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ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial
HP. Hartung, T. Berger, RA. Bermel, B. Brochet, WM. Carroll, T. Holmøy, R. Karabudak, J. Killestein, C. Nos, F. Patti, A. Perrin Ross, L. Vanopdenbosch, T. Vollmer, R. Buffels, M. Garas, K. Kadner, M. Manfrini, Q. Wang, MS. Freedman
Jazyk angličtina Země Německo
Typ dokumentu časopisecké články, randomizované kontrolované studie, multicentrická studie
- MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- humanizované monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- imunologické faktory * aplikace a dávkování škodlivé účinky MeSH
- intravenózní infuze MeSH
- lidé středního věku MeSH
- lidé MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
INTRODUCTION: 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.
Brain and Mind Centre University of Sydney Sydney Australia
Centre d'Esclerosi Múltiple de Catalunya Vall d'Hebron Hospital Universitari Barcelona Spain
Department of Neurology Akershus University Hospital Lørenskog Norway
Department of Neurology AZ Sint Jan Brugge Oostende Brugge Belgium
Department of Neurology Hacettepe University Faculty of Medicine Ankara Turkey
Department of Neurology Medical University of Vienna Vienna Austria
Department of Neurology Palacky University Olomouc Olomouc Czech Republic
Department of Neurology UKD Medical Faculty Heinrich Heine University Düsseldorf Düsseldorf Germany
F Hoffmann La Roche Ltd Basel Switzerland
INSERM U 1215 Neurocentre Magendie University of Bordeaux Bordeaux France
Institute of Clinical Medicine University of Oslo Oslo Norway
Loyola University Chicago Chicago Maywood IL USA
Mellen Center for MS Neurological Institute Cleveland Clinic Cleveland OH USA
University of Colorado Anschutz Medical Campus Aurora CO USA
Citace poskytuje Crossref.org
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- $a INTRODUCTION: 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.
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