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4. 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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5. Infections and multiple sclerosis: Recommendations from the French Multiple Sclerosis Society

Author

Papeix, C., Donzé, C., Lebrun-Frénay, C., Laplaud, D., Thouvenot, E., Ayrignac, X., Pourcher-Martinez, V., Zéphir, H., de Seze, J., Michel, L., Bensa, C., Cara-Dalliere, C., Guen-noc, A.M., Casez, O., Maarouf, A., Bourre, B., Kwiatkowski, A., Cohen, M., Maillart, E., Collongues, N., Louapre, C., Androdias, G., Guegen, A., Audoin, B., Mattey, G., Bernady, P., Faucheux, J.M., Labauge, P., Meckies, C., Stankoff, B., Tourniaire, P., Dinh, A., Guennoc, A.M., Durnad-Dubief, F., Wiertlewski, S., Derache, N., Le page, E., Pittion, S., Vukusic, S., Clavelou, P., Heinzlef, O., Colamarino, R., Planque, E., Rico, A., Sheiber nogueira, C., de Seze, M., Ciron, J., Alchaar, H., Bensmail, D., Biotti, D., Branger, P., Brochet, B., Castan, B., Creange, A., Creisson, E., DeBroucker, T., Depaz, R., Douay, X., Dulau, C., Faucher, M., Fournier, M., Fromont, A., Gallien, P., Gout, O., Grimaud, J., Hervé, Y., Kerbrat, A., Kremer, L., Lanotte, L., Magy, L., Mania, A., Maurousset, A., Moisset, X., Montcuquet, A., Moreau, T., Morel, N., Patry, I., Peaureaux, D., Pouget, M.C., Ruet, A., Saint-Val, C., Stahl, J.P., Taithe, F., Tattevin, P., Vaillant, M., Vuoto, F., and Donze, C.

Published
2021
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6. Artificial intelligence to predict clinical disability in patients with multiple sclerosis using FLAIR MRI

Author

Brochet, B., Casey, R., Cotton, F., De Sèze, J., Douek, P., Guillemin, F., Laplaud, D., Lebrun-Frenay, C., Mansuy, L., Moreau, T., Olaiz, J., Pelletier, J., Rigaud-Bully, C., Stankoff, B., Vukusic, S., Marignier, R., Debouverie, M., Edan, G., Ciron, J., Ruet, A., Collongues, N., Lubetzki, C., Vermersch, P., Labauge, P., Defer, G., Cohen, M., Fromont, A., Wiertlewsky, S., Berger, E., Clavelou, P., Audoin, B., Giannesini, C., Gout, O., Thouvenot, E., Heinzlef, O., Al-Khedr, A., Bourre, B., Casez, O., Cabre, P., Montcuquet, A., Créange, A., Camdessanché, J.-P., Faure, J., Maurousset, A., Patry, I., Hankiewicz, K., Pottier, C., Maubeuge, N., Labeyrie, C., Nifle, C., Ameli, R., Anxionnat, R., Attye, A., Bannier, E., Barillot, C., Ben Salem, D., Boncoeur-Martel, M.-P., Bonneville, F., Boutet, C., Brisset, J.-C., Cervenanski, F., Claise, B., Commowick, O., Constans, J.-M., Dardel, P., Desal, H., Dousset, Vincent, Durand-Dubief, F., Ferre, J.-C., Gerardin, E., Glattard, T., Grand, S., Grenier, T., Guillevin, R., Guttmann, C., Krainik, A., Kremer, S., Lion, S., Menjot de Champfleur, N., Mondot, L., Outteryck, O., Pyatigorskaya, N., Pruvo, J.-P., Rabaste, S., Ranjeva, J.-P., Roch, J.-A., Sadik, J.C., Sappey-Marinier, D., Savatovsky, J., Tanguy, J.-Y., Tourbah, A., Tourdias, T., Roca, P., Colas, L., Tucholka, A., Rubini, P., Cackowski, S., Ding, J., Budzik, J.-F., Renard, F., Doyle, S., Barbier, E.L., Bousaid, I., Lassau, N., and Verclytte, S.

Published
2020
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7. New OFSEP recommendations for MRI assessment of multiple sclerosis patients: Special consideration for gadolinium deposition and frequent acquisitions

Author

Ameli, R., Anxionnat, R., Audoin, B., Attye, A., Bannier, E., Barillot, C., Ben Salem, D., Boncoeur-Martel, M.-P., Bonhomme, G., Bonneville, F., Boutet, C., Brisset, J.C., Cervenanski, F., Claise, B., Commowick, O., Constans, J.-M., Cotton, F., Dardel, P., Desal, H., Dousset, V., Durand-Dubief, F., Ferre, J.-C., Gaultier, A., Gerardin, E., Glattard, T., Grand, S., Grenier, T., Guillevin, R., Guttmann, C., Krainik, A., Kremer, S., Lion, S., Champfleur, N. Menjot De, Mondot, L., Outteryck, O., Pyatigorskaya, N., Pruvo, J.-P., Rabaste, S., Ranjeva, J.-P., Roch, J.-A., Sadik, J.-C., Sappey-Marinier, D., Savatovsky, J., Stankoff, B., Tanguy, J.-Y., Tourbah, A., Tourdias, T., Brochet, B., Casey, R., De Sèze, J., Douek, P., Guillemin, F., Laplaud, D., Lebrun-Frenay, C., Mansuy, L., Moreau, T., Olaiz, J., Pelletier, J., Rigaud-Bully, C., Vukusic, S., Debouverie, M., Edan, G., Ciron, J., Lubetzki, C., Vermersch, P., Labauge, P., Defer, G., Berger, E., Clavelou, P., Gout, O., Thouvenot, E., Heinzlef, O., Al-Khedr, A., Bourre, B., Casez, O., Cabre, P., Montcuquet, A., Créange, A., Camdessanché, J.-P., Bakchine, S., Maurousset, A., Patry, I., De Broucker, T., Pottier, C., Neau, J.-P., Labeyrie, C., Nifle, C., Brisset, Jean-Christophe, Kremer, Stephane, Hannoun, Salem, Bonneville, Fabrice, Durand-Dubief, Francoise, Tourdias, Thomas, Barillot, Christian, Guttmann, Charles, Vukusic, Sandra, Dousset, Vincent, and Cotton, Francois

Published
2020
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13. 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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14. 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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15. 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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17. 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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19. [18F]DPA-714: Effect of co-medications, age, sex, BMI and TSPO polymorphism on the human plasma input function.

