Is rinvoq safe for patients with a history of blood clots?

Rinvoq's Black Box Warning on Blood Clots

Rinvoq (upadacitinib), a JAK inhibitor from AbbVie, carries a black box warning for serious infections, increased risk of death, malignancy, major cardiovascular events, and thrombosis—including blood clots like deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial clots.[1][2] The label states: "Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with JAK inhibitors."[1]

Patients with a history of blood clots face heightened risk, as clinical trials showed higher thrombosis rates in those with cardiovascular risk factors.[3]

Clinical Trial Data on Thrombosis Risk

In SELECT trials for rheumatoid arthritis (RA), thrombosis occurred in 0.3-1.3% of Rinvoq patients (doses 15-30 mg) vs. 0.1-0.4% on placebo or TNF inhibitors, over 12-56 weeks.[1][4]
- RA patients: 1.1 events/100 patient-years on 15 mg.
- Psoriatic arthritis: Similar rates, with one fatal PE reported.
Risk rose with higher doses and prior cardiovascular issues; history of clots was an exclusion criterion in some pivotal studies.[3][4]

Real-world data from post-marketing surveillance confirms cases in patients with clot history, often alongside other risks like smoking or immobility.[2]

Who Should Avoid Rinvoq?

Rinvoq is contraindicated in active serious infections but not explicitly for clot history. However:
- Prescribing info advises against use in patients with known thrombosis risk factors unless benefits outweigh risks.[1]
- Avoid in those with active DVT/PE or recent arterial clots.[2]
Guidelines (e.g., ACR for RA) recommend caution or alternatives like abatacept for high-risk patients.[5]

Management and Monitoring for At-Risk Patients

If prescribed despite history:
- Assess thrombosis risk before starting; consider prophylaxis (e.g., low-dose anticoagulants).[1][2]
- Monitor for clot symptoms (leg swelling, chest pain, shortness of breath).
- Lowest effective dose (15 mg) preferred; discontinue if clot occurs.[1]
No specific Rinvoq trials test safety directly in clot-history patients—data relies on broader JAK inhibitor evidence.[3]

Alternatives for Patients with Clot History

• TNF inhibitors (e.g., Humira, Enbrel): Lower thrombosis risk in head-to-head trials vs. JAKs.[4][5]
  
• IL-17/IL-23 inhibitors (e.g., Cosentyx, Skyrizi): Minimal clot signals.[5]
  
• Non-biologics like methotrexate: Safest for thrombosis-prone patients.
  Consult rheumatologist; shared decision-making weighs disease severity vs. clot recurrence (5-10% annual risk post-DVT).[6]
  
  [1]: Rinvoq Prescribing Information (FDA)
  [2]: FDA Drug Safety Communication on JAK Inhibitors
  [3]: SELECT Trial Publications (NEJM)
  [4]: AbbVie Rinvoq Safety Data
  [5]: ACR RA Guidelines 2021
  [6]: ASH VTE Guidelines