Topical Tacrolimus for Atopic Dermatitis

Summary

A Cochrane review [Abstract] 1 included 20 studies with a total of 5885 children and adults with moderate to severe atopic dermatitis. The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses.Tacrolimus 0.1% was better than low-potency topical corticosteroids (TCS) by the physician's assessment (mostly blinded)(risk ratio (RR) 3.09, 95% confidence interval (CI) 2.14 to 4.45; 1 study, n = 371, moderate-quality evidence). It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 1.32, 95% CI 1.17 to 1.49; 1 study, n = 972, moderate level of evidence). Compared with the lower concentration of 0.03%, the tacrolimus 0.1% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 0.82, 95% CI 0.72 to 0.92, 6 studies, n = 1640, high-quality evidence). Tacrolimus 0.1% compared with moderate-to-potent corticosteroids showed no difference by the physician's assessment.Tacrolimus 0.03% was superior to mild corticosteroids for the physician's assessment (RR 2.58, 95% CI 1.96 to 3.38, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 1.64, 95% CI 1.41 to 1.90; 1 study, n = 416, moderate quality of evidence). In the comparison of tacrolimus 0.03% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes).

Tacrolimus 0.1% was better than pimecrolimus 1% by the physician's assessment (RR 1.80, 95% CI 1.34 to 2.42; 2 studies; n = 506, moderate quality of evidence). One trial showed a trend of better outcome with tacrolimus 0.03% compared with pimecrolimus 1% on the physician's assessment (RR 1.42, 95% CI 1.02 to 1.98; 1 study, n = 139, low-quality evidence).

Burning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 0.03% (RR 2.48, 95% CI 1.96 to 3.14, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections. Symptoms observed were mild and transient. The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects.Serious adverse events were rare. No cases of lymphoma were noted in the included studies nor in the non-comparative studies. Cases were only noted in spontaneous reports, cohorts, and case-control studies.