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1.

001-es BibID:BIBFORM085749
Első szerző:Brown, Jeremy William L.
Cím:The risk of relapse following on-treatment clinically silent lesions in patients with relapsing-remitting multiple sclerosis / Brown, J. W. L., Lugaresi A., Horakova D., Havrdova E., Jokubaitis V., Lechner-Scott J., Trojano M., Min M., Shaw C., Shuey N., Slee M., Mccombe P., Van Pesch V., Van Wijmeersch B., Prevost J., Moore F., Prat A., Girard M., Duquette P., Ayrignac X., Sempere A. Perez, Sanchez-Menoyo J. L., Ramo-Tello C., Csépány Tünde, Hutchinson M., De Luca G., Bergamaschi R., Granella F., Curti E., Tsantes E., Sola P., Ferraro D., Alroughani R., Hupperts R., Al-Harbi T., Sidhom Y., Boz C., Terzi M., Ozakbas S., Soysal A., Pucci E., Izquierdo G., Iuliano G., Rio M. Edite, Spitaleri D., Grammond P., Grand'Maison F., Butzkueven H., Kalincik T.
Dátum:2017
ISSN:1352-4585
Tárgyszavak:Orvostudományok Klinikai orvostudományok idézhető absztrakt
folyóiratcikk
Megjelenés:Multiple Sclerosis. - 23 : Suppl. 3 (2017), p. 992-994. -
További szerzők:Lugaresi, Alessandra Horakova, Dana Havrdova, Eva Jokubaitis, Vilija Lechner-Scott, Jeannette Trojano, Maria Min, M. Shaw, C. A. Shuey, Neil Slee, Mark McCombe, Pamela Pesch, Vincent van Van Wijmeersch, Bart Prevost, Julie Moore, Fraser Prat, Alexandre Girard, Marc Duquette, Pierre Ayrignac, X. Sempere, Perez A. Sanchez-Menoyo, Jose Ramo-Tello, Cristina Csépány Tünde (1956-) (neurológus, pszichiáter) Hutchinson, Michael De Luca, Giacomo Bergamaschi, Roberto Granella, Franco Curti, E. Tsantes, E. Sola, Patrizia Ferraro, D. Alroughani, Raed Hupperts, Raymond Al-Harbi, Talal Sidhom, Youssef Boz, Cavit Terzi, Murat Ozakbas, Serkan Soysal, Aysun Pucci, Eugenio Izquierdo, Guillermo Iuliano, Gerardo Rio, Edite M. Spitaleri, Daniele Grammond, Pierre Grand'Maison, Francois Butzkueven, Helmut Kalincik, Tomas
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2.

