Melanoma Risk for Patients Treated With Biologics Is Inconclusive

May 21, 2020

Researchers writing in JAMA Dermatology this week report that patients with inflammatory bowel disease, rheumatoid arthritis, and psoriasis who are treated with biologics may have a "clinically meaningful" increase in melanoma risk, but the jury is still out.

Researchers writing in JAMA Dermatology this week report that patients with inflammatory bowel disease, rheumatoid arthritis, and psoriasis who are treated with biologics may have a "clinically meaningful" increase in melanoma risk, but the jury is still out.

The risk is not entirely conclusive, but it cannot be ruled out, wrote researchers who were led by Richard B. Warren, MBChB, PhD, of the University of Manchester, United Kingdom.

"The findings suggest that clinically important increases in melanoma risk in patients treated with biologic therapy for common inflammatory diseases cannot be ruled out based on current evidence. However, further studies with large patient numbers that adjust for key risk factors are needed to resolve the issue of long-term safety of biologic therapy," researchers wrote.

The findings are based on a systematic review and meta-analysis of seven randomized clinical trials, cohort studies and control studies of 34,029 patients treated with biologics and  135,370 patients who were biologic-naive. Patients who were treated with biologics had an increased risk of melanoma compared to patients who were treated with conventional systemic therapy, but the difference was not statistically significant.

A number of studies have reported an increased risk of melanoma in patients with autoimmune disease who are treated with TNF inhibitors. The theory is that the risk of melanoma increases when the immune system is suppressed, but previous studies compared autoimmune patients to the general population instead of comparing autoimmune patients who were treated with or without autoimmune suppressing biologics agents. So, the actual risk is not really known.

In this analysis, researchers found that biologic treatment was positively associated with melanoma in patients with inflammatory bowel disease (pRR, 1.20; 95% CI, 0.60-2.40); rheumatoid arthritis  (pRR, 1.20; 95% CI, 0.83-1.74), and psoriasis (hazard ratio, 1.57; 95% CI, 0.61-4.09) as compared to biologic naive patients. But the findings were not statistically significant as some studies included in the analysis did not adjust for other risk factors.

"The results of our study correspond with those of the previous analysis, suggesting that treatment with biologics is not significantly associated with an increased risk of melanoma in patients with RA compared with biologic-naive patients treated with conventional systemic therapy," authors wrote.

REFERNCE:  Shamarke Esse, MRes; Kayleigh J. Mason, PhD; Adele C. Green, MBBS, PhD; et al. "Melanoma Risk in Patients Treated With Biologic Therapy for Common Inflammatory Diseases, A Systematic Review and Meta-analysis." JAMA Dermatology. May 20, 2020.