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Comparative Effectiveness of Autologous Hematopoietic Stem Cell Transplant vs Fingolimod, Natalizumab, and Ocrelizumab in Highly Active Relapsing-Remitting Multiple Sclerosis
T. Kalincik, S. Sharmin, I. Roos, MS. Freedman, H. Atkins, J. Burman, J. Massey, I. Sutton, B. Withers, R. Macdonell, A. Grigg, Ø. Torkildsen, L. Bo, AK. Lehmann, EK. Havrdova, E. Krasulova, M. Trnený, T. Kozak, A. van der Walt, H. Butzkueven, P....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, práce podpořená grantem
- MeSH
- dospělí MeSH
- fingolimod hydrochlorid terapeutické užití MeSH
- lidé MeSH
- natalizumab terapeutické užití MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * MeSH
- transplantace hematopoetických kmenových buněk * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
IMPORTANCE: Autologous hematopoietic stem cell transplant (AHSCT) is available for treatment of highly active multiple sclerosis (MS). OBJECTIVE: To compare the effectiveness of AHSCT vs fingolimod, natalizumab, and ocrelizumab in relapsing-remitting MS by emulating pairwise trials. DESIGN, SETTING, AND PARTICIPANTS: This comparative treatment effectiveness study included 6 specialist MS centers with AHSCT programs and international MSBase registry between 2006 and 2021. The study included patients with relapsing-remitting MS treated with AHSCT, fingolimod, natalizumab, or ocrelizumab with 2 or more years study follow-up including 2 or more disability assessments. Patients were matched on a propensity score derived from clinical and demographic characteristics. EXPOSURE: AHSCT vs fingolimod, natalizumab, or ocrelizumab. MAIN OUTCOMES: Pairwise-censored groups were compared on annualized relapse rates (ARR) and freedom from relapses and 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening and improvement. RESULTS: Of 4915 individuals, 167 were treated with AHSCT; 2558, fingolimod; 1490, natalizumab; and 700, ocrelizumab. The prematch AHSCT cohort was younger and with greater disability than the fingolimod, natalizumab, and ocrelizumab cohorts; the matched groups were closely aligned. The proportion of women ranged from 65% to 70%, and the mean (SD) age ranged from 35.3 (9.4) to 37.1 (10.6) years. The mean (SD) disease duration ranged from 7.9 (5.6) to 8.7 (5.4) years, EDSS score ranged from 3.5 (1.6) to 3.9 (1.9), and frequency of relapses ranged from 0.77 (0.94) to 0.86 (0.89) in the preceding year. Compared with the fingolimod group (769 [30.0%]), AHSCT (144 [86.2%]) was associated with fewer relapses (ARR: mean [SD], 0.09 [0.30] vs 0.20 [0.44]), similar risk of disability worsening (hazard ratio [HR], 1.70; 95% CI, 0.91-3.17), and higher chance of disability improvement (HR, 2.70; 95% CI, 1.71-4.26) over 5 years. Compared with natalizumab (730 [49.0%]), AHSCT (146 [87.4%]) was associated with marginally lower ARR (mean [SD], 0.08 [0.31] vs 0.10 [0.34]), similar risk of disability worsening (HR, 1.06; 95% CI, 0.54-2.09), and higher chance of disability improvement (HR, 2.68; 95% CI, 1.72-4.18) over 5 years. AHSCT (110 [65.9%]) and ocrelizumab (343 [49.0%]) were associated with similar ARR (mean [SD], 0.09 [0.34] vs 0.06 [0.32]), disability worsening (HR, 1.77; 95% CI, 0.61-5.08), and disability improvement (HR, 1.37; 95% CI, 0.66-2.82) over 3 years. AHSCT-related mortality occurred in 1 of 159 patients (0.6%). CONCLUSION: In this study, the association of AHSCT with preventing relapses and facilitating recovery from disability was considerably superior to fingolimod and marginally superior to natalizumab. This study did not find evidence for difference in the effectiveness of AHSCT and ocrelizumab over a shorter available follow-up time.
