Cancer risk in patients with rheumatoid arthritis receiving biologic and targeted synthetic disease modifying antirheumatic drugs: results from the BIOBADASER III registry

Abstract

Objectives: To assess the risk of cancer in patients with rheumatoid arthritis (RA) treated with biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).

Methods: We analyzed RA patients from the BIOBADASER III registry, a multicentre national registry of b/tsDMARDs, included from 2000 to 2023. Patients with a history of cancer were excluded. Incidence rates (IRs) were analysed, and adjusted Cox regression models were used to estimate hazard ratios (HRs) for all cancers excluding non-melanoma skin cancer (NMSC), as well as for NMSC. Tumor necrosis factor inhibitors (TNFi) served as the reference for comparison.

Results: Among 4,635 RA patients (mean age 55.5 years; 79% female; median follow-up 3.6 years), 187 incident cancers were identified. For all cancers excluding NMSC, adjusted HRs (95% CI) compared with TNFi were: 1.2 (0.8-1.6) for IL6i, 0.9 (0.5-1.4) for CD20i, 1.2 (0.8-1.8) for JAKi, and 1.1 (0.8-1.6) for CTLA4-A. For NMSC, adjusted HRs (95% CI) were 0.6 (0.2-1.5) for IL6i, 0.6 (0.2-1.8) for CD20i, 0.7 (0.2-2) for JAKi, and 1.1 (0.5-2.6) for CTLA4-A. No increased cancer risk was observed when adjusting for cardiovascular risk or treatment line, for either cancer type.

Conclusions: In this large, real-world cohort of RA patients, we found no increased cancer risk associated with any bDMARDs or tsDMARDs compared with TNFi.

Keywords: DMARDs; biologics; cancer; epidemiology; registries; rheumatoid arthritis; targeted therapies.