1. The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies
- Author
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Andersen, JB, Sharmin, S, Lefort, M, Koch-Henriksen, N, Sellebjerg, F, Sorensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Horakova, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Maison, FG, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Skibina, O, Solaro, C, Karabudak, R, Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, Seze, JD, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, J-P, Marousset, A, Patry, I, Hankiewicz, K, Pottier, C, Maubeuge, N, Labeyrie, C, Nifle, C, Leray, E, Laplaud, DA, Butzkueven, H, Kalincik, T, Vukusic, S, Magyari, M, Andersen, JB, Sharmin, S, Lefort, M, Koch-Henriksen, N, Sellebjerg, F, Sorensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Horakova, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Maison, FG, Yamout, B, Prat, A, Girard, M, Duquette, P, Boz, C, Trojano, M, McCombe, P, Slee, M, Lechner-Scott, J, Turkoglu, R, Sola, P, Ferraro, D, Granella, F, Shaygannejad, V, Prevost, J, Skibina, O, Solaro, C, Karabudak, R, Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, Seze, JD, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun, C, Moreau, T, Berger, E, Clavelou, P, Pelletier, J, Stankoff, B, Gout, O, Thouvenot, E, Heinzlef, O, Al-Khedr, A, Bourre, B, Casez, O, Cabre, P, Montcuquet, A, Wahab, A, Camdessanche, J-P, Marousset, A, Patry, I, Hankiewicz, K, Pottier, C, Maubeuge, N, Labeyrie, C, Nifle, C, Leray, E, Laplaud, DA, Butzkueven, H, Kalincik, T, Vukusic, S, and Magyari, M
- Abstract
BACKGROUND: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. METHODS: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. RESULTS: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. CONCLUSION: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.
- Published
- 2021