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Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis

dc.rights.licenseopenen_US
dc.contributor.authorBROCHET, Bruno
dc.contributor.authorDELOIRE, Mathilde
dc.contributor.authorGERMAIN, Christine
dc.contributor.authorOUALLET, Jean Christophe
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorWITTKOP, Linda
dc.contributor.authorDULAU, Cecile
dc.contributor.authorPEREZ, Paul
dc.contributor.authorTHEVENOT, Florian
dc.contributor.authorDE SEZE, Jerome
dc.contributor.authorZEPHIR, Helene
dc.contributor.authorVERMERSCH, Patrick
dc.contributor.authorPITTION, Sophie
dc.contributor.authorDEBOUVERIE, Marc
dc.contributor.authorLAPLAUD, David-Axel
dc.contributor.authorCLAVELOU, Pierre
dc.contributor.authorRUET, Aurelie
dc.date.accessioned2021-01-18T13:25:38Z
dc.date.available2021-01-18T13:25:38Z
dc.date.issued2020
dc.identifier.issn1098-1101 (Electronic) 0733-2459 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/25824
dc.description.abstractEnIntroduction No randomized controlled clinical trial of therapeutic plasma exchanges (TPE) has yet been performed for moderate‐to‐severe relapses of multiple sclerosis (MS). Objective To compare TPE to sham‐TPE in patients with a recent steroid‐resistant moderate‐to‐severe MS relapse. Methods Patients presenting with an MS relapse of less than 2 months without improvement and 15 days after a course of steroids were randomized. Specific criteria were used for each relapse type to define moderate‐to‐severe disability. The primary endpoint was the proportion of patients with at least a moderate improvement based on objective and functional evaluation after 1 month. Results Thirty‐eight patients were randomized. The intention‐to‐treat analysis included 14 patients in the TPE group and 17 in the Sham‐TPE group. The proportion of patients with at least moderate improvement at 1 month did not differ between the groups (P = .72), although 57.1% of the TPE group had full recovery compared with 17.6% of the sham group. Considering optic neuritis (ON), a significant difference in the proportion of different levels of improvement was observed in favor of the TPE group (P = .04). The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham‐TPE group at months 1 (P < .01), 3 (P < .05), and 6 (P < .05). No major side effects were observed. Conclusions A significant difference between TPE and Sham‐TPE at the primary endpoint was only observed in patients with ON. Neurological function improved significantly more often in the TPE group than in the sham‐TPE group.
dc.language.isoENen_US
dc.subjectMORPH3Eus
dc.title.enDouble-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis
dc.title.alternativeJ Clin Apheren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1002/jca.21788en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed32369661en_US
bordeaux.journalJournal of Clinical Apheresisen_US
bordeaux.page281-289en_US
bordeaux.volume35en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue4en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamMORPH3Eusen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03166191
hal.version1
hal.date.transferred2021-03-11T09:33:11Z
hal.exporttrue
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