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6. Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

Author

Lefort, M., Sharmin, S., Andersen, J. B., Vukusic, S., Casey, R., Debouverie, M., Edan, G., Ciron, J., Ruet, A., De Sèze, J., Maillart, E., Zephir, H., Labauge, P., Defer, G., Lebrun-Frenay, 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., Camdessanché, J. P., Maurousset, A., Ben Nasr, H., Hankiewicz, K., Pottier, C., Maubeuge, N., Dimitri-Boulos, D., Nifle, C., Laplaud, D. A., Horakova, D., Havrdova, E. K., Alroughani, R., Izquierdo, G., Eichau, S., Ozakbas, S., Patti, F., Onofrj, M., Lugaresi, A., Terzi, M., Grammond, P., Grand’Maison, F., 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., Maimone, D., Skibina, O., Buzzard, K., Van der Walt, A., Karabudak, R., Van Wijmeersch, B., Csepany, T., Spitaleri, D., Vucic, S., Koch-Henriksen, N., Sellebjerg, F., Soerensen, P. S., Hilt Christensen, C. C., Rasmussen, P. V., Jensen, M. B., Frederiksen, J. L., Bramow, S., Mathiesen, H. K., Schreiber, K. I., Butzkueven, H., Magyari, M., Kalincik, T., and Leray, E.

Published
2022
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9. Urinary tract infections and multiple sclerosis: Recommendations from the French Multiple Sclerosis Society

Author

Donzé, C., Papeix, C., Lebrun-Frénay, C., Collongues, N., de Seze, M., Dinh, A., Even, A., Scheiber-Nogueira, C., Bensa, C., Bourre, B., Carra-Dallière, C., Ciron, J., Cohen, M., Guennoc, A.M., Louapre, C., Lebreton, F., Michel, L., Maillart, E., Audoin, B., Ayrignac, X., Bernady, P., Brochet, B., Clavelou, P., Colamarino, R., Declemy, A., de Seze, J., Derache, N., Faucheux, J.-M., Heinzlef, O., Labauge, P., Laplaud, D., Lepage, E., Leray, E., Magy, L., Mathey, G., Mekies, C., Mondain, V., Planque, E., Pelletier, J., Pittion, S., Stankhof, B., Tournaire, P., Thouvenot, E., Vukusic, S., Wiertlevski, S., Zephir, H., Alchaar, H., Androdias, G., Benazet, M., Bensmail, D., Biotti, D., Blanchard-Dauphin, A., Bonnan, M., Boutière, C., Branger, P., Bresch, S., Bru, J.-P., Camdessanché, J.-P., Castel Canal, E., Coustans, M., Casez, O., Castan, B., Creange, A., Creisson, E., De Broucker, T., Depaz, R., Douay, X., Dulau, C., Durand-Dubief, F., Fagniez, O., Faucher, M., Floch, A., Fournier, M., Fromont, A., Gallien, P., Gamé, X., Gault, D., Gayou, A., Giroux, M., Gout, O., Grimaud, J., Hautecoeur, P., Kerbrat, A., Kremer, L., Kwiatkowski, A., Labeyrie, C., Lachaud, S., Lanctin-Garcia, C., Lanotte, L., Manchon, E., Maurousset, A., Milor, A.-M., Moisset, X., Mont-Cuquet, A., Moreau, T., Ouallet, J.-C., Patry, I., Peaureaux, D., Pouget, M.-C., Pourcher Martinez, V., Radot, C., Ruet, A., Saint-Val, C., Salmon, A., Taithe, F., Tatevin, P., Vaillant, M., Stahl, J.-P., Vuoto, F., Zaenker, C., and Lebrun-Frenay, C.

