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Association between tumor necrosis factor-α antagonists and risk of cancer in patients with inflammatory bowel
Nynne Nyboe Andersen1, Björn Pasternak1, Saima Basit1
1Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
Importance:
A Cochrane review and network meta-analysis concluded that there is need for more research on adverse effects, including cancer, after treatment with tumor necrosis factor α (TNF-α) antagonists and that national registries and large databases would provide relevant sources of data to evaluate these effects.
Objective:
To investigate whether patients with inflammatory bowel disease (IBD) exposed to TNF-α antagonists were at increased risk of developing cancer.
Design, Setting, And Participants:
Nationwide register-based cohort study in Denmark, 1999-2012. Participants were 56,146 patients 15 years or older with IBD identified in the National Patient Registry, of whom 4553 (8.1%) were exposed to TNF-α antagonists. Cancer cases were identified in the Danish Cancer Registry.
Main Outcomes And Measures:
Rate ratios (RRs) for incident cancer (overall and site-specific) comparing TNF-α antagonist users and nonusers, estimated using Poisson regression adjusted for age, calendar year, disease duration, propensity scores, and use of other IBD medications.
Results:
During 489,433 person-years of follow-up (median, 9.3 years [interquartile range, 4.2-14.0]), 81 of 4553 patients exposed to TNF-α antagonists (1.8%) (median follow-up, 3.7 years [interquartile range, 1.8-6.0]) and 3465 of 51,593 unexposed patients (6.7%) developed cancer, yielding a fully adjusted RR of 1.07 (95% CI, 0.85-1.36). There was no significantly increased risk of cancer in analyses according to time since first TNF-α antagonist exposure (less than 1 year: RR, 1.10 [95% CI, 0.67-1.81]; 1 to less than 2 years: RR, 1.22 [95% CI, 0.77-1.93]; 2 to less than 5 years: RR, 0.82 [95% CI, 0.54-1.24]; 5 or more years: RR, 1.33 [95% CI, 0.88-2.03]) and in analyses according to the number of TNF-α antagonist doses received (1 to 3 doses: RR, 1.02 [95% CI, 0.71-1.47]; 4 to 7 doses: RR, 0.89 [95% CI, 0.55-1.42]; 8 or more doses: RR, 1.29 [95% CI, 0.90-1.85]). No site-specific cancers were in significant excess in fully adjusted models.
Conclusions And Relevance:
In this Danish nationwide study, exposure to TNF-α antagonists among patients with IBD was not associated with an increased risk of cancer over a median follow-up of 3.7 years among those exposed. An increased risk associated with longer-term accumulated doses and follow-up cannot be excluded.
Insights
This study found no increased cancer risk in inflammatory bowel disease patients using tumor necrosis factor α (TNF-α) antagonists. However, longer-term effects and higher doses warrant further investigation.
Area of Science:
- Gastroenterology
- Oncology
- Pharmacovigilance
Background:
- Previous research indicated a need for more data on cancer risk associated with tumor necrosis factor α (TNF-α) antagonists.
- Large-scale databases are crucial for evaluating long-term adverse effects of these treatments.
Purpose of the Study:
- To determine if patients with inflammatory bowel disease (IBD) treated with TNF-α antagonists have a higher risk of developing cancer.
- To analyze cancer risk based on duration and dosage of TNF-α antagonist exposure.
Main Methods:
- A nationwide, register-based cohort study was conducted in Denmark from 1999 to 2012.
- Data included 56,146 IBD patients, with 4,553 exposed to TNF-α antagonists, identified from national registries.
- Cancer incidence was compared between exposed and unexposed groups using adjusted Poisson regression models.
Main Results:
- Over approximately 489,000 person-years of follow-up, the adjusted rate ratio for cancer in TNF-α antagonist users versus non-users was 1.07 (95% CI, 0.85-1.36).
- No significantly increased cancer risk was observed based on the duration of TNF-α antagonist exposure or the number of doses received.
- Analyses did not reveal any specific cancer types with a significantly elevated risk in the exposed group.
Conclusions:
- This Danish nationwide study suggests that TNF-α antagonist exposure in IBD patients is not associated with an increased risk of cancer over a median follow-up of 3.7 years for exposed individuals.
- The possibility of an increased risk with longer cumulative exposure and extended follow-up periods cannot be ruled out.
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