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Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm, Open-Label Trial

Hartung, Hans-Peter
Autor Autorita ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Benedict, Ralph H B
Autor Benedict, Ralph H B From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Berger, Thomas
Autor Berger, Thomas ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Bermel, Robert A
Autor Bermel, Robert A ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Brochet, Bruno
Autor Brochet, Bruno ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Carroll, William M
Autor Carroll, William M ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Freedman, Mark S
Autor Freedman, Mark S ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Holmøy, Trygve
Autor Holmøy, Trygve ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Karabudak, Rana
Autor Karabudak, Rana ORCID From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands
Nos, Carlos
Autor Nos, Carlos From the Department of Neurology (H.-P.H.), UKD, Centre of Neurology and Neuropsychiatry and LVR-Klinikum, Heinrich-Heine University Düsseldorf, Germany Brain and Mind Centre (H.-P.H.), University of Sydney, Australia Department of Neurology (H.-P.H.), Palacky University Olomouc, Czech Republic Department of Neurology (R.H.B.B.), Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY Department of Neurology (T.B.), Medical University of Vienna, Comprehensive Center for Clinical Neurosciences and Mental Health, Austria Mellen Center for MS (R.A.B.), Cleveland Clinic, OH Neurocentre Magendie INSERM (B.B.), Université de Bordeaux, France Department of Neurology (W.M.C.), Sir Charles Gairdner Hospital, Perron Institute for Neurological and Translational Science, The University of Western Australia, Nedlands Department of Medicine and the Ottawa Hospital Research Institute (M.S.F.), University of Ottawa, Ontario, Canada Department of Neurology (T.H.), Akershus University Hospital, Lørenskog Institute of Clinical Medicine (T.H.), University of Oslo, Norway Department of Neurology (R.K.), Hacettepe University Faculty of Medicine, Ankara, Turkey Centre d'Esclerosi Mútiple de Catalunya (Cemcat) (C.N.), Vall d'Hebron Hospital Universitari, Barcelona, Spain Department of Medical and Surgical Sciences and Advanced Technologies (F.P.), GF Ingrassia, Neuroscience Section and Multiple Sclerosis Centre, University of Catania PO Policlinico G Rodolico, Italy Loyola University Chicago (A.P.R.), IL Department of Neurology (L.V.), AZ Sint-Jan Brugge-Oostende, Belgium Department of Neurology (T.V.), University of Colorado School of Medicine, Aurora Medical Image Analysis Center (MIAC AG) (J.W.), Department of Biomedical Engineering, University of Basel F. Hoffmann-La Roche Ltd (J.W., S.C., K.K., T.K., I.K., C.R., G.-A.T.), Basel, Switzerland and Department of Neurology (J.K.), VU University Medical Centre, Amsterdam, the Netherlands

Neurology. 2024 ; 103 (12) : e210049. [pub] 20241203

ISSN 1526-632X
Medvik
Zdroj

BACKGROUND AND OBJECTIVES: Early treatment of multiple sclerosis (MS) reduces disease activity and the risk of long-term disease progression. Effectiveness of ocrelizumab is established in relapsing MS (RMS); however, data in early RMS are lacking. We evaluated the 4-year effectiveness and safety of ocrelizumab as a first-line therapy in treatment-naive patients with recently diagnosed relapsing-remitting MS (RRMS). METHODS: ENSEMBLE was a prospective, 4-year, international, multicenter, single-arm, open-label, phase IIIb study. Patients were treatment naive, aged 18-55 years, had early-stage RRMS with a disease duration ≤3 years, Expanded Disability Status Scale (EDSS) score ≤3.5, and ≥1 clinically reported relapse(s) or ≥1 signs of brain inflammatory activity on MRI in the prior 12 months. Patients received IV ocrelizumab 600 mg every 24 weeks. Effectiveness endpoints over 192 weeks were proportion of patients with no evidence of disease activity (NEDA-3; defined as absence of relapses, 24-week confirmed disability progression [CDP], and MRI measures, with prespecified MRI rebaselining at week 8), 24-week/48-week CDP and 24-week confirmed disability improvement, annualized relapse rate (ARR), mean change in EDSS score from baseline, and safety. Cognitive status, patient-reported outcomes, and serum neurofilament light chain (NfL) were assessed. Descriptive analysis was performed on the intention-to-treat population. RESULTS: Baseline characteristics (N = 678) were consistent with early-stage RRMS (n = 539 patients, 64.6% female, age 40 years and younger; median age: 31.0 years; duration since: MS symptom onset 0.78 years, RRMS diagnosis 0.24 years; mean baseline EDSS score [SD] 1.71 [0.95]). At week 192, most of the patients had NEDA-3 (n = 394/593, 66.4%), 85.0% had no MRI activity, 90.9% had no relapses, and 81.8% had no 24-week CDP over the study duration. Adjusted ARR at week 192 was low (0.020, 95% CI 0.015-0.027). NfL levels were reduced to and remained within the healthy donor range, by week 48 and week 192, respectively. No new or unexpected safety signals were observed. DISCUSSION: Disease activity based on clinical and MRI measures was absent in most of the patients treated with ocrelizumab over 4 years in the ENSEMBLE study. Safety was consistent with the known profile of ocrelizumab. Although this single-arm study was limited by lack of a parallel group for comparison of outcome measures, the positive benefit-risk profile observed may provide confidence to adopt ocrelizumab as a first-line treatment in newly diagnosed patients with early RMS. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that adult patients with early-stage MS who were treatment naive maintained low disease activity (NEDA-3) over 4 years with ocrelizumab treatment; no new safety signals were detected. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier NCT03085810; first submitted March 16, 2017; first patient enrolled: March 27, 2017; available at clinicaltrials.gov/ct2/show/NCT03085810.

Článek

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

Journal of neurology. 2024 ; 271 (7) : 4348-4360. [pub] 20240422

J Neurol
ISSN 1432-1459
Medvik
Zdroj

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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