No Increased Cancer Risk Observed with Non-TNFi Biologics in Patients with RA

In Rheumatology, a large, registry-based cohort study of patients with rheumatoid arthritis (RA) found no increased risk of cancer associated with treatment using tocilizumab/sarilumab, abatacept, or rituximab compared with tumor necrosis factor inhibitors (TNFi) or conventional synthetic DMARDs.

Using data from the Danish Rheumatology Quality Register (DANBIO), researchers analyzed 21,982 biologic disease-modifying antirheumatic drug (bDMARD) treatment initiations from 2006 to 2020. The study included 96,475 person-years of follow-up and identified 1,423 incident cancers. Each treatment episode was evaluated in a time-updated fashion to account for changing exposure over time.

Hazard ratios (HRs) for overall cancer were not statistically significantly increased for any of the alternative biologic agents compared with TNFi. Specifically, HRs ranged from 0.7 to 1.1 across tocilizumab/sarilumab, abatacept, and rituximab treatment groups. “Treatment with tocilizumab/sarilumab, abatacept or rituximab in patients with RA was not associated with increased risks of cancer,” the study reported.

Abatacept exposure longer than five years showed a non-significant trend toward increased cancer risk compared with TNFi (HR 1.41; 95% CI 0.74–2.71), but this did not reach statistical significance.

Notably, rituximab treatment showed a non-significant trend toward reduced risk for hematologic malignancies, with HRs of 0.09 (95% CI 0.00–2.06) compared to TNFi and 0.13 (95% CI 0.00–1.89) compared to bDMARD-naïve patients.

These findings provide reassurance for clinicians selecting biologic therapies beyond TNFi in RA management. The study supports the long-term safety of these agents with regard to cancer outcomes, particularly in real-world clinical settings.

Reference
Westermann R, Cordtz RL, Duch K, et al. Cancer risk with tocilizumab/sarilumab, abatacept and rituximab treatment in patients with rheumatoid arthritis: a Danish cohort study. Rheumatology (Oxford). 2025;64(3):1019-1028. doi:10.1093/rheumatology/keae140