Efficacy and safety of topical calcineurin inhibitors for the treatment of atopic dermatitis: meta-analysis of randomized clinical trