Authors' objectives:

The aim of this report was to assess the effectiveness of tacrolimus ointment for the topical treatment of atopic dermatitis (AD), the frequency and severity of adverse events when used in adults and children 2 years and over, and the cost-effectiveness of tacrolimus compared to current treatments.

Authors' results and conclusions: 228 studies were found but only 25 were RCTs that met all the inclusion criteria. Of these, five studies were eliminated because they were duplicate reports. 11 studies of the 20 finally included trials compared tacrolimus against vehicle and 9 against steroids. 4 studies were published in Japanese. The quality of the studies varied. Studies published in Japanese were analysed without an ITT analysis. Meta-analysis using physicians assessment scales of studies comparing tacrolimus with vehicle (i.e. thought to be an inactive treatment) revealed that tacrolimus 0.03% and 0.1% were superior, with a RR of 2.87(95% CI 2.40, 3.43) and 3.42 (95% CI 2.88,4.09). However, 0.1% did not provide additional benefits in children compared with 0.03%. Tacrolimus proved to be more effective than mild to moderately potent steroids with a RR of 1.67 (95% CI 1.27, 2.19). However, when compared with high-potency steroids it showed only a slight superiority, with a RR of 1.13 (95% C1 0.98, 1.31). These results are limited by the exclusion of 2 studies that did not provide enough information to be included in the meta-analyses. Sensitivity analysis considering a higher cut-off point of clinical improvement (90% instead of 75% improvement) and ITT analysis resulted in an increase of the effectiveness of tacrolimus compared with mild topical steroids, while its effectiveness decreased compared with high-potency corticosteroids.

Authors' recommendations: Tacrolimus ointment at 0.03% and 0.1% is more effective than vehicle for treatment of AD in adults and children in the short-term. Tacrolimus was also more effective than mild to moderately potent topical steroids. It was marginally more effective than high-potency topical steroids, though this superiority was less evident when variables were changed in sensitivity analysis. Additional data to allow inclusion of all studies found would permit more definitive conclusions to be drawn. Primary research is required to assess the long-term effectiveness of tacrolimus, especially with high-potency steroids.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.birmingham.ac.uk/Documents/college-mds/haps/projects/WMHTAC/REPreports/2003/atopic_dermatitis.pdf

Year Published: 2004

URL for published report: http://www.birmingham.ac.uk/research/activity/mds/projects/HaPS/PHEB/WMHTAC/REP/reports-list.aspx

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: West Midlands Health Technology Assessment Collaboration

Contact Address: Elaena Donald-Lopez, West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT Tel: +44 121 414 7450; Fax: +44 121 414 7878

Contact Name: louise.a.taylor@bham.ac.uk

Contact Email: louise.a.taylor@bham.ac.uk

Copyright: University of Birmingham