OBJECTIVE: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents. METHODS: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses. RESULTS: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p < 0.001). No difference in the rate of sustained disability progression events was observed between the groups. The change in overall disability burden (quantified as area under the disability-time curve) differed between natalizumab and fingolimod (-0.12 vs 0.04 per year, respectively, p < 0.001). INTERPRETATION: This study suggests that in active multiple sclerosis during treatment with injectable disease-modifying therapies, switching to natalizumab is more effective than switching to fingolimod in reducing relapse rate and short-term disability burden.
OBJECTIVE: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents. METHODS: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses. RESULTS: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p < 0.001). No difference in the rate of sustained disability progression events was observed between the groups. The change in overall disability burden (quantified as area under the disability-time curve) differed between natalizumab and fingolimod (-0.12 vs 0.04 per year, respectively, p < 0.001). INTERPRETATION: This study suggests that in active multiple sclerosis during treatment with injectable disease-modifying therapies, switching to natalizumab is more effective than switching to fingolimod in reducing relapse rate and short-term disability burden.
Authors: Maria Trojano; Mar Tintore; Xavier Montalban; Jan Hillert; Tomas Kalincik; Pietro Iaffaldano; Tim Spelman; Maria Pia Sormani; Helmut Butzkueven Journal: Nat Rev Neurol Date: 2017-01-13 Impact factor: 42.937
Authors: Tim Spelman; Tomas Kalincik; Vilija Jokubaitis; Annie Zhang; Fabio Pellegrini; Heinz Wiendl; Shibeshih Belachew; Robert Hyde; Freek Verheul; Alessandra Lugaresi; Eva Havrdová; Dana Horáková; Pierre Grammond; Pierre Duquette; Alexandre Prat; Gerardo Iuliano; Murat Terzi; Guillermo Izquierdo; Raymond M M Hupperts; Cavit Boz; Eugenio Pucci; Giorgio Giuliani; Patrizia Sola; Daniele L A Spitaleri; Jeannette Lechner-Scott; Roberto Bergamaschi; François Grand'Maison; Franco Granella; Ludwig Kappos; Maria Trojano; Helmut Butzkueven Journal: Neurol Clin Pract Date: 2016-04
Authors: Johannes Lorscheider; Vilija G Jokubaitis; Tim Spelman; Guillermo Izquierdo; Alessandra Lugaresi; Eva Havrdova; Dana Horakova; Maria Trojano; Pierre Duquette; Marc Girard; Alexandre Prat; François Grand'Maison; Pierre Grammond; Eugenio Pucci; Cavit Boz; Patrizia Sola; Diana Ferraro; Daniele Spitaleri; Jeanette Lechner-Scott; Murat Terzi; Vincent Van Pesch; Gerardo Iuliano; Roberto Bergamaschi; Cristina Ramo-Tello; Franco Granella; Celia Oreja-Guevara; Helmut Butzkueven; Tomas Kalincik Journal: Neurology Date: 2017-08-09 Impact factor: 9.910