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1.
001-es BibID:
BIBFORM067755
Első szerző:
Kalincik, Tomas
Cím:
Treatment effectiveness of alemtuzumab compared with natalizumab, fingolimod, and interferon beta in relapsing-remitting multiple sclerosis : a cohort study / Tomas Kalincik, J. William L. Brown, Neil Robertson, Mark Willis, Neil Scolding, Claire M. Rice, Alastair Wilkins, Owen Pearson, Tjalf Ziemssen, Michael Hutchinson, Christopher McGuigan, Vilija Jokubaitis, Tim Spelman, Dana Horakova, Eva Havrdova, Maria Trojano, Guillermo Izquierdo, Alessandra Lugaresi, Alexandre Prat, Marc Girard, Pierre Duquette, Pierre Grammond, Raed Alroughani, Eugenio Pucci, Patrizia Sola, Raymond Hupperts, Jeannette Lechner-Scott, Murat Terzi, Vincent Van Pesch, Csilla Rozsa, François Grand'Maison, Cavit Boz, Franco Granella, Mark Slee, Daniele Spitaleri, Javier Olascoaga, Roberto Bergamaschi, Freek Verheul, Steve Vucic, Pamela McCombe, Suzanne Hodgkinson, Jose Luis Sanchez-Menoyo, Radek Ampapa, Magdolna Simo, Tunde Csepany, Cristina Ramo, Edgardo Cristiano, Michael Barnett, Helmut Butzkueven, Alasdair Coles, MSBase Study Group
Dátum:
2017
ISSN:
1474-4422
Megjegyzések:
BackgroundAlemtuzumab, an anti-CD52 antibody, is proven to be more efficacious than interferon beta-1a in the treatment of relapsing-remitting multiple sclerosis, but its efficacy relative to more potent immunotherapies is unknown. We compared the effectiveness of alemtuzumab with natalizumab, fingolimod, and interferon beta in patients with relapsing-remitting multiple sclerosis treated for up to 5 years.MethodsIn this international cohort study, we used data from propensity-matched patients with relapsing-remitting multiple sclerosis from the MSBase and six other cohorts. Longitudinal clinical data were obtained from 71 MSBase centres in 21 countries and from six non-MSBase centres in the UK and Germany between Nov 1, 2015, and June 30, 2016. Key inclusion criteria were a diagnosis of definite relapsing-remitting multiple sclerosis, exposure to one of the study therapies (alemtuzumab, interferon beta, fingolimod, or natalizumab), age 65 years or younger, Expanded Disability Status Scale (EDSS) score 6?5 or lower, and no more than 10 years since the first multiple sclerosis symptom. The primary endpoint was annualised relapse rate. The secondary endpoints were cumulative hazards of relapses, disability accumulation, and disability improvement events. We compared relapse rates with negative binomial models, and estimated cumulative hazards with conditional proportional hazards models.FindingsPatients were treated between Aug 1, 1994, and June 30, 2016. The cohorts consisted of 189 patients given alemtuzumab, 2155 patients given interferon beta, 828 patients given fingolimod, and 1160 patients given natalizumab. Alemtuzumab was associated with a lower annualised relapse rate than interferon beta (0?19 [95% CI 0?14?0?23] vs 0?53 [0?46?0?61], p<0?0001) and fingolimod (0?15 [0?10?0?20] vs 0?34 [0?26?0?41], p<0?0001), and was associated with a similar annualised relapse rate as natalizumab (0?20 [0?14?0?26] vs 0?19 [0?15?0?23], p=0?78). For the disability outcomes, alemtuzumab was associated with similar probabilities of disability accumulation as interferon beta (hazard ratio [HR] 0?66 [95% CI 0?36?1?22], p=0?37), fingolimod (1?27 [0?60?2?70], p=0?67), and natalizumab (0?81 [0?47?1?39], p=0?60). Alemtuzumab was associated with similar probabilities of disability improvement as interferon beta (0?98 [0?65?1?49], p=0?93) and fingolimod (0?50 [0?25?1?01], p=0?18), and a lower probability of disability improvement than natalizumab (0?35 [0?20?0?59], p=0?0006).InterpretationAlemtuzumab and natalizumab seem to have similar effects on annualised relapse rates in relapsing-remitting multiple sclerosis. Alemtuzumab seems superior to fingolimod and interferon beta in mitigating relapse activity. Natalizumab seems superior to alemtuzumab in enabling recovery from disability. Both natalizumab and alemtuzumab seem highly effective and viable immunotherapies for multiple sclerosis. Treatment decisions between alemtuzumab and natalizumab should be primarily governed by their safety profiles.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:
Lancet Neurology 16 : 4 (2017), p. 271-281. -
További szerzők:
Brown, Jeremy William L.
Robertson, Neil
Willis, Mark
Scolding, Neil
Rice, Claire M.
Wilkins, Alastair
Pearson, Owen
Ziemssen, Tjalf
Hutchinson, Michael
McGuigan, Christopher
Jokubaitis, Vilija
Spelman, Tim
Horakova, Dana
Havrdova, Eva
Trojano, Maria
Izquierdo, Guillermo
Lugaresi, Alessandra
Prat, Alexandre
Girard, Marc
Duquette, Pierre
Grammond, Pierre
Alroughani, Raed
Pucci, Eugenio
Sola, Patrizia
Hupperts, Raymond
Lechner-Scott, Jeannette
Terzi, Murat
Pesch, Vincent van
Rózsa Csilla
Grand'Maison, Francois
Boz, Cavit
Granella, Franco
Slee, Mark
Spitaleri, Daniele
Olascoaga, Javier
Bergamaschi, Roberto
Verheul, Freek
Vucic, Steve
McCombe, Pamela
Hodgkinson, Suzanne
Sanchez-Menoyo, Jose
Ampapa, Radek
Simó Magdolna
Csépány Tünde (1956-) (neurológus, pszichiáter)
Ramo, Cristina
Cristiano, Edgardo
Barnett, Michael
Butzkueven, Helmut
Coles, Alasdair
MSBase Study Group
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
2.
001-es BibID:
BIBFORM103333
035-os BibID:
(Scopus)85090969423 (WOS)000607095300025
Első szerző:
Roos, Izanne
Cím:
Delay from treatment start to full effect of immunotherapies for multiple sclerosis / Roos Izanne, Leray Emmanuelle, Frascoli Federico, Casey Romain, Brown J. William L., Horakova Dana, Havrdova Eva K., Trojano Maria, Patti Francesco, Izquierdo Guillermo, Eichau Sara, Onofrj Marco, Lugaresi Alessandra, Prat Alexandre, Girard Marc, Grammond Pierre, Sola Patrizia, Ferraro Diana, Ozakbas Serkan, Bergamaschi Roberto, Sá Maria José, Cartechini Elisabetta, Boz Cavit, Granella Franco, Hupperts Raymond, Terzi Murat, Lechner-Scott Jeannette, Spitaleri Daniele, Van Pesch Vincent, Soysal Aysun, Olascoaga Javier, Prevost Julie, Aguera-Morales Eduardo, Slee Mark, Csepany Tunde, Turkoglu Recai, Sidhom Youssef, Gouider Riadh, Van Wijmeersch Bart, McCombe Pamela, Macdonell Richard, Coles Alasdair, Malpas Charles B., Butzkueven Helmut, Vukusic Sandra, Kalincik Tomas, MSBase and OFSEP investigators
Dátum:
2020
ISSN:
0006-8950
Megjegyzések:
In multiple sclerosis, treatment start or switch is prompted by evidence of disease activity. Whilst immunomodulatory therapies reduce disease activity, the time required to attain maximal effect is unclear. In this study we aimed to develop a method that allows identification of the time to manifest fully and clinically the effect of multiple sclerosis treatments (Ơtherapeutic lag') on clinical disease activity represented by relapses and progression-of-disability events. Data from two multiple sclerosis registries, MSBase (multinational) and OFSEP (French), were used. Patients diagnosed with multiple sclerosis, minimum 1-year exposure to treatment, minimum 3-year pretreatment follow-up and yearly review were included in the analysis. For analysis of disability progression, all events in the subsequent 5-year period were included. Density curves, representing incidence of relapses and 6-month confirmed progression events, were separately constructed for each sufficiently represented therapy. Monte Carlo simulations were performed to identify the first local minimum of the first derivative after treatment start; this point represented the point of stabilization of treatment effect, after the maximum treatment effect was observed. The method was developed in a discovery cohort (MSBase), and externally validated in a separate, non-overlapping cohort (OFSEP). A merged MSBase-OFSEP cohort was used for all subsequent analyses. Annualized relapse rates were compared in the time before treatment start and after the stabilization of treatment effect following commencement of each therapy. We