Published
2020
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10. Immunization and multiple sclerosis: Recommendations from the French Multiple Sclerosis Society

Author

Abadie, V., Achour, C., Ader, F., Alchaar, H., Alkhedr, A., Andreux, F., Androdias, G., Arjmand, R., Audoin, B., Audry, D., Aufauvre, D., Autreaux, C., Ayrignac, X., Bailbe, M., Benazet, M., Bensa, C., Bensmail, D., Berger, E., Bernady, P., Bertagna, Y., Biotti, D., Blanchard-Dauphin, A., Bonenfant, J., Bonnan, M., Bonnemain, B., Borgel, F., Botelho-Nevers, E., Boucly, S., Bourre, B., Boutière, C., Branger, P., Brassat, D., Bresch, S., Breuil, V., Brochet, B., Brugeilles, H., Bugnon, P., Cabre, P., Camdessanché, J.-P., Carra-Dalière, C., Casez, O., Chamouard, J.-M., Chassande, B., Chataignier, P., Chbicheb, M., Chenet, A., Ciron, J., Clavelou, P., Cohen, M., Colamarino, R., Collongues, N., Coman, I., Corail, P.-R., Courtois, S., Coustans, M., Creange, A., Creisson, E., Daluzeau, N., Davenas, C., De Seze, J., Debouverie, M., Depaz, R., Derache, N., Divio, L., Douay, X., Dulau, C., Durand-Dubief, F., Edan, G., Elias, Z., Fagniez, O., Faucher, M., Faucheux, J.-M., Fournier, M., Gagneux-Brunon, A., Gaida, P., Galli, P., Gallien, P., Gaudelus, J., Gault, D., Gayou, A., Genevray, M., Gentil, A., Gere, J., Gignoux, L., Giroux, M., Givron, P., Gout, O., Grimaud, J., Guennoc, A.-M., Hadhoum, N., Hautecoeur, P., Heinzlef, O., Jaeger, M., Jeannin, S., Kremer, L., Kwiatkowski, A., Labauge, P., Labeyrie, C., Lachaud, S., Laffont, I., Lanctin-Garcia, C., Lannoy, J., Lanotte, L., Laplaud, D., Latombe, D., Lauxerois, M., Le Page, E., Lebrun-Frenay, C., Lejeune, P., Lejoyeux, P., Lemonnier, B., Leray, E., Loche, C.-M., Louapre, C., Lubetzki, C., Maarouf, A., Mada, B., Magy, L., Maillart, E., Manchon, E., Marignier, R., Marque, P., Mathey, G., Maurousset, A., Mekies, C., Merienne, M., Michel, L., Milor, A.-M., Moisset, X., Montcuquet, A., Moreau, T., Morel, N., Moussa, M., Naudillon, J.-P., Normand, M., Olive, P., Ouallet, J.-C., Outteryck, O., Pacault, C., Papeix, C., Patry, I., Peaureaux, D., Pelletier, J., Pichon, B., Pittion, S., Planque, E., Pouget, M.-C., Pourcher, V., Radot, C., Robert, I., Rocher, F., Ruet, A., Saint-Val, C., Salle, J.-Y., Salmon, A., Sartori, E., Schaeffer, S., Stankhof, B., Taithe, F., Thouvenot, E., Tizon, C., Tourbah, A., Tourniaire, P., Vaillant, M., Vermersch, P., Vidil, S., Wahab, A., Warter, M.-H., Wiertlewski, S., Wiplosz, B., Wittwer, B., Zaenker, C., Zephir, H., Lebrun, C., and Vukusic, S.

Published
2019
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18. Historique de la sclérose en plaques

Author

Defer, Gilles, primary, Debouverie, Marc, additional, Bardou, I., additional, Benamar, M., additional, Bernard-Valnet, R., additional, Branger, P., additional, Brassat, D., additional, Benallègue, N., additional, Calocer, F., additional, Damotte, V., additional, Dejardin, O., additional, Dejean, A., additional, Derache, N., additional, Docagne, F., additional, Donzé, C., additional, Dubessy, A.-L., additional, Fontaine, B., additional, Fournié, G., additional, Fromont, A., additional, Garcia, A., additional, Hautecœur, P., additional, Lanotte, L., additional, Laplaud, D., additional, Le Mauff, B., additional, Lebas, H., additional, Leray, E., additional, Mathey, G., additional, Merkler, D., additional, Michel, L., additional, Michieletto, M., additional, Morille, J., additional, Nicol, B., additional, Pierrot-Deseilligny, C., additional, Pittion-Vouyovitch, S., additional, Rebeix, I., additional, Saoudi, A., additional, Seilhean, D., additional, Stankoff, B., additional, Toutirais, O., additional, Vivien, D., additional, and Vukusic, S., additional

Published
2019
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19. Immunologie de la sclérose en plaques

Author

Defer, Gilles, primary, Debouverie, Marc, additional, Bardou, I., additional, Benamar, M., additional, Bernard-Valnet, R., additional, Branger, P., additional, Brassat, D., additional, Benallègue, N., additional, Calocer, F., additional, Damotte, V., additional, Dejardin, O., additional, Dejean, A., additional, Derache, N., additional, Docagne, F., additional, Donzé, C., additional, Dubessy, A.-L., additional, Fontaine, B., additional, Fournié, G., additional, Fromont, A., additional, Garcia, A., additional, Hautecœur, P., additional, Lanotte, L., additional, Laplaud, D., additional, Le Mauff, B., additional, Lebas, H., additional, Leray, E., additional, Mathey, G., additional, Merkler, D., additional, Michel, L., additional, Michieletto, M., additional, Morille, J., additional, Nicol, B., additional, Pierrot-Deseilligny, C., additional, Pittion-Vouyovitch, S., additional, Rebeix, I., additional, Saoudi, A., additional, Seilhean, D., additional, Stankoff, B., additional, Toutirais, O., additional, Vivien, D., additional, and Vukusic, S., additional

Published
2019
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20. Épidémiologie, environnement et génétique dans la sclérose en plaques

Author

Defer, Gilles, primary, Debouverie, Marc, additional, Bardou, I., additional, Benamar, M., additional, Bernard-Valnet, R., additional, Branger, P., additional, Brassat, D., additional, Benallègue, N., additional, Calocer, F., additional, Damotte, V., additional, Dejardin, O., additional, Dejean, A., additional, Derache, N., additional, Docagne, F., additional, Donzé, C., additional, Dubessy, A.-L., additional, Fontaine, B., additional, Fournié, G., additional, Fromont, A., additional, Garcia, A., additional, Hautecœur, P., additional, Lanotte, L., additional, Laplaud, D., additional, Le Mauff, B., additional, Lebas, H., additional, Leray, E., additional, Mathey, G., additional, Merkler, D., additional, Michel, L., additional, Michieletto, M., additional, Morille, J., additional, Nicol, B., additional, Pierrot-Deseilligny, C., additional, Pittion-Vouyovitch, S., additional, Rebeix, I., additional, Saoudi, A., additional, Seilhean, D., additional, Stankoff, B., additional, Toutirais, O., additional, Vivien, D., additional, and Vukusic, S., additional

Published
2019
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21. Histoire naturelle de la sclérose en plaques

Author

Defer, Gilles, primary, Debouverie, Marc, additional, Bardou, I., additional, Benamar, M., additional, Bernard-Valnet, R., additional, Branger, P., additional, Brassat, D., additional, Benallègue, N., additional, Calocer, F., additional, Damotte, V., additional, Dejardin, O., additional, Dejean, A., additional, Derache, N., additional, Docagne, F., additional, Donzé, C., additional, Dubessy, A.-L., additional, Fontaine, B., additional, Fournié, G., additional, Fromont, A., additional, Garcia, A., additional, Hautecœur, P., additional, Lanotte, L., additional, Laplaud, D., additional, Le Mauff, B., additional, Lebas, H., additional, Leray, E., additional, Mathey, G., additional, Merkler, D., additional, Michel, L., additional, Michieletto, M., additional, Morille, J., additional, Nicol, B., additional, Pierrot-Deseilligny, C., additional, Pittion-Vouyovitch, S., additional, Rebeix, I., additional, Saoudi, A., additional, Seilhean, D., additional, Stankoff, B., additional, Toutirais, O., additional, Vivien, D., additional, and Vukusic, S., additional

Published
2019
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27. Disease Reactivation After Cessation of Disease-Modifying Therapy in Patients With Relapsing-Remitting Multiple Sclerosis.

