-
Je něco špatně v tomto záznamu ?
Comparison Between Dimethyl Fumarate, Fingolimod, and Ocrelizumab After Natalizumab Cessation
C. Zhu, T. Kalincik, D. Horakova, Z. Zhou, K. Buzzard, O. Skibina, R. Alroughani, G. Izquierdo, S. Eichau, J. Kuhle, F. Patti, F. Grand'Maison, S. Hodgkinson, P. Grammond, J. Lechner-Scott, E. Butler, A. Prat, M. Girard, P. Duquette, RAL....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu pozorovací studie, multicentrická studie, časopisecké články
- MeSH
- dimethyl fumarát škodlivé účinky MeSH
- dospělí MeSH
- fingolimod hydrochlorid * terapeutické užití MeSH
- imunologické faktory škodlivé účinky MeSH
- imunosupresiva škodlivé účinky MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- natalizumab škodlivé účinky MeSH
- recidiva MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
IMPORTANCE: Natalizumab cessation is associated with a risk of rebound disease activity. It is important to identify the optimal switch disease-modifying therapy strategy after natalizumab to limit the risk of severe relapses. OBJECTIVES: To compare the effectiveness and persistence of dimethyl fumarate, fingolimod, and ocrelizumab among patients with relapsing-remitting multiple sclerosis (RRMS) who discontinued natalizumab. DESIGN, SETTING, AND PARTICIPANTS: In this observational cohort study, patient data were collected from the MSBase registry between June 15, 2010, and July 6, 2021. The median follow-up was 2.7 years. This was a multicenter study that included patients with RRMS who had used natalizumab for 6 months or longer and then were switched to dimethyl fumarate, fingolimod, or ocrelizumab within 3 months after natalizumab discontinuation. Patients without baseline data were excluded from the analysis. Data were analyzed from May 24, 2022, to January 9, 2023. EXPOSURES: Dimethyl fumarate, fingolimod, and ocrelizumab. MAIN OUTCOMES AND MEASURES: Primary outcomes were annualized relapse rate (ARR) and time to first relapse. Secondary outcomes were confirmed disability accumulation, disability improvement, and subsequent treatment discontinuation, with the comparisons for the first 2 limited to fingolimod and ocrelizumab due to the small number of patients taking dimethyl fumarate. The associations were analyzed after balancing covariates using an inverse probability of treatment weighting method. RESULTS: Among 66 840 patients with RRMS, 1744 had used natalizumab for 6 months or longer and were switched to dimethyl fumarate, fingolimod, or ocrelizumab within 3 months of natalizumab discontinuation. After excluding 358 patients without baseline data, a total of 1386 patients (mean [SD] age, 41.3 [10.6] years; 990 female [71%]) switched to dimethyl fumarate (138 [9.9%]), fingolimod (823 [59.4%]), or ocrelizumab (425 [30.7%]) after natalizumab. The ARR for each medication was as follows: ocrelizumab, 0.06 (95% CI, 0.04-0.08); fingolimod, 0.26 (95% CI, 0.12-0.48); and dimethyl fumarate, 0.27 (95% CI, 0.12-0.56). The ARR ratio of fingolimod to ocrelizumab was 4.33 (95% CI, 3.12-6.01) and of dimethyl fumarate to ocrelizumab was 4.50 (95% CI, 2.89-7.03). Compared with ocrelizumab, the hazard ratio (HR) of time to first relapse was 4.02 (95% CI, 2.83-5.70) for fingolimod and 3.70 (95% CI, 2.35-5.84) for dimethyl fumarate. The HR of treatment discontinuation was 2.57 (95% CI, 1.74-3.80) for fingolimod and 4.26 (95% CI, 2.65-6.84) for dimethyl fumarate. Fingolimod use was associated with a 49% higher risk for disability accumulation compared with ocrelizumab. There was no significant difference in disability improvement rates between fingolimod and ocrelizumab. CONCLUSION AND RELEVANCE: Study results show that among patients with RRMS who switched from natalizumab to dimethyl fumarate, fingolimod, or ocrelizumab, ocrelizumab use was associated with the lowest ARR and discontinuation rates, and the longest time to first relapse.