Author

Peyronneau, MA, Kuhnast, B, Nguyen, D-L, Jego, B, Sayet, G, Caillé, F, Lavisse, S, Gervais, P, Stankoff, B, Sarazin, M, Remy, P, Bouilleret, V, Leroy, C, and Bottlaender, M.

Subjects
TRANSLOCATOR proteins, POSITRON emission tomography, BODY mass index, SOLID phase extraction
Abstract

Purpose: We aimed to assess the effect of concomitant medication, age, sex, body mass index and 18-kDa translocator protein (TSPO) binding affinity status on the metabolism and plasma pharmacokinetics of [18F]DPA-714 and their influence on the plasma input function in a large cohort of 201 subjects who underwent brain and whole-body PET imaging to investigate the role of neuroinflammation in neurological diseases. Methods: The non-metabolized fraction of [18F]DPA-714 was estimated in venous plasma of 138 patients and 63 healthy controls (HCs; including additional arterial sampling in 16 subjects) during the 90 min brain PET acquisition using a direct solid-phase extraction method. The mean fraction between 70 and 90 min post-injection ([18F]DPA-71470–90) and corresponding normalized plasma concentration (SUV70-90) were correlated with all factors using a multiple linear regression model. Differences between groups (arterial vs venous measurements; HCs vs patients; high- (HAB), mixed- (MAB) and low-affinity binders (LAB); subjects with vs without co-medications, females vs males were also assessed using the non-parametric Mann–Whitney or Kruskal–Wallis ANOVA tests. Finally, the impact of co-medications on the brain uptake of [18F]DPA-714 at equilibrium was investigated. Results: As no significant differences were observed between arterial and venous [18F]DPA-71470–90 and SUV70-90, venous plasma was used for correlations. [18F]DPA-71470–90 was not significantly different between patients and HCS (59.7 ± 12.3% vs 60.2 ± 12.9%) despite high interindividual variability. However, 47 subjects exhibiting a huge increase or decrease of [18F]DPA-71470–90 (up to 88% or down to 23%) and SUV70-90 values (2–threefold) were found to receive co-medications identified as inhibitors or inducers of CYP3A4, known to catalyse [18F]DPA-714 metabolism. Comparison between cortex-to-plasma ratios using individual input function (VTIND) or population-based input function derived from untreated HCs (VTPBIF) indicated that non-considering the individual metabolism rate led to a bias of about 30% in VT values. Multiple linear regression model analysis of subjects free of these co-medications suggested significant correlations between [18F]DPA-71470–90 and age, BMI and sex while TSPO polymorphism did not influence the metabolism of the radiotracer. [18F]DPA-714 metabolism fell with age and BMI and was significantly faster in females than in males. Whole-body PET/CT exhibited a high uptake of the tracer in TSPO-rich organs (heart wall, spleen, kidneys...) and those involved in metabolism and excretion pathways (liver, gallbladder) in HAB and MAB with a strong decrease in LAB (-89% and -85%) resulting in tracer accumulation in plasma (4.5 and 3.3-fold increase). Conclusion: Any co-medication that inhibits or induces CYP3A4 as well as TSPO genetic status, age, BMI and sex mostly contribute to interindividual variations of the radiotracer metabolism and/or concentration that may affect the input function of [18F]DPA-714 and consequently its human brain and peripheral uptake. Trial registration: INFLAPARK, NCT02319382, registered December 18, 2014, retrospectively registered; IMABIO 3, NCT01775696, registered January 25, 2013, retrospectively registered; INFLASEP, NCT02305264, registered December 2, 2014, retrospectively registered; EPI-TEP, EudraCT 2017–003381-27, registered September 24, 2018. [ABSTRACT FROM AUTHOR]

Published
2023
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20. 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

21. 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

22. 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

23. 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

25. Improving the decision to switch from first to second-line therapy in MS: a dynamic scoring system

Author

Sabathe, C., Casey, Romain, Vukusic, S., Leray, Emmanuelle, Mathey, G., de Seze, J., Ciron, J., Wiertlewski, S., Ruet, A., Pelletier, J., Zephir, H., Michel, L., Lebrun-Frenay, C., Moisset, X., Thouvenot, Eric, Camdessanche, J. -P., Bakchine, Serge, Stankoff, B., Al Khedr, A., Cabre, P., Maillart, E., Berger, E., Heinzlef, O., Hankiewicz, K., Moreau, T., Gout, O., Bourre, B., Wahab, A., Labauge, Pierre, Montcuquet, A., Defer, G., Maurousset, A., Maubeuge, N., Dalia, D. Boulos, Ben Nasr, H., Nifle, C., Casez, O., Laplaud, D. -A., Foucher, yohann, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), 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), Hospices Civils de Lyon (HCL), 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), Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC), Université de Lorraine (UL), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Strasbourg, CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Bordeaux (UB), Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB), Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de la Timone [CHU - APHM] (TIMONE), Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), 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], Microenvironment, Cell Differentiation, Immunology and Cancer (MICMAC), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Nice [Cimiez], Hôpital Cimiez [Nice] (CHU), CHU Clermont-Ferrand, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre Hospitalier Universitaire de Reims (CHU Reims), Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Amiens-Picardie, CHU de la Martinique [Fort de France], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Neurologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHI Poissy-Saint-Germain, Centre Hospitalier de Saint-Denis [Ile-de-France], Centre d'épidémiologie des populations (CEP), Université de Bourgogne (UB)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, Fondation Ophtalmologique Adolphe de Rotschild, CHU Rouen, Normandie Université (NU), CHU Henri Mondor [Créteil], CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Limoges, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), INSERM CIC 0802 (INSERM - CHU de Poitiers), Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hémostase, Inflammation, Thrombose (HITH - U1176 Inserm - CHU Bicêtre), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)-Université Paris-Saclay, Hôpital Sud Francilien Corbeil Essonne, Centre de Référence des Maladies Auto-Inflammatoires et des Amyloses [CH Versailles] (CeRéMAIA - Hôpital André Mignot), Centre Hospitalier de Versailles André Mignot (CHV), Laboratoire de Génétique Chromosomique [CHU de Grenoble], CHU Grenoble, Agence Nationale de la Recherche French National Research Agency (ANR) uropean Commission [ANR-10COHO-002], Fond de dotation de l'Universite de Nantes, Foundation EDMUS, ANR-10-COHO-0002,OFSEP,Observatoire Français de la Sclérose en Plaques(2010), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Centre de recherche en neurosciences de Lyon (CRNL), 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), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA)-Hôpital de Hautepierre [Strasbourg]-Nouvel Hôpital Civil de Strasbourg, CHU Toulouse [Toulouse], Physiopathologie de la Plasticité Neuronale (Neurocentre Magendie - U1215 Inserm), Lille Neurosciences & Cognition - U 1172 (LilNCog (ex-JPARC)), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Henri Mondor, Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Université de Poitiers, Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