Author

Roos I., Malpas C., Leray E., Casey R., Horakova D., Havrdova E.K., Debouverie M., Patti F., De Seze J., Izquierdo G., Eichau S., Edan G., Prat A., Girard M., Ozakbas S., Grammond P., Zephir H., Ciron J., Maillart E., Moreau T., Amato M.P., Labauge P., Alroughani R., Buzzard K., Skibina O., Terzi M., Laplaud D.A., Berger E., Grand'Maison F., Lebrun-Frenay C., Cartechini E., Boz C., Lechner-Scott J., Clavelou P., Stankoff B., Prevost J., Kappos L., Pelletier J., Shaygannejad V., Yamout B.I., Khoury S.J., Gerlach O., Spitaleri D.L.A., Van Pesch V., Gout O., Turkoglu R., Heinzlef O., Thouvenot E., McCombe P.A., Soysal A., Bourre B., Slee M., Castillo-Trivino T., Bakchine S., Ampapa R., Butler E.G., Wahab A., Macdonell R.A., Aguera-Morales E., Cabre P., Ben N.H., Van der Walt A., Laureys G., Van Hijfte L., Ramo-Tello C.M., Maubeuge N., Hodgkinson S., Sanchez-Menoyo J.L., Barnett M.H., Labeyrie C., Vucic S., Sidhom Y., Gouider R., Csepany T., Sotoca J., de Gans K., Al-Asmi A., Fragoso Y.D., Vukusic S., Butzkueven H., Kalincik T., Roos I., Malpas C., Leray E., Casey R., Horakova D., Havrdova E.K., Debouverie M., Patti F., De Seze J., Izquierdo G., Eichau S., Edan G., Prat A., Girard M., Ozakbas S., Grammond P., Zephir H., Ciron J., Maillart E., Moreau T., Amato M.P., Labauge P., Alroughani R., Buzzard K., Skibina O., Terzi M., Laplaud D.A., Berger E., Grand'Maison F., Lebrun-Frenay C., Cartechini E., Boz C., Lechner-Scott J., Clavelou P., Stankoff B., Prevost J., Kappos L., Pelletier J., Shaygannejad V., Yamout B.I., Khoury S.J., Gerlach O., Spitaleri D.L.A., Van Pesch V., Gout O., Turkoglu R., Heinzlef O., Thouvenot E., McCombe P.A., Soysal A., Bourre B., Slee M., Castillo-Trivino T., Bakchine S., Ampapa R., Butler E.G., Wahab A., Macdonell R.A., Aguera-Morales E., Cabre P., Ben N.H., Van der Walt A., Laureys G., Van Hijfte L., Ramo-Tello C.M., Maubeuge N., Hodgkinson S., Sanchez-Menoyo J.L., Barnett M.H., Labeyrie C., Vucic S., Sidhom Y., Gouider R., Csepany T., Sotoca J., de Gans K., Al-Asmi A., Fragoso Y.D., Vukusic S., Butzkueven H., and Kalincik T.

Abstract

OBJECTIVES: To evaluate the rate of return of disease activity after cessation of multiple sclerosis (MS) disease-modifying therapy. METHOD(S): This was a retrospective cohort study from two large observational MS registries: MSBase and OFSEP. Patients with relapsing-remitting MS who had ceased a disease-modifying therapy and were followed up for the subsequent 12-months were included in the analysis. The primary study outcome was annualised relapse rate in the 12 months after disease-modifying therapy discontinuation stratified by patients who did, and did not, commence a subsequent therapy. The secondary endpoint was the predictors of first relapse and disability accumulation after treatment discontinuation. RESULT(S): 14,213 patients, with 18,029 eligible treatment discontinuation epochs, were identified for seven therapies. Annualised rates of relapse (ARR) started to increase 2-months after natalizumab cessation (month 2-4 ARR, 95% confidence interval): 0.47, 0.43-0.51). Commencement of a subsequent therapy within 2-4 months reduced the magnitude of disease reactivation (mean ARR difference: 0.15, 0.08-0.22). After discontinuation of fingolimod, rates of relapse increased overall (month 1-2 ARR: 0.80, 0.70-0.89), and stabilised faster in patients who started a new therapy within 1-2 months (mean ARR difference: 0.14, -0.01-0.29). Magnitude of disease reactivation for other therapies was low, but reduced further by commencement of another treatment 1-10 months after treatment discontinuation. Predictors of relapse were higher relapse rate in the year before cessation, female sex, younger age and higher EDSS. Commencement of a subsequent therapy reduced both the risk of relapse (HR 0.76, 95%CI 0.72-0.81) and disability accumulation (0.73, 0.65-0.80). CONCLUSION(S): The rate of disease reactivation after treatment cessation differs among MS treatments, with the peaks of relapse activity ranging from 1 to 10 months in untreated cohorts that discontinued different t

