1. ¹Risk Management Resources, 726 Route 202 South, Suite 320-361, Bridgewater, New Jersey, USA
2. ²St Vincent's Clinical School, Faculty of Medicine, UNSW, Sydney, Australia
3. ³Risk Management Resources – EU, Zaragoza, Spain
4. ⁴Clinical Safety and Epidemiology, Novartis Farmecéutica, Gran Vía de las Cortes Catalanas, Barcelona, Spain
5. ⁵Department of Dermatology, Hopital Universitaire Purpan, Place du Dr Baylac, Toulouse Cedex, France
6. ⁶Clinical Research Dermatology, Novartis Pharma, Basel, Switzerland

Correspondence: Dr Felix M. Arellano, Risk Management Resources, 726 Route 202 South, Suite 320-361, Bridgewater New Jersey 08807, USA. E-mail: arellano@riskmr.com

Received 16 April 2006; Revised 21 September 2006; Accepted 22 September 2006; Published online 9 November 2006.

Abstract

Systemic use of immunosuppressant agents increases the risk of lymphoma in transplantation. We performed a nested case–control study in the PharMetrics database to evaluate the association between topical immunosuppressants and lymphoma in a cohort of patients with atopic dermatitis. We identified cases of lymphoma and randomly selected four controls for each case, matched by length of follow-up. We used conditional logistic regression to calculate odds ratio (OR) and 95% confidence intervals (CIs) of the association between topical immunosuppressants and lymphoma. Two hundred and ninety-four cases of lymphoma occurred in 293,253 patients, 81 in patients younger than 20 years. The adjusted analysis yielded the following OR (95%CI) for: severity (OR 2.4; 95% CI 1.5–3.8), oral steroids 1.5 (1.0–2.4), "super potent" topical steroids 1.2 (0.8–1.8) , "low potency" topical steroids OR 1.1 (0.7–1.6); pimecrolimus 0.8(0.4–1.6), tacrolimus OR 0.8 (0.4–1.7), and concomitant topical steroids, pimecrolimus, and tacrolimus 1.0 (0.3–4.1). We did not find an increased risk of lymphoma in patients treated with topical calcineurin inhibitors. It is difficult to disentangle the effects of severity of disease on outcome versus the true effects of drugs. However, in the adjusted analysis, severity of AD was the main factor associated with an increased risk of lymphoma.