001-es BibID:BIBFORM083269
Első szerző:Fambiatos, Adam
Cím:Risk of secondary progressive multiple sclerosis : a longitudinal study / Adam Fambiatos, Vilija Jokubaitis, Dana Horakova, Eva Kubala Havrdova, Maria Trojano, Alexandre Prat, Marc Girard, Pierre Duquette, Alessandra Lugaresi, Guillermo Izquierdo, Francois Grand'Maison, Pierre Grammond, Patrizia Sola, Diana Ferraro, Raed Alroughani, Murat Terzi, Raymond Hupperts, Cavit Boz, Jeannette Lechner-Scott, Eugenio Pucci, Roberto Bergamaschi, Vincent Van Pesch, Serkan Ozakbas, Franco Granella, Recai Turkoglu, Gerardo Iuliano, Daniele Spitaleri, Pamela McCombe, Claudio Solaro, Mark Slee, Radek Ampapa, Aysun Soysal, Thor Petersen, Jose Luis Sanchez-Menoyo, Freek Verheul, Julie Prevost, Youssef Sidhom, Bart Van Wijmeersch, Steve Vucic, Edgardo Cristiano, Maria Laura Saladino, Norma Deri, Michael Barnett, Javier Olascoaga, Fraser Moore, Olga Skibina, Orla Gray, Yara Fragoso, Bassem Yamout, Cameron Shaw, Bhim Singhal, Neil Shuey, Suzanne Hodgkinson, Ayse Altintas, Talal Al-Harbi, Tunde Csepany, Bruce Taylor, Jordana Hughes, Jae-Kwan Jun, Anneke van der Walt, Tim Spelman, Helmut Butzkueven, Tomas Kalincik, MSBase Study Group
Dátum:2020
ISSN:1352-4585
Megjegyzések:Background: The risk factors for conversion from relapsing-remitting to secondary progressive multiple sclerosis remain highly contested. Objective: The aim of this study was to determine the demographic, clinical and paraclinical features that influence the risk of conversion to secondary progressive multiple sclerosis. Methods: Patients with adult-onset relapsing?remitting multiple sclerosis and at least four recorded disability scores were selected from MSBase, a global observational cohort. The risk of conversion to objectively defined secondary progressive multiple sclerosis was evaluated at multiple time points per patient using multivariable marginal Cox regression models. Sensitivity analyses were performed. Results: A total of 15,717 patients were included in the primary analysis. Older age (hazard ratio (HR) = 1.02, p < 0.001), longer disease duration (HR = 1.01, p = 0.038), a higher Expanded Disability Status Scale score (HR = 1.30, p < 0.001), more rapid disability trajectory (HR = 2.82, p < 0.001) and greater number of relapses in the previous year (HR = 1.07, p = 0.010) were independently associated with an increased risk of secondary progressive multiple sclerosis. Improving disability (HR = 0.62, p = 0.039) and disease-modifying therapy exposure (HR = 0.71, p = 0.007) were associated with a lower risk. Recent cerebral magnetic resonance imaging activity, evidence of spinal cord lesions and oligoclonal bands in the cerebrospinal fluid were not associated with the risk of conversion. Conclusion: Risk of secondary progressive multiple sclerosis increases with age, duration of illness and worsening disability and decreases with improving disability. Therapy may delay the onset of secondary progression.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Multiple Sclerosis. - 26 : 1 (2020), p. 79-90. -
További szerzők:Jokubaitis, Vilija Horakova, Dana Kubala Havrdova, Eva Trojano, Maria Prat, Alexandre Girard, Marc Duquette, Pierre Lugaresi, Alessandra Izquierdo, Guillermo Grand'Maison, Francois Grammond, Pierre Sola, Patrizia Ferraro, Diana Alroughani, Raed Terzi, Murat Hupperts, Raymond Boz, Cavit Lechner-Scott, Jeannette Pucci, Eugenio Bergamaschi, Roberto Pesch, Vincent van Ozakbas, Serkan Granella, Franco Turkoglu, Recai Iuliano, Gerardo Spitaleri, Daniele McCombe, Pamela Solaro, Claudio Slee, Mark Ampapa, Radek Soysal, Aysun Petersen, Thor Sanchez-Menoyo, Jose Verheul, Freek Prevost, Julie Sidhom, Youssef Van Wijmeersch, Bart Vucic, Steve Cristiano, Edgardo Saladino, Maria Laura Deri, Norma Barnett, Michael Olascoaga, Javier Moore, Fraser Skibina, Olga Gray, Orla Fragoso, Yara Yamout, Bassem Shaw, Cameron Singhal, Bhim Shuey, Neil Hodgkinson, Suzanne Altintas, Ayse Al-Harbi, Talal Csépány Tünde (1956-) (neurológus, pszichiáter) Taylor, Bruce V. Hughes, Jordana Jun, Jae-Kwan Walt, Anneke van der Spelman, Tim Butzkueven, Helmut Kalincik, Tomas MSBase Study Group
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3.

