TY - JOUR
T1 - Use of Topical Tacrolimus and Topical Pimecrolimus in Four European Countries
T2 - A Multicentre Database Cohort Study
AU - Kuiper, Josephina G
AU - van Herk-Sukel, Myrthe P P
AU - Castellsague, Jordi
AU - Pottegård, Anton
AU - Berglind, Ingegärd Anveden
AU - Dedman, Daniel
AU - Gutierrez, Lia
AU - Calingaert, Brian
AU - Hallas, Jesper
AU - Sundström, Anders
AU - Gallagher, Arlene M
AU - Kaye, James A
AU - Pardo, Carolina
AU - Rothman, Kenneth J
AU - Perez-Gutthann, Susana
N1 - Funding Information:
Funding The study was funded by Astellas Pharma. In June 2016, LEO Pharma became the marketing authorization holder of Pro-topic® and provided partial funding. The contract grants the research team independent publication rights. The sponsor had no role in the data collection or analysis and was not involved in the interpretation of results; however, in line with the ENCePP Guide on Methodological Standards in Pharmacoepidemiology [1], the sponsor had the opportunity to view the results and interpretations included in the manuscript and provide comments before submission of the manuscript for publication.
Publisher Copyright:
© 2018, The Author(s).
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/6
Y1 - 2018/6
N2 - BACKGROUND: Despite 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.OBJECTIVE: To assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe.METHODS: Multicentre 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.RESULTS: 32,052 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.CONCLUSIONS: The 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.
AB - BACKGROUND: Despite 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.OBJECTIVE: To assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe.METHODS: Multicentre 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.RESULTS: 32,052 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.CONCLUSIONS: The 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.
UR - https://www.scopus.com/pages/publications/85048306096
U2 - 10.1007/s40801-018-0133-1
DO - 10.1007/s40801-018-0133-1
M3 - Article
C2 - 29736842
SN - 2199-1154
VL - 5
SP - 109
EP - 116
JO - Drugs - real world outcomes
JF - Drugs - real world outcomes
IS - 2
ER -