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

International audience; Meeting Abstract 035

Published
2021
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26. DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France: a pooled analysis from Italy and France

Author

Sormani, M. (Maria Pia) P. (P), Salvetti, M. (Marco), Labauge, P. (Pierre), Schiavetti, I. (Irene), Zephir, H. (Helene), Carmisciano, L. (Luca), Bensa, C. (Caroline), De Rossi, N. (Nicola), Pelletier, J. (Jean), Cordioli, C. (Cinzia), Vukusic, S. (Sandra), Moiola, L. (Lucia), Kerschen, P. (Philippe), Radaelli, M. (Marta), Théaudin, M. (Marie), Immovilli, P. (Paolo), Casez, O. (Olivier), Capobianco, M. (Marco), Ciron, J. (Jonathan), Trojano, M. (Maria), Stankoff, B. (Bruno), Créange, A. (Alain), Tedeschi, G. (Gioacchino), Clavelou, P. (Pierre), Comi, G. (Giancarlo), Thouvenot, E. (Eric), Battaglia, M. (Mario) A. (Alberto), Moreau, T. (Thibault), Patti, F. (Francesco), De Sèze, J. (Jérôme), Louapre, C. (Celine), and Musc

Subjects
Aucun
Abstract

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR = 2.05, 95%CI = 1.39-3.02, p

Published
2021

27. Myelin-oligodendrocyte glycoprotein antibody-associated disease

Author

Marignier, R. Hacohen, Y. Cobo-Calvo, A. Pröbstel, A.-K. Aktas, O. Alexopoulos, H. Amato, M.-P. Asgari, N. Banwell, B. Bennett, J. Brilot, F. Capobianco, M. Chitnis, T. Ciccarelli, O. Deiva, K. De Sèze, J. Fujihara, K. Jacob, A. Kim, H.J. Kleiter, I. Lassmann, H. Leite, M.-I. Linington, C. Meinl, E. Palace, J. Paul, F. Petzold, A. Pittock, S. Reindl, M. Sato, D.K. Selmaj, K. Siva, A. Stankoff, B. Tintore, M. Traboulsee, A. Waters, P. Waubant, E. Weinshenker, B. Derfuss, T. Vukusic, S. Hemmer, B.

Abstract

Myelin-oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a recently identified autoimmune disorder that presents in both adults and children as CNS demyelination. Although there are clinical phenotypic overlaps between MOGAD, multiple sclerosis, and aquaporin-4 antibody-associated neuromyelitis optica spectrum disorder (NMOSD) cumulative biological, clinical, and pathological evidence discriminates between these conditions. Patients should not be diagnosed with multiple sclerosis or NMOSD if they have anti-MOG antibodies in their serum. However, many questions related to the clinical characterisation of MOGAD and pathogenetic role of MOG antibodies are still unanswered. Furthermore, therapy is mainly based on standard protocols for aquaporin-4 antibody-associated NMOSD and multiple sclerosis, and more evidence is needed regarding how and when to treat patients with MOGAD. © 2021 Elsevier Ltd

Published
2021

28. 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

29. Dysregulated functional and metabolic response in multiple sclerosis patient macrophages correlate with a more inflammatory state, reminiscent of trained immunity

Author

Fransson, J., primary, Bachelin, C., additional, Deknuydt, F., additional, Ichou, F., additional, Guillot-Noël, L., additional, Ponnaiah, M., additional, Gloaguen, A., additional, Maillart, E., additional, Stankoff, B., additional, Tenenhaus, A., additional, Mochel, F., additional, Fontaine, B., additional, Louapre, C., additional, and Zujovic, V., additional

Published
2021
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30. Artificial intelligence to predict clinical disability in patients with multiple sclerosis using FLAIR MRI

