European Registries Show No Melanoma Risk with Biologics Save

The combined analysis of 130,315 rheumatoid arthritis (RA) patients from 11 European registries did not reveal an association between invasive (malignant) melanoma and the use of biologic therapies.

Numerous population and cohort studies have consistently shown no association between solid tumor malignancies and the use of TNF inhibitors and other biologics. While the rates of such cancers (lung, skin, breast, colon, etc.) are the same as that seen in RA regardless of therapy, there is still uncertainty with regard to the risk of invasive melanoma.

Investigators from 11 biologic registers from nine European countries pooled their data to investigate the incidence of invasive cutaneous melanomas in patients with RA treated with TNF inhibitors (TNFi), other biologic disease modifying drugs and non-biologic therapy.

Pooled standardized incidence ratios (SIR) and incidence rate ratios (IRRs) comparing biologic cohorts to biologic-naïve were calculated across countries by taking the size of the register into account.

The combined registriies examined 130,315 RA patients (579,983 patient-years) were culled to identify 287 RA patients who developed a first melanoma. Pooled SIRs were not elevated in patients receiving biologic-naïve (SIR 1.1; 95% CI 0.9 to 1.4), TNFi (SIR 1.2; 0.99 to 1.6) or rituximab (SIR 1.3; 0.6 to 2.6) compared to the general population. 

Incidence rates in compared those on biologic to biologic naive patients. The invasive melanoma IRRs were also not significantly increased in RA patients taking TNFi (IRR 1.1; 95% CI 0.8 to 1.6), rituximab (IRR 1.2; 0.5 to 2.9), tocilizumab or abatacept.

While this large European collaborative project failed to show an increased risk of first invasive melanoma in patients receiving TNFi or other biologics, it did not assess the safety of administering such agents to RA patients with a past history of invasive (malignant) melanoma.