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ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial

dc.rights.licenseopenen_US
dc.contributor.authorHARTUNG, Hans-Peter
dc.contributor.authorBERGER, Thomas
dc.contributor.authorBERMEL, Robert A.
hal.structure.identifierNeurocentre Magendie : Physiopathologie de la Plasticité Neuronale [U1215 Inserm - UB]
dc.contributor.authorBROCHET, Bruno
dc.contributor.authorCARROLL, William M.
dc.contributor.authorHOLMØY, Trygve
dc.contributor.authorKARABUDAK, Rana
dc.contributor.authorKILLESTEIN, Joep
dc.contributor.authorNOS, Carlos
dc.contributor.authorPATTI, Francesco
dc.contributor.authorPERRIN ROSS, Amy
dc.contributor.authorVANOPDENBOSCH, Ludo
dc.contributor.authorVOLLMER, Timothy
dc.contributor.authorBUFFELS, Regine
dc.contributor.authorGARAS, Monika
dc.contributor.authorKADNER, Karen
dc.contributor.authorMANFRINI, Marianna
dc.contributor.authorWANG, Qing
dc.contributor.authorFREEDMAN, Mark S.
dc.date.accessioned2025-05-31T08:09:45Z
dc.date.available2025-05-31T08:09:45Z
dc.date.issued2024-07
dc.identifier.issn0340-5354en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/206800
dc.description.abstractEnIntroduction: Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). The safety profile and patient preference for conventional versus shorter ocrelizumab infusions were investigated in the ENSEMBLE PLUS study. Methods: ENSEMBLE PLUS was a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810), comparing outcomes in patients with early-stage relapsing–remitting MS receiving ocrelizumab 600 mg over the approved 3.5-h (conventional) versus 2-h (shorter) infusion. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first randomized dose (RD); the secondary endpoint included IRR frequency at subsequent RDs. Results: At first RD, the number of patients with an IRR in the conventional (101/373; 27.1%) versus shorter (107/372; 28.8%) infusion group was similar (difference, stratified estimates [95% CI]: 1.9% [− 4.4, 8.2]). Most IRRs (conventional: 99.4%; shorter: 97.7%) were mild/moderate. IRR frequency decreased over the course of RDs; three patients discontinued from the shorter infusion arm but continued with conventional infusion. Overall, > 98% of IRRs resolved without sequelae in both groups. Pre-randomization throat irritation was predictive of future throat irritation as an IRR symptom. Adverse events (AEs) and serious AEs were consistent with the known ocrelizumab safety profile. On completion of ENSEMBLE PLUS, most patients chose to remain on (95%) or switch to (80%) shorter infusion. Conclusion: ENSEMBLE PLUS demonstrates the safety and tolerability of shorter ocrelizumab infusions. Most patients remained on/switched to shorter infusion after unblinding; IRRs did not strongly influence patient decisions. Clinical Trials Registration: Substudy of ENSEMBLE (NCT03085810). Registration: March 21, 2017. © The Author(s) 2024.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enENSEMBLE PLUS
dc.subject.enInfusion-related reaction
dc.subject.enOcrelizumab
dc.subject.enPhase 3
dc.subject.enRelapsing–remitting multiple sclerosis
dc.subject.enShorter infusion
dc.title.enENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial
dc.title.alternativeJ Neurolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s00415-024-12326-zen_US
dc.subject.halSciences du Vivant [q-bio]/Neurosciences [q-bio.NC]en_US
dc.identifier.pubmed38649522en_US
bordeaux.journalJournal of Neurologyen_US
bordeaux.page4348 – 4360en_US
bordeaux.volume271en_US
bordeaux.hal.laboratoriesNeurocentre Magendie - U1215en_US
bordeaux.issue7en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamRelations glie-neuroneen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-05091159
hal.version1
hal.date.transferred2025-05-31T08:09:51Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccCC BYen_US
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