Author

Roca, P., primary, Attye, A., additional, Colas, L., additional, Tucholka, A., additional, Rubini, P., additional, Cackowski, S., additional, Ding, J., additional, Budzik, J.-F., additional, Renard, F., additional, Doyle, S., additional, Barbier, E.L., additional, Bousaid, I., additional, Casey, R., additional, Vukusic, S., additional, Lassau, N., additional, Verclytte, S., additional, Cotton, F., additional, Brochet, B., additional, De Sèze, J., additional, Douek, P., additional, Guillemin, F., additional, Laplaud, D., additional, Lebrun-Frenay, C., additional, Mansuy, L., additional, Moreau, T., additional, Olaiz, J., additional, Pelletier, J., additional, Rigaud-Bully, C., additional, Stankoff, B., additional, Marignier, R., additional, Debouverie, M., additional, Edan, G., additional, Ciron, J., additional, Ruet, A., additional, Collongues, N., additional, Lubetzki, C., additional, Vermersch, P., additional, Labauge, P., additional, Defer, G., additional, Cohen, M., additional, Fromont, A., additional, Wiertlewsky, S., additional, Berger, E., additional, Clavelou, P., additional, Audoin, B., additional, Giannesini, C., additional, Gout, O., additional, Thouvenot, E., additional, Heinzlef, O., additional, Al-Khedr, A., additional, Bourre, B., additional, Casez, O., additional, Cabre, P., additional, Montcuquet, A., additional, Créange, A., additional, Camdessanché, J.-P., additional, Faure, J., additional, Maurousset, A., additional, Patry, I., additional, Hankiewicz, K., additional, Pottier, C., additional, Maubeuge, N., additional, Labeyrie, C., additional, Nifle, C., additional, Ameli, R., additional, Anxionnat, R., additional, Bannier, E., additional, Barillot, C., additional, Ben Salem, D., additional, Boncoeur-Martel, M.-P., additional, Bonneville, F., additional, Boutet, C., additional, Brisset, J.-C., additional, Cervenanski, F., additional, Claise, B., additional, Commowick, O., additional, Constans, J.-M., additional, Dardel, P., additional, Desal, H., additional, Dousset, Vincent, additional, Durand-Dubief, F., additional, Ferre, J.-C., additional, Gerardin, E., additional, Glattard, T., additional, Grand, S., additional, Grenier, T., additional, Guillevin, R., additional, Guttmann, C., additional, Krainik, A., additional, Kremer, S., additional, Lion, S., additional, Menjot de Champfleur, N., additional, Mondot, L., additional, Outteryck, O., additional, Pyatigorskaya, N., additional, Pruvo, J.-P., additional, Rabaste, S., additional, Ranjeva, J.-P., additional, Roch, J.-A., additional, Sadik, J.C., additional, Sappey-Marinier, D., additional, Savatovsky, J., additional, Tanguy, J.-Y., additional, Tourbah, A., additional, and Tourdias, T., additional

Published
2020
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31. New OFSEP recommendations for MRI assessment of multiple sclerosis patients: Special consideration for gadolinium deposition and frequent acquisitions

Author

Brisset, Jean-Christophe, primary, Kremer, Stephane, additional, Hannoun, Salem, additional, Bonneville, Fabrice, additional, Durand-Dubief, Francoise, additional, Tourdias, Thomas, additional, Barillot, Christian, additional, Guttmann, Charles, additional, Vukusic, Sandra, additional, Dousset, Vincent, additional, Cotton, Francois, additional, Ameli, R., additional, Anxionnat, R., additional, Audoin, B., additional, Attye, A., additional, Bannier, E., additional, Barillot, C., additional, Ben Salem, D., additional, Boncoeur-Martel, M.-P., additional, Bonhomme, G., additional, Bonneville, F., additional, Boutet, C., additional, Brisset, J.C., additional, Cervenanski, F., additional, Claise, B., additional, Commowick, O., additional, Constans, J.-M., additional, Cotton, F., additional, Dardel, P., additional, Desal, H., additional, Dousset, V., additional, Durand-Dubief, F., additional, Ferre, J.-C., additional, Gaultier, A., additional, Gerardin, E., additional, Glattard, T., additional, Grand, S., additional, Grenier, T., additional, Guillevin, R., additional, Guttmann, C., additional, Krainik, A., additional, Kremer, S., additional, Lion, S., additional, Champfleur, N. Menjot De, additional, Mondot, L., additional, Outteryck, O., additional, Pyatigorskaya, N., additional, Pruvo, J.-P., additional, Rabaste, S., additional, Ranjeva, J.-P., additional, Roch, J.-A., additional, Sadik, J.-C., additional, Sappey-Marinier, D., additional, Savatovsky, J., additional, Stankoff, B., additional, Tanguy, J.-Y., additional, Tourbah, A., additional, Tourdias, T., additional, Brochet, B., additional, Casey, R., additional, De Sèze, J., additional, Douek, P., additional, Guillemin, F., additional, Laplaud, D., additional, Lebrun-Frenay, C., additional, Mansuy, L., additional, Moreau, T., additional, Olaiz, J., additional, Pelletier, J., additional, Rigaud-Bully, C., additional, Vukusic, S., additional, Debouverie, M., additional, Edan, G., additional, Ciron, J., additional, Lubetzki, C., additional, Vermersch, P., additional, Labauge, P., additional, Defer, G., additional, Berger, E., additional, Clavelou, P., additional, Gout, O., additional, Thouvenot, E., additional, Heinzlef, O., additional, Al-Khedr, A., additional, Bourre, B., additional, Casez, O., additional, Cabre, P., additional, Montcuquet, A., additional, Créange, A., additional, Camdessanché, J.-P., additional, Bakchine, S., additional, Maurousset, A., additional, Patry, I., additional, De Broucker, T., additional, Pottier, C., additional, Neau, J.-P., additional, Labeyrie, C., additional, and Nifle, C., additional

Published
2020
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32. Clinical Characteristics and Outcomes in Patients With Coronavirus Disease 2019 and Multiple Sclerosis

Author

Louapre, C. (Céline), Collongues, N. (Nicolas), Stankoff, B. (Bruno), Giannesini, C. (Claire), Papeix, C. (Caroline), Bensa, C. (Caroline), Deschamps, R. (Romain), Créange, A. (Alain), Wahab, A. (Abir), Pelletier, J. (Jean), Heinzlef, O. (Olivier), Labauge, P. (Pierre), Guilloton, L. (Laurent), Ahle, G. (Guido), Goudot, M. (Mathilde), Bigaut, K. (Kevin), Laplaud, D. (David-Axel), Vukusic, S. (Sandra), Lubetzki, C. (Catherine), and De Sèze, J. (Jérôme)

