|OPERA I / OPERA II (Pooled)a
Incidence rate per 100 PY (95% CI)
Incidence rate per 100 PY (95% CI)
|Phase 3 Controlled Treatment Period||0.14 (0.02,0.52)||0.07 (0,0.38)||0.41 (0.08,1.20)||0.25 (0.07,0.64)|
a Two identical phase 3, global, randomised, double-blind, double-dummy studies with a 96-week controlled period during which 1,656 patients with relapsing forms of MS received either intravenous ocrelizumab (600 mg) every 24 weeks or subcutaneous interferon beta-1a (44 μg) three times weekly.5
b A phase 3, global, randomised, double-blind study with a ≥120-week controlled period during which 732 patients with primary progressive MS received either intravenous ocrelizumab (600 mg) or placebo every 24 weeks.6
|Data Cut-off Datea||Patients on Ocrelizumab (n)||PY||Fatalities (n)||Incidence Rate per 100 PY||95% CIs|
|JUL 2015||2147||4484.5||8||0.178||0.077, 0.352|
|JAN 2016||2279||5710.7||8||0.140||0.060, 0.276|
|SEP 2016||2300||6940.9||11||0.158||0.079, 0.284|
|FEB 2017||2301||7747.8||13||0.168||0.089, 0.287|
|SEP 2017||3778||9473.5||16||0.169||0.097, 0.274|
|FEB 2018||3811||10,918.5||17||0.156||0.091, 0.249|
|JAN 2019||4611||14,328.5||23||0.161||0.102, 0.241|
|JAN 2020||5680||18,218.4||26||0.143||0.093, 0.209|
a Data cuts are cumulative; each data cut includes the previous cut and fatalities are included from both the controlled treatment period and open-label extension.
b Includes all patients exposed to ocrelizumab in the global and US MS clinical trials; excludes patients in compassionate use programme.
The causes of the fatalities in the all-exposure population are as follows: Suicide (n=6), cardiac arrest (n=2), metastatic pancreatic cancer (n=2), pneumonia (n=1), acute coronary insufficiency (n=1), adenocarcinoma of oesophagus (n=1), probable seronegative autoimmune encephalitis (n=1), aspiration pneumonia (n=1), bladder cancer (n=1), epileptic seizure (n=1), bronchopneumonia (n=1), MS disease progression (n=1), pulmonary embolism (n=1), systemic inflammatory response syndrome of undetermined origin (n=1), unknown (n=1), urinary infection/urosepsis (n=1), injury (n=1), medically assisted suicide (n=1), and fall (n=1)
|Market Perioda||Patients on Ocrelizumab (n)b||PY||Fatalities (n)c||Incidence Rate per 100 PY|
|Ocrelizumab Post-Marketing||APR 2017–DEC 2017
|APR 2017–MAR 2018
|APR 2017–MAY 2018
|APR 2017–JULY 2018
|APR 2017–SEP 2018
|APR 2017–DEC 2018
|APR 2017–MAY 2019
|APR 2017–JULY 2019||~114,943||~111,166||293||0.26|
|APR 2017–DEC 2019
|APR 2017 - JUL 2020||~167,684||~235,630||666||0.28|
a Numbers reported include only the post-marketing period and are inclusive of the whole month stated.
b The number of post-marketing patients exposed to ocrelizumab is based on estimated total number of vials sold, as well as US claims data.
c Based on reported fatalities in the Roche safety database in patients treated with ocrelizumab within the designated post-marketing period.
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 overrepresentation of the more serious outcomes; and reporting rates can be stimulated by external factors such as press reports.
The causes of fatalities 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.
CI=confidence interval; IFN=interferon; MS=multiple sclerosis; PY=patient-years; US=United States.