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Olumiant Summary of Product Characteristics (SmPC)
Patients with rheumatoid arthritis (RA) have an increased cardiovascular (CV) risk based on their RA.
risk was evaluated in the BARI phase 3 RA clinical program using the
FRS and RRS.1
Risk Score Results
FRS represents the likelihood of an individual patient experiencing a
CVD event in the next 10 years. It is calculated for men and women
aged ≥30 and ≤74 years with no prior history of CVD.1
were no consistent statistically significant within-group changes
from baseline in FRS or statistically significant differences between
the BARI 4 mg and placebo groups.1
Risk Score Results
RRS is an alternative to the FRS for characterization of CV risk in
non-diabetic men and women aged ≥45 and ≤80 years with no prior
history of CVD and/or cerebrovascular events and also represents the
likelihood of an individual patient experiencing a CVD event in the
next 10 years.1
was a statistically significant within-group decrease in RRS for
BARI 4 mg and placebo, with no statistically significant
difference between treatment groups in any study, except for one
study, RA-BEAM, where there were statistically significantly larger
decreases in BARI 4 mg compared to placebo.1
findings applied to non-diabetic patients aged 45 to 80 with no
prior CVD (regardless of hsCRP status) and the subgroup of
non-diabetic patients aged 45 to 80 with no prior CVD and baseline
hsCRP ≤20 mg/L, except for RA-BEAM, where there is no significant
within-group decrease in RRS for placebo group.1
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
= cardiovascular disease
= Framingham Risk Score
= high-sensitivity C-reactive protein
= Reynolds Risk Score
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.
Date of Last Review:July 15, 2019
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