Subjects
Aucun
Abstract

Importance: Risk factors associated with the severity of coronavirus disease 2019 (COVID-19) in patients with multiple sclerosis (MS) are unknown. Disease-modifying therapies (DMTs) may modify the risk of developing a severe COVID-19 infection, beside identified risk factors such as age and comorbidities. Objective: To describe the clinical characteristics and outcomes in patients with MS and COVID-19 and identify factors associated with COVID-19 severity. Design, Setting, and Participants: The Covisep registry is a multicenter, retrospective, observational cohort study conducted in MS expert centers and general hospitals and with neurologists collaborating with MS expert centers and members of the Société Francophone de la Sclérose en Plaques. The study included patients with MS presenting with a confirmed or highly suspected diagnosis of COVID-19 between March 1, 2020, and May 21, 2020. Exposures: COVID-19 diagnosed with a polymerase chain reaction test on a nasopharyngeal swab, thoracic computed tomography, or typical symptoms. Main Outcomes and Measures: The main outcome was COVID-19 severity assessed on a 7-point ordinal scale (ranging from 1 [not hospitalized with no limitations on activities] to 7 [death]) with a cutoff at 3 (hospitalized and not requiring supplemental oxygen). We collected demographics, neurological history, Expanded Disability Severity Scale score (EDSS; ranging from 0 to 10, with cutoffs at 3 and 6), comorbidities, COVID-19 characteristics, and outcomes. Univariate and multivariate logistic regression models were used to estimate the association of collected variables with COVID-19 outcomes. Results: A total of 347 patients (mean [SD] age, 44.6 [12.8] years, 249 women; mean [SD] disease duration, 13.5 [10.0] years) were analyzed. Seventy-three patients (21.0%) had a COVID-19 severity score of 3 or more, and 12 patients (3.5%) died of COVID-19. The median EDSS was 2.0 (range, 0-9.5), and 284 patients (81.8%) were receiving DMT. There was a higher proportion of patients with a COVID-19 severity score of 3 or more among patients with no DMT relative to patients receiving DMTs (46.0% vs 15.5%; P

Published
2020

33. Individual mapping of innate immune cell activation is a candidate marker of patient-specific trajectories of disability worsening in Multiple Sclerosis

Author

Bodini, B, Poirion, E, Tonietto, M, Benoit, C, Palladino, R, Maillart, E, Portera, E, Battaglini, M, Bera, G, Kuhnast, B, Louapre, C, Bottlaender, M, and Stankoff, B

Subjects
Nuclear Medicine & Medical Imaging, PET, Neurology, Image Processing, fungi, microglia, 1103 Clinical Sciences, worsening disability, disability worsening, multiple sclerosis, TSPO, Positron Emission Tomography
Abstract

Objective: To develop a novel approach to generate individual maps of white matter (WM) innate immune cell activation using 18F-DPA-714 translocator protein (TSPO) positron emission tomography (PET), and to explore the relationship between these maps and individual trajectories of disability worsening in patients with multiple sclerosis (MS). Methods: Patients with MS (n = 37), whose trajectories of disability worsening over the 2 years preceding study entry were calculated, and healthy controls (n = 19) underwent magnetic resonance magnetic and 18F-DPA-714 PET. A threshold of significant activation of 18F-DPA-714 binding was calculated with a voxel-wise randomized permutation-based comparison between patients and controls, and used to classify each WM voxel in patients as characterized by a significant activation of innate immune cells (DPA+) or not. Individual maps of innate immune cell activation in the WM were employed to calculate the extent of activation in WM regions-of-interests and to classify each WM lesion as "DPA-active", "DPA-inactive" or "unclassified". Results: Compared with the WM of healthy controls, patients with MS had a significantly higher percentage of DPA+ voxels in the normal-appearing WM, (NAWM in patients=24.9±9.7%; WM in controls=14.0±7.8%, p

Published
2019

38. Efficacité comparée du Teriflunomide et du Dimethyl-Fumarate : une étude observationnelle française multicentrique

Author

Laplaud, D.-A., primary, Barbin, L., additional, Casey, R., additional, Debouverie, M., additional, Vukusic, S., additional, Labauge, P., additional, Brassat, D., additional, Wiertlewski, S., additional, De Seze, J., additional, Edan, G., additional, Brochet, B., additional, Moreau, T., additional, Berger, E., additional, Clavelou, P., additional, Castelnovo, G., additional, Ciron, J., additional, Pelletier, J., additional, Bourre, B., additional, Lubetzki, C., additional, Al Khedr, A., additional, Vermersch, P., additional, Lebrun-Frenay, C., additional, Defer, G., additional, Tourbah, A., additional, Camdessanche, J.-P., additional, Stankoff, B., additional, Labeyrie, C., additional, Patry, I., additional, Creange, A., additional, Gout, O., additional, Heinzlef, O., additional, Casez, O., additional, Magy, L., additional, Guennoc, A.-M., additional, De Broucker, T., additional, Nifle, C., additional, Dupel-Pottier, C., additional, Leray, E., additional, Rollot, F., additional, and Foucher, Y., additional

Published
2018
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40. Neuraxial analgesia is not associated with an increased risk of post-partum relapses in MS

