Topical Treatments with Pimecrolimus, Tacrolimus and Medium- to High-Potency Corticosteroids, and Risk of LymphomaSchneeweiss S. · Doherty M. · Zhu S. · Funch D. · Schlienger R.G. · Fernandez-Vidaurre C. · Seeger J.D.
aDepartment of Epidemiology, Harvard School of Public Health, Boston, Mass., bi3 Drug Safety, Waltham, Mass., and cGlobal Clinical Epidemiology, Novartis Pharmaceuticals, East Hanover, N.J., USA; dGlobal Clinical Epidemiology, Novartis Pharma AG, Basel, Switzerland
Background/Aims: A potential risk of lymphoma associated with the use of topical calcineurin inhibitors is debated. We assessed the risk of lymphoma among patients treated with topical pimecrolimus, tacrolimus or corticosteroids. Methods: We conducted a cohort study using health insurance claims data. Cohorts of initiators of topical pimecrolimus, tacrolimus and corticosteroids, along with cohorts of persons with untreated dermatitis and randomly sampled enrollees were identified from January 2002 to June 2006. Lymphomas were identified using insurance claims and adjudicated by medical records review. We adjusted for confounders by propensity score matching. Results: Among 92,585 pimecrolimus initiators contributing 121,289 person-years of follow-up, we identified 26 lymphomas yielding an incidence of 21/100,000 person-years. This incidence of lymphoma was similar to that among tacrolimus users (rate ratio, RR = 1.16; 95% confidence interval, CI = 0.74–1.82) as well as corticosteroid users (RR = 1.15; 95% CI = 0.49–2.72). All three topical treatments were associated with an increased risk of lymphoma compared with the general population (RRPim = 2.89; RRTac = 2.82; RRCort = 2.10) suggesting increased detection of preexisting lymphomas. Conclusion: This study did not find an increased risk of lymphoma among initiators of topical pimecrolimus relative to other topical agents during an average follow-up of 1.3 years. Longer-term studies may be needed.
John D. Seeger, PharmD, DrPH
i3 Drug Safety, 950 Winter Street
Waltham, MA 02451 (USA)
Tel. +1 781 472 8469, Fax +1 781 472 8464
This study was funded by Novartis, manufacturer of pimecrolimus (Elidel®), through a contract to i3 Drug Safety. Dr. Schneeweiss was a consultant to i3 Drug Safety. Drs. Schlienger and Fernandez-Vidaurre are employees of Novartis. The study was designed and conducted by i3 Drug Safety, and Novartis was encouraged to comment on the design, analysis and manuscript.
Received: October 31, 2008
Accepted after revision: December 26, 2008
Published online: March 17, 2009
Number of Print Pages : 15
Number of Figures : 1, Number of Tables : 7, Number of References : 17
Vol. 219, No. 1, Year 2009 (Cover Date: June 2009)
Journal Editor: Saurat J.-H. (Geneva)
ISSN: 1018-8665 (Print), eISSN: 1421-9832 (Online)
For additional information: http://www.karger.com/DRM