Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Kardiovaskulär risk

Patienter med reumatoid artrit (RA) har en ökad kardiovaskulär (CV) risk baserat på deras RA.

Summary

Cardiovascular risk was evaluated in the BARI phase 3 RA clinical program using the FRS and RRS.1

Framingham Risk Score Results

The 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

There 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

Reynolds Risk Score Results

The 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

  • There 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

  • Similar 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

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

CV = cardiovascular

CVD = cardiovascular disease

FRS = Framingham Risk Score

hsCRP = high-sensitivity C-reactive protein

PBO = placebo

RA = rheumatoid arthritis

RRS = Reynolds Risk Score

This 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.

Datum fӧr senaste ӧversyn 2019 M07 15


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