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Abstract
Objective:
A systematic review and meta-analysis was conducted to determine the efficacy and tolerability of tacrolimus ointment for the treatment of atopic dermatitis (AD) compared with topical corticosteroids.
Methods:
Electronic searches were performed in Medline, Embase and the Cochrane Library, as well as relevant conference proceedings. Two researchers independently selected trials investigating the efficacy and/or safety of tacrolimus ointment in the treatment of AD. No language restrictions were applied. Relevant outcome data from included trials were extracted by two independent reviewers. Direct meta-analysis to calculate relative risks (RR) (95% confidence intervals (CIs)) was conducted on dichotomous efficacy/safety outcomes of interest.
Results:
Seventeen trials comparing tacrolimus ointment with topical corticosteroids in both paediatric (n = 2328) and adult (n = 2849) patients were identified. No studies comparing tacrolimus ointment with class IV topical corticosteroids were identified. Tacrolimus 0.1% ointment was found to be of similar efficacy to class I/II and class III topical corticosteroids. In three individual trials (comparing tacrolimus 0.1% ointment to a topical corticosteroid), evaluation of the Physician's Global Evaluation of Clinical Response (PGECR) resulted in RRs of 0.95 (95% CI 0.78–1.16), 3.09 (95% CI 2.14–4.45) and 1.35 (95% CI 0.86–2.12), where values above one favour tacrolimus ointment. With the exception that tacrolimus ointment caused more skin burning than comparator treatments (tacrolimus 0.03% versus a class III topical corticosteroid, the RR was 3.00 (95% CI 1.21–7.43) in favour of the corticosteroid), no significant differences with regards to side-effects and withdrawals due to AEs were found. Quality of life data were reported in two studies. While one study reported greater improvements in tacrolimus-treated adult patients compared with topical steroids, the second reported greater improvements in paediatric patients treated with steroids compared with tacrolimus ointment.
Conclusions:
The current review and meta-analysis showed tacrolimus ointment to be of similar efficacy to corticosteroids. The interpretation of available data is limited by heterogeneity in outcome measures between trials. Further trials are needed to assess the impact of treatments on patient reported outcomes.
Transparency
Declaration of funding
The review was funded by Astellas Pharma Europe Ltd.
Declaration of financial/other relationships
C.C. is a paid employee of Astellas Pharma Europe Ltd. S.M. undertook paid consultancy work for Astellas Pharma Europe Ltd. Å.S. and A.G. have no conflict of interest arising from being named as authors on the manuscript.
Acknowledgements
No assistance in the preparation of this article is to be declared.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.