The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies. / Andersen, Johanna B.; Sharmin, Sifat; Lefort, Mathilde; Koch-Henriksen, Nils; Sellebjerg, Finn; Sørensen, Per Soelberg; Hilt Christensen, Claudia C.; Rasmussen, Peter V.; Jensen, Michael B.; Frederiksen, Jette L.; Bramow, Stephan; Mathiesen, Henrik K.; Schreiber, Karen I.; Horakova, Dana; Havrdova, Eva K.; Alroughani, Raed; Izquierdo, Guillermo; Eichau, Sara; Ozakbas, Serkan; Patti, Francesco; Onofrj, Marco; Lugaresi, Alessandra; Terzi, Murat; Grammond, Pierre; Grand Maison, Francois; Yamout, Bassem; Prat, Alexandre; Girard, Marc; Duquette, Pierre; Boz, Cavit; Trojano, Maria; McCombe, Pamela; Slee, Mark; Lechner-Scott, Jeannette; Turkoglu, Recai; Sola, Patrizia; Ferraro, Diana; Granella, Franco; Shaygannejad, Vahid; Prevost, Julie; Skibina, Olga; Solaro, Claudio; Karabudak, Rana; Wijmeersch, Bart V.; Csepany, Tunde; Spitaleri, Daniele; Vucic, Steve; Casey, Romain; Debouverie, Marc; Edan, Gilles; Ciron, Jonathan; Ruet, Aurélie; Sèze, Jérôme D.; Maillart, Elisabeth; Zephir, Hélène; Labauge, Pierre; Defer, Gilles; Lebrun, Christine; Moreau, Thibault; Berger, Eric; Clavelou, Pierre; Pelletier, Jean; Stankoff, Bruno; Gout, Olivier; Thouvenot, Eric; Heinzlef, Olivier; Al-Khedr, Abdullatif; Bourre, Bertrand; Casez, Olivier; Cabre, Philippe; Montcuquet, Alexis; Wahab, Abir; Camdessanché, Jean Philippe; Marousset, Aude; Patry, Ivania; Hankiewicz, Karolina; Pottier, Corinne; Maubeuge, Nicolas; Labeyrie, Céline; Nifle, Chantal; Leray, Emmanuelle; Laplaud, David A.; Butzkueven, Helmut; Kalincik, Tomas; Vukusic, Sandra; Magyari, Melinda.
In: Multiple Sclerosis and Related Disorders, Vol. 53, 103012, 2021.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies
AU - Andersen, Johanna B.
AU - Sharmin, Sifat
AU - Lefort, Mathilde
AU - Koch-Henriksen, Nils
AU - Sellebjerg, Finn
AU - Sørensen, Per Soelberg
AU - Hilt Christensen, Claudia C.
AU - Rasmussen, Peter V.
AU - Jensen, Michael B.
AU - Frederiksen, Jette L.
AU - Bramow, Stephan
AU - Mathiesen, Henrik K.
AU - Schreiber, Karen I.
AU - Horakova, Dana
AU - Havrdova, Eva K.
AU - Alroughani, Raed
AU - Izquierdo, Guillermo
AU - Eichau, Sara
AU - Ozakbas, Serkan
AU - Patti, Francesco
AU - Onofrj, Marco
AU - Lugaresi, Alessandra
AU - Terzi, Murat
AU - Grammond, Pierre
AU - Grand Maison, Francois
AU - Yamout, Bassem
AU - Prat, Alexandre
AU - Girard, Marc
AU - Duquette, Pierre
AU - Boz, Cavit
AU - Trojano, Maria
AU - McCombe, Pamela
AU - Slee, Mark
AU - Lechner-Scott, Jeannette
AU - Turkoglu, Recai
AU - Sola, Patrizia
AU - Ferraro, Diana
AU - Granella, Franco
AU - Shaygannejad, Vahid
AU - Prevost, Julie
AU - Skibina, Olga
AU - Solaro, Claudio
AU - Karabudak, Rana
AU - Wijmeersch, Bart V.
AU - Csepany, Tunde
AU - Spitaleri, Daniele
AU - Vucic, Steve
AU - Casey, Romain
AU - Debouverie, Marc
AU - Edan, Gilles
AU - Ciron, Jonathan
AU - Ruet, Aurélie
AU - Sèze, Jérôme D.
AU - Maillart, Elisabeth
AU - Zephir, Hélène
AU - Labauge, Pierre
AU - Defer, Gilles
AU - Lebrun, Christine
AU - Moreau, Thibault
AU - Berger, Eric
AU - Clavelou, Pierre
AU - Pelletier, Jean
AU - Stankoff, Bruno
AU - Gout, Olivier
AU - Thouvenot, Eric
AU - Heinzlef, Olivier
AU - Al-Khedr, Abdullatif
AU - Bourre, Bertrand
AU - Casez, Olivier
AU - Cabre, Philippe
AU - Montcuquet, Alexis
AU - Wahab, Abir
AU - Camdessanché, Jean Philippe
AU - Marousset, Aude
AU - Patry, Ivania
AU - Hankiewicz, Karolina
AU - Pottier, Corinne
AU - Maubeuge, Nicolas
AU - Labeyrie, Céline
AU - Nifle, Chantal
AU - Leray, Emmanuelle
AU - Laplaud, David A.
AU - Butzkueven, Helmut
AU - Kalincik, Tomas
AU - Vukusic, Sandra
AU - Magyari, Melinda
N1 - Publisher Copyright: © 2021 Elsevier B.V.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Fingolimod
KW - Head-to-head comparison
KW - Multiple sclerosis
KW - Natalizumab
KW - Treatment effectiveness
U2 - 10.1016/j.msard.2021.103012
DO - 10.1016/j.msard.2021.103012
M3 - Journal article
C2 - 34116480
AN - SCOPUS:85107568058
VL - 53
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
SN - 2211-0348
M1 - 103012
ER -
ID: 276330596