BMJ  2005;330:516 (5 March), doi:10.1136/bmj.38376.439653.D3 (published 24 February 2005)

Primary care

Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials

¹ School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester M13 9PL, ² Peninsula Technology Assessment Group, Universities of Exeter and Plymouth, ³ Department of Dermatology, University of Nottingham

Objective To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis.

Design Systematic review and meta-analysis.

Data sources Electronic searches of the Cochrane Library, Medline, and Embase.

Study selection Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability.

Data extraction Efficacy: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections.

Data synthesis 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ.

Conclusions Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Atopic and non-atopic eczema

Sara Brown and Nick J Reynolds
BMJ 2006 332: 584-588. [Extract] [Full Text] [PDF]

Tacrolimus 0.1% matches potent steroids in eczema
BMJ 2005 330: 0. [Full Text]

Itching for a solution

Peter Lapsley
BMJ 2005 330: 522. [Extract] [Full Text] [PDF]

Related external webpages:

NHS Health Technology Assessment Programme

This article has been cited by other articles:

• Kato, A., Chustz, R. T., Ogasawara, T., Kulka, M., Saito, H., Schleimer, R. P., Matsumoto, K. (2009). Dexamethasone and FK506 Inhibit Expression of Distinct Subsets of Chemokines in Human Mast Cells. J. Immunol. 182: 7233-7243 [Abstract] [Full text]  
• Stern, R. S. (2006). Topical calcineurin inhibitors labeling: putting the "box" in perspective.. Arch Dermatol 142: 1233-1235 [Full text]  
• Phipatanakul, W. (2006). Efficacy and Tolerability of Pimecrolimus and Tacrolimus in the Treatment of Atopic Dermatitis: Meta-analysis of Randomised Controlled Trials. Pediatrics 118: S16-S17 [Abstract]  
• Brown, S., Reynolds, N. J (2006). Atopic and non-atopic eczema. BMJ 332: 584-588 [Full text]  
• Tlacuilo-Parra, A., Guevara-Gutierrez, E., Gutierrez-Murillo, F., Soto-Ortiz, A., Barba-Gomez, F., Hernandez-Torres, M., Salazar-Paramo, M. (2005). Pimecrolimus 1% cream for the treatment of discoid lupus erythematosus. Rheumatology (Oxford) 44: 1564-1568 [Abstract] [Full text]  
• Williams, H. C. (2005). Atopic Dermatitis. NEJM 352: 2314-2324 [Full text]  
• Yan, A. C. (2005). Topical Pimecrolimus and Tacrolimus versus Topical Corticosteroids for Atopic Dermatitis. AAP Grand Rounds 13: 62-63 [Full text]  
• Wooltorton, E. (2005). Eczema drugs tacrolimus (Protopic) and pimecrolimus (Elidel): cancer concerns. CMAJ 172: 1179-1180 [Full text]  
• (2005). Tacrolimus for Atopic Dermatitis. JWatch General 2005: 3-3 [Full text]  
• (2005). Tacrolimus and Pimecrolimus: Are They Better Than Steroids?. Journal Watch Dermatology 2005: 1-1 [Full text]  
• Lapsley, P. (2005). Itching for a solution. BMJ 330: 522-522 [Full text]  

Online poll

Find out more >>