Immunosuppressant drug-associated skin cancer: A real-world pharmacovigilance database analysis.

Abstract

e21575 Background: The association between immunosuppressant drugs and skin cancer has been frequently reported; however, the precise relationship remains uncertain. Skin cancer is among the most common cancers associated with long-term immunosuppressant drug use. The FDA Adverse Event Reporting System (FAERS) is a publicly available tool that collects reports of adverse events related to the use of certain drugs and biologic agents, thereby generating real-world data. Methods: The FAERS database was searched for skin cancer as an adverse event. Nine drugs belonging to different immunosuppressant classes were shortlisted. Reporting odds ratio (ROR) was used to measure disproportionality in reporting of adverse events for these drugs. Results: When skin cancer was analyzed as a percentage of all cancers reported as an adverse event for a particular drug,sirolimus had the highest percentage (30.11%) followed by infliximab (23.91%), azathioprine (23.69%), cyclosporine (19.71%), adalimumab (16.79%), mycophenolate (16.77%), etanercept (15.69%), tacrolimus (14.07%) and methotrexate (10.95%). Drugs with highest ROR for skin cancer included sirolimus (2.12, 1.88-2.39) followed by infliximab (1.68, 1.62-1.75) and azathioprine (1.54, 1.44-1.66). Drugs with lowest ROR for skin cancer included methotrexate (0.55, 0.52-0.57) followed by tacrolimus (0.78, 0.74-0.83) and etanercept (0.89, 0.85-0.93). Conclusions: Although all immunosuppressive drugs have been associated with an increased risk of developing skin cancer, it is advisable to exercise caution with prescribing sirolimus, infliximab and azathioprine in patients with preexisting risk. While methotrexate use is known to possess an increased risk, it had the lowest odds of skin cancer compared to other drugs in the study. Prospective studies are needed to understand the true incidence of skin cancer associated with the use of immunosuppressant drugs. [Table: see text]