001-es BibID:BIBFORM103011
035-os BibID:(Scopus)85102090793 (Wos)000656637200025
Első szerző:Kalincik, Tomas
Cím:Effect of Disease-Modifying Therapy on Disability in Relapsing-Remitting Multiple Sclerosis Over 15 Years / Kalincik Tomas, Diouf Ibrahima, Sharmin Sifat, Malpas Charles, Spelman Tim, Horakova Dana, Havrdova Eva Kubala, Trojano Maria, Izquierdo Guillermo, Lugaresi Alessandra, Prat Alexandre, Girard Marc, Duquette Pierre, Grammond Pierre, Jokubaitis Vilija, van der Walt Anneke, Grand'Maison Francois, Sola Patrizia, Ferraro Diana, Shaygannejad Vahid, Alroughani Raed, Hupperts Raymond, Terzi Murat, Boz Cavit, Lechner-Scott Jeannette, Pucci Eugenio, Van Pesch Vincent, Granella Franco, Bergamaschi Roberto, Spitaleri Daniele, Slee Mark, Vucic Steve, Ampapa Radek, McCombe Pamela, Ramo-Tello Cristina, Prevost Julie, Olascoaga Javier, Cristiano Edgardo, Barnett Michael, Saladino Maria Laura, Sanchez-Menoyo Jose Luis, Hodgkinson Suzanne, Rozsa Csilla, Hughes Stella, Moore Fraser, Shaw Cameron, Butler Ernest, Skibina Olga, Gray Orla, Kermode Allan, Csepany Tunde, Singhal Bhim, Shuey Neil, Piroska Imre, Taylor Bruce, Simo Magdolna, Sirbu Carmen-Adella, Sas Attila, Butzkueven Helmut, MSBase Study Group
Dátum:2021
ISSN:0028-3878 1526-632X
Megjegyzések:Objective To test the hypothesis that immunotherapy prevents long-term disability in relapsing-remitting multiple sclerosis (MS), we modeled disability outcomes in 14,717 patients. Methods We studied patients from MSBase followed for ?1 year, with ?3 visits, ?1 visit per year, and exposed to MS therapy, and a subset of patients with ?15-year follow-up. Marginal structural models were used to compare the cumulative hazards of 12-month confirmed increase and decrease in disability, Expanded Disability Status Scale (EDSS) step 6, and the incidence of relapses between treated and untreated periods. Marginal structural models were continuously readjusted for patient age, sex, pregnancy, date, disease course, time from first symptom, prior relapse history, disability, and MRI activity. Results A total of 14,717 patients were studied. During the treated periods, patients were less likely to experience relapses (hazard ratio 0.60, 95% confidence interval [CI] 0.43?0.82, p = 0.0016), worsening of disability (0.56, 0.38?0.82, p = 0.0026), and progress to EDSS step 6 (0.33, 0.19?0.59, p = 0.00019). Among 1,085 patients with ?15-year follow-up, the treated patients were less likely to experience relapses (0.59, 0.50?0.70, p = 10?9) and worsening of disability (0.81, 0.67?0.99, p = 0.043). Conclusion Continued treatment with MS immunotherapies reduces disability accrual by 19%?44% (95% CI 1%?62%), the risk of need of a walking aid by 67% (95% CI 41%?81%), and the frequency of relapses by 40?41% (95% CI 18%?57%) over 15 years. This study provides evidence that disease-modifying therapies are effective in improving disability outcomes in relapsing-remitting MS over the long term. Classification of Evidence This study provides Class IV evidence that, for patients with relapsing-remitting MS, long-term exposure to immunotherapy prevents neurologic disability.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Neurology. - 96 : 5 (2021), p. e783-e797. -
További szerzők:Diouf, Ibrahima Sharmin, Sifat Malpas, Charles Spelman, Tim Horakova, Dana Havrdova, Eva Trojano, Maria Izquierdo, Guillermo Lugaresi, Alessandra Prat, Alexandre Girard, Marc Duquette, Pierre Grammond, Pierre Jokubaitis, Vilija Walt, Anneke van der Grand'Maison, Francois Sola, Patrizia Ferraro, Diana Shaygannejad, Vahid Alroughani, Raed Hupperts, Raymond Terzi, Murat Boz, Cavit Lechner-Scott, Jeannette Pucci, Eugenio Pesch, Vincent van Granella, Franco Bergamaschi, Roberto Spitaleri, Daniele Slee, Mark Vucic, Steve Ampapa, Radek McCombe, Pamela Ramo-Tello, Cristina Prevost, Julie Olascoaga, Javier Cristiano, Edgardo Barnett, Michael Saladino, Maria Laura Sanchez-Menoyo, Jose Hodgkinson, Suzanne Rózsa Csilla Hughes, Stella Moore, Fraser Shaw, Cameron Butler, Ernest Skibina, Olga Gray, Orla Kermode, Allan G. Csépány Tünde (1956-) (neurológus, pszichiáter) Singhal, Bhim Shuey, Neil Piroska Imre Taylor, Bruce V. Simó Magdolna Sirbu, Carmen-Adella Sas Attila Butzkueven, Helmut MSBase Study Group
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4.

