BACKGROUND: There is a concern that topical use of immunosuppressants might increase the risk of lymphoma, particularly in children and adolescents. A previous study using PharMetrics data (1995–2005) found no evidence of an altered lymphoma risk in association with use of TCS or TCIs (pimecrolimus [PIC] or tacrolimus [TAC]) in patients with atopic dermatitis (AD).
OBJECTIVES: To assess the risk of lymphoma among AD patients exposed to TCS and/or TCIs with a specific focus on patients <20 years old.
METHODS: Nested case-control study on the risk of lymphoma in a cohort of patients with AD in the US Phar- Metrics database (1995–2009). Cases of lymphoma were identified using ICD-9 codes compatible with lymphoma. Multivariable logistic regression was used to estimate the odds ratio (OR; with 95% confidence intervals [CI]) of lymphoma overall and of various lymphoma subtypes associated with use of TCS and/or TCIs.
RESULTS: A total of 625,915 patients with a diagnosis of AD met the criteria for inclusion in the cohort, 63% were <20 years old. Overall, there were 760 cases of lymphoma (106 Hodgkin’s disease, 200 Non-Hodgkin’s lymphoma [118 Tcell lymphoma, 30 B-cell lymphoma, 52 indeterminate], 454 not otherwise classified). The adjusted OR for overall lymphoma associated with TCS use was 0.94 (95% CI 0.79–0.13); for topical PIC 0.85 (95% CI 0.60–1.19), for topical TAC 1.34 (95% CI 0.87–2.07). In patients <20 years of age there was no evidence of an increased lymphoma risk. We found an increased risk of T-cell lymphoma associated with topical TAC use (OR 5.38, 95% CI 2.04– 14.20)
CONCLUSIONS: This study showed no increased risk of overall lymphoma in AD patients treated with TCS or TCIs. The results suggest an increased risk of T-cell lymphoma in association with topical TAC use.