Use of Topical Tacrolimus and Topical Pimecrolimus in Four European Countries: A Multicentre Database Cohort Study

Abstract

BackgroundDespite the concerns about a potential increased risk of skin cancer and lymphoma with the use of topical tacrolimus and pimecrolimus, no population-based studies have given an overview of the use of these drugs in Europe.ObjectiveTo assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe.MethodsMulticentre database cohort study comprising data from the Netherlands, Denmark, Sweden and the UK. We analysed users of topical tacrolimus and pimecrolimus starting from the date of first availability (between 2002 and 2003) or start establishment of the prescription database in Sweden (2006) through 2011. Use was assessed separately for children (≤ 18 years) and adults.Results32,052 children and 104,902 adults were treated with topical tacrolimus, and 32,125 children and 58,280 adults were treated with topical pimecrolimus. The number of users increased rapidly after first availability, especially for topical tacrolimus. Topical tacrolimus was more frequently used in all countries except Denmark. For both drugs, there was a decrease in users after 2004 in the Netherlands and Denmark and after 2005 in the UK, especially among children. This decrease was largest in Denmark. The decrease in the number of users was temporary for topical tacrolimus, while use remained relatively low for topical pimecrolimus.ConclusionsThe number of topical tacrolimus and pimecrolimus users increased rapidly after regulatory approval. A transient reduction in topical tacrolimus use and a persistent reduction in topical pimecrolimus use was seen after 2004 in the Netherlands and Denmark and after 2005 in the UK.

Safety of pimecrolimus and tacrolimus in the topical therapy of atopic dermatitis

“…The TCS are effective for both active inflammation and for prophylaxis; however, there are no data to support a specific agent among the TCS classes, and there is limited evidence to recommend an optimal dosing or frequency regimen [8,11]. Although TCS have long been considered and offered as a first line therapy for treatment of AD, they are associated with serious adverse side effects [5][6][7][8][9].…”

“…Both drugs are approved for second-line treatment, when other treatments have been ineffective or are contraindicated. [6]. The American Academy of Dermatology (AAD) Guidelines recommend that TCS can be initially used to control a flare, whereas TCI can be applied as maintenance therapy to prevent relapse, although the evidence for this concurrent regimen has been inconsistent.…”

“…There was a temporary decrease in the use of topical T and persistent reduction in topical P in Europe since 2004. Safety warnings issued by regulatory agencies about a potential risk of cancer may have contributed to the reduction in users especially in children, in all countries [6]. In 2006, the FDA agency issued a label change; in the European Union as well as in the United States the labeling of topical T and topical P was updated by adding a warning about cautious use, in order to reduce the potential risk of skin cancer and lymphoma.…”