BACKGROUND: There is a concern that topical use of immunosuppressants in patients with atopic dermatitis (AD) might increase the risk of lymphoma, particularly in children and adolescents. A previous study (covering the period 1995-2005) found no evidence of an increased lymphoma risk in association with use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCIs) (pimecrolimus cream [PIC] or tacrolimus ointment [TAC]) in patients with AD. The objective of this presentation is 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 AD patients in the US PharMetrics database (1995-2009), a large US health claims database that includes medical and pharmacy claims for more than 55 million members from more than 90 US health plans. Cases of lymphoma were identified by ICD-9 codes. Multivariable logistic regression was used to estimate the odds ratio (OR; with 95% confidence intervals [CI]) of overall lymphoma associated with use of TCS and/or TCIs.
RESULTS: 625,915 patients with a diagnosis of AD met the criteria for inclusion in the cohort; 63% were \20 years old. The number of patients during the follow-up period using TCS but not TCIs was 263,477 (42%); 63,056 (10%) patients were treated with TCIs, alone or in combination with TCS, of whom 40,685 were users of PIC, 17,793 of TAC, and 4,578 of PIC and TAC. Overall, there were 760 cases of lymphoma (106 Hodgkin disease, 200 non-Hodgkin lymphoma [118 T-cell lymphoma, 30 B-cell lymphoma, 52 indeterminate], and 454 not otherwise classified). The adjusted OR for overall lymphoma associated with TCS use was 0.90 (95% CI, 0.75-1.07); for PIC 0.76 (95% CI, 0.54-1.08), for TAC 1.24 (95% CI, 0.80-1.91). PIC was not associated with lymphoma irrespective of the cumulative dose increments: OR 0.53 (95% CI, 0.05-5.22) for cumulative doses\0.3g; 1.03 (95% CI, 0.68-1.55) for doses 0.3 to\0.6g; 0.72 (95%, CI 0.40-1.29) for doses of 0.6 to\1g; and OR 0.83 (95% CI, 0.54-1.27) for cumulative $1g. In patients\20 years of age there was no evidence of increased overall lymphoma risk. The corresponding adjusted ORs were 0.72 (95% CI, 0.48-1.06) for TCS; 0.64 (95% CI, 0.34-1.21) for PIC; and 0.96 (95% CI, 0.38-2.45) for TAC.
CONCLUSIONS: This study found no increased risk of overall lymphoma in AD patients treated with TCS or TCIs. In patients\20 years the results were similar.
