Does Rinvoq Increase Cancer Risk?
Rinvoq (upadacitinib), a JAK inhibitor for rheumatoid arthritis, psoriasis, and other inflammatory conditions, carries warnings about potential malignancy risk in its prescribing information. Clinical trials and post-marketing data show higher rates of serious infections and cancers compared to placebo, though causality isn't definitively proven. The label states: "Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors," based on safety data from trials like SELECT.[1][2]
What Do Clinical Trial Data Show?
In the SELECT program (over 4,000 patients), Rinvoq users had a malignancy incidence of 0.9-1.6 events per 100 patient-years, versus 0.5-1.0 for placebo or active comparators like adalimumab. Common cancers included lung, breast, and melanoma. Long-term extension studies up to 6.5 years report similar rates, with no clear dose-response pattern for 15 mg daily dosing.[1][3] Risk appears elevated in patients with prior malignancy or heavy smoking history.
How Does This Compare to Other JAK Inhibitors?
Rinvoq's malignancy signal aligns with Xeljanz (tofacitinib), which prompted FDA's 2021 boxed warning for JAK class after higher cancer rates in rheumatoid arthritis trials (HR 1.48 for solid tumors).[4] Olumiant (baricitinib) shows comparable rates around 1.0-1.4 per 100 patient-years. All share black-box warnings for infections, clots, heart events, and cancers due to JAK inhibition suppressing immune surveillance.[1][5]
Who Faces Higher Risk?
Patients over 50 with cardiovascular risk factors saw the strongest signals in trials. Smokers, those with prior cancer, or on combination immunosuppressants (e.g., methotrexate) have elevated odds. Label advises avoiding in active malignancy; monitor high-risk patients closely with cancer screening.[1][2] Real-world data from registries like CORRONA confirm trial findings, with adjusted HR ~1.2-1.5 for skin and lung cancers.[6]
What Do Regulators Say?
FDA requires a boxed warning on Rinvoq for malignancies, citing trial data and class effects. EMA echoes this, noting "increased risk cannot be excluded." No outright contraindication, but prescribers must discuss risks via REMS-like counseling. Post-approval surveillance continues via FAERS, with 2023 reports of ~500 malignancy cases linked to Rinvoq.[1][7]
Can You Still Take Rinvoq If Worried About Cancer?
Guidelines (ACR/EULAR) recommend it for moderate-severe cases unresponsive to TNF inhibitors, weighing benefits against risks. Alternatives like biologics (e.g., Stelara) or other JAKs may have lower signals in some data. Discuss screening (e.g., skin checks, mammograms) and lifestyle factors with your doctor; periodic risk reassessment is standard.[3][8]
[1]: Rinvoq Prescribing Information (FDA)
[2]: Drugs.com - Rinvoq Side Effects
[3]: New England Journal of Medicine - SELECT Trials
[4]: FDA Drug Safety Communication - JAK Inhibitors
[5]: Olumiant Label (FDA)
[6]: Arthritis & Rheumatology - Real-World JAK Safety
[7]: EMA Rinvoq Assessment
[8]: ACR RA Guidelines 2021