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001-es BibID:BIBFORM120944
035-os BibID:(Scopus)85122546501
Első szerző:Brouwer, Edward De
Cím:Corrigendum to Longitudinal machine learning modeling of MS patient trajectories improves predictions of disability progression : [Computer Methods and Programs in Biomedicine, Volume 208, (September 2021) 106180] / Edward De Brouwer, Thijs Becker, Yves Moreau, Eva Kubala Havrdova, Maria Trojano, Sara Eichau, Serkan Ozakbas, Marco Onofrj, Pierre Grammond, Jens Kuhle, Ludwig Kappos, Patrizia Sola, Elisabetta Cartechini, Jeannette Lechner-Scott, Raed Alroughani, Oliver Gerlach, Tomas Kalincik, Franco Granella, Francois Grand'Maison, Roberto Bergamaschi, Maria José Sá, Bart Van Wijmeersch, Aysun Soysal, Jose Luis Sanchez-Menoyo, Claudio Solaro, Cavit Boz, Gerardo Iuliano, Katherine Buzzard, Eduardo Aguera-Morales, Murat Terzi, Tamara Castillo Trivio, Daniele Spitaleri, Vincent Van Pesch, Vahid Shaygannejad, Fraser Moore, Celia Oreja-Guevara, Davide Maimone, Riadh Gouider, Tunde Csepany, Cristina Ramo-Tello, Liesbet Peeters
Dátum:2022
ISSN:0169-2607
Megjegyzések:Background and Objectives Research in Multiple Sclerosis (MS) has recently focused on extracting knowledge from real-world clinical data sources. This type of data is more abundant than data produced during clinical trials and potentially more informative about real-world clinical practice. However, this comes at the cost of less curated and controlled data sets. In this work we aim to predict disability progression by optimally extracting information from longitudinal patient data in the real-world setting, with a special focus on the sporadic sampling problem. Methods We use machine learning methods suited for patient trajectories modeling, such as recurrent neural networks and tensor factorization. A subset of 6682 patients from the MSBase registry is used. Results We can predict disability progression of patients in a two-year horizon with an ROC-AUC of 0.85, which represents a 32% decrease in the ranking pair error (1-AUC) compared to reference methods using static clinical features. Conclusions Compared to the models available in the literature, this work uses the most complete patient history for MS disease progression prediction and represents a step forward towards AI-assisted precision medicine in MS.
Tárgyszavak:Orvostudományok Klinikai orvostudományok hozzászólás
folyóiratcikk
Multiple sclerosis
Machine learning
Longitudinal data
Recurrent neural networks
Electronic health records
Disability progression
Real-world data
Megjelenés:Computer Methods And Programs In Biomedicine. - 213 (2022), p. 1-3. -
További szerzők:Becker, Thijs Moreau, Yves Havrdova, Eva Trojano, Maria Eichau, Sara Ozakbas, Serkan Onofrj, Marco Grammond, Pierre Kuhle, Jens Kappos, Ludwig Sola, Patrizia Cartechini, Elisabetta Lechner-Scott, Jeannette Alroughani, Raed Gerlach, Oliver Kalincik, Tomas Granella, Franco Grand'Maison, Francois Bergamaschi, Roberto Sá, Maria José Wijmeersch, Bart Van Soysal, Aysun Sanchez-Menoyo, Jose Solaro, Claudio Boz, Cavit Iuliano, Gerardo Buzzard, Katherine Aguera-Morales, Eduardo Terzi, Murat Trivio, Tamara Castillo Spitaleri, Daniele Pesch, Vincent van Shaygannejad, Vahid Moore, Fraser Oreja-Guevara, Celia Maimone, Davide Gouider, Riadh Csépány Tünde (1956-) (neurológus, pszichiáter) Ramo-Tello, Cristina Peeters, Liesbet
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2.

001-es BibID:BIBFORM132948
035-os BibID:(scopus)105011883480 (wos)001538131900001
Első szerző:Cortese, Marianna
Cím:Serum Alpha-Linolenic Acid and Long-Term Multiple Sclerosis Activity and Progression / Cortese Marianna, Peng Xiaojing, Edan Gilles, Freedman Mark S., Hartung Hans-Peter, Montalban Xavier, Sandbrink Rupert, Radü Ernst-Wilhelm, Barkhof Frederik, Wicklein Eva-Maria, Kappos Ludwig, Ascherio Alberto, Bjornevik Kjetil, BENEFIT Study Group
Dátum:2025
ISSN:0028-3878 1526-632X
Megjegyzések:Background and Objectives Higher dietary intake of alpha-linolenic acid (ALA), a plant-derived omega-3 polyunsaturated fatty acid (PUFA), was associated with a lower risk of multiple sclerosis (MS) in a prospective cohort study and lower risk of new lesions, relapses, and disability progression in a patient cohort. We examined whether serum levels of ALA and other PUFAs predicted MS outcomes up to 11 years after clinical onset. Methods This prospective study was conducted among participants in the BENEFIT clinical trial, who had serum samples collected starting at randomization. Serum fatty acids were measured using gas chromatography. We evaluated the association of individual fatty acids with time to clinically definite MS (CDMS) and other measures of disease activity and progression using Cox, negative binomial, and linear regression. Results We followed 468 participants for 5 years, including 278 followed to year 11. At baseline, the median age was 30 years and 71% were women. Higher baseline serum ALA levels were associated with a lower risk of CDMS and relapses during follow-up. The multivariable-adjusted hazard ratios for CDMS comparing top to bottom quartile were 0.60 (95% CI 0.39?0.95) and 0.60 (95% CI 0.37?0.98) after 5 and 11 years, respectively. The multivariable adjusted risk ratios for relapses comparing top to bottom quartile were 0.60 (95% CI 0.38?0.94) and 0.65 (95% CI 0.43?0.99) after 5 and 11 years, respectively. None of the other 35 fatty acids were associated with CDMS risk. Three fatty acids were associated with relapse rate after 5 years, but not 11 years. Higher ALA levels were associated with a slower decline in MS Functional Composite, an assessment of disability, at 5 years. The association was similar at 11 years, but the results did not retain statistical significance. Baseline ALA levels were not associated with subsequent changes in cognitive function, time to confirmed Expanded Disability Status Scale progression, new active lesions, or brain volume loss. Discusssion Higher serum ALA levels were associated with a lower risk of CDMS, relapses, and disability progression in a large prospective cohort. The results were null or inconsistent for other fatty acids.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Neurology. - 105 : 3 (2025), p. 1-11. -
További szerzők:Peng, Xiaojing Edan, Gilles Freedman, Mark S. Hartung, Hans-Peter Montalbán, Xavier Sandbrink, Rupert Radü, Ernst-Wilhelm Barkhof, Frederik Wicklein, Eva-Maria Kappos, Ludwig Ascherio, Alberto Bjornevik, Kjetil Csépány Tünde (1956-) (neurológus, pszichiáter) Csiba László (1952-) (neurológus, pszichiáter) BENEFIT Study Group
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3.

001-es BibID:BIBFORM103017
035-os BibID:(Wos)000685503300008 (Scopus)85107912293
Első szerző:De Brouwer, Edward
Cím:Longitudinal machine learning modeling of MS patient trajectories improves predictions of disability progression / De Brouwer Edward, Becker Thijs, Moreau Yves, Havrdova Eva Kubala, Trojano Maria, Eichau Sara, Ozakbas Serkan, Onofrj Marco, Grammond Pierre, Kuhle Jens, Kappos Ludwig, Sola Patrizia, Cartechini Elisabetta, Lechner-Scott Jeannette, Alroughani Raed, Gerlach Oliver, Kalincik Tomas, Granella Franco, Grand'Maison Francois, Bergamaschi Roberto, José Sá Maria, Van Wijmeersch Bart, Soysal Aysun, Sanchez-Menoyo Jose Luis, Solaro Claudio, Boz Cavit, Iuliano Gerardo, Buzzard Katherine, Aguera-Morales Eduardo, Terzi Murat, Trivio Tamara Castillo, Spitaleri Daniele, Van Pesch Vincent, Shaygannejad Vahid, Moore Fraser, Oreja-Guevara Celia, Maimone Davide, Gouider Riadh, Csepany Tunde, Ramo-Tello Cristina, Peeters Liesbet
Dátum:2021
ISSN:0169-2607
Megjegyzések:Background and Objectives: Research in Multiple Sclerosis (MS) has recently focused on extracting knowledge from real-world clinical data sources. This type of data is more abundant than data produced during clinical trials and potentially more informative about real-world clinical practice. However, this comes at the cost of less curated and controlled data sets. In this work we aim to predict disability progression by optimally extracting information from longitudinal patient data in the real-world setting, with a special focus on the sporadic sampling problem. Methods: We use machine learning methods suited for patient trajectories modeling, such as recurrent neural networks and tensor factorization. A subset of 6682 patients from the MSBase registry is used. Results: We can predict disability progression of patients in a two-year horizon with an ROC-AUC of 0.85, which represents a 32% decrease in the ranking pair error (1-AUC) compared to reference methods using static clinical features. Conclusions: Compared to the models available in the literature, this work uses the most complete patient history for MS disease progression prediction and represents a step forward towards AI-assisted precision medicine in MS.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Computer Methods And Programs In Biomedicine. - 208 (2021), p. 1-14. -
További szerzők:Becker, Thijs Moreau, Yves Havrdova, Eva Trojano, Maria Eichau, Sara Ozakbas, Serkan Onofrj, Marco Grammond, Pierre Kuhle, Jens Kappos, Ludwig Sola, Patrizia Cartechini, Elisabetta Lechner-Scott, Jeannette Alroughani, Raed Gerlach, Oliver Kalincik, Tomas Granella, Franco Grand'Maison, Francois Bergamaschi, Roberto José Sá, Maria Wijmeersch, Bart Van Soysal, Aysun Sanchez-Menoyo, Jose Solaro, Claudio Boz, Cavit Iuliano, Gerardo Buzzard, Katherine Aguera-Morales, Eduardo Terzi, Murat Trivio, Tamara Castillo Spitaleri, Daniele Pesch, Vincent van Shaygannejad, Vahid Moore, Fraser Oreja-Guevara, Celia Maimone, Davide Gouider, Riadh Csépány Tünde (1956-) (neurológus, pszichiáter) Ramo-Tello, Cristina Peeters, Liesbet
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4.