Published
2022

28. Impact of methodological choices in comparative effectiveness studies: application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

Author

Lefort, M, Sharmin, S, Andersen, JB, Vukusic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, De Seze, J, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun-Frenay, 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, JP, Maurousset, A, Ben Nasr, H, Hankiewicz, K, Pottier, C, Maubeuge, N, Nifle, C, Laplaud, DA, Horakova, D, Dimitri-Boulos, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Grand'Maison, F, 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, Maimone, D, Skibina, O, Buzzard, K, Van der Walt, A, Karabudak, R, Van Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Koch-Henriksen, N, Sellebjerg, F, Soerensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Butzkueven, H, Magyari, M, Kalincik, T, Leray, E, Lefort, M, Sharmin, S, Andersen, JB, Vukusic, S, Casey, R, Debouverie, M, Edan, G, Ciron, J, Ruet, A, De Seze, J, Maillart, E, Zephir, H, Labauge, P, Defer, G, Lebrun-Frenay, 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, JP, Maurousset, A, Ben Nasr, H, Hankiewicz, K, Pottier, C, Maubeuge, N, Nifle, C, Laplaud, DA, Horakova, D, Dimitri-Boulos, D, Havrdova, EK, Alroughani, R, Izquierdo, G, Eichau, S, Ozakbas, S, Patti, F, Onofrj, M, Lugaresi, A, Terzi, M, Grammond, P, Grand'Maison, F, 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, Maimone, D, Skibina, O, Buzzard, K, Van der Walt, A, Karabudak, R, Van Wijmeersch, B, Csepany, T, Spitaleri, D, Vucic, S, Koch-Henriksen, N, Sellebjerg, F, Soerensen, PS, Christensen, CCH, Rasmussen, P, Jensen, MB, Frederiksen, JL, Bramow, S, Mathiesen, HK, Schreiber, K, Butzkueven, H, Magyari, M, Kalincik, T, and Leray, E

Abstract

BACKGROUND: Natalizumab and fingolimod are used as high-efficacy treatments in relapsing-remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies. METHODS: Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for estimating average treatment effect for treated or average treatment effect for the entire population. Analyses were conducted both in intention-to-treat and per-protocol frameworks. The impact of the positivity assumption was also assessed. RESULTS: Overall, 5,148 relapsing-remitting multiple sclerosis patients were included. In this well-powered sample, the 95% confidence intervals of the estimates overlapped widely. Propensity scores weighting and propensity scores matching procedures led to consistent results. Some differences were observed between average treatment effect for the entire population and average treatment effect for treated estimates. Intention-to-treat analyses were more conservative than per-protocol analyses. The most pronounced irregularities in outcomes and propensity scores were introduced by violation of the positivity assumption. CONCLUSIONS: This applied study elucidates the influence of methodological decisions on the results of comparative effectiveness studies of treatments for multiple sclerosis. According to our results, there are no material differences between conclusions obtained with propensity scores matching or propensity scores weighting given that a study is sufficiently powered, models are correctly specified and positivity assumption is ful

Published
2022

29. Disease Reactivation After Cessation of Disease-Modifying Therapy in Patients With Relapsing-Remitting Multiple Sclerosis