Author

Lavie, Caroline, primary, Rollot, Fabien, additional, Durand-Dubief, Françoise, additional, Marignier, Romain, additional, Ionescu, Iuliana, additional, Casey, Romain, additional, Moreau, Thibault, additional, Tourniaire, Patricia, additional, Hutchinson, Michael, additional, D’Hooghe, Marie Béatrice, additional, Laplaud, David-Axel, additional, Clavelou, Pierre, additional, De Sèze, Jérôme, additional, Debouverie, Marc, additional, Brassat, David, additional, Pelletier, Jean, additional, Lebrun-Frenay, Christine, additional, Le Page, Emmanuelle, additional, Castelnovo, Giovanni, additional, Berger, Eric, additional, Hautecoeur, Patrick, additional, Heinzlef, Olivier, additional, Durelli, Luca, additional, Clerico, Marinella, additional, Trojano, Maria, additional, Patti, Francesco, additional, Vukusic, Sandra, additional, Alpérovitch, A., additional, Carton, H., additional, d’Hooghe, M.B., additional, Hommes, O., additional, Hutchinson, M., additional, Adeleine, P., additional, Biron, A., additional, Cortinovis-Tourniaire, P., additional, Grimaud, J., additional, Hours, M., additional, Moreau, T., additional, Vukusic, S., additional, Confavreux, C., additional, Chauplannaz, G., additional, Latombe, D., additional, Clanet, M., additional, Lau, G., additional, Rumbach, L., additional, Goas, J.Y., additional, Rouhart, F., additional, Mazingue, A., additional, Roullet, E., additional, Madigand, M., additional, Hautecoeur, P., additional, Brunet, P., additional, Edan, G., additional, Allaire, C., additional, Riffault, G., additional, Leche, J., additional, Benoit, T., additional, Simonin, C., additional, Ziegler, F., additional, Baron, J.C., additional, Rivrain, Y., additional, Dumas, R., additional, Loche, D., additional, Bourrin, J.C., additional, Huttin, B., additional, Delisse, B., additional, Gibert, I., additional, Boulay, C., additional, Verceletto, M., additional, Durand, G., additional, Bonneviot, G., additional, Gil, R., additional, Hedreville, M.A., additional, Belair, C., additional, Poitevin, R.J., additional, Devoize, J.L., additional, Wyremblewski, P., additional, Delestre, F., additional, Setiey, A., additional, Comi, G., additional, Filippi, M., additional, Ghezzi, A., additional, Martinelli, V., additional, Rossi, P., additional, Zaffaroni, M., additional, Tola, M.R., additional, Amato, M.P., additional, Fioretti, C., additional, Meucci, G., additional, Inglese, M., additional, Mancardi, G.L., additional, Gambi, D., additional, Thomas, A., additional, Cavazzuti, M., additional, Citterio, A., additional, Heltberg, A., additional, Hansen, H.J., additional, Fernandez, O., additional, Romero, F., additional, Arbizu, T., additional, Hernandez, J.J., additional, De Andres de Frutos, C., additional, Geffner Sclarky, D., additional, Aladro Benito, Y., additional, Reyes Yanes, P., additional, Aguilar, M, additional, Burguera, J.A., additional, Yaya, R., additional, Bonakim Dib, W., additional, Arzua-Mouronte, D., additional, Sindic, C.J.M., additional, Medaer, R., additional, Roose, H., additional, Geens, K.M.J., additional, Guillaume, D., additional, Van Zandycke, M., additional, Janssens, J., additional, Cornette, M., additional, Mol, L., additional, Weilbach, F., additional, Flachenecker, P., additional, Hartung, H.P., additional, Haas, J., additional, Tendolkar, I., additional, Sindrn, E., additional, Kölmel, H.W., additional, Reichel, D., additional, Rauch, M., additional, Preuss, S., additional, Poser, S., additional, Mauch, E., additional, Strausser-Fuchs, S., additional, Kolleger, H., additional, Hawkins, S., additional, Howell, S.J.L., additional, Rees, J.E., additional, Thompson, A., additional, Johnson, M., additional, Boggild, M., additional, Gregory, R.P., additional, Bates, D., additional, Bone, I., additional, Polman, C., additional, Frequin, S., additional, Jongen, P., additional, Correia de Sa, J., additional, Rio, M.E., additional, Huber, S., additional, Lechner-Scott, J., additional, Kappos, L., additional, Ionescu, I., additional, Cornu, C., additional, El-Etr, M., additional, Baulieu, E.E., additional, Schumacher, M, additional, Miller, D.H., additional, Pugeat, M., additional, d’Archangues, C., additional, Conard, J., additional, Ménard, J., additional, Sitruk-Ware, R., additional, Pelissier, C., additional, Dat, S., additional, Belaïsch-Allard, J., additional, Athéa, N., additional, Büschsenschutz, D., additional, Lyon-Caen, O., additional, Gonsette, R., additional, Boissel, J.P., additional, Ffrench, P., additional, Durand-Dubief, F., additional, Cotton, F., additional, Pachai, C., additional, Bracoud, L., additional, Androdias, G., additional, Marignier, R., additional, Laplaud, D.A., additional, Wiertlewski, S., additional, Lanctin-Garcia, C., additional, Couvreur, G., additional, Madinier, G., additional, Clavelou, P., additional, Taithe, F., additional, Aufauvre, D., additional, Guy, N., additional, Ferrier, A., additional, De Sèze, J., additional, Collongues, N., additional, Debouverie, M., additional, Viala, F., additional, Brassat, D., additional, Gerdelat-Mas, A., additional, Henry, P., additional, Pelletier, J., additional, Rico-Lamy, A., additional, Lebrun-Frenay, C., additional, Lepage, E., additional, Deburghraeve, V., additional, Castelnovo, G., additional, Berger, E., additional, Blondiau, M., additional, Heinzlef, O., additional, Coustans, M., additional, Clerc, C., additional, Rieu, L., additional, Lauxerois, M., additional, Hinzelin, G., additional, Ouallet, J.C., additional, Minier, D., additional, Vion, P., additional, Gromaire-Fayolle, N., additional, Derache, N., additional, Thouvenot, E., additional, Sallansonnet-Froment, M., additional, Tourniaire, P., additional, Toureille, L., additional, Borgel, F., additional, Stankoff, B., additional, Moroianu, C., additional, Guennoc, A.M., additional, Tournier-Gervason, C.L., additional, Peysson, S., additional, Trojano, M., additional, Patti, F., additional, D’Amico, E., additional, Motti, L., additional, Durelli, L., additional, and Tavella, A., additional

Published
2018
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41. Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study

