug for various reasons except therapeutic failure. Patients didn't receive any other disease modifying treatment after discontinuing natalizumab. RESULTS: A total of 27 patients with very active RRMS before natalizumab start (mean annualized relapse rate of 2.3, MRI activity in 21 of 27 patients) were studied. Within 6 months after discontinuing natalizumab, 18 patients (67%) experienced clinical relapse and 3 additional patients had radiological activity, without clinical relapse. Four patients (15%) experienced a rebound activity, with severe relapse and 20 or more gadolinium enhancing lesions on MRI. CONCLUSION: Such observational data didn't support the concept of drug holiday when using natalizumab in very active RRMS.
Authors: Vilija G Jokubaitis; Vivien Li; Tomas Kalincik; Guillermo Izquierdo; Suzanne Hodgkinson; Raed Alroughani; Jeannette Lechner-Scott; Alessandra Lugaresi; Pierre Duquette; Marc Girard; Michael Barnett; Francois Grand'Maison; Maria Trojano; Mark Slee; Giorgio Giuliani; Cameron Shaw; Cavit Boz; Daniele L A Spitaleri; Freek Verheul; Jodi Haartsen; Danny Liew; Helmut Butzkueven Journal: Neurology Date: 2014-03-07 Impact factor: 9.910
Authors: Michael Kaufman; Bruce A C Cree; Jerome De Sèze; Robert J Fox; Ralf Gold; Hans-Peter Hartung; Douglas Jeffery; Ludwig Kappos; Xavier Montalbán; Bianca Weinstock-Guttman; Barry Ticho; Petra Duda; Amy Pace; Denise Campagnolo Journal: J Neurol Date: 2014-11-09 Impact factor: 4.849
Authors: Giancarlo Comi; Stuart D Cook; Gavin Giovannoni; Kottil Rammohan; Peter Rieckmann; Per Soelberg Sørensen; Patrick Vermersch; Anthony C Hamlett; Vissia Viglietta; Steven J Greenberg Journal: J Neurol Date: 2012-12-21 Impact factor: 4.849