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1.
001-es BibID:
BIBFORM103017
035-os BibID:
(Wos)000685503300008 (Scopus)85107912293 (cikkazonosító)106180
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
Van Wijmeersch, Bart
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
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
2.
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
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
3.
001-es BibID:
BIBFORM107545
035-os BibID:
(cikkazonosító)15706 (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
Van Wijmeersch, Bart
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
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
4.
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
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
5.
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:
Saját polcon:
6.
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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DOI
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Saját polcon:
7.
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
Van Wijmeersch, Bart
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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