Author

Barbin, L. (Laetitia), Rousseau, C. (Chloe), Jousset, N. (Natacha), Casey, R. (Romain), Debouverie, M. (Marc), Vukusic, S. (Sandra), De Seze, J. (Jerome), Brassat, D. (David), Wiertlewski, S. (Sandrine), Brochet, B. (Bruno), Pelletier, J. (Jean), Vermersch, P. (Patrick), Edan, G. (Gilles), Lebrun-Frenay, C. (Christine), Clavelou, P. (Pierre), Thouvenot, E. (Eric), Camdessanché, J. (Jean-Philippe), Tourbah, A. (Ayman), Stankoff, B. (Bruno), Al Khedr, A. (Abdullatif), Cabre, P. (Philippe), Papeix, C. (Caroline), Berger, E. (Eric), Heinzlef, O. (Olivier), Debroucker, T. (Thomas), Moreau, T. (Thibault), Gout, O. (Olivier), Bourre, B. (Bertrand), Créange, A. (Alain), Labauge, P. (Pierre), Magy, L. (Laurent), Defer, G. (Gilles), Foucher, Y. (Yohann), Laplaud, D. (David A), CFSEP and OFSEP groups, Jonchère, Laurent, Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Biostatistique, Pharmacoépidémiologie et Mesures Subjectives en Santé, PRES Université Nantes Angers Le Mans (UNAM), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), ReLSEP, Lorraine Register of MS, EA 4360, Department of Neurology, CHU Nancy, Department of Neurology, CHU Lyon, Service de Neurologie [Lyon], Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de Neurologie, Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Service de neurologie [Bordeaux], CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Université de Bordeaux (UB), Pôle de Neurosciences Cliniques, Department of Neurology, Hôpital de la Timone [CHU - APHM] (TIMONE), Inflammation: mécanismes et régulation et interactions avec la nutrition et les candidoses, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, Laboratoire d'Immunologie (EA 2686), Université de Lille, Droit et Santé, Service de neurologie D, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Nice (CHU Nice), CHU Clermont-Ferrand, CHU Saint-Etienne, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Service Hospitalier Frédéric Joliot (SHFJ), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Neurologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU de la Martinique [Fort de France], CHU Pitié-Salpêtrière [AP-HP], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Neurologie [CHRU Besançon], Service de Neurologie [CHU de Poissy], CHU De Poissy, Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Fondation Ophtalmologique Rothschild, Excitabilité nerveuse et thérapeutique (ENT), Hôpital Henri Mondor-EA 4391, Service de Physiologie Explorations Fonctionnelles-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), CHU Limoges, Service de Neurologie [CHU Caen], 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), Biostatistique, Recherche Clinique et Mesures Subjectives en Santé, Université de Nantes (UN), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Pitié-Salpêtrière [AP-HP], Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-EA 4391, Service de Physiologie Explorations Fonctionnelles-Hôpital Henri Mondor, Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Centre de Physiopathologie Toulouse Purpan ex IFR 30 et IFR 150 (CPTP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre National de la Recherche Scientifique (CNRS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Pitié-Salpêtrière [APHP], CHU Saint-Antoine [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], CHU Pitié-Salpêtrière [APHP], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), and Service de Neurologie [CHU Besançon]

Subjects
Male, [SDV]Life Sciences [q-bio], Aucun, diagnosis, drug therapy, epidemiology, Cohort Studies, 0302 clinical medicine, Natalizumab, Medicine, 030212 general & internal medicine, 10. No inequality, Fingolimod, 3. Good health, [SDV] Life Sciences [q-bio], Treatment Outcome, Cohort, Female, France, Immunosuppressive Agents, medicine.drug, Cohort study, Adult, medicine.medical_specialty, Multiple Sclerosis, Sciences du Vivant [q-bio]/Neurosciences [q-bio.NC], Article, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Fingolimod Hydrochloride, Internal medicine, Humans, Immunologic Factors, Expanded Disability Status Scale, business.industry, Multiple sclerosis, medicine.disease, Surgery, Propylene Glycols, therapeutic use, Propensity score matching, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

OBJECTIVE: To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis. METHODS: Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were collected for 326 patients treated with natalizumab and 303 with fingolimod. The statistical analysis was performed using 2 different methods: logistic regression and propensity scores (inverse probability treatment weighting). RESULTS: The confounder-adjusted proportion of patients with at least one relapse within the first and second year of treatment was lower in natalizumab-treated patients compared to the fingolimod group (21.1% vs 30.4% at first year, p = 0.0092; and 30.9% vs 41.7% at second year, p = 0.0059) and supported the trend observed in nonadjusted analysis (21.2% vs 27.1% at 1 year, p = 0.0775). Such statistically significant associations were also observed for gadolinium (Gd)-enhancing lesions and new T2 lesions at both 1 year (Gd-enhancing lesions: 9.3% vs 29.8%, p < 0.0001; new T2 lesions: 10.6% vs 29.6%, p < 0.0001) and 2 years (Gd-enhancing lesions: 9.1% vs 22.1%, p = 0.0025; new T2 lesions: 16.9% vs 34.1%, p = 0.0010) post treatment initiation. CONCLUSION: Taken together, these results suggest the superiority of natalizumab over fingolimod to prevent relapses and new T2 and Gd-enhancing lesions at 1 and 2 years. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RRMS, natalizumab decreases the proportion of patients with at least one relapse within the first year of treatment compared to fingolimod. comparative study journal article multicenter study observational study research support, non-u.s. gov't 2016 Feb 23 2016 01 29 imported

Published
2016
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44. Mitoxantrone prior to interferon beta-1b in aggressive relapsing multiple sclerosis: a 3-year randomised trial

Author

Edan, G, Comi, G, Le Page, E, Leray, E, Rocca, Ma, Filippi, M, French–Italian Mitoxantrone Interferon beta 1b Trial Group Trojano, M, Paolicelli, D, D'Onghia, M, Rumbach, L, Clavelou, P, Aufauvre, D, Moreau, T, Amato, Mp, Portaccio, E, Ghezzi, A, Mancardi, A, Vermersch, P, Hautecoeur, P, De Sèze, J, Magy, L, Vallat, Jm, Confavreux, C, Vukusic, S, Ionescu, I, Blanc, S, Pelletier, J, Malikova Klemina, I, Ranjeva, Jp, Debouverie, M, Pittion, S, Lebrun, C, Roullet, E, Heinzlef, O, Gout, O, Lubetzki, C, Stankoff, B, Tourbah, A, Veillard, D, Warter, Jm, Tranchant, C, Berry, I, Brassat, D, Clanet, M, Durelli, Luca, Clerico, Marinella, Service de Neurologie [Rennes] = Neurology [Rennes], CHU Pontchaillou [Rennes], Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-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), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), École des Hautes Études en Santé Publique [EHESP] (EHESP), Edan, G, Comi, Giancarlo, Le Page, E, Leray, E, Rocca, Ma, Filippi, Massimo, French Italian Mitoxantrone Interferon beta 1b Trial, Group, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR)

Subjects
Oncology, Male, medicine.medical_treatment, Gadolinium, Severity of Illness Index, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, 030212 general & internal medicine, 10. No inequality, Brain, Immunosuppression, Magnetic Resonance Imaging, 3. Good health, Psychiatry and Mental health, Methylprednisolone, Drug Therapy, Combination, Female, Immunosuppressive Agents, medicine.drug, Interferon beta-1b, Adult, medicine.medical_specialty, Multiple Sclerosis, Neuroimaging, Drug Administration Schedule, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Immunologic Factors, Mitoxantrone, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Interferon-beta, medicine.disease, Surgery, Secondary progressive, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

