From the FDA Drug Label
In the controlled portions of clinical trials of all the TNF-blockers in adults, more cases of lymphoma have been observed among TNF-blocker-treated patients compared to control-treated patients In the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, 2 lymphomas occurred among 7973 adalimumab-treated patients versus 1 among 4848 control-treated patients Rates of lymphoma in clinical trials of adalimumab cannot be compared to rates of lymphoma in clinical trials of other TNF blockers and may not predict the rates observed in a broader patient population
Lymph nodes should be monitored in patients on long-term Humira (adalimumab) therapy, as there is an increased risk of lymphoma associated with TNF-blocker use, including adalimumab products 1.
- Patients with a history of prolonged immunosuppressant therapy or those with highly active disease and/or chronic exposure to immunosuppressant therapies may be at a higher risk for the development of lymphoma.
- The potential risk with the combination of azathioprine or 6-mercaptopurine and Adalimumab-fkjp should be carefully considered.
From the Research
Yes, lymph nodes should be monitored in patients on long-term Humira (adalimumab) therapy. Patients and healthcare providers should be vigilant for lymph node enlargement or persistent swelling during routine follow-up appointments, which typically occur every 3-6 months. Humira is a TNF-alpha inhibitor that suppresses parts of the immune system, which can potentially increase the risk of lymphoma and other malignancies, as reported in a case study where a patient developed simultaneous lymphoma and breast cancer with lymph node metastases while on adalimumab therapy 2. While routine imaging for lymph node assessment is not typically recommended without symptoms, any unexplained lymphadenopathy (swollen lymph nodes), especially if persistent, painful, or accompanied by symptoms like fever, night sweats, or weight loss, should prompt immediate medical evaluation. This monitoring is particularly important because the risk of lymphoma is slightly elevated in patients taking TNF inhibitors like Humira, though the absolute risk remains low, as shown in a study with up to 6 years of follow-up in the PYRAMID registry, which found that the observed lymphoma rate was lower than the estimated background rate 3. The risk may be higher in patients with rheumatoid arthritis or inflammatory bowel disease who have had long-standing, severe disease or previous immunosuppressive therapy. Patients should be educated about self-monitoring for unusual lumps or swelling in the neck, armpits, or groin areas and report these promptly to their healthcare provider.
Some key points to consider:
- Adalimumab increases the risk of rare serious infections, including reactivation of tuberculosis, and deep fungal and other serious and atypical infections 4.
- The use of adalimumab has been associated with a promotion of lymphoma, medically significant cytopenias, and worsening or initiation of congestive heart failure, a lupus-like syndrome, and multiple sclerosis/neurological disease 4.
- Patients with any of these problems should have their use of adalimumab extremely carefully considered, and laboratory monitoring of blood counts and liver functions should be performed at least intermittently 4.
- A study found that about a third of patients with rheumatoid arthritis treated with adalimumab may develop anti-adalimumab antibodies, which are associated with reduced drug levels, loss of drug efficacy, clinical non-response, and an increased risk of adverse effects 5.
- Another case report highlighted the potential long-term risks associated with chronic immune modulation, including the development of advanced-stage Merkel cell carcinoma with lymph node involvement in a patient treated with adalimumab 6.
Overall, while the absolute risk of lymphoma and other malignancies remains low, monitoring of lymph nodes is crucial in patients on long-term Humira (adalimumab) therapy, especially in those with a history of rheumatoid arthritis or inflammatory bowel disease, to promptly identify and manage any potential complications.