Author

Roos, I, Malpas, C, Leray, E, Casey, R, Horakova, D, Havrdova, EK, Debouverie, M, Patti, F, De Seze, J, Izquierdo, G, Eichau, S, Edan, G, Prat, A, Girard, M, Ozakbas, S, Grammond, P, Zephir, H, Ciron, J, Maillart, E, Moreau, T, Amato, MP, Labauge, P, Alroughani, R, Buzzard, K, Skibina, O, Terzi, M, Laplaud, DA, Berger, E, Grand'Maison, F, Lebrun-Frenay, C, Cartechini, E, Boz, C, Lechner-Scott, J, Clavelou, P, Stankoff, B, Prevost, J, Kappos, L, Pelletier, J, Shaygannejad, V, Yamout, B, Khoury, SJ, Gerlach, O, Spitaleri, DLA, Van Pesch, V, Gout, O, Turkoglu, R, Heinzlef, O, Thouvenot, E, McCombe, PA, Soysal, A, Bourre, B, Slee, M, Castillo-Trivino, T, Bakchine, S, Ampapa, R, Butler, EG, Wahab, A, Macdonell, RA, Aguera-Morales, E, Cabre, P, Ben, NH, Van der Walt, A, Laureys, G, Van Hijfte, L, Ramo-Tello, CM, Maubeuge, N, Hodgkinson, S, Sanchez-Menoyo, JL, Barnett, MH, Labeyrie, C, Vucic, S, Sidhom, Y, Gouider, R, Csepany, T, Sotoca, J, de Gans, K, Al-Asmi, A, Fragoso, YD, Vukusic, S, Butzkueven, H, Kalincik, T, Roos, I, Malpas, C, Leray, E, Casey, R, Horakova, D, Havrdova, EK, Debouverie, M, Patti, F, De Seze, J, Izquierdo, G, Eichau, S, Edan, G, Prat, A, Girard, M, Ozakbas, S, Grammond, P, Zephir, H, Ciron, J, Maillart, E, Moreau, T, Amato, MP, Labauge, P, Alroughani, R, Buzzard, K, Skibina, O, Terzi, M, Laplaud, DA, Berger, E, Grand'Maison, F, Lebrun-Frenay, C, Cartechini, E, Boz, C, Lechner-Scott, J, Clavelou, P, Stankoff, B, Prevost, J, Kappos, L, Pelletier, J, Shaygannejad, V, Yamout, B, Khoury, SJ, Gerlach, O, Spitaleri, DLA, Van Pesch, V, Gout, O, Turkoglu, R, Heinzlef, O, Thouvenot, E, McCombe, PA, Soysal, A, Bourre, B, Slee, M, Castillo-Trivino, T, Bakchine, S, Ampapa, R, Butler, EG, Wahab, A, Macdonell, RA, Aguera-Morales, E, Cabre, P, Ben, NH, Van der Walt, A, Laureys, G, Van Hijfte, L, Ramo-Tello, CM, Maubeuge, N, Hodgkinson, S, Sanchez-Menoyo, JL, Barnett, MH, Labeyrie, C, Vucic, S, Sidhom, Y, Gouider, R, Csepany, T, Sotoca, J, de Gans, K, Al-Asmi, A, Fragoso, YD, Vukusic, S, Butzkueven, H, and Kalincik, T

Abstract

BACKGROUND AND OBJECTIVES: To evaluate the rate of return of disease activity after cessation of multiple sclerosis (MS) disease-modifying therapy. METHODS: This was a retrospective cohort study from 2 large observational MS registries: MSBase and OFSEP. Patients with relapsing-remitting MS who had ceased a disease-modifying therapy and were followed up for the subsequent 12 months were included in the analysis. The primary study outcome was annualized relapse rate in the 12 months after disease-modifying therapy discontinuation stratified by patients who did, and did not, commence a subsequent therapy. The secondary endpoint was the predictors of first relapse and disability accumulation after treatment discontinuation. RESULTS: A total of 14,213 patients, with 18,029 eligible treatment discontinuation epochs, were identified for 7 therapies. Annualized rates of relapse (ARRs) started to increase 2 months after natalizumab cessation (month 2-4 ARR 0.47, 95% CI 0.43-0.51). Commencement of a subsequent therapy within 2-4 months reduced the magnitude of disease reactivation (mean ARR difference: 0.15, 0.08-0.22). After discontinuation of fingolimod, rates of relapse increased overall (month 1-2 ARR: 0.80, 0.70-0.89) and stabilized faster in patients who started a new therapy within 1-2 months (mean ARR difference: 0.14, -0.01 to 0.29). The magnitude of disease reactivation for other therapies was low but reduced further by commencement of another treatment 1-10 months after treatment discontinuation. Predictors of relapse were a higher relapse rate in the year before cessation, female sex, younger age, and higher EDSS score. Commencement of a subsequent therapy reduced both the risk of relapse (HR 0.76, 95% CI 0.72-0.81) and disability accumulation (0.73, 0.65-0.80). DISCUSSION: The rate of disease reactivation after treatment cessation differs among MS treatments, with the peaks of relapse activity ranging from 1 to 10 months in untreated cohorts that discontinued di

