The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies
| Title: | The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies |
|---|---|
| Authors: | Andersen J. B.; Sharmin S.; Lefort M.; Koch-Henriksen N.; Sellebjerg F.; Sorensen P. S.; Hilt Christensen C. C.; Rasmussen P. V.; Jensen M. B.; Frederiksen J. L.; Bramow S.; Mathiesen H. K.; Schreiber K. I.; 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.; Skibina O.; Solaro C.; Karabudak R.; Wijmeersch B. V.; Csepany T.; Spitaleri D.; Vucic S.; Casey R.; Debouverie M.; Edan G.; Ciron J.; Ruet A.; Seze J. D.; 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 D. A.; Butzkueven H.; Kalincik T.; Vukusic S.; Magyari M. |
| Contributors: | Andersen, J. B.; Sharmin, S.; Lefort, M.; Koch-Henriksen, N.; Sellebjerg, F.; Sorensen, P. S.; Hilt Christensen, C. C.; Rasmussen, P. V.; Jensen, M. B.; Frederiksen, J. L.; Bramow, S.; Mathiesen, H. K.; Schreiber, K. I.; 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.; Skibina, O.; Solaro, C.; Karabudak, R.; Wijmeersch, B. V.; Csepany, T.; Spitaleri, D.; Vucic, S.; Casey, R.; Debouverie, M.; Edan, G.; Ciron, J.; Ruet, A.; Seze, J. D.; 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, D. A.; Butzkueven, H.; Kalincik, T.; Vukusic, S.; Magyari, M. |
| Publication Year: | 2021 |
| Collection: | Archivio della ricerca dell'Università di Modena e Reggio Emilia (Unimore: IRIS) |
| Subject Terms: | Fingolimod; Head-to-head comparison; Multiple sclerosi; Natalizumab; Treatment effectiveness |
| Description: | 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. |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/34116480; info:eu-repo/semantics/altIdentifier/wos/WOS:000687405300017; volume:53; firstpage:103012; lastpage:103012; journal:MULTIPLE SCLEROSIS AND RELATED DISORDERS; https://hdl.handle.net/11380/1251078 |
| DOI: | 10.1016/j.msard.2021.103012 |
| Availability: | https://hdl.handle.net/11380/1251078; https://doi.org/10.1016/j.msard.2021.103012 |
| Rights: | info:eu-repo/semantics/openAccess ; license:[IR] creative-commons ; license uri:http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.ED31B4F3 |
| Database: | BASE |