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Published on: July 20, 2019
Tumor necrosis factor α inhibitor therapy and cancer risk in chronic immune-mediated diseases
Kevin Haynes1, Timothy Beukelman, Jeffrey R Curtis
1University of Pennsylvania, Department of Epidemiology and Biostatistics, Philadelphia, PA 19104, USA. khaynes@upenn.edu
Objective:
To compare the incidence of cancer following tumor necrosis factor α (TNFα) inhibitor therapy to that with commonly used alternative therapies across multiple immune-mediated diseases.
Methods:
The Safety Assessment of Biological Therapeutics study used data from 4 sources: national Medicaid and Medicare databases, Tennessee Medicaid, pharmacy benefits plans for Medicare beneficiaries in New Jersey and Pennsylvania, and Kaiser Permanente Northern California. Propensity score-adjusted hazard ratios (HRs) and 95% confidence intervals (95% CIs) were computed to estimate the relative rates of cancer, comparing those treated with TNFα inhibitors to those treated with alternative disease-modifying therapies. The cancer-finding algorithm had a positive predictive value ranging from 31% for any leukemia to 89% for female breast cancer.
Results:
We included 29,555 patients with rheumatoid arthritis (RA) (13,102 person-years), 6,357 patients with inflammatory bowel disease (1,508 person-years), 1,298 patients with psoriasis (371 person-years), and 2,498 patients with psoriatic arthritis (618 person-years). The incidence of any solid cancer was not elevated in RA (HR 0.80 [95% CI 0.59-1.08]), inflammatory bowel disease (HR 1.42 [95% CI 0.47-4.26]), psoriasis (HR 0.58 [95% CI 0.10-3.31]), or psoriatic arthritis (HR 0.74 [95% CI 0.20-2.76]) during TNFα inhibitor therapy compared to disease-specific alternative therapy. Among RA patients, the incidence of any of the 10 most common cancers in the US and of nonmelanoma skin cancer was not increased with TNFα inhibitor therapy compared to treatment with comparator drugs.
Conclusion:
Short-term cancer risk was not elevated among patients treated with TNFα inhibitor therapy relative to commonly used therapies for immune- mediated chronic inflammatory diseases in this study.
Insights
Tumor necrosis factor α (TNFα) inhibitor therapy did not increase short-term cancer risk in patients with immune-mediated diseases compared to alternative treatments. This finding supports the safety of TNFα inhibitors for managing chronic inflammatory conditions.
Area of Science:
- Immunology
- Oncology
- Rheumatology
Background:
- Immune-mediated chronic inflammatory diseases (ICIDs) like rheumatoid arthritis and inflammatory bowel disease are often treated with disease-modifying therapies.
- Tumor necrosis factor α (TNFα) inhibitors are a class of biologic agents used to manage ICIDs.
- Concerns exist regarding the potential oncogenic risk associated with TNFα inhibitor therapy.
Purpose of the Study:
- To compare the incidence of cancer in patients receiving TNFα inhibitor therapy versus those on alternative therapies for ICIDs.
- To assess the short-term cancer risk associated with TNFα inhibitors across various immune-mediated conditions.
Main Methods:
- The Safety Assessment of Biological Therapeutics study utilized data from multiple large healthcare databases.
- Propensity score-adjusted hazard ratios were calculated to compare cancer incidence between TNFα inhibitor users and alternative therapy users.
- A validated algorithm was used for cancer detection, with varying positive predictive values for different cancer types.
Main Results:
- Across rheumatoid arthritis, inflammatory bowel disease, psoriasis, and psoriatic arthritis, no elevated incidence of any solid cancer was observed with TNFα inhibitor therapy compared to alternative treatments.
- Specifically in rheumatoid arthritis patients, TNFα inhibitor use was not associated with an increased incidence of the 10 most common US cancers or nonmelanoma skin cancer.
- Hazard ratios for solid cancers generally showed no significant increase, with some confidence intervals including 1.
Conclusions:
- Short-term cancer risk was not found to be elevated in patients treated with TNFα inhibitors compared to those receiving commonly used alternative therapies for immune-mediated chronic inflammatory diseases.
- These findings suggest that TNFα inhibitors are a relatively safe treatment option in terms of short-term oncogenic risk for these conditions.
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