Related Experiment Video
Updated: Oct 21, 2025
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis
Stephen L Hauser1, Ludwig Kappos2, Xavier Montalban2
1From the Department of Neurology (S.L.H.), University of California, San Francisco; Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering (L.K.), Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel, University of Basel, Switzerland; Department of Neurology-Neuroimmunology (X.M.), Multiple Sclerosis Centre of Catalonia (CEMCAT), Vall d'Hebron University Hospital, Barcelona, Spain; F. Hoffmann-La Roche Ltd. (L.C., C.C., R.H., H.K., N.P.), Basel, Switzerland; Genentech, Inc. (A.P.), South San Francisco, CA; IQVIA Solutions Inc. (K.P.), Amsterdam, The Netherlands; and Department of Neurology (J.S.W.), McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth). stephen.hauser@ucsf.edu.
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.
More Related Videos
Related Concept Videos
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
01:20Myasthenia Gravis: Overview and Treatment
These antibodies interfere with the function of the nicotinic receptors in three ways: by binding to the receptor and disrupting acetylcholine binding; by causing cross-linking of receptors which...
01:20Antiepileptic Drugs: Potassium Channel Activators
Ezogabine has gained approval as an adjunctive treatment...