dc.contributor
Institut Català de la Salut
dc.contributor
[Hauser SL] Department of Neurology, University of California, San Francisco. [Kappos L] Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Switzerland. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Craveiro L, Chognot C, Hughes R] F. Hoffmann-La Roche Ltd., Basel, Switzerland
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Hauser, Stephen L.
dc.contributor.author
Montalban Gairín, Xavier
dc.contributor.author
Craveiro, Licinio
dc.contributor.author
Chognot, Cathy
dc.contributor.author
Hughes, Richard
dc.contributor.author
Kappos, Ludwig
dc.date.accessioned
2025-10-24T10:18:04Z
dc.date.available
2025-10-24T10:18:04Z
dc.date.issued
2022-07-18T12:37:26Z
dc.date.issued
2022-07-18T12:37:26Z
dc.date.issued
2021-10-19
dc.identifier
Hauser SL, Kappos L, Montalban X, Craveiro L, Chognot C, Hughes R, et al. Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis. Neurology. 2021 Oct 19;97(16):e1546–59.
dc.identifier
https://hdl.handle.net/11351/7792
dc.identifier
10.1212/WNL.0000000000012700
dc.identifier
000708601400017
dc.identifier.uri
http://hdl.handle.net/11351/7792
dc.description.abstract
Multiple sclerosis; Patient safety; Medical care
dc.description.abstract
Esclerosis múltiple; Seguridad del paciente; Atención médica
dc.description.abstract
Esclerosi múltiple; Seguretat del pacient; Atenció mèdica
dc.description.abstract
Background and Objectives To report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) enrolled in clinical trials or treated in real-world postmarketing settings.
Methods Safety analyses are based on integrated clinical and laboratory data for all patients who received OCR in 11 clinical trials, including the controlled treatment and open-label extension (OLE) periods of the phase 2 and 3 trials, plus the phase 3b trials VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, CONSONANCE, and LIBERTO. For selected adverse events (AEs), additional postmarketing data were used. Incidence rates of serious infections (SIs) and malignancies were contextualized using multiple epidemiologic sources.
Results At data cutoff (January 2020), 5,680 patients with multiple sclerosis (MS) received OCR (18,218 patient-years [PY] of exposure) in clinical trials. Rates per 100 PY (95% confidence interval) of AEs (248; 246–251), serious AEs (7.3; 7.0–7.7), infusion-related reactions (25.9; 25.1–26.6), and infections (76.2; 74.9–77.4) were similar to those within the controlled treatment period of the phase 3 trials. Rates of the most common serious AEs, including SIs (2.01; 1.81–2.23) and malignancies (0.46; 0.37–0.57), were consistent with the ranges reported in epidemiologic data.
Discussion Continuous administration of OCR for up to 7 years in clinical trials, as well as its broader use for more than 3 years in the real-world setting, are associated with a favorable and manageable safety profile, without emerging safety concerns, in a heterogeneous MS population.
Classification of Evidence This analysis provides Class III evidence that long-term, continuous treatment with OCR has a consistent and favorable safety profile in patients with RMS and PPMS. This study is rated Class III because of the use of OLE data and historical controls.
dc.description.abstract
This work was supported by financial support from F. Hoffmann-La Roche Ltd, Basel, Switzerland, for the study and publication of the manuscript.
dc.format
application/pdf
dc.publisher
Lippincott Williams & Wilkins
dc.relation
Neurology;97(16)
dc.relation
https://doi.org/10.1212/WNL.0000000000012700
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Esclerosi múltiple - Tractament
dc.subject
Medicaments - Efectes secundaris
dc.subject
Anticossos monoclonals
dc.subject
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
dc.title
Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
