Exposure to ocrelizumab and comparator (IFN β-1a or placebo) in the Phase III pooled RMS population, PPMS population and ocrelizumab all-exposure population in total PY. Investigator text for AEs was encoded using MedDRA versions 18.1 and 21.1. Multiple occurrences of the same AE in one patient are counted multiple times. SIs are defined as serious AEs reported using terms in the MedDRA SOC Infections and infestations. 95% CIs were calculated using an exact method based on the Poisson distribution. Patients are considered in the ongoing year, eg, Year 6 contains patients completing at least 5 years in the study and ongoing during the sixth year.
a Includes patients who received any dose of ocrelizumab during the controlled treatment and associated OLE periods of the Phase II and Phase III studies, plus VELOCE, CHORDS, CASTING (and associated LTE), OBOE and ENSEMBLE.
b Includes patients who received placebo during the controlled treatment period, and any dose of ocrelizumab during the controlled treatment and associated OLE period of the ORATORIO study.
c Includes patients who received IFN β-1a during the controlled treatment period, and any dose of ocrelizumab during the controlled treatment and associated OLE period of the OPERA I and OPERA II studies.
|No. of SIs||222||71||151||14||208||7||215|
|Rates of SI per 100 PY||2.24||3.54||1.89||5.48||2.14||2.74||2.21|
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.
*There are well-recognised limitations that should be considered when interpreting spontaneous post-marketing safety reports, including events 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 over representation of the more serious outcomes; and reporting rates can be stimulated by external factors such as press reports.
†The incidence rates of SI are derived from varied sources, and intended to provide context. Confounding factors that may influence incidence rates have not been accounted for, and therefore, no direct comparisons should be made. Such factors may include, but are not limited to, type of MS, disease duration, risk factors, geographical region, population size, drug exposure, comorbid conditions, treatment history, and duration of follow-up.
The causes of infections 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.
AE, adverse event; DBP, double-blind period; CI, confidence interval; DMT, disease-modifying treatment; HR, hazard ratio; IFN, interferon; Ig, immunoglobulin; LTE, long-term extension; LLN, lower limit of normal; MedDRA, Medical Dictionary for Regulatory Activities; MS, multiple sclerosis; OCR, ocrelizumab; OLE, open-label extension; PBO, placebo; PML, progressive multifocal leukoencephalopathy; PPMS, primary progressive multiple sclerosis; PY, patient-year; RMS, relapsing multiple sclerosis; SI, serious infection; SOC, system organ class; UTI, urinary tract infection.