001-es BibID:BIBFORM083272
Első szerző:Kalincik, Tomas
Cím:Immunotherapy prevents long-term disability in relapsing multiple sclerosis over 15 years / Tomas Kalincik, Sifat Sharmin, Charles Malpas, Tim Spelman, Dana Horakova, Eva Kubala Havrdova, Maria Trojano, Guillermo Izquierdo, Alessandra Lugaresi, Alexandre Prat, Marc Girard, Pierre Duquette, Pierre Grammond, Vilija Jokubaitis, Anneke van der Walt, Francois Grand'Maison, Patrizia Sola, Diana Ferraro, Vahid Shaygannejad, Raed Alroughani, Raymond Hupperts, Murat Terzi, Cavit Boz, Jeannette Lechner-Scott, Eugenio Pucci, Vincent Van Pesch, Franco Granella, Roberto Bergamaschi, Daniele Spitaleri, Mark Slee, Steve Vucic, Radek Ampapa, Pamela McCombe, Cristina Ramo-Tello, Julie Prevost, Javier Olascoaga, Edgardo Cristiano, Michael Barnett, Maria Laura Saladino, Jose Luis Sanchez-Menoyo, Suzanne Hodgkinson, Csilla Rozsa, Stella Hughes, Fraser Moore, Cameron Shaw, Ernest Butler, Olga Skibina, Orla Gray, Allan Kermode, Tunde Csepany, Bhim Singhal, Neil Shuey, Imre Piroska, Bruce Taylor, Magdolna Simo, Carmen-Adella Sirbu, Attila Sas, Helmut Butzkueven, MSBase Study group
Dátum:2019
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:bioRxiv. - 2019 (2019), p. 1-41. -
További szerzők:Sharmin, Sifat Malpas, Charles Spelman, Tim Horakova, Dana Havrdova, Eva Trojano, Maria Izquierdo, Guillermo Lugaresi, Alessandra Prat, Alexandre Girard, Marc Duquette, Pierre Grammond, Pierre Jokubaitis, Vilija Walt, Anneke van der Grand'Maison, Francois Sola, Patrizia Ferraro, Diana Shaygannejad, Vahid Alroughani, Raed Hupperts, Raymond Terzi, Murat Boz, Cavit Lechner-Scott, Jeannette Pucci, Eugenio Pesch, Vincent van Granella, Franco Bergamaschi, Roberto Spitaleri, Daniele Slee, Mark Vucic, Steve Ampapa, Radek McCombe, Pamela Ramo-Tello, Cristina Prevost, Julie Olascoaga, Javier Cristiano, Edgardo Barnett, Michael Saladino, Maria Laura Sanchez-Menoyo, Jose Hodgkinson, Suzanne Rózsa Csilla Hughes, Stella Moore, Fraser Shaw, Cameron Butler, Ernest Skibina, Olga Gray, Orla Kermode, Allan G. Csépány Tünde (1956-) (neurológus, pszichiáter) Singhal, Bhim Shuey, Neil Piroska Imre Taylor, Bruce V. Simó Magdolna Sirbu, Carmen-Adella Sas Attila Butzkueven, Helmut MSBase Study Group
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5.

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
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6.

001-es BibID:BIBFORM058152
Első szerző:Kalincik, Tomas
Cím:Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis / Tomas Kalincik, Dana Horakova, Tim Spelman, Vilija Jokubaitis, Maria Trojano, Alessandra Lugaresi, Guillermo Izquierdo, Csilla Rozsa, Pierre Grammond, Raed Alroughani, Pierre Duquette, Marc Girard, Eugenio Pucci, Jeannette Lechner-Scott, Mark Slee, Ricardo Fernandez-Bolanos, Francois Grand'Maison, Raymond Hupperts, Freek Verheul, Suzanne Hodgkinson, Celia Oreja-Guevara, Daniele Spitaleri, Michael Barnett, Murat Terzi, Roberto Bergamaschi, Pamela McCombe, Jose Sanchez-Menoyo, Magdolna Simo, Tunde Csepany, Gabor Rum, Cavit Boz, Eva Havrdova, Helmut Butzkueven
Dátum:2015
ISSN:0364-5134
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Annals Of Neurology. - 77 : 3 (2015), p. 425-435. -
További szerzők:Horakova, Dana Spelman, Tim Jokubaitis, Vilija Trojano, Maria Lugaresi, Alessandra Izquierdo, Guillermo Rózsa Csilla Grammond, Pierre Alroughani, Raed Duquette, Pierre Girard, Marc Pucci, Eugenio Lechner-Scott, Jeannette Slee, Mark Fernandez-Bolanos, Ricardo Grand'Maison, Francois Hupperts, Raymond Verheul, Freek Hodgkinson, Suzanne Oreja-Guevara, Celia Spitaleri, Daniele Barnett, Michael Terzi, Murat Bergamaschi, Roberto McCombe, Pamela Sanchez-Menoyo, Jose Simó Magdolna Csépány Tünde (1956-) (neurológus, pszichiáter) Rum Gábor Boz, Cavit Havrdova, Eva Butzkueven, Helmut
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7.

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
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