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Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis.
Ann Neurol 2015; 77(3):425-35AN

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.

Authors+Show Affiliations

Department of Medicine, University of Melbourne, Melbourne, Australia; Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25546031

Citation

Kalincik, Tomas, et al. "Switch to Natalizumab Versus Fingolimod in Active Relapsing-remitting Multiple Sclerosis." Annals of Neurology, vol. 77, no. 3, 2015, pp. 425-35.
Kalincik T, Horakova D, Spelman T, et al. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Ann Neurol. 2015;77(3):425-35.
Kalincik, T., Horakova, D., Spelman, T., Jokubaitis, V., Trojano, M., Lugaresi, A., ... Butzkueven, H. (2015). Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Annals of Neurology, 77(3), pp. 425-35. doi:10.1002/ana.24339.
Kalincik T, et al. Switch to Natalizumab Versus Fingolimod in Active Relapsing-remitting Multiple Sclerosis. Ann Neurol. 2015;77(3):425-35. PubMed PMID: 25546031.
* Article titles in AMA citation format should be in sentence-case
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 - Butzkueven,Helmut, AU - ,, Y1 - 2015/01/17/ PY - 2014/07/05/received PY - 2014/12/08/revised PY - 2014/12/21/accepted PY - 2014/12/30/entrez PY - 2014/12/30/pubmed PY - 2015/4/29/medline SP - 425 EP - 35 JF - Annals of neurology JO - Ann. Neurol. VL - 77 IS - 3 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 (-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. SN - 1531-8249 UR - https://www.unboundmedicine.com/medline/citation/25546031/Switch_to_natalizumab_versus_fingolimod_in_active_relapsing_remitting_multiple_sclerosis_ L2 - https://doi.org/10.1002/ana.24339 DB - PRIME DP - Unbound Medicine ER -