a Includes patients who received any dose of OCR during the controlled treatment and associated OLE periods of the phase 2 and phase 3 studies plus VELOCE, CHORDS, CASTING, LIBERTO, OBOE, CONSONANCE, and ENSEMBLE (data as of January 2020).
bIncludes SI without hospitalisation.
Exposure to ocrelizumab in the phase 3 pooled RMS and PPMS populations in total PY. Investigator text for AEs was encoded using MedDRA versions 18.0, 18.1, and 22.1. 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 7 contains patients completing at least 6 years in the study and ongoing during the seventh year.
a Yearly rates of serious infections in patients with RMS or PPMS treated with ocrelizumab during the CTPs and associated OLE periods of the phase 3 trials (OPERA 1, OPERA 2, and ORATORIO) for a period of up to 7 years. It includes patients randomised to ocrelizumab and patients who received PBO or IFN β-1a during the CTPs, but subsequently switched to OCR at the beginning of the OLE periods (N=2,092; 10,924 PY).
b The exposure in PY during Year 7 is limited for meaningful interpretation, so these data are presented in the plots with dotted lines.
|No. of SIs||88||173||20||241||9||252|
|Rates of SI per 100 PY||3.42||1.93||5.68||2.16||2.57||2.26|
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.
*Includes patients who received any dose of OCR during the controlled treatment and associated OLE periods of the phase 2 and phase 3 studies plus VELOCE, CHORDS, CASTING, LIBERTO, OBOE, CONSONANCE, and ENSEMBLE (data as of January 2020).
†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 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; CI=confidence interval; DBP=double-blind period; 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.