Cancer risk in patients with rheumatoid arthritis receiving biologic and targeted synthetic disease-modifying antirheumatic drugs: results from the BIOBADASER III registry
Authors' conclusion
In this large, real-world cohort of RA patients, we found no increased cancer risk associated with any bDMARDs or tsDMARDs compared with TNFi.
Study context
- Population
- RA patients treated with b/tsDMARDs in the BIOBADASER III registry, 2000–2023, without history of cancer (mean age 55.5 years; 79% female)187 incident cancers
- Participants
- 4,635 patients
- Exposure
- IL6i, CD20i, JAKi and CTLA4-A vs TNF inhibitor (TNFi) in RA
- Outcome
- All cancers excluding non-melanoma skin cancer (NMSC), and NMSC
Methodological detailsmulticentre national registry, adjusted Cox regression
- Multicentre national registry
- Adjusted Cox regression
Main finding
As reported in the abstract
All cancers excluding NMSC, adjusted HR
Each group vs TNFiAdjusted hazard ratio (95% CI)
IL6i
1.2(0.8–1.6)
CD20i
0.9(0.5–1.4)
JAKi
1.2(0.8–1.8)
CTLA4-A
1.1(0.8–1.6)
Observational data: associations, not effects.
Further findings
| Outcome | aHR (95% CI) | |
|---|---|---|
| NMSC, adjusted HRIL6ivs TNFi | 0.6 (0.2–1.5) | |
| NMSC, adjusted HRCD20ivs TNFi | 0.6 (0.2–1.8) | |
| NMSC, adjusted HRJAKivs TNFi | 0.7 (0.2–2) | |
| NMSC, adjusted HRCTLA4-Avs TNFi | 1.1 (0.5–2.6) | |
| 0.20.5125Adjusted hazard ratio (log scale) |
Cancer risk adjusted for CV risk or treatment line, both cancer types
- No increased cancer risk observed
Original publication
Cancer risk in patients with rheumatoid arthritis receiving biologic and targeted synthetic disease-modifying antirheumatic drugs: results from the BIOBADASER III registry. Rheumatology (Oxford). Published 22 October 2025. doi:10. 1093/ rheumatology/ keaf556
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