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Shorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis

dc.rights.licenseopenen_US
dc.contributor.authorHARTUNG, H.-P.
dc.contributor.authorBERGER, T.
dc.contributor.authorBERMEL, R.A.
hal.structure.identifierNeurocentre Magendie : Physiopathologie de la Plasticité Neuronale [U1215 Inserm - UB]
dc.contributor.authorBROCHET, Bruno
dc.contributor.authorCARROLL, W.M.
dc.contributor.authorHOLMØY, T.
dc.contributor.authorKARABUDAK, R.
dc.contributor.authorKILLESTEIN, J.
dc.contributor.authorNOS, C.
dc.contributor.authorPATTI, F.
dc.contributor.authorROSS, A.P.
dc.contributor.authorVANOPDENBOSCH, L.
dc.contributor.authorVOLLMER, T.
dc.contributor.authorBUFFELS, R.
dc.contributor.authorGARAS, M.
dc.contributor.authorKADNER, K.
dc.contributor.authorMANFRINI, M.
dc.contributor.authorWANG, Q.
dc.contributor.authorFREEDMAN, M.S.
dc.date.accessioned2025-03-21T16:23:46Z
dc.date.available2025-03-21T16:23:46Z
dc.date.issued2020-11
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/205638
dc.description.abstractEnBackground: Ocrelizumab is an approved intravenously administered anti-CD20 antibody for multiple sclerosis (MS). Shortening the 600 mg infusion to 2 hours reduces the total site stay from 5.5–6 hours (approved infusion duration including mandatory pre-medication and post-infusion observation) to 4 hours. The safety profile of shorter-duration ocrelizumab infusions was investigated using results from ENSEMBLE PLUS. Methods: ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early-stage relapsing-remitting MS received ocrelizumab 600 mg infusions every 24 weeks for 192 weeks. In ENSEMBLE PLUS, ocrelizumab 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration); the durations of the initial infusions (2×300 mg, 14 days apart) were unaffected. The primary endpoint was the proportion of patients with infusion-related reactions (IRRs) following the first Randomized Dose. Results: From November 1, 2018, to December 13, 2019, 745 patients were randomized 1:1 to the conventional or shorter infusion group. At the first Randomized Dose, 99/373 patients (26.5%) in the conventional and 107/372 patients (28.8%) in the shorter infusion group experienced IRRs. The majority of IRRs were mild or moderate; >99% of all IRRs resolved without sequelae in both groups (conventional infusion group, 99/99; shorter infusion group, 106/107). No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuations occurred. During the first Randomized Dose, 22/373 (5.9%) and 39/372 (10.5%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. Adverse events were consistent with the known safety profile of ocrelizumab. Conclusion: The rates and severity of IRRs were similar between conventional and shorter infusions. No new safety signals were detected. Shortening the infusion time to 2 hours reduces the total site stay time (including mandatory pre-medication/infusion/observation) from 5.5–6 hours to 4 hours, and may reduce patient and site staff burden. A short video summarizing the key results is provided in supplemental material. © 2020 The Authors
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enOcrelizumab
dc.subject.enShorter infusion
dc.subject.enRelapsing-remitting multiple sclerosis
dc.subject.enInfusion-related reaction
dc.title.enShorter infusion time of ocrelizumab: Results from the randomized, double-blind ENSEMBLE PLUS substudy in patients with relapsing-remitting multiple sclerosis
dc.title.alternativeMult Scler Relat Disorden_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.msard.2020.102492en_US
dc.subject.halSciences du Vivant [q-bio]/Neurosciences [q-bio.NC]en_US
dc.identifier.pubmed33039944en_US
bordeaux.journalMultiple Sclerosis and Related Disordersen_US
bordeaux.volume46en_US
bordeaux.hal.laboratoriesNeurocentre Magendie - U1215en_US
bordeaux.issue102492en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamRelations glie-neuroneen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDAgence Nationale de la Rechercheen_US
hal.identifierhal-05001308
hal.version1
hal.date.transferred2025-03-21T16:23:51Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccCC BY-NC-NDen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Multiple%20Sclerosis%20and%20Related%20Disorders&rft.date=2020-11&rft.volume=46&rft.issue=102492&rft.au=HARTUNG,%20H.-P.&BERGER,%20T.&BERMEL,%20R.A.&BROCHET,%20Bruno&CARROLL,%20W.M.&rft.genre=article


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