TY - JOUR
T1 - Switch to natalizumab versus fingolimod in active relapsing–remitting multiple sclerosis
AU - Kalincik, Tomas
AU - Horakova, Dana
AU - Spelman, Tim
AU - Jokubaitis, Vilija
AU - Trojano, Maria
AU - Lugaresi, Alessandra
AU - Izquierdo, Guillermo
AU - Rozsa, Csilla
AU - Grammond, Pierre
AU - Alroughani, Raed
AU - Duquette, Pierre
AU - Girard, Marc
AU - Pucci, Eugenio
AU - Lechner-Scott, Jeannette
AU - Slee, Mark
AU - Fernandez-Bolanos, Ricardo
AU - Grand'Maison, Francois
AU - Hupperts, Raymond
AU - Verheul, Freek
AU - Hodgkinson, Suzanne
AU - Oreja-Guevara, Celia
AU - Spitaleri, Daniele
AU - Barnett, Michael
AU - Terzi, Murat
AU - Bergamaschi, Roberto
AU - McCombe, Pamela
AU - Sanchez-Menoyo, Jose
AU - Simo, Magdolna
AU - Csepany, Tunde
AU - Rum, Gabor
AU - Boz, Cavit
AU - Havrdova, Eva
AU - Butzkeuven, Helmut
PY - 2015/3/1
Y1 - 2015/3/1
N2 - 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 (20.12 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.
AB - 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 (20.12 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.
UR - http://www.scopus.com/inward/record.url?scp=84923772724&partnerID=8YFLogxK
U2 - 10.1002/ana.24339
DO - 10.1002/ana.24339
M3 - Article
SN - 0364-5134
VL - 77
SP - 425
EP - 435
JO - Annals of Neurology
JF - Annals of Neurology
IS - 3
ER -