Published
2022

30. Impact of methodological choices in comparative effectiveness studies:application in natalizumab versus fingolimod comparison among patients with multiple sclerosis

Author

Lefort, M., Sharmin, S., Andersen, J. B., Vukusic, S., Casey, R., Debouverie, M., Edan, G., Ciron, J., Ruet, A., De Sèze, J., Maillart, E., Zephir, H., Labauge, P., Defer, G., Lebrun-Frenay, 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., Camdessanché, J. P., Maurousset, A., Ben Nasr, H., Hankiewicz, K., Pottier, C., Maubeuge, N., Dimitri-Boulos, D., Nifle, C., Laplaud, D. A., Horakova, D., Havrdova, E. K., Alroughani, R., Izquierdo, G., Eichau, S., Ozakbas, S., Patti, F., Onofrj, M., Lugaresi, A., Terzi, M., Grammond, P., Grand’Maison, F., 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., Maimone, D., Skibina, O., Buzzard, K., Van der Walt, A., Karabudak, R., Van Wijmeersch, B., Csepany, T., Spitaleri, D., Vucic, S., Koch-Henriksen, N., Sellebjerg, F., Soerensen, P. S., Hilt Christensen, C. C., Rasmussen, P. V., Jensen, M. B., Frederiksen, J. L., Bramow, S., Mathiesen, H. K., Schreiber, K. I., Butzkueven, H., Magyari, M., Kalincik, T., Leray, E., Lefort, M., Sharmin, S., Andersen, J. B., Vukusic, S., Casey, R., Debouverie, M., Edan, G., Ciron, J., Ruet, A., De Sèze, J., Maillart, E., Zephir, H., Labauge, P., Defer, G., Lebrun-Frenay, 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., Camdessanché, J. P., Maurousset, A., Ben Nasr, H., Hankiewicz, K., Pottier, C., Maubeuge, N., Dimitri-Boulos, D., Nifle, C., Laplaud, D. A., Horakova, D., Havrdova, E. K., Alroughani, R., Izquierdo, G., Eichau, S., Ozakbas, S., Patti, F., Onofrj, M., Lugaresi, A., Terzi, M., Grammond, P., Grand’Maison, F., 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., Maimone, D., Skibina, O., Buzzard, K., Van der Walt, A., Karabudak, R., Van Wijmeersch, B., Csepany, T., Spitaleri, D., Vucic, S., Koch-Henriksen, N., Sellebjerg, F., Soerensen, P. S., Hilt Christensen, C. C., Rasmussen, P. V., Jensen, M. B., Frederiksen, J. L., Bramow, S., Mathiesen, H. K., Schreiber, K. I., Butzkueven, H., Magyari, M., Kalincik, T., and Leray, E.

Abstract

Background: Natalizumab and fingolimod are used as high-efficacy treatments in relapsing–remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies. Methods: Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for estimating average treatment effect for treated or average treatment effect for the entire population. Analyses were conducted both in intention-to-treat and per-protocol frameworks. The impact of the positivity assumption was also assessed. Results: Overall, 5,148 relapsing–remitting multiple sclerosis patients were included. In this well-powered sample, the 95% confidence intervals of the estimates overlapped widely. Propensity scores weighting and propensity scores matching procedures led to consistent results. Some differences were observed between average treatment effect for the entire population and average treatment effect for treated estimates. Intention-to-treat analyses were more conservative than per-protocol analyses. The most pronounced irregularities in outcomes and propensity scores were introduced by violation of the positivity assumption. Conclusions: This applied study elucidates the influence of methodological decisions on the results of comparative effectiveness studies of treatments for multiple sclerosis. According to our results, there are no material differences between conclusions obtained with propensity scores matching or propensity scores weighting given that a study is sufficiently powered, models are correctly specified and positivity assumption is

Published
2022

33. Influence of socio-economic status on excess mortality of multiple sclerosis

Author

Wilson, S., Calocer, F., Rollot, F., Fauvernier, M., Remontet, L, Tron, L, Leray, E., Dejardin, O., Defer, G., Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre de Recherches sur l'Action Politique en Europe (ARENES), Université de Rennes (UR)-Institut d'Études Politiques [IEP] - Rennes-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Centre National de la Recherche Scientifique (CNRS), École des Hautes Études en Santé Publique [EHESP] (EHESP), Département Méthodes quantitatives en santé publique (METIS), Recherche sur les services et le management en santé (RSMS), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and ARSEP foundation 'Fondation pour l'aide a la recherche sur la Sclerose en Plaques'

