Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.
*NMSC data have been excluded from these analyses as they are classified as a non-serious event and excluded from databases like SEER.
†There are well-recognised limitations that should be considered when interpreting spontaneous post-marketing safety reports, including events that may not be causally related to drug exposure; in the real-world setting, events are frequently confounded by factors such as multiple drug use and the presence of pre-existing comorbidities; reporting bias may exist for more significant outcomes, which may result in an overrepresentation of the more serious outcomes; and reporting rates can be stimulated by external factors, such as press reports.
The causes of malignancies are recorded as reported to the company; while the company follows up on all reports to identify the cause, an exact diagnosis is not always possible. Some of the investigations remain ongoing and, therefore, the information may be subject to change.
Abbreviations: AE=adverse event; CI=confidence interval; IFN=interferon; MedDRA=Medical Dictionary for Regulatory Activities; MS=multiple sclerosis; NMSC=non-melanoma skin cancer; OCR=ocrelizumab; OLE=open-label extension; PPMS=primary progressive MS; PY=patient-years; RMS=relapsing MS; SEER=Surveillance, Epidemiology, and End Results Program.