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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:	BIBFORM103566
035-os BibID:	(WoS)000874431500025 (Scopus)85141339945
Első szerző:	Roos, Izanne
Cím:	Disease Reactivation After Cessation of Disease-Modifying Therapy in Patients With Relapsing-Remitting Multiple Sclerosis / Roos Izanne, Malpas Charles, Leray Emmanuelle, Casey Romain, Horakova Dana, Havrdova Eva Kubala, Debouverie Marc, Patti Francesco, De Seze Jerome, Izquierdo Guillermo, Eichau Sara, Edan Gilles, Prat Alexandre, Girard Marc, Ozakbas Serkan, Grammond Pierre, Zephir Helene, Ciron Jonathan, Maillart Elisabeth, Moreau Thibault, Amato Maria Pia, Labauge Pierre, Alroughani Raed, Buzzard Katherine, Skibina Olga, Terzi Murat, Laplaud David Axel, Berger Eric, Grand'Maison Francois, Lebrun-Frenay Christine, Cartechini Elisabetta, Boz Cavit, Lechner-Scott Jeannette, Clavelou Pierre, Stankoff Bruno, Prevost Julie, Kappos Ludwig, Pelletier Jean, Shaygannejad Vahid, Yamout Bassem I., Khoury Samia J., Gerlach Oliver, Spitaleri Daniele L. A., Van Pesch Vincent, Gout Olivier, Turkoglu Recai, Heinzlef Olivier, Thouvenot Eric, McCombe Pamela Ann, Soysal Aysun, Bourre Bertrand, Slee Mark, Castillo-Trivino Tamara, Bakchine Serge, Ampapa Radek, Butler Ernest Gerard, Wahab Abir, Macdonell Richard A., Aguera-Morales Eduardo, Cabre Philippe, Ben Nasr Haifa, Van der Walt Anneke, Laureys Guy, Van Hijfte Liesbeth, Ramo-Tello Cristina M., Maubeuge Nicolas, Hodgkinson Suzanne, Sánchez-Menoyo José Luis, Barnett Michael H., Labeyrie Celine, Vucic Steve, Sidhom Youssef, Gouider Riadh, Csepany Tunde, Sotoca Javier, de Gans Koen, Al-Asmi Abdullah, Fragoso Yara Dadalti, Vukusic Sandra, Butzkueven Helmut, Kalincik Tomas, MSBase and OFSEP
Dátum:	2022
ISSN:	0028-3878 1526-632X
Megjegyzések:	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 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. Results: 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: 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 therapies. These results suggest that untreated intervals should be minimised after stopping anti-trafficking therapies (natalizumab and fingolimod). Classification of evidence: This study provides class III that disease reactivation occurs within months of discontinuation of multiple sclerosis disease-modifying therapies. Risk of disease activity is reduced by commencement of a subsequent therapy.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Neurology. - 99 : 17 (2022), p. e1926-e1944. -
További szerzők:	Malpas, Charles Leray, Emmanuelle Casey, Romain Horakova, Dana Havrdova, Eva Debouverie, Marc Patti, Francesco De Seze, Jérôme Izquierdo, Guillermo Eichau, Sara Edan, Gilles Prat, Alexandre Girard, Marc Ozakbas, Serkan Grammond, Pierre Zephir, Hélène Ciron, Jonathan Maillart, Elisabeth Moreau, Thibault Amato, Maria Pia Labauge, Pierre Alroughani, Raed Buzzard, Katherine Skibina, Olga Terzi, Murat Laplaud, David Berger, Eric Grand'Maison, Francois Lebrun-Frenay, Christine Cartechini, Elisabetta Boz, Cavit Lechner-Scott, Jeannette Clavelou, Pierre Stankoff, Bruno Prevost, Julie Kappos, Ludwig Pelletier, Jean Shaygannejad, Vahid Yamout, Bassem Khoury, Samia J. Gerlach, Oliver Spitaleri, Daniele L. A. Pesch, Vincent van Gout, Olivier Turkoglu, Recai Heinzlef, Olivier Thouvenot, Eric McCombe, Pamela Soysal, Aysun Bourre, Bertrand Slee, Mark Castillo Triviño, Tamara Bakchine, Serge Ampapa, Radek Butler, Ernest Wahab, Abir Macdonell, Richard Aguera-Morales, Eduardo Cabre, Philippe Ben Nasr, Haifa Walt, Anneke van der Laureys, Guy Van Hijfte, Liesbeth Ramo-Tello, Cristina Maubeuge, Nicolas Hodgkinson, Suzanne Sanchez-Menoyo, Jose Barnett, Michael Labeyrie, Céline Vucic, Steve Sidhom, Youssef Gouider, Riadh Csépány Tünde (1956-) (neurológus, pszichiáter) Sotoca, Javier de Gans, Koen Al-Asmi, Abdullah Fragoso, Yara Vukusic, Sandra Butzkueven, Helmut Kalincik, Tomas OFSEP and the MSBase investigators
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