Subjects
Multiple sclerosis, [SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract P46638th Congress of the European-Committee-for-Treatment-and-Research-in-Multiple-SclerosisAmsterdam, NETHERLANDSOCT 26-28, 2022

Published
2022

34. Impact of education level on multiple sclerosis disability progression in France

Author

Lefort, Mathilde, Dejardin, O., Calocer, F., Defer, G., Leray, E., Jonchère, Laurent, Centre de Recherches sur l'Action Politique en Europe (ARENES), Université de Rennes (UR)-Institut d'Études Politiques [IEP] - Rennes-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Centre National de la Recherche Scientifique (CNRS), École des Hautes Études en Santé Publique [EHESP] (EHESP), Département Méthodes quantitatives en santé publique (METIS), Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Recherche sur les services et le management en santé (RSMS), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Collectif de recherche handicap, autonomie et société inclusive (CoRHASI), EDMUS Foundation, and ARSEP Foundation

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract O15438th Congress of the European-Committee-for-Treatment-and-Research-in-Multiple-SclerosisAmsterdam, NETHERLANDSOCT 26-28, 2022

Published
2022

35. Use of pregnancy-related healthcare in women with multiple sclerosis

Author

Mainguy, M., Le Page, E., Michel, Laure, Leray, E., Jonchère, Laurent, Centre de Recherches sur l'Action Politique en Europe (ARENES), Université de Rennes (UR)-Institut d'Études Politiques [IEP] - Rennes-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Centre National de la Recherche Scientifique (CNRS), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Recherche sur les services et le management en santé (RSMS), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), École des Hautes Études en Santé Publique [EHESP] (EHESP), Département Méthodes quantitatives en santé publique (METIS), Collectif de recherche handicap, autonomie et société inclusive (CoRHASI), and ARSEP Foundation (Aide a la Recherche sur la Sclerose En Plaques)

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract P475Meeting 38th Congress of the European-Committee-for-Treatment-and-Research-in-Multiple-SclerosisAmsterdam, NETHERLANDSOCT 26-28, 2022

Published
2022

36. High and low efficacy therapy in secondary progressive multiple sclerosis

Author

Roos, I., Leray, E., Buzzard, K., Skibina, O., Lechner-Scott, J., Malpas, C. B., Butzkueven, H., Vukusic, S, Kalincik, T., University of Melbourne, Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), École des Hautes Études en Santé Publique [EHESP] (EHESP), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Monash university, The Royal Melbourne Hospital, University of Newcastle [Callaghan, Australia] (UoN), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Hospices Civils de Lyon (HCL)

Subjects
[SDV]Life Sciences [q-bio]
Abstract

International audience; Meeting Abstract

Published
2022

49. Identification of Therapeutic Lag in Multiple Sclerosis

Author

Alroughani, Raed, IULİANO, Gerardo, Hupperts, Raymond, LechnerScott, Jeannette, Spitaleri, Daniele, Van Pesch, Vincent, Soysal, Aysun, Prevost, Julie, AgueraMorales, E, Urtaza, FJO, Türkoğlu, Recai, Sidhom, Youssef, Gouider, Riadh, Van Wijmeersch, Bart, Butzkueven, Helmut, Malpas, Charles, Vukusic, S, Kalincik, Tomas, ÖZAKBAŞ, SERKAN, Horakova, Dana, GI, Ayuso, Duquette, Pierre, ROOS, I, Leray, E, FRASCOLİ, F, Casey, Romain, Havrdova, Eva, Trojano, Maria, Madueno, SE, Patti, Francesco, Onofrj, Marco, Lugaresi, Alessandra, Prat, Alexandre, Girard, Marc, Grammond, Pierre, Sola, Patrizia, Bergamaschi, Roberto, BOZ, CAVİT, Cartechini, E, SA, MJ, TERZİ, MURAT, GrandMaison, Francois, and Granella, Franco

Published
2020

50. The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies

Author

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

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