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Effect of Nonmyeloa...
Effect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression in Patients With Relapsing-Remitting Multiple Sclerosis : A Randomized Clinical Trial
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- Burt, Richard K. (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Balabanov, Roumen (författare)
- Northwestern Univ, Feinberg Sch Med, Dept Neurol, Chicago, IL 60611 USA
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- Burman, Joachim, 1974- (författare)
- Uppsala universitet,Neurologi
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- Sharrack, Basil (författare)
- Sheffield Teaching Hosp NHS Fdn Trust, Dept Neurosci, Sheffield, S Yorkshire, England;Sheffield Teaching Hosp NHS Fdn Trust, Sheffield NIHR Translat Neurosci BBC, Sheffield, S Yorkshire, England;Univ Sheffield, Sheffield, S Yorkshire, England
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- Snowden, John A. (författare)
- Univ Sheffield, Sheffield, S Yorkshire, England;Sheffield Teaching Hosp NHS Fdn Trust, Dept Haematol & Oncol, Sheffield, S Yorkshire, England;Sheffield Teaching Hosp NHS Fdn Trust, Dept Metab, Sheffield, S Yorkshire, England
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- Oliveira, Maria Carolina (författare)
- Univ Sao Paulo, Ctr Cell Based Therapy, Dept Internal Med, Ribeirao Preto Med Sch, Ribeirao Preto, Brazil
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- Fagius, Jan (författare)
- Uppsala universitet,Neurologi
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- Rose, John (författare)
- Univ Utah, Dept Neurol, Salt Lake City, UT USA
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- Nelson, Flavia (författare)
- Univ Minnesota, Dept Neurol, Div Multiple Sclerosis, Minneapolis, MN 55455 USA
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- Barreira, Amilton Antunes (författare)
- Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Neurosci & Behav Sci, Ribeirao Preto, Brazil
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- Carlson, Kristina (författare)
- Uppsala universitet,Hematologi
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- Han, Xiaoqiang (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Moraes, Daniela (författare)
- Univ Sao Paulo, Ctr Cell Based Therapy, Dept Internal Med, Ribeirao Preto Med Sch, Ribeirao Preto, Brazil
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- Morgan, Amy (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Quigley, Kathleen (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Yaung, Kimberly (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Buckley, Regan (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Alldredge, Carri (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Clendenan, Allison (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Calvario, Michelle A. (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Henry, Jacquelyn (författare)
- Northwestern Univ, Dept Med, Div Immunotherapy, Feinberg Sch Med, Chicago, IL 60611 USA
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- Jovanovic, Borko (författare)
- Northwestern Univ, Feinberg Sch Med, Dept Prevent Med, Chicago, IL 60611 USA
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- Helenowski, Irene B. (författare)
- Northwestern Univ, Feinberg Sch Med, Dept Prevent Med, Chicago, IL 60611 USA
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(creator_code:org_t)
- AMER MEDICAL ASSOC, 2019
- 2019
- Engelska.
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Ingår i: Journal of the American Medical Association (JAMA). - : AMER MEDICAL ASSOC. - 0098-7484 .- 1538-3598. ; 321:2, s. 165-174
- Relaterad länk:
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https://jamanetwork....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- IMPORTANCE Hematopoietic stem cell transplantation (HSCT) represents a potentially useful approach to slow or prevent progressive disability in relapsing-remitting multiple sclerosis (MS).OBJECTIVE To compare the effect of nonmyeloablative HSCT vs disease-modifying therapy (DMT) on disease progression.DESIGN, SETTING, AND PARTICIPANTS Between September 20, 2005, and July 7, 2016, a total of 110 patients with relapsing-remitting MS, at least 2 relapses while receiving DMT in the prior year, and an Expanded Disability Status Scale (EDSS; score range, 0-10 [10 = worst neurologic disability]) score of 2.0 to 6.0 were randomized at 4 US, European, and South American centers. Final follow-up occurred in January 2018 and database lock in February 2018.INTERVENTIONS Patients were randomized to receive HSCT along with cyclophosphamide (200mg/kg) and antithymocyte globulin (6mg/kg) (n = 55) or DMT of higher efficacy or a different class than DMT taken during the previous year (n = 55).MAIN OUTCOMES AND MEASURES The primary end point was disease progression, defined as an EDSS score increase after at least 1 year of 1.0 point or more (minimal clinically important difference, 0.5) on 2 evaluations 6 months apart, with differences in time to progression estimated as hazard ratios. RESULTS Among 110 randomized patients (73 [66%] women; mean age, 36 [SD, 8.6] years), 103 remained in the trial, with 98 evaluated at 1 year and 23 evaluated yearly for 5 years (median follow-up, 2 years; mean, 2.8 years). Disease progression occurred in 3 patients in the HSCT group and 34 patients in the DMT group. Median time to progression could not be calculated in the HSCT group because of too few events; it was 24 months (interquartile range, 18-48 months) in the DMT group (hazard ratio, 0.07; 95% CI, 0.02-0.24; P < .001). During the first year, mean EDSS scores decreased (improved) from 3.38 to 2.36 in the HSCT group and increased (worsened) from 3.31 to 3.98 in the DMT group (between-group mean difference,-1.7; 95% CI,-2.03 to -1.29; P < .001). There were no deaths and no patients who received HSCT developed nonhematopoietic grade 4 toxicities (such as myocardial infarction, sepsis, or other disabling or potential life-threatening events).CONCLUSIONS AND RELEVANCE In this preliminary study of patients with relapsing-remitting MS, nonmyeloablative HSCT, compared with DMT, resulted in prolonged time to disease progression. Further research is needed to replicate these findings and to assess long-term outcomes and safety.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
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Burt, Richard K.
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Balabanov, Roume ...
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Burman, Joachim, ...
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Sharrack, Basil
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Snowden, John A.
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Oliveira, Maria ...
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Fagius, Jan
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Rose, John
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Nelson, Flavia
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Barreira, Amilto ...
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Carlson, Kristin ...
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Han, Xiaoqiang
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Moraes, Daniela
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Morgan, Amy
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Quigley, Kathlee ...
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Yaung, Kimberly
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Buckley, Regan
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Alldredge, Carri
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Clendenan, Allis ...
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Calvario, Michel ...
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Henry, Jacquelyn
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Jovanovic, Borko
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Helenowski, Iren ...
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