International audience; Objectives: The long-term impact of interferon-beta-1b (IFN) might be improved by short-term immunosuppression with mitoxantrone (MITOX) in aggressive relapsing-remitting multiple sclerosis (ARMS) patients. Methods: In this 3-year clinical and MRI study, 109 ARMS patients (two or more relapses in the previous 12 months and one or more gadolinium (Gd)-enhancing MRI lesion) were randomised into two groups: 54 patients received MITOX monthly (12 mg/m2; maximum 20 mg) combined with 1 g of methylprednisolone (MP) for 6 months followed by IFN for the last 27 months, and 55 patients received IFN for 3 years combined with 1 g of MP monthly for the first 6 months. The primary endpoint was the time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months. Results: The time to worsen by at least one Expanded Disability Status Scale point confirmed at 3 months was delayed by 18 months in the MITOX group compared with the IFN group (p

Published
2011
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45. THE PREVENTION OF POST-PARTUM RELAPSES WITH PROGESTIN AND ESTRADIOL IN MULTIPLE SCLEROSIS (POPART'MUS) TRIAL: RATIONALE, OBJECTIVES AND STATE OF ADVANCEMENT

Author

Vukusic, S, Ionescu, I, El Etr, M, Schumacher, M, Baulieu, Ee, Cornu, C, Confavreux, C, Clanet, M, Brassat, D, Viala, F, Moreau, T, Couvreur, G, Madinier, G, Debouverie, M, Laplaud, D, Wiertlewski, S, Clavelou, P, Aufauvre, D, Pelletier, J, Rico Lamy, A, Edan, G, Le Page, E, Rumbach, L, Berger, E, Hautecoeur, P, Lebrun Frenay, C, Labauge, P, Castelnovo, G, Heinzlef, O, Brochet, B, Ouallet, Jc, Clerc, C, Rieu, L, Lauxerois, M, Hinzelin, G, Froment Sallansonnet, M, Stankoff, B, Borgel, F, Toureille Borlet, L, Minier, D, Coustans, M, Tourniaire, P, Durelli, Luca, Tavella, A, Trojano, M, Carrozzo, A, Patti, F, Zaffaroni, M, and Motti, L.

Published
2009

46. Interferon beta-1a in relapsing multiple sclerosis: four-year extension of the European IFNbeta-1a Dose-Comparison Study

Author

Clanet, M., Kappos, L., Hartung, H.P., Hohlfeld, R., Kristoferitsch, W., Schrieber, A., Schlederer, A., Seeldrayers, P., Piette, A., Papacostas, S., Kyriallis, K., Pantzaris, A., Brochet, B., Gayou, A., Rouanet, M., Rouant, F., Confavreux, C., Riche, G., Blanc, S., Achiti, J., Magnier, C., Aubertin, P., Mekies, C., Brassat, D., Thalamas, C., Vuilleman, C., Senard, A., Lau, G., Cesaro, P., Degos, F., Defer, G., Schaeffer, S., Edan, G., de Marco, A., Cahagne, V., Belliard, S., Lyon-Caen, O., Stankoff, B., Lubetzki, C., Arnulf, I., Damier, P., Pelletier, J., Tamman, D., Suchet, L., Dalecky, A., Rumbach, L., Moulin, A., Berger, E., Roullet, E., Pez, D., Heinzlef, O., Lecanuet, P., Vermersch, P., Engles, A., Dengler, R., Heidenreich, F., Lindert, A., Koehler, A., Windhagen, A., Steiner, A., Zschenderlein, R., Luenemann, J., Gelderblom, H., Kassim, N., Storch-Hagenlocher, B., Koerner, A., Vogt-Schaden, A., Stingle, A., Storch-Hagenlocher, A., Sailer, 27449, Matzke, A., Dose, A., Weiler, C., Kunze, K., Heesen, C., Bamborschke, P., Petereit, H., Liu, A., Nolden, A., Grunwald, F., Menck, A., Grupe, A., Rieckmann, P., Weilbach, A., Flachenecker, A., Chan, A., Maurer, A., de Keyser, Jacques, Zwanniken, G., Zorgdrager, A., Montalban, X., Nos, A., Fernandez, O., Tamayo, J.A., Romero, F., Arbizu, T., Martinez-Yelamos, A., Martin, A, and Casado, A.

Subjects
Adult, Male, medicine.medical_specialty, Injections, Intramuscular, Central nervous system disease, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Internal medicine, Epidemiology, Clinical endpoint, medicine, Humans, 030212 general & internal medicine, Clinical efficacy, business.industry, Incidence (epidemiology), Multiple sclerosis, Interferon beta-1a, Interferon-beta, medicine.disease, Surgery, Europe, Interferon β 1a, Treatment Outcome, Neurology, Disease Progression, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug, Follow-Up Studies
Abstract

Background: Multiple sclerosis (MS) is a chronic disease requiring long-term monitoring of treatment. Objective: To assess the four-year clinical efficacy of intramuscular (IM) IFNb-1a in patients with relapsing MS from the European IFNb-1a Dose-C omparison Study. Methods: Patients who completed 36 months of treatment (Part 1) of the European IFNb-1a Dose-C omparison Study were given the option to continue double-blind treatment with IFNb-1a 30 mcg or 60 mcg IM once weekly (Part 2). Analyses of 48-month data were performed on sustained disability progression, relapses, and neutralizing antibody (NA b) formation. Results: O f 608/802 subjects who completed 36 months of treatment, 493 subjects continued treatment and 446 completed 48 months of treatment and follow-up. IFNb-1a 30 mcg and 60 mcg IM once weekly were equally effective for up to 48 months. There were no significant differences between doses over 48 months on any of the clinical endpoints, including rate of disability progression, cumulative percentage of patients who progressed (48% and 43%, respectively), and annual relapse rates; relapses tended to decrease over 48 months. The incidence of patients who were positive for NAbs at any time during the study was low in both treatment groups. Conclusion: C ompared with 60-mcg IM IFNb-1a once weekly, a dose of 30 mcg IM IFNb-1a once weekly maintains the same clinical efficacy over four years.

Published
2004

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