Roberto Bomprezzi1, Siddharama Pawate2. 1. MaineGeneral Neurology, MaineGeneral Medical Center, 15 Enterprise Dr, Augusta, ME 04330, USA. 2. Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Abstract
BACKGROUND: The enthusiasm for natalizumab, a highly efficacious agent in the treatment of multiple sclerosis (MS), has been tempered by the risks of progressive multifocal leukoencephalopathy associated with its use, and strategies to minimize those risks are of great interest. Extended interval dosing (EID) has been proposed as a way to maintain the efficacy of natalizumab while reducing exposure to it. We reviewed a cohort of patients who received natalizumab at 6-8-week intervals instead of the typical infusions every 4 weeks with the goal to assess if patients on EID had an increase in clinical relapses. METHODS: This is a retrospective review of all patients with MS treated with natalizumab at two MS centers where patients were offered the opportunity to switch to an EID every 6 or 8 weeks. RESULTS: A total of 361 patients received natalizumab for 22 ± 13 months (minimum duration 6 months). Of these, 96 patients received EID natalizumab at some point for 20 ± 11 months (minimum duration 6 months). Over the study period, there was no significant difference between the relapse rate in the monthly dosing (13%) and the EID (13%) groups of patients. CONCLUSION: Natalizumab is effective in controlling MS as very few clinical relapses were observed in our dataset. We found that EID did not compromise the treatment effect as measured by relapse rate and no significant breakthrough disease activity was observed. EID is an optional regimen for maintenance natalizumab therapy, but prospective studies are warranted to determine its efficacy.
BACKGROUND: The enthusiasm for natalizumab, a highly efficacious agent in the treatment of multiple sclerosis (MS), has been tempered by the risks of progressive multifocal leukoencephalopathy associated with its use, and strategies to minimize those risks are of great interest. Extended interval dosing (EID) has been proposed as a way to maintain the efficacy of natalizumab while reducing exposure to it. We reviewed a cohort of patients who received natalizumab at 6-8-week intervals instead of the typical infusions every 4 weeks with the goal to assess if patients on EID had an increase in clinical relapses. METHODS: This is a retrospective review of all patients with MS treated with natalizumab at two MS centers where patients were offered the opportunity to switch to an EID every 6 or 8 weeks. RESULTS: A total of 361 patients received natalizumab for 22 ± 13 months (minimum duration 6 months). Of these, 96 patients received EIDnatalizumab at some point for 20 ± 11 months (minimum duration 6 months). Over the study period, there was no significant difference between the relapse rate in the monthly dosing (13%) and the EID (13%) groups of patients. CONCLUSION:Natalizumab is effective in controlling MS as very few clinical relapses were observed in our dataset. We found that EID did not compromise the treatment effect as measured by relapse rate and no significant breakthrough disease activity was observed. EID is an optional regimen for maintenance natalizumab therapy, but prospective studies are warranted to determine its efficacy.
Authors: Carolina Holmén; Fredrik Piehl; Jan Hillert; Anna Fogdell-Hahn; Malin Lundkvist; Elin Karlberg; Petra Nilsson; Charlotte Dahle; Nils Feltelius; Anders Svenningsson; Jan Lycke; Tomas Olsson Journal: Mult Scler Date: 2011-01-12 Impact factor: 6.312
Authors: Ludwig Kappos; David Bates; Gilles Edan; Mefkûre Eraksoy; Antonio Garcia-Merino; Nikolaos Grigoriadis; Hans-Peter Hartung; Eva Havrdová; Jan Hillert; Reinhard Hohlfeld; Marcelo Kremenchutzky; Olivier Lyon-Caen; Ariel Miller; Carlo Pozzilli; Mads Ravnborg; Takahiko Saida; Christian Sindic; Karl Vass; David B Clifford; Stephen Hauser; Eugene O Major; Paul W O'Connor; Howard L Weiner; Michel Clanet; Ralf Gold; Hans H Hirsch; Ernst-Wilhelm Radü; Per Soelberg Sørensen; John King Journal: Lancet Neurol Date: 2011-08 Impact factor: 44.182
Authors: Joep Killestein; Anke Vennegoor; Eva M Strijbis; Alexandra Seewann; Bob W van Oosten; Bernard M J Uitdehaag; Chris H Polman Journal: Ann Neurol Date: 2010-09 Impact factor: 10.422
Authors: Eva Havrdova; Steven Galetta; Michael Hutchinson; Dusan Stefoski; David Bates; Chris H Polman; Paul W O'Connor; Gavin Giovannoni; J Theodore Phillips; Fred D Lublin; Amy Pace; Richard Kim; Robert Hyde Journal: Lancet Neurol Date: 2009-02-07 Impact factor: 44.182
Authors: Hans Lindå; Anders von Heijne; Eugene O Major; Caroline Ryschkewitsch; Johan Berg; Tomas Olsson; Claes Martin Journal: N Engl J Med Date: 2009-09-10 Impact factor: 91.245
Authors: Paul O'Connor; David Miller; Katherine Riester; Minhua Yang; Michael Panzara; Catherine Dalton; Katherine Miszkiel; Omar Khan; George Rice; William Sheremata Journal: Mult Scler Date: 2005-10 Impact factor: 6.312
Authors: Tamara Castillo-Trivino; Ellen M Mowry; Alberto Gajofatto; Dorothee Chabas; Elizabeth Crabtree-Hartman; Bruce A Cree; Douglas S Goodin; Ari J Green; Darin T Okuda; Daniel Pelletier; Scott S Zamvil; Eric Vittinghoff; Emmanuelle Waubant Journal: PLoS One Date: 2011-02-03 Impact factor: 3.240
Authors: Robert J Fox; Bruce A C Cree; Jerome De Sèze; Ralf Gold; Hans-Peter Hartung; Douglas Jeffery; Ludwig Kappos; Michael Kaufman; Xavier Montalbán; Bianca Weinstock-Guttman; Britt Anderson; Amy Natarajan; Barry Ticho; Petra Duda Journal: Neurology Date: 2014-03-28 Impact factor: 9.910
Authors: Zoé LE van Kempen; Cyra E Leurs; Birgit I Witte; Annick de Vries; Mike P Wattjes; Theo Rispens; Joep Killestein Journal: Mult Scler Date: 2017-05-09 Impact factor: 6.312
Authors: Robert T Naismith; Barry Hendin; Sibyl Wray; DeRen Huang; Fiorenza Gaudenzi; Qunming Dong; Bjørn Sperling; Monica Mann; Brian Werneburg Journal: Mult Scler J Exp Transl Clin Date: 2019-01-30
Authors: T Sehr; U Proschmann; K Thomas; M Marggraf; E Straube; H Reichmann; A Chan; T Ziemssen Journal: J Neuroinflammation Date: 2016-06-27 Impact factor: 8.322