Is Rinvoq (upadacitinib) contraindicated in patients with heart disease?

Rinvoq (Upadacitinib) Use in Patients with Heart Disease

Rinvoq (upadacitinib) is not absolutely contraindicated in patients with heart disease, but should be used with caution due to potential increased cardiovascular risks, particularly in patients with pre-existing cardiovascular disease risk factors.

Cardiovascular Safety Profile of Rinvoq

• Upadacitinib belongs to the JAK inhibitor class, which has been associated with increased risk of major adverse cardiovascular events (MACE), including myocardial infarction and stroke 1
• The European Medicines Agency recommends cautious use of JAK inhibitors as first-line agents in patients at risk for adverse cardiovascular outcomes, including those with a history of cardiovascular disease 2
• In clinical trials, rates of MACE with upadacitinib were comparable to active comparators like adalimumab and methotrexate, but most patients experiencing MACE had two or more baseline cardiovascular risk factors 3
• Post-marketing surveillance data shows different patterns of adverse event reporting among JAK inhibitors, with tofacitinib having the highest proportion of cardiovascular-related events (14.1%) compared to other JAK inhibitors 4

Risk Stratification for Rinvoq Use in Heart Disease Patients

• Higher risk patients include:

  • Those aged ≥65 years 2
  • Current or previous long-term smokers 2
  • Patients with established cardiovascular disease 2, 3
  • Patients with multiple cardiovascular risk factors 3

• An integrated post-hoc analysis of the SELECT phase III rheumatoid arthritis clinical program showed that while cardiovascular risk was higher in patients with pre-existing risk factors, the risk was comparable between upadacitinib-treated and adalimumab-treated patients 1

Monitoring Recommendations

• Regular cardiovascular risk assessment should be performed at least annually in patients taking Rinvoq 5
• Cardiovascular risk factors to monitor include dyslipidemia, hypertension, smoking status, family history of premature coronary disease, and presence of micro- or macroalbuminuria 5
• Patients with increased cardiovascular risk should be managed according to standard guidelines for cardiovascular disease prevention 5

Specific Heart Disease Considerations

• In patients with treated congestive heart failure (CHF), certain medications like thiazolidinediones are contraindicated, but there is no specific contraindication for JAK inhibitors like Rinvoq in heart failure patients 5
• For patients with coronary artery disease, standard preventive therapies (ACE inhibitors, aspirin, and statins) should be continued unless contraindicated 5
• Patients with a prior myocardial infarction should receive beta-blockers (if not contraindicated) to reduce mortality, in addition to their Rinvoq therapy 5

Practical Approach to Using Rinvoq in Heart Disease Patients

1. Assess baseline cardiovascular risk factors before initiating therapy 3
2. Consider alternative therapies in patients with multiple cardiovascular risk factors 2
3. If Rinvoq is deemed necessary despite cardiovascular risk:
   • Optimize management of cardiovascular risk factors 5
   • Use the lowest effective dose (15 mg once daily rather than higher doses) 1, 6
   • Monitor for signs and symptoms of cardiovascular events 3

Conclusion

While Rinvoq is not absolutely contraindicated in heart disease patients, careful consideration of individual risk factors and close monitoring are essential. The decision to use Rinvoq in patients with heart disease should weigh the potential benefits against the possible increased risk of adverse cardiovascular events, particularly in those with multiple risk factors.