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Italy
Center of Neuroimmunology Service of Neurology Hospital Clinic de Barcelona Barcelona Spain
Central Clinical School Monash University Melbourne Victoria Australia
CHUM MS Center and Universite de Montreal Montreal Quebec Canada
Cliniques Universitaires Saint Luc Brussels Belgium
CORe Department of Medicine University of Melbourne Melbourne Victoria Australia
Department of Haematology Austin Health Melbourne Victoria Australia
Department of Haematology Haukeland University Hospital Bergen Norway
Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom
Department of Haematology St Vincent's Hospital Sydney Sydney New South Wales Australia
Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy
Department of Medical Sciences Neurology Uppsala University Uppsala Sweden
Department of Medicine School of Clinical Sciences Monash University Melbourne Victoria Australia
Department of Medicine Sultan Qaboos University Hospital Al Khodh Oman
Department of Neurology Antwerp University Hospital Edegem Belgium
Department of Neurology Austin Health Melbourne Victoria Australia
Department of Neurology Box Hill Hospital Melbourne Victoria Australia
Department of Neurology Buffalo General Medical Center Buffalo New York
Department of Neurology Centro Hospitalar Universitario de Sao Joao Porto Portugal
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Neurology Hacettepe University Hospitals Ankara Turkey
Department of Neurology Haukeland University Hospital Bergen Norway
Department of Neurology Razi University Hospital Manouba Tunis Tunisia
Department of Neurology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom
Department of Neurology St Vincent's Hospital Sydney Sydney New South Wales Australia
Department of Neurology The Alfred Hospital Melbourne Victoria Australia
Department of Neurology University Hospital Ghent Ghent Belgium
Dipartimento di Scienze Biomediche e Neuromotorie Università di Bologna Bologna Italy
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Dokuz Eylul University Konak Izmir Turkey
Faculty of Medicine of Tunis University of Tunis El Manar Tunis Tunisia
Flinders University Adelaide South Australia Australia
Garibaldi Hospital Catania Italy
Groene Hart Ziekenhuis Gouda the Netherlands
Haydarpasa Numune Training and Research Hospital Istanbul Turkey
Hospital de Galdakao Usansolo Galdakao Spain
Hospital Universitario Donostia San Sebastián Spain
IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy
Liverpool Hospital Sydney New South Wales Australia
Menzies Institute for Medical Research University of Tasmania Hobart Tasmania Australia
Monash Medical Centre Melbourne Victoria Australia
Monash University Melbourne Victoria Australia
Multiple Sclerosis Center University of Catania Catania Italy
Neuroimmunology Centre Department of Neurology Royal Melbourne Hospital Melbourne Victoria Australia
Ottawa Hospital Research Institute University of Ottawa Ottawa Ontario Canada
Perron Institute University of Western Australia Nedlands Western Australia Australia
Royal Brisbane and Women's Hospital Brisbane Queensland Australia
Royal Hobart Hospital Hobart Tasmania Australia
School for Mental Health and Neuroscience Maastricht University Maastricht the Netherlands
School of Medicine and Public Health University Newcastle Newcastle New South Wales Australia
St Vincent's Clinical School University of New South Wales Sydney New South Wales Australia
Universidade Metropolitana de Santos Santos Brazil
Université Catholique de Louvain Ottignies Louvain la Neuve Belgium
University Hospital Reina Sofia Cordoba Spain
University of Melbourne Melbourne Victoria Australia
University of Ottawa Department of Medicine Ottawa Hospital Research Institute Ottawa Ontario Canada
University of Queensland Brisbane Queensland Australia
University of Sydney Sydney New South Wales Australia
UOC Neurologia Azienda Sanitaria Unica Regionale Marche AV3 Macerata Italy
Citace poskytuje Crossref.org
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- $a Kalincik, Tomas $u Neuroimmunology Centre, Department of Neurology, Royal Melbourne Hospital, Melbourne, Victoria, Australia $u CORe, Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
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- $a IMPORTANCE: Autologous hematopoietic stem cell transplant (AHSCT) is available for treatment of highly active multiple sclerosis (MS). OBJECTIVE: To compare the effectiveness of AHSCT vs fingolimod, natalizumab, and ocrelizumab in relapsing-remitting MS by emulating pairwise trials. DESIGN, SETTING, AND PARTICIPANTS: This comparative treatment effectiveness study included 6 specialist MS centers with AHSCT programs and international MSBase registry between 2006 and 2021. The study included patients with relapsing-remitting MS treated with AHSCT, fingolimod, natalizumab, or ocrelizumab with 2 or more years study follow-up including 2 or more disability assessments. Patients were matched on a propensity score derived from clinical and demographic characteristics. EXPOSURE: AHSCT vs fingolimod, natalizumab, or ocrelizumab. MAIN OUTCOMES: Pairwise-censored groups were compared on annualized relapse rates (ARR) and freedom from relapses and 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening and improvement. RESULTS: Of 4915 individuals, 167 were treated with AHSCT; 2558, fingolimod; 1490, natalizumab; and 700, ocrelizumab. The prematch AHSCT cohort was younger and with greater disability than the fingolimod, natalizumab, and ocrelizumab cohorts; the matched groups were closely aligned. The proportion of women ranged from 65% to 70%, and the mean (SD) age ranged from 35.3 (9.4) to 37.1 (10.6) years. The mean (SD) disease duration ranged from 7.9 (5.6) to 8.7 (5.4) years, EDSS score ranged from 3.5 (1.6) to 3.9 (1.9), and frequency of relapses ranged from 0.77 (0.94) to 0.86 (0.89) in the preceding year. Compared with the fingolimod group (769 [30.0%]), AHSCT (144 [86.2%]) was associated with fewer relapses (ARR: mean [SD], 0.09 [0.30] vs 0.20 [0.44]), similar risk of disability worsening (hazard ratio [HR], 1.70; 95% CI, 0.91-3.17), and higher chance of disability improvement (HR, 2.70; 95% CI, 1.71-4.26) over 5 years. Compared with natalizumab (730 [49.0%]), AHSCT (146 [87.4%]) was associated with marginally lower ARR (mean [SD], 0.08 [0.31] vs 0.10 [0.34]), similar risk of disability worsening (HR, 1.06; 95% CI, 0.54-2.09), and higher chance of disability improvement (HR, 2.68; 95% CI, 1.72-4.18) over 5 years. AHSCT (110 [65.9%]) and ocrelizumab (343 [49.0%]) were associated with similar ARR (mean [SD], 0.09 [0.34] vs 0.06 [0.32]), disability worsening (HR, 1.77; 95% CI, 0.61-5.08), and disability improvement (HR, 1.37; 95% CI, 0.66-2.82) over 3 years. AHSCT-related mortality occurred in 1 of 159 patients (0.6%). CONCLUSION: In this study, the association of AHSCT with preventing relapses and facilitating recovery from disability was considerably superior to fingolimod and marginally superior to natalizumab. This study did not find evidence for difference in the effectiveness of AHSCT and ocrelizumab over a shorter available follow-up time.
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