American University of Beirut Medical Center Beirut Lebanon
Austin Health Melbourne Victoria Australia
Brain and Mind Centre Sydney New South Wales Australia
Buffalo General Medical Center Buffalo New York
Centro Hospitalar Universitario de São João Porto Portugal
Charles University Prague and General University Hospital Prague Czech Republic
CHUM MS Center and Université de Montréal Montréal Québec Canada
CISSS Chaudière Appalache Levis Québec Canada
Cliniques Universitaires Saint Luc Brussels Belgium
CSSS Saint Jérôme Saint Jerome Québec Canada
Department of Neurology Alfred Hospital Melbourne Victoria Australia
Department of Neurology Box Hill Hospital Melbourne Victoria Australia
Department of Neurology Royal Melbourne Hospital Melbourne Victoria Australia
Department of Neuroscience Central Clinical School Monash University Melbourne Victoria Australia
Dokuz Eylul University Konak Izmir Turkey
Flinders University Adelaide South Australia Australia
Hospital Universitario Virgen Macarena Sevilla Spain
KTU Medical Faculty Farabi Hospital Trabzon Turkey
Liverpool Hospital Sydney New South Wales Australia
Mayis University Samsun Turkey
Monash Medical Centre Melbourne Victoria Australia
Multiple Sclerosis Center University of Catania Catania Italy
Neuro Rive Sud Longueuil Québec Canada
Rehabilitation and MS Centre Overpelt and Hasselt University Hasselt Belgium
School of Public Health and Preventive Medicine Monash University Melbourne Victoria Australia
Universitary Hospital Ghent Ghent Belgium
University Hospital and University of Basel Basel Switzerland
University Newcastle Newcastle New South Wales Australia
University of Western Australia Nedlands Western Australia Australia
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc23016979
- 003
- CZ-PrNML
- 005
- 20231026105350.0
- 007
- ta
- 008
- 231013s2023 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1001/jamaneurol.2023.1542 $2 doi
- 035 __
- $a (PubMed)37273217
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Zhu, Chao $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia
- 245 10
- $a Comparison Between Dimethyl Fumarate, Fingolimod, and Ocrelizumab After Natalizumab Cessation / $c C. Zhu, T. Kalincik, D. Horakova, Z. Zhou, K. Buzzard, O. Skibina, R. Alroughani, G. Izquierdo, S. Eichau, J. Kuhle, F. Patti, F. Grand'Maison, S. Hodgkinson, P. Grammond, J. Lechner-Scott, E. Butler, A. Prat, M. Girard, P. Duquette, RAL. Macdonell, B. Weinstock-Guttman, S. Ozakbas, M. Slee, MJ. Sa, V. Van Pesch, M. Barnett, B. Van Wijmeersch, O. Gerlach, J. Prevost, M. Terzi, C. Boz, G. Laureys, L. Van Hijfte, AG. Kermode, J. Garber, B. Yamout, SJ. Khoury, D. Merlo, M. Monif, V. Jokubaitis, A. van der Walt, H. Butzkueven, MSBase Study Group
- 520 9_
- $a IMPORTANCE: Natalizumab cessation is associated with a risk of rebound disease activity. It is important to identify the optimal switch disease-modifying therapy strategy after natalizumab to limit the risk of severe relapses. OBJECTIVES: To compare the effectiveness and persistence of dimethyl fumarate, fingolimod, and ocrelizumab among patients with relapsing-remitting multiple sclerosis (RRMS) who discontinued natalizumab. DESIGN, SETTING, AND PARTICIPANTS: In this observational cohort study, patient data were collected from the MSBase registry between June 15, 2010, and July 6, 2021. The median follow-up was 2.7 years. This was a multicenter study that included patients with RRMS who had used natalizumab for 6 months or longer and then were switched to dimethyl fumarate, fingolimod, or ocrelizumab within 3 months after natalizumab discontinuation. Patients without baseline data were excluded from the analysis. Data were analyzed from May 24, 2022, to January 9, 2023. EXPOSURES: Dimethyl fumarate, fingolimod, and ocrelizumab. MAIN OUTCOMES AND MEASURES: Primary outcomes were annualized relapse rate (ARR) and time to first relapse. Secondary outcomes were confirmed disability accumulation, disability improvement, and subsequent treatment discontinuation, with the comparisons for the first 2 limited to fingolimod and ocrelizumab due to the small number of patients taking dimethyl fumarate. The associations were analyzed after balancing covariates using an inverse probability of treatment weighting method. RESULTS: Among 66 840 patients with RRMS, 1744 had used natalizumab for 6 months or longer and were switched to dimethyl fumarate, fingolimod, or ocrelizumab within 3 months of natalizumab discontinuation. After excluding 358 patients without baseline data, a total of 1386 patients (mean [SD] age, 41.3 [10.6] years; 990 female [71%]) switched to dimethyl fumarate (138 [9.9%]), fingolimod (823 [59.4%]), or ocrelizumab (425 [30.7%]) after natalizumab. The ARR for each medication was as follows: ocrelizumab, 0.06 (95% CI, 0.04-0.08); fingolimod, 0.26 (95% CI, 0.12-0.48); and dimethyl fumarate, 0.27 (95% CI, 0.12-0.56). The ARR ratio of fingolimod to ocrelizumab was 4.33 (95% CI, 3.12-6.01) and of dimethyl fumarate to ocrelizumab was 4.50 (95% CI, 2.89-7.03). Compared with ocrelizumab, the hazard ratio (HR) of time to first relapse was 4.02 (95% CI, 2.83-5.70) for fingolimod and 3.70 (95% CI, 2.35-5.84) for dimethyl fumarate. The HR of treatment discontinuation was 2.57 (95% CI, 1.74-3.80) for fingolimod and 4.26 (95% CI, 2.65-6.84) for dimethyl fumarate. Fingolimod use was associated with a 49% higher risk for disability accumulation compared with ocrelizumab. There was no significant difference in disability improvement rates between fingolimod and ocrelizumab. CONCLUSION AND RELEVANCE: Study results show that among patients with RRMS who switched from natalizumab to dimethyl fumarate, fingolimod, or ocrelizumab, ocrelizumab use was associated with the lowest ARR and discontinuation rates, and the longest time to first relapse.
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a dospělí $7 D000328
- 650 12
- $a fingolimod hydrochlorid $x terapeutické užití $7 D000068876
- 650 _2
- $a natalizumab $x škodlivé účinky $7 D000069442
- 650 _2
- $a dimethyl fumarát $x škodlivé účinky $7 D000069462
- 650 _2
- $a lokální recidiva nádoru $x farmakoterapie $7 D009364
- 650 12
- $a relabující-remitující roztroušená skleróza $x farmakoterapie $7 D020529
- 650 _2
- $a imunosupresiva $x škodlivé účinky $7 D007166
- 650 _2
- $a imunologické faktory $x škodlivé účinky $7 D007155
- 650 _2
- $a recidiva $7 D012008
- 655 _2
- $a pozorovací studie $7 D064888
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Kalincik, Tomas $u Clinical Outcomes Research Unit (CORe), Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia $u Department of Neurology, Royal Melbourne Hospital, Melbourne, Victoria, Australia
- 700 1_
- $a Horakova, Dana $u Charles University in Prague and General University Hospital, Prague, Czech Republic
- 700 1_
- $a Zhou, Zhen $u School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
- 700 1_
- $a Buzzard, Katherine $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia $u Department of Neurology, Box Hill Hospital, Melbourne, Victoria, Australia
- 700 1_
- $a Skibina, Olga $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia $u Department of Neurology, Box Hill Hospital, Melbourne, Victoria, Australia $u Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
- 700 1_
- $a Alroughani, Raed $u Amiri Hospital, Sharq, Kuwait
- 700 1_
- $a Izquierdo, Guillermo $u Hospital Universitario Virgen Macarena, Sevilla, Spain
- 700 1_