identified 11 180 eligible treatment epochs for analysis of relapses and 4088 treatment epochs for disability progression. External validation was performed in four therapies, with no significant difference in the bootstrapped mean differences in therapeutic lag duration between registries. The duration of therapeutic lag for relapses was calculated for 10 therapies and ranged between 12 and 30 weeks. The duration of therapeutic lag for disability progression was calculated for seven therapies and ranged between 30 and 70 weeks. Significant differences in the pre- versus post-treatment annualized relapse rate were present for all therapies apart from intramuscular interferon beta-1a. In conclusion we have developed, and externally validated, a method to objectively quantify the duration of therapeutic lag on relapses and disability progression in different therapies in patients more than 3 years from multiple sclerosis onset. Objectively defined periods of expected therapeutic lag allows insights into the evaluation of treatment response in randomized clinical trials and may guide clinical decision-making in patients who experience early on-treatment disease activity. This method will subsequently be applied in studies that evaluate the effect of patient and disease characteristics on therapeutic lag.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
multiple sclerosis
therapeutic lag
Megjelenés:
Brain. - 143 : 9 (2020), p. 2742-2756. -
További szerzők:
Leray, Emmanuelle
Frascoli, Federico
Casey, Romain
Brown, J. William L.
Horakova, Dana
Havrdova, Eva
Trojano, Maria
Patti, Francesco
Izquierdo, Guillermo
Eichau, Sara
Onofrj, Marco
Lugaresi, Alessandra
Prat, Alexandre
Girard, Marc
Grammond, Pierre
Sola, Patrizia
Ferraro, Diana
Ozakbas, Serkan
Bergamaschi, Roberto
Sá, Maria José
Cartechini, Elisabetta
Boz, Cavit
Granella, Franco
Hupperts, Raymond
Terzi, Murat
Lechner-Scott, Jeannette
Spitaleri, Daniele
Pesch, Vincent van
Soysal, Aysun
Olascoaga, Javier
Prevost, Julie
Aguera-Morales, Eduardo
Slee, Mark
Csépány Tünde (1956-) (neurológus, pszichiáter)
Turkoglu, Recai
Sidhom, Youssef
Gouider, Riadh
Van Wijmeersch, Bart
McCombe, Pamela
Macdonell, Richard
Coles, Alasdair
Malpas, Charles B.
Butzkueven, Helmut
Vukusic, Sandra
Kalincik, Tomas
OFSEP and the MSBase investigators
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
3.
001-es BibID:
BIBFORM094875
035-os BibID:
(WoS)000677275500001 (Scopus)85099300704
Első szerző:
Roos, Izanne
Cím:
Determinants of therapeutic lag in multiple sclerosis / Izanne Roos, Emmanuelle Leray, Federico Frascoli, Romain Casey, J. William L. Brown, Dana Horakova, Eva Kubala Havrdova, Marc Debouverie, Maria Trojano, Francesco Patti, Guillermo Izquierdo, Sara Eichau, Gilles Edan, Alexandre Prat, Marc Girard, Pierre Duquette, Marco Onofrj, Alessandra Lugaresi, Pierre Grammond, Jonathan Ciron , Aurélie Ruet, Serkan Ozakbas, Jérôme De Seze, Céline Louapre, Hélène Zephir, Maria José Sá, Patrizia Sola, Diana Ferraro, Pierre Labauge, Gilles Defer, Roberto Bergamaschi, Christine Lebrun-Frenay, Cavit Boz, Elisabetta Cartechini, Thibault Moreau, David Laplaud, Jeannette Lechner-Scott, Francois Grand'Maison, Oliver Gerlach, Murat Terzi, Franco Granella, Raed Alroughani, Gerardo Iuliano, Vincent Van Pesch, Bart Van Wijmeersch, Daniele L. A. Spitaleri, Aysun Soysal, Eric Berger, Julie Prevost, Eduardo Aguera-Morales, Pamela McCombe, Tamara Castillo Triviño, Pierre Clavelou, Jean Pelletier, Recai Turkoglu, Bruno Stankoff, Olivier Gout, Eric Thouvenot, Olivier Heinzlef, Youssef Sidhom, Riadh Gouider, Tunde Csepany, Bertrand Bourre, Abdullatif Al Khedr, Olivier Casez, Philippe Cabre, Alexis Montcuquet, Abir Wahab, Jean-Philippe Camdessanche, Aude Maurousset, Ivania Patry, Karolina Hankiewicz, Corinne Pottier, Nicolas Maubeuge, Céline Labeyrie, Chantal Nifle, Alasdair Coles, Charles B. Malpas, Sandra Vukusic, Helmut Butzkueven, Tomas Kalincik, MSBase and OFSEP study groups
