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001-es BibID:BIBFORM103015
035-os BibID:(cikkazonosító)155 (Scopus)85130953245 (Wos)000805581400002
Első szerző:Lefort, Mathilde
Cím:Impact of methodological choices in comparative effectiveness studies : application in natalizumab versus fingolimod comparison among patients with multiple sclerosis / Lefort M., Sharmin S., Andersen J. B., 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., 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.
Dátum:2022
ISSN:1471-2288
Megjegyzések: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 diferent 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 fulfilled.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:BMC Medical Research Methodology. - 22 : 1 (2022), p. 1-14. -
További szerzők:Sharmin, Sifat Andersen, Johanna Balslev Vukusic, Sandra Casey, Romain Debouverie, Marc Edan, Gilles Ciron, Jonathan Ruet, Aurélie De Seze, Jérôme Maillart, Elisabeth Zephir, Hélène Labauge, Pierre Defer, Gilles Lebrun-Frenay, 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 Camdessanche, Jean-Philippe Maurousset, Aude Ben Nasr, Haifa Hankiewicz, Karolina Pottier, Corinne Maubeuge, Nicolas Dimitri-Boulos, D. Nifle, Chantal Laplaud, David Horakova, Dana Havrdova, Eva 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 Maimone, Davide Skibina, Olga Buzzard, Katherine Walt, Anneke van der Karabudak, Rana Van Wijmeersch, Bart Csépány Tünde (1956-) (neurológus, pszichiáter) Spitaleri, Daniele Vucic, Steve Koch-Henriksen, Niels Sellebjerg, Finn Thorup Soerensen, Per Soelberg Hilt Christensen, Claudia C. Rasmussen, Peter Vestergaard Jensen, Michael Broksgaard Frederiksen, Jette Lautrup Bramow, Stephan Mathiesen, Henrik Kahr Schreiber, Karen Butzkueven, Helmut Magyari Melinda Kalincik, Tomas Leray, Emmanuelle
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001-es BibID:BIBFORM103010
035-os BibID:(Wos)000697081200001 (Scopus)85115657202
Első szerző:Sharmin, Sifat
Cím:Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis : a Subgroup Analysis From Three International Cohorts / Sharmin Sifat, Lefort Mathilde, Andersen Johanna Balslev, Leray Emmanuelle, Horakova Dana, Havrdova Eva Kubala, Alroughani Raed, Izquierdo Guillermo, 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, Prevost Julie, Maimone Davide, Skibina Olga, Buzzard Katherine, Van der Walt Anneke, Van Wijmeersch Bart, Csepany Tunde, Spitaleri Daniele, Vucic Steve, Casey Romain, Debouverie Marc, Edan Gilles, Ciron Jonathan, Ruet Aurélie, De Seze Jérome, Maillart Elisabeth, Zephir Hélene, Labauge Pierre, Defer Gilles, Lebrun-Frénay Christine, Moreau Thibault, Berger Eric, Clavelou Pierre, Pelletier Jean, Stankoff Bruno, Gout Olivier, Thouvenot Eric, Heinzlef Olivier, Al-Khedr Abullatif, Bourre Bertrand, Casez Olivier, Cabre Philippe, Montcuquet Alexis, Wahab Abir, Camdessanché Jean-Philippe, Maurousset Aude, Patry Ivania, Hankiewicz Karolina, Pottier Corinne, Maubeuge Nicolas, Labeyrie Céline, Nifle Chantal, Laplaud David, Koch-Henriksen Niels, Sellebjerg Finn Thorup, Soerensen Per Soelberg, Pfleger Claudia Christina, Rasmussen Peter Vestergaard, Jensen Michael Broksgaard, Frederiksen Jette Lautrup, Bramow Stephan, Mathiesen Henrik Kahr, Schreiber Karen Ingrid, Magyari Melinda, Vukusic Sandra, Butzkueven Helmut, Kalincik Tomas, Danish Multiple Sclerosis Registry, OFSEP and the MSBase investigators
Dátum:2021
ISSN:1172-7047
Megjegyzések:Introduction Natalizumab has proved to be more efective than fngolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). Whether this association is universal for all patient groups remains to be determined. Objective The aim of this study was to compare the relative efectiveness of natalizumab and fngolimod in RRMS subgroups defned by the baseline demographic and clinical characteristics of interest. Methods Patients with RRMS who were given natalizumab or fngolimod were identifed in a merged cohort from three international registries. Efcacy outcomes were compared across subgroups based on patients' sex, age, disease duration, Expanded Disability Status Scale (EDSS) score, and disease and magnetic resonance imaging (MRI) activity 12 months prior to treatment initiation. Study endpoints were number of relapses (analyzed with weighted negative binomial generalized linear model) and 6-month confrmed disability worsening and improvement events (weighted Cox proportional hazards model), recorded during study therapy. Each patient was weighted using inverse probability of treatment weighting based on propensity score. Results A total of 5148 patients (natalizumab 1989; fngolimod 3159) were included, with a mean ? standard deviation age at baseline of 38 ? 10 years, and the majority (72%) were women. The median on-treatment follow-up was 25 (quartiles 15?41) months. Natalizumab was associated with fewer relapses than fngolimod (incidence rate ratio [IRR]; 95% confdence interval [CI]) in women (0.76; 0.65?0.88); in those aged ? 38 years (0.64; 0.54?0.76); in those with disease duration ? 7 years (0.63; 0.53?0.76); in those with EDSS score < 4 (0.75; 0.64?0.88), < 6 (0.80; 0.70?0.91), and ? 6 (0.52; 0.31?0.86); and in patients with pre-baseline relapses (0.74; 0.64?0.86). A higher probability of confrmed disability improvement on natalizumab versus fngolimod (hazard ratio [HR]; 95% CI) was observed among women (1.36; 1.10?1.66); those aged > 38 years (1.34; 1.04?1.73); those with disease duration > 7 years (1.33; 1.01?1.74); those with EDSS score < 6 (1.21; 1.01?1.46) and ? 6 (1.93; 1.11?3.34); and patients with no new MRI lesion (1.73; 1.19?2.51). Conclusions Overall, in women, younger patients, those with shorter disease durations, and patients with pre-treatment relapses, natalizumab was associated with a lower frequency of multiple sclerosis relapses than fngolimod. It was also associated with an increased chance of recovery from disability among most patients, particularly women and those with no recent MRI activity.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
multiple sclerosis natalizumab fingolimod
Megjelenés:Cns Drugs. - 35 (2021), p. 1217-1232. -
További szerzők:Lefort, Mathilde Andersen, Johanna Balslev Leray, Emmanuelle Horakova, Dana Havrdova, Eva Alroughani, Raed Izquierdo, Guillermo 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 Prevost, Julie Maimone, Davide Skibina, Olga Buzzard, Katherine Walt, Anneke van der Van Wijmeersch, Bart Csépány Tünde (1956-) (neurológus, pszichiáter) Spitaleri, Daniele Vucic, Steve Casey, Romain Debouverie, Marc Edan, Gilles Ciron, Jonathan Ruet, Aurélie De Seze, Jérôme Maillart, Elisabeth Zephir, Hélène Labauge, Pierre Defer, Gilles Lebrun-Frenay, 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 Camdessanche, Jean-Philippe Maurousset, Aude Patry, Ivania Hankiewicz, Karolina Pottier, Corinne Maubeuge, Nicolas Labeyrie, Céline Nifle, Chantal Laplaud, David Koch-Henriksen, Niels Sellebjerg, Finn Thorup Soerensen, Per Soelberg Pfleger, Claudia Christina Rasmussen, Peter Vestergaard Jensen, Michael Broksgaard Frederiksen, Jette Lautrup Bramow, Stephan Mathiesen, Henrik Kahr Schreiber, Karen Magyari Melinda Vukusic, Sandra Butzkueven, Helmut Kalincik, Tomas Danish Multiple Sclerosis Registry OFSEP and the MSBase investigators
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