- $a Eichau, Sara $u Hospital Universitario Virgen Macarena, Sevilla, Spain
- 700 1_
- $a Kuhle, Jens $u University Hospital and University of Basel, Basel, Switzerland
- 700 1_
- $a Patti, Francesco $u Multiple Sclerosis Center, University of Catania, Catania, Italy
- 700 1_
- $a Grand'Maison, Francois $u Neuro Rive-Sud, Longueuil, Québec, Canada
- 700 1_
- $a Hodgkinson, Suzanne $u Liverpool Hospital, Sydney, New South Wales, Australia
- 700 1_
- $a Grammond, Pierre $u CISSS Chaudière-Appalache, Levis, Québec, Canada
- 700 1_
- $a Lechner-Scott, Jeannette $u University Newcastle, Newcastle, New South Wales, Australia
- 700 1_
- $a Butler, Ernest $u Monash Medical Centre, Melbourne, Victoria, Australia
- 700 1_
- $a Prat, Alexandre $u CHUM MS Center and Université de Montréal, Montréal, Québec, Canada
- 700 1_
- $a Girard, Marc $u CHUM MS Center and Université de Montréal, Montréal, Québec, Canada
- 700 1_
- $a Duquette, Pierre $u CHUM MS Center and Université de Montréal, Montréal, Québec, Canada
- 700 1_
- $a Macdonell, Richard A L $u Austin Health, Melbourne, Victoria, Australia
- 700 1_
- $a Weinstock-Guttman, Bianca $u Buffalo General Medical Center, Buffalo, New York
- 700 1_
- $a Ozakbas, Serkan $u Dokuz Eylul University, Konak/Izmir, Turkey
- 700 1_
- $a Slee, Mark $u Flinders University, Adelaide, South Australia, Australia
- 700 1_
- $a Sa, Maria Jose $u Centro Hospitalar Universitario de São João, Porto, Portugal
- 700 1_
- $a Van Pesch, Vincent $u Cliniques Universitaires Saint-Luc, Brussels, Belgium
- 700 1_
- $a Barnett, Michael $u Brain and Mind Centre, Sydney, New South Wales, Australia
- 700 1_
- $a Van Wijmeersch, Bart $u Rehabilitation and MS-Centre Overpelt and Hasselt University, Hasselt, Belgium
- 700 1_
- $a Gerlach, Oliver $u Zuyderland Medical Center, Sittard-Geleen, the Netherlands
- 700 1_
- $a Prevost, Julie $u CSSS Saint-Jérôme, Saint-Jerome, Québec, Canada
- 700 1_
- $a Terzi, Murat $u 19 Mayis University, Samsun, Turkey
- 700 1_
- $a Boz, Cavit $u KTU Medical Faculty Farabi Hospital, Trabzon, Turkey
- 700 1_
- $a Laureys, Guy $u Universitary Hospital Ghent, Ghent, Belgium
- 700 1_
- $a Van Hijfte, Liesbeth $u Universitary Hospital Ghent, Ghent, Belgium
- 700 1_
- $a Kermode, Allan G $u University of Western Australia, Nedlands, Western Australia, Australia
- 700 1_
- $a Garber, Justin $u Westmead Hospital, Sydney, New South Wales, Australia
- 700 1_
- $a Yamout, Bassem $u American University of Beirut Medical Center, Beirut, Lebanon
- 700 1_
- $a Khoury, Samia J $u American University of Beirut Medical Center, Beirut, Lebanon
- 700 1_
- $a Merlo, Daniel $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia
- 700 1_
- $a Monif, Mastura $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia $u Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
- 700 1_
- $a Jokubaitis, Vilija $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia
- 700 1_
- $a van der Walt, Anneke $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia $u Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
- 700 1_
- $a Butzkueven, Helmut $u Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Victoria, Australia $u Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
- 710 2_
- $a MSBase Study Group
- 773 0_
- $w MED00180402 $t JAMA neurology $x 2168-6157 $g Roč. 80, č. 7 (2023), s. 739-748
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/37273217 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20231013 $b ABA008
- 991 __
- $a 20231026105344 $b ABA008
- 999 __
- $a ok $b bmc $g 2000479 $s 1203341
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2023 $b 80 $c 7 $d 739-748 $e 2023Jul01 $i 2168-6157 $m JAMA Neurology $n JAMA Neurol $x MED00180402
- LZP __
- $a Pubmed-20231013
