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Long-term risk of skin cancer and lymphoma in users of topical tacrolimus and pimecrolimus: Final results from the extension of the cohort study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)

Clinical Epidemiology Jan 06, 2022

Arana A, Pottegård A, Kuiper JG, et al. - This study provides little evidence linking use of topical calcineurin inhibitors with skin cancer and lymphoma; these observations could have been influenced by confounding by indication, surveillance bias, and reverse causation. Even if causal, the public health effect of these excess risks would be low and limited to the first years of exposure.

  • In this cohort study, a total of 126,908/61,841 adults and 32,605/27,961 children initiating treatment with tacrolimus/pimecrolimus, respectively, were included to estimate the long-term risk of skin cancer and lymphoma related to topical calcineurin inhibitor use in adults and children, separately.

  • Among adults, incidence rate ratios (IRRs) and (95% confidence intervals) for tacrolimus vs corticosteroid users were estimated to be < 1 for melanoma, non-Hodgkin lymphoma, and Hodgkin lymphoma; and 1.80 (1.25– 2.58) for cutaneous T-cell lymphoma.

  • IRRs for pimecrolimus in adults were estimated to be < 1 for non-Hodgkin lymphoma, cutaneous T-cell lymphoma, and Hodgkin’s lymphoma; and 1.21 (1.03– 1.41) for melanoma; and 1.28 (1.20– 1.35) for nonmelanoma skin cancer.

  • Findings were inconclusive in children because of few events.

  • No higher incidence rate ratios were reported in adults at ≥ 5 years after first topical calcineurin inhibitor exposure, relative to those in overall analyses.

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