Dátum:
2021
ISSN:
1352-4585
Megjegyzések:
Background: A delayed onset of treatment effect, termed therapeutic lag, may influence the assessment of treatment response in some patient subgroups. Objectives: The objective of this study is to explore the associations of patient and disease characteristics with therapeutic lag on relapses and disability accumulation. Methods: Data from MSBase, a multinational multiple sclerosis (MS) registry, and OFSEP, the French MS registry, were used. Patients diagnosed with MS, minimum 1 year of exposure to MS treatment and 3 years of pre-treatment follow-up, were included in the analysis. Studied outcomes were incidence of relapses and disability accumulation. Therapeutic lag was calculated using an objective, validated method in subgroups stratified by patient and disease characteristics. Therapeutic lag under specific circumstances was then estimated in subgroups defined by combinations of clinical and demographic determinants. Results: High baseline disability scores, annualised relapse rate (ARR) ? 1 and male sex were associated with longer therapeutic lag on disability progression in sufficiently populated groups: females with expanded disability status scale (EDSS) < 6 and ARR < 1 had mean lag of 26.6 weeks (95% CI = 18.2-34.9), males with EDSS < 6 and ARR < 1 31.0 weeks (95% CI = 25.3-36.8), females with EDSS < 6 and ARR ? 1 44.8 weeks (95% CI = 24.5-65.1), and females with EDSS ? 6 and ARR < 1 54.3 weeks (95% CI = 47.2-61.5). Conclusions: Pre-treatment EDSS and ARR are the most important determinants of therapeutic lag.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Neurology
multiple sclerosis
observational study
therapeutic lag
Megjelenés:
Multiple Sclerosis. - 27 : 12 (2021), p. 1838-1851. -
További szerzők:
Leray, Emmanuelle
Frascoli, Federico
Casey, Romain
Brown, J. William L.
Horakova, Dana
Havrdova, Eva
Debouverie, Marc
Trojano, Maria
Patti, Francesco
Izquierdo, Guillermo
Eichau, Sara
Edan, Gilles
Prat, Alexandre
Girard, Marc
Duquette, Pierre
Onofrj, Marco
Lugaresi, Alessandra
Grammond, Pierre
Ciron, Jonathan
Ruet, Aurélie
Ozakbas, Serkan
De Seze, Jérôme
Louapre, Céline
Zephir, Hélène
Sá, Maria José
Sola, Patrizia
Ferraro, Diana
Labauge, Pierre
Defer, Gilles
Bergamaschi, Roberto
Lebrun-Frenay, Christine
Boz, Cavit
Cartechini, Elisabetta
Moreau, Thibault
Laplaud, David
Lechner-Scott, Jeannette
Grand'Maison, Francois
Gerlach, Oliver
Terzi, Murat
Granella, Franco
Alroughani, Raed
Iuliano, Gerardo
Pesch, Vincent van
Van Wijmeersch, Bart
Spitaleri, Daniele L. A.
Soysal, Aysun
Berger, Eric
Prevost, Julie
Aguera-Morales, Eduardo
McCombe, Pamela
Castillo Triviño, Tamara
Clavelou, Pierre
Pelletier, Jean
Turkoglu, Recai
Stankoff, Bruno
Gout, Olivier
Thouvenot, Eric
Heinzlef, Olivier
Sidhom, Youssef
Gouider, Riadh
Csépány Tünde (1956-) (neurológus, pszichiáter)
Bourre, Bertrand
Al Khedr, Abdullatif
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
Coles, Alasdair
Malpas, Charles B.
Vukusic, Sandra
Butzkueven, Helmut
Kalincik, Tomas
MSBase and OFSEP study groups
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
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