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Comparative Study
. 2015 Mar;77(3):425-35.
doi: 10.1002/ana.24339. Epub 2015 Jan 17.

Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis

Tomas Kalincik  1 , Dana Horakova, Tim Spelman, Vilija Jokubaitis, Maria Trojano, Alessandra Lugaresi, Guillermo Izquierdo, Csilla Rozsa, Pierre Grammond, Raed Alroughani, Pierre Duquette, Marc Girard, Eugenio Pucci, Jeannette Lechner-Scott, Mark Slee, Ricardo Fernandez-Bolanos, Francois Grand'Maison, Raymond Hupperts, Freek Verheul, Suzanne Hodgkinson, Celia Oreja-Guevara, Daniele Spitaleri, Michael Barnett, Murat Terzi, Roberto Bergamaschi, Pamela McCombe, Jose Sanchez-Menoyo, Magdolna Simo, Tunde Csepany, Gabor Rum, Cavit Boz, Eva Havrdova, Helmut Butzkueven; MSBase Study Group
Affiliations
Comparative Study

Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis

Tomas Kalincik et al. Ann Neurol. 2015 Mar.

Abstract

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.

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