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Is the Use of Tacrolimus and Pimecrolimus Associated With Risk of Skin Cancer?

By: Victoria Kuhr, BA
Posted: Wednesday, January 26, 2022

The Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE) study proposed that little evidence was found to associate the use of topical calcineurin inhibitors such as tacrolimus and pimecrolimus with the occurrence of skin cancer and lymphoma, according to Alejandro Arana, MD, of RTI Health Solutions, Barcelona, and colleagues. Elevated incidence rate ratios for melanoma and non-melanoma skin cancer among adult users of topical pimecrolimus may represent a causal effect, so heightened awareness of such potential risks in users of these topical immunomodulators is encouraged by the study authors. A detailed report of these findings was published in Clinical Epidemiology.

“The study shows that any excess risk from the prescriptions would be low and confined to a few years after first exposure,” said the authors.

The cohort study was conducted in Denmark, Sweden, the United Kingdom, and the Netherlands. The study included new patients to the tacrolimus, pimecrolimus, and corticosteroid groups.

The study focused on 126,908 adults and 32,605 children treated with tacrolimus and 61,841 adults and 27,961 children treated with pimecrolimus. The median dose of active substance was 0.3 g for both tacrolimus and pimecrolimus (equivalent to a single 30-g tube of 0.1% of each prescription). Both had a median number of one prescription. Average follow up times were at least 10 years for 19% of adults and 32% of children.

The incidence ratio rates for tacrolimus versus corticosteroid users in adults was less than 1 (95% confidence interval) for melanoma, non-Hodgkin lymphoma, and Hodgkin lymphoma, suggesting no increased risk of these outcomes in users of topical tacrolimus compared with users of topical corticosteroids. The incidence ratio rates for any type of lymphoma associated with the use of pimecrolimus was also less than 1. However, in adults, the incidence ratio rates for melanoma and non-melanoma skin cancer in users of topical pimecrolimus were elevated. The incidence ratio rates in children were inconclusive.

Disclosure: For full disclosures of the study authors, visit ncbi.nlm.nih.gov.


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