001-es BibID:BIBFORM119146
035-os BibID:(scopus)85177103067 (wos)001030569800001
Első szerző:Diouf, Ibrahima
Cím:Effectiveness of multiple disease-modifying therapies in relapsing-remitting multiple sclerosis : causal inference to emulate a multiarm randomised trial / Diouf Ibrahima, Malpas Charles B., Sharmin Sifat, Roos Izanne, Horakova Dana, Kubala Havrdova Eva, Patti Francesco, Shaygannejad Vahid, Ozakbas Serkan, Eichau Sara, Onofrj Marco, Lugaresi Alessandra, Alroughani Raed, Prat Alexandre, Duquette Pierre, Terzi Murat, Boz Cavit, Grand'Maison Francois, Sola Patrizia, Ferraro Diana, Grammond Pierre, Yamout Bassem, Altintas Ayse, Gerlach Oliver, Lechner-Scott Jeannette, Bergamaschi Roberto, Karabudak Rana, Iuliano Gerardo, McGuigan Christopher, Cartechini Elisabetta, Hughes Stella, Sa Maria Jose, Solaro Claudio, Kappos Ludwig, Hodgkinson Suzanne, Slee Mark, Granella Franco, de Gans Koen, McCombe Pamela A., Ampapa Radek, van der Walt Anneke, Butzkueven Helmut, Sánchez-Menoyo José Luis, Vucic Steve, Laureys Guy, Sidhom Youssef, Gouider Riadh, Castillo-Trivino Tamara, Gray Orla, Aguera-Morales Eduardo, Al-Asmi Abdullah, Shaw Cameron, Al-Harbi Talal M., Csepany Tunde, Sempere Angel P., Trevino Frenk Irene, Stuart Elizabeth A., Kalincik Tomas
Dátum:2023
ISSN:0022-3050
Megjegyzések:Background Simultaneous comparisons of multiple disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS) over an extended follow-up are lacking. Here we emulate a randomised trial simultaneously comparing the effectiveness of six commonly used therapies over 5 years. Methods Data from 74 centres in 35 countries were sourced from MSBase. For each patient, the first eligible intervention was analysed, censoring at change/discontinuation of treatment. The compared interventions included natalizumab, fingolimod, dimethyl fumarate, teriflunomide, interferon beta, glatiramer acetate and no treatment. Marginal structural Cox models (MSMs) were used to estimate the average treatment effects (ATEs) and the average treatment effects among the treated (ATT), rebalancing the compared groups at 6-monthly intervals on age, sex, birth-year, pregnancy status, treatment, relapses, disease duration, disability and disease course. The outcomes analysed were incidence of relapses, 12-month confirmed disability worsening and improvement. Results 23 236 eligible patients were diagnosed with RRMS or clinically isolated syndrome. Compared with glatiramer acetate (reference), several therapies showed a superior ATE in reducing relapses: natalizumab (HR=0.44, 95% CI=0.40 to 0.50), fingolimod (HR=0.60, 95% CI=0.54 to 0.66) and dimethyl fumarate (HR=0.78, 95% CI=0.66 to 0.92). Further, natalizumab (HR=0.43, 95% CI=0.32 to 0.56) showed a superior ATE in reducing disability worsening and in disability improvement (HR=1.32, 95% CI=1.08 to 1.60). The pairwise ATT comparisons also showed superior effects of natalizumab followed by fingolimod on relapses and disability. Conclusions The effectiveness of natalizumab and fingolimod in active RRMS is superior to dimethyl fumarate, teriflunomide, glatiramer acetate and interferon beta. This study demonstrates the utility of MSM in emulating trials to compare clinical effectiveness among multiple interventions simultaneously.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
MULTIPLE SCLEROSIS
STATISTICS
Megjelenés:Journal Of Neurology Neurosurgery And Psychiatry. - 94 : 12 (2023), p. 1004-1011. -
További szerzők:Malpas, Charles B. Sharmin, Sifat Roos, Izanne Horakova, Dana Kubala Havrdova, Eva Patti, Francesco Shaygannejad, Vahid Ozakbas, Serkan Eichau, Sara Onofrj, Marco Lugaresi, Alessandra Alroughani, Raed Prat, Alexandre Duquette, Pierre Terzi, Murat Boz, Cavit Grand'Maison, Francois Sola, Patrizia Ferraro, Diana Grammond, Pierre Yamout, Bassem Altintas, Ayse Gerlach, Oliver Lechner-Scott, Jeannette Bergamaschi, Roberto Karabudak, Rana Iuliano, Gerardo McGuigan, Christopher Cartechini, Elisabetta Hughes, Stella Sá, Maria José Solaro, Claudio Kappos, Ludwig Hodgkinson, Suzanne Slee, Mark Granella, Franco de Gans, Koen McCombe, Pamela Ampapa, Radek Walt, Anneke van der Butzkueven, Helmut Sanchez-Menoyo, Jose Vucic, Steve Laureys, Guy Sidhom, Youssef Gouider, Riadh Castillo Triviño, Tamara Gray, Orla Aguera-Morales, Eduardo Al-Asmi, Abdullah Shaw, Cameron Al-Harbi, Talal Csépány Tünde (1956-) (neurológus, pszichiáter) Sempere, Perez A. Trevino-Frenk, Irene Stuart, Elizabeth A. Kalincik, Tomas
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Intézményi repozitóriumban (DEA) tárolt változat
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5.

001-es BibID:BIBFORM107545
035-os BibID:(Scopus)85148460657 (WoS)000952991100026
Első szerző:Diouf, Ibrahima
Cím:Variability of the response to immunotherapy among subgroups of patients with multiple sclerosis / Diouf Ibrahima, Malpas Charles B., Sharmin Sifat, Roos Izanne, Horakova Dana, Havrdova Eva Kubala, Patti Francesco, Shaygannejad Vahid, Ozakbas Serkan, Izquierdo Guillermo, Eichau Sara, Onofrj Marco, Lugaresi Alessandra, Alroughani Raed, Prat Alexandre, Girard Marc, Duquette Pierre, Terzi Murat, Boz Cavit, Grand'Maison Francois, Hamdy Sherif, Sola Patrizia, Ferraro Diana, Grammond Pierre, Turkoglu Recai, Buzzard Katherine, Skibina Olga, Yamout Bassem, Altintas Ayse, Gerlach Oliver, van Pesch Vincent, Blanco Yolanda, Maimone Davide, Lechner-Scott Jeannette, Bergamaschi Roberto, Karabudak Rana, Iuliano Gerardo, McGuigan Chris, Cartechini Elisabetta, Barnett Michael, Hughes Stella, Sa Maria José, Solaro Claudio, Kappos Ludwig, Ramo-Tello Cristina, Cristiano Edgardo, Hodgkinson Suzanne, Spitaleri Daniele, Soysal Aysun, Petersen Thor, Slee Mark, Butler Ernest, Granella Franco, de Gans Koen, McCombe Pamela, Ampapa Radek, Van Wijmeersch Bart, van der Walt Anneke, Butzkueven Helmut, Prevost Julie, Sinnige L. G. F., Sanchez-Menoyo Jose Luis, Vucic Steve, Laureys Guy, Van Hijfte Liesbeth, Khurana Dheeraj, Macdonell Richard, Gouider Riadh, Castillo-Trivino Tamara, Gray Orla, Aguera-Morales Eduardo, Al-Asmi Abdullah, Shaw Cameron, Deri Norma, Al-Harbi Talal, Fragoso Yara, Csepany Tunde, Perez Sempere Angel, Trevino-Frenk Irene, Schepel Jan, Moore Fraser, Kalincik Tomas
Dátum:2023
ISSN:1351-5101
Megjegyzések:Background This study assessed the effect of patient characteristics on the response to disease modifying therapy (DMT) in in multiple sclerosis (MS). Methods We extracted data from 61,810 patients from 135 centres across 35 countries from the MSBase registry. The selection criteria were: clinically isolated syndrome or definite MS; follow-up ?1 year; ?3 EDSS scores; and with ?1 score recorded per year. Marginal structural models with interaction terms were used to compare the hazards of 12-month confirmed worsening and improvement of disability, and the incidence of relapses between treated and untreated patients stratified by their characteristics. Results Among 24,344 patients with relapsing MS, those on DMTs experienced 48% reduction in relapse incidence (hazard ratio (HR)=0.52, 95%CI=0.45-0.60), 46% lower risk of disability worsening (HR=0.54, 95%CI=0.41-0.71) and 32% greater chance of disability improvement (HR=1.32, 95%CI=1.09-1.59). The effect of DMTs on EDSS worsening and improvement and the risk of relapses was attenuated with more severe disability. The magnitude of the effect of DMT on suppressing relapses declined with higher prior relapse rate and prior cerebral MRI activity. We did not find any evidence for the effect of age on the effectiveness of DMT. After inclusion of 1985 participants with progressive MS, the effect of DMT on disability mostly depended on MS phenotype, whereas its effect on relapses was driven mainly by prior relapse activity. Conclusions DMT is generally most effective among patients with lower disability and in relapsing MS phenotypes. There is no evidence attenuation of the effect of DMT with age.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:European Journal Of Neurology. - 30 : 4 (2023), p. 1014-1024. -
További szerzők:Malpas, Charles B. Sharmin, Sifat Roos, Izanne Horakova, Dana Havrdova, Eva Patti, Francesco Shaygannejad, Vahid Ozakbas, Serkan Izquierdo, Guillermo Eichau, Sara Onofrj, Marco Lugaresi, Alessandra Alroughani, Raed Prat, Alexandre Girard, Marc Duquette, Pierre Terzi, Murat Boz, Cavit Grand'Maison, Francois Hamdy, Sherif Sola, Patrizia Ferraro, Diana Grammond, Pierre Turkoglu, Recai Buzzard, Katherine Skibina, Olga Yamout, Bassem Altintas, Ayse Gerlach, Oliver Pesch, Vincent van Blanco, Yolanda Maimone, Davide Lechner-Scott, Jeannette Bergamaschi, Roberto Karabudak, Rana Iuliano, Gerardo McGuigan, Christopher Cartechini, Elisabetta Barnett, Michael Hughes, Stella Sá, Maria José Solaro, Claudio Kappos, Ludwig Ramo-Tello, Cristina Cristiano, Edgardo Hodgkinson, Suzanne Spitaleri, Daniele Soysal, Aysun Petersen, Thor Slee, Mark Butler, Ernest Granella, Franco de Gans, Koen McCombe, Pamela Ampapa, Radek Wijmeersch, Bart Van Walt, Anneke van der Butzkueven, Helmut Prevost, Julie Sinnige, L. G. F. Sanchez-Menoyo, Jose Vucic, Steve Laureys, Guy Van Hijfte, Liesbeth Khurana, Dheeraj Macdonell, Richard Gouider, Riadh Castillo Triviño, Tamara Gray, Orla Aguera-Morales, Eduardo Al-Asmi, Abdullah Shaw, Cameron Deri, Norma Al-Harbi, Talal Fragoso, Yara Csépány Tünde (1956-) (neurológus, pszichiáter) Perez Sempere, Angel Trevino-Frenk, Irene Schepel, Jan Moore, Fraser Kalincik, Tomas
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Intézményi repozitóriumban (DEA) tárolt változat
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6.

001-es BibID:BIBFORM067748
Első szerző:Kappos, Ludwig
Cím:The 11-year long-term follow-up study from the randomized BENEFIT CIS trial / Ludwig Kappos, Gilles Edan, Mark S. Freedman, Xavier Montalbán, Hans-Peter Hartung, Bernhard Hemmer, Edward J. Fox, Frederik Barkhof, Sven Schippling, Andrea Schulze, Dirk Pleimes, Christoph Pohl, Rupert Sandbrink, Gustavo Suarez, Eva-Maria Wicklein, BENEFIT Study Group
Dátum:2016
ISSN:0028-3878
Megjegyzések:Objective: To assess outcomes for patients treated with interferon beta-1b immediately after clinically isolated syndrome (CIS) or after a short delay.Methods: Participants in BENEFIT (Betaferon/Betaseron in Newly Emerging MS for Initial Treatment) were randomly assigned to receive interferon beta-1b (early treatment) or placebo (delayed treatment). After conversion to clinically definite multiple sclerosis (CDMS) or 2 years, patients on placebo could switch to interferon beta-1b or another treatment. Eleven years after randomization, patients were reassessed.Results: Two hundred seventy-eight (59.4%) of the original 468 patients (71.3% of those eligible atparticipating sites) were enrolled (early: 167 [57.2%]; delayed: 111 [63.1%]). After 11 years, risk of CDMS remained lower in the early-treatment arm compared with the delayed-treatment arm (p 50.0012), with longer time to first relapse (median [Q1, Q3] days: 1,888 [540, not reached] vs 931 [253, 3,296]; p50.0005) and lower overall annualized relapse rate (0.21 vs 0.26; p50.0018). Only25 patients (5.9%, overall; early, 4.5%; delayed, 8.3%) converted to secondary progressive multiple sclerosis. Expanded Disability Status Scale scores remained low and stable, with no differencebetween treatment arms (median [Q1,Q3]: 2.0 [1.0, 3.0]). The early-treatment group had better Paced Auditory Serial Addition Task?3 total scores (p 5 0.0070). Employment rates remained high, and health resource utilization tended to be low in both groups.MRI metrics did not differ between groups.Conclusions: Although the delay in treatment was relatively short, several clinical outcomes favored earlier treatment. Along with low rates of disability and disease progression in bothgroups, this supports the value of treatment at CIS.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Neurology 87 : 10 (2016), p. 978-987. -
További szerzők:Edan, Gilles Freedman, Mark S. Montalbán, Xavier Hartung, Hans-Peter Hemmer, Bernhard Fox, Edward J. Barkhof, Frederik Schippling, Sven Schulze, Andrea Pleimes, Dirk Pohl, Christoph Sandbrink, Rupert Suarez, Gustavo Wicklein, Eva-Maria Csiba László (1952-) (neurológus, pszichiáter) Csépány Tünde (1956-) (neurológus, pszichiáter) BENEFIT Study Group
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Intézményi repozitóriumban (DEA) tárolt változat
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7.

001-es BibID:BIBFORM005123
Első szerző:Kappos, Ludwig
Cím:Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis : a multicentre, randomised, double-blind, placebo-controlled phase IIb studye / Kappos L., Gold R., Miller D. H., Macmanus D. G., Havrdova E., Limmroth V., Polman C. H., Schmierer K., Yousry T. A., Yang M., Eraksoy M., Meluzinova E., Rektor I., Dawson K. T., Sandrock A. W., O'Neill G. N., BG-12 Phase IIb Study Investigators
Dátum:2008
Megjegyzések:Oral fumarate (BG00012) might have dual anti-inflammatory and neuroprotective eff ects. Our aim was to assess the efficacy and safety of BG00012 in patients with relapsing-remitting multiple sclerosis. Methods 257 patients, aged 18-55 years, with relapsing-remitting multiple sclerosis were randomly assigned to receive 120 mg once daily (n=64), 120 mg three times daily (n=64), or 240 mg three times daily (n=64) BG00012, or placebo (n=65) for 24 weeks. During an extension period of 24 weeks for safety assessment, patients treated with placebo received BG00012 240 mg three times daily. The primary endpoint was total number of new gadolinium enhancing (GdE) lesions on brain MRI scans at weeks 12, 16, 20, and 24. Additional endpoints included cumulative number of new GdE lesions (weeks 4-24), new or enlarging T2-hyperintense lesions, new T1-hypointense lesions at week 24, and annualised relapse rate. Analysis was done on the effi cacy-evaluable population. Safety and tolerability were also assessed. This study is registered with ClinicalTrials.gov, number NCT00168701. Findings Treatment with BG00012 240 mg three times daily reduced by 69% the mean total number of new GdE lesions from week 12 to 24 compared with placebo (1-4 vs 4-5, p<0-0001). It also reduced number of new or enlarging T2-hyperintense (p=0-0006) and new T1-hypointense p=0-014) lesions compared with placebo. BG00012 reduced annualised relapse rate by 32% (0-44 vs 0-65 for placebo; p=0-272). Adverse events more common in patients given BG00012 than in those given placebo included abdominal pain, flushing, and hot flush. Dose-related adverse events in patients on BG00012 were headache, fatigue, and feeling hot. Interpretation The anti-inflammatory effects and favourable safety profi le of BG00012 warrant further long-term phase III studies in large patient groups.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Lancet. - 372 : 9648 (2008), p. 1463-1472. -
További szerzők:Gold, Ralf Miller, David H. Macmanus, David G. Havrdova, Eva Limmroth, Volker Polman, Chris H. Schmierer, Klaus Yousry, Tarek A. Yang, Minhua Eraksoy, Mefkure Meluzinova, Eva Rektor, Ivan Dawson, Katherine T. Sandrock, Alfred W. O'Neill, Gilmore N. Csépány Tünde (1956-) (neurológus, pszichiáter) Csiba László (1952-) (neurológus, pszichiáter) BG-12 Phase IIb Study Investigators
Internet cím:elektronikus változat
DOI
Borító:

8.

001-es BibID:BIBFORM135460
035-os BibID:(Scopus)105002792941 (WoS)001470351300001
Első szerző:Müller, Jannis
Cím:Standardized Definition of Progression Independent of Relapse Activity (PIRA) in Relapsing-Remitting Multiple Sclerosis / Jannis Müller, Sifat Sharmin, Johannes Lorscheider, Serkan Ozakbas, Rana Karabudak, Dana Horakova, Bianca Weinstock-Guttman, Vahid Shaygannejad, Masoud Etemadifar, Raed Alroughani, Francesco Patti, Sara Eichau, Alexandre Prat, Alessandra Lugaresi, Valentina Tomassini, Allan G. Kermode, Maria Pia Amato, Recai Turkoglu, Ayse Altintas, Katherine Buzzard, Aysun Soysal, Anneke van der Walt, Helmut Butzkueven, Yolanda Blanco, Oliver Gerlach, Samia J. Khoury, Michael Barnett, Nevin John, Jeannette Lechner-Scott, Matteo Foschi, Andrea Surcinelli, Vincent van Pesch, Julie Prevost, Maria Jose Sa, Davide Maimone, Marie D'hooghe, Stella Hughes, Suzanne Hodgkinson, Chris McGuigan, Elisabetta Cartechini, Bruce Taylor, Daniele Spitaleri, Mark Slee, Pamela McCombe, Bassem Yamout, Pascal Benkert, Jens Kuhle, Ludwig Kappos, Izanne Roos, Tomas Kalincik, PGCertBiostat, MSBase Study Group
Dátum:2025
Megjegyzések:Importance: Progression independent of relapse activity (PIRA) is a significant contributor to long-term disability accumulation in relapsing-remitting multiple sclerosis (MS). Prior studies have used varying PIRA definitions, hampering the comparability of study results. Objective: To compare various definitions of PIRA. Design, setting, and participants: This cohort study involved a retrospective analysis of prospectively collected data from the MSBase registry from July 2004 to July 2023. The participants were patients with MS from 186 centers across 43 countries who had clinically definite relapsing-remitting MS, a complete minimal dataset, and 3 or more documented Expanded Disability Status Scale (EDSS) assessments. Exposure: Three-hundred sixty definitions of PIRA as combinations of the following criteria: baseline disability (fixed baseline with re-baselining after PIRA, or plus re-baselining after relapses, or plus re-baselining after improvements), minimum confirmation period (6, 12, or 24 months), confirmation magnitude (EDSS score at/above worsening score or at/above threshold compared with baseline), freedom from relapse at EDSS score worsening (90 days prior, 90 days prior and 30 days after, 180 days prior and after, since previous EDSS assessment, or since baseline), and freedom from relapse at confirmation (30 days prior, 90 days prior, 30 days before and after, or between worsening and confirmation). Main outcome and measure: For each definition, we quantified PIRA incidence and persistence (ie, absence of a 3-month confirmed EDSS improvement over ?5 years). Results: Among 87 239 patients with MS, 33 303 patients fulfilled the inclusion criteria; 24 152 (72.5%) were female and 9151 (27.5%) were male. At the first visits, the mean (SD) age was 36.4 (10.9) years; 28 052 patients (84.2%) had relapsing-remitting MS, and the median (IQR) EDSS score was 2.0 (1.0-3.0). Participants had a mean (SD) 15.1 (11.9) visits over 8.9 (5.2) years. PIRA incidence ranged from 0.141 to 0.658 events per decade and persistence from 0.753 to 0.919, depending on the definition. In particular, the baseline and confirmation period influenced PIRA detection. The following definition yielded balanced incidence and persistence: a significant disability worsening compared with a baseline (reset after each PIRA event, relapse, and EDSS score improvement), in absence of relapses since the last EDSS assessment, confirmed with EDSS scores (not preceded by relapses within 30 days) that remained above the worsening threshold for at least 12 months. Conclusion and relevance: Incidence and persistence of PIRA are determined by the definition used. The proposed standardized definition aims to enhance comparability among studies.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:JAMA Neurology. - 82 : 6 (2025), p. 614-625. -
További szerzők:Sharmin, Sifat Lorscheider, Johannes Ozakbas, Serkan Karabudak, Rana Horakova, Dana Weinstock-Guttman, Bianca Shaygannejad, Vahid Etemadifar, Masoud Alroughani, Raed Patti, Francesco Eichau, Sara Prat, Alexandre Lugaresi, Alessandra Tomassini, Valentina Kermode, Allan G. Amato, Maria Pia Turkoglu, Recai Altintas, Ayse Buzzard, Katherine Soysal, Aysun Walt, Anneke van der Butzkueven, Helmut Blanco, Yolanda Gerlach, Oliver Khoury, Samia J. Barnett, Michael John, Nevin Lechner-Scott, Jeannette Foschi, Matteo Surcinelli, Andrea Pesch, Vincent van Prevost, Julie Sa, Maria Jose Maimone, Davide D'hooghe, Marie Hughes, Stella Hodgkinson, Suzanne McGuigan, Christopher Cartechini, Elisabetta Taylor, Bruce V. Spitaleri, Daniele Slee, Mark McCombe, Pamela Yamout, Bassem Benkert, Pascal Kuhle, Jens Kappos, Ludwig Roos, Izanne Kalincik, Tomas Csépány Tünde (1956-) (neurológus, pszichiáter) MSBase Study Group PGCertBiostat
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9.

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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10.

001-es BibID:BIBFORM103021
035-os BibID:(Wos)000809732300001 (Scopus)85131507832
Első szerző:Sharmin, Sifat
Cím:Confirmed disability progression as a marker of permanent disability in multiple sclerosis / Sharmin Sifat, Bovis Francesca, Malpas Charles, Horakova Dana, Havrdova Eva Kubala, Izquierdo Guillermo, Eichau Sara, Trojano Maria, Prat Alexandre, Girard Marc, Duquette Pierre, Onofrj Marco, Lugaresi Alessandra, Grand'Maison Francois, Grammond Pierre, Sola Patrizia, Ferraro Diana, Terzi Murat, Gerlach Oliver, Alroughani Raed, Boz Cavit, Shaygannejad Vahid, van Pesch Vincent, Cartechini Elisabetta, Kappos Ludwig, Lechner-Scott Jeannette, Bergamaschi Roberto, Turkoglu Recai, Solaro Claudio, Iuliano Gerardo, Granella Franco, Van Wijmeersch Bart, Spitaleri Daniele, Slee Mark, McCombe Pamela, Prevost Julie, Ampapa Radek, Ozakbas Serkan, Sanchez-Menoyo Jose Luis, Soysal Aysun, Vucic Steve, Petersen Thor, de Gans Koen, Butler Ernest, Hodgkinson Suzanne, Sidhom Youssef, Gouider Riadh, Cristiano Edgardo, Castillo-Trivino Tamara, Saladino Maria Laura, Barnett Michael, Moore Fraser, Rozsa Csilla, Yamout Bassem, Skibina Olga, van der Walt Anneke, Buzzard Katherine, Gray Orla, Hughes Stella, Sempere Angel Perez, Singhal Bhim, Fragoso Yara, Shaw Cameron, Kermode Allan, Taylor Bruce, Simo Magdolna, Shuey Neil, Al-Harbi Talal, Macdonell Richard, Dominguez Jose Andres, Csepany Tunde, Sirbu Carmen-Adella, Sormani Maria Pia, Butzkueven Helmut, Kalincik Tomas
Dátum:2022
ISSN:1351-5101
Megjegyzések:Background and purpose: The prevention of disability over the long term is the main treatment goal in multiple sclerosis (MS); however, randomized clinical trials evaluate only short-term treatment effects on disability. This study aimed to define criteria for 6-month confirmed disability progression events of MS with a high probability of resulting in sustained long-term disability worsening. Methods: In total, 14,802 6- month confirmed disability progression events were identified in 8741 patients from the global MSBase registry. For each 6-month confirmed progression event (13,321 in the development and 1481 in the validation cohort), a sustained progression score was calculated based on the demographic and clinical characteristics at the time of progression that were predictive of long-term disability worsening. The score was externally validated in the Cladribine Tablets Treating Multiple Sclerosis Orally (CLARITY) trial. Results: The score was based on age, sex, MS phenotype, relapse activity, disability score and its change from baseline, number of affected functional system domains and worsening in six of the domains. In the internal validation cohort, a 61% lower chance of improvement was estimated with each unit increase in the score (hazard ratio 0.39, 95% confidence interval 0.29?0.52; discriminatory index 0.89). The proportions of progression events sustained at 5 years stratified by the score were 1: 72%; 2: 88%; 3: 94%; 4: 100%. The results of the CLARITY trial were confirmed for reduction of disability progression that was >88% likely to be sustained (events with score ?1.5).Conclusions: Clinicodemographic characteristics of 6-month confirmed disability progression events identify those at high risk of sustained long-term disability. This knowledge will allow future trials to better assess the effect of therapy on long-term disability accrual.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:European Journal Of Neurology. - 29 : 8 (2022), p. 2321-2334. -
További szerzők:Bovis, Francesca Malpas, Charles Horakova, Dana Havrdova, Eva Izquierdo, Guillermo Eichau, Sara Trojano, Maria Prat, Alexandre Girard, Marc Duquette, Pierre Onofrj, Marco Lugaresi, Alessandra Grand'Maison, Francois Grammond, Pierre Sola, Patrizia Ferraro, Diana Terzi, Murat Gerlach, Oliver Alroughani, Raed Boz, Cavit Shaygannejad, Vahid Pesch, Vincent van Cartechini, Elisabetta Kappos, Ludwig Lechner-Scott, Jeannette Bergamaschi, Roberto Turkoglu, Recai Solaro, Claudio Iuliano, Gerardo Granella, Franco Wijmeersch, Bart Van Spitaleri, Daniele Slee, Mark McCombe, Pamela Prevost, Julie Ampapa, Radek Ozakbas, Serkan Sanchez-Menoyo, Jose Soysal, Aysun Vucic, Steve Petersen, Thor de Gans, Koen Butler, Ernest Hodgkinson, Suzanne Sidhom, Youssef Gouider, Riadh Cristiano, Edgardo Castillo Triviño, Tamara Saladino, Maria Laura Barnett, Michael Moore, Fraser Rózsa Csilla Yamout, Bassem Skibina, Olga Walt, Anneke van der Buzzard, Katherine Gray, Orla Hughes, Stella Sempere, Perez A. Singhal, Bhim Fragoso, Yara Shaw, Cameron Kermode, Allan G. Taylor, Bruce V. Simó Magdolna Shuey, Neil Al-Harbi, Talal Macdonell, Richard Dominguez, Jose Andres Csépány Tünde (1956-) (neurológus, pszichiáter) Sirbu, Carmen-Adella Sormani, Maria Pia Butzkueven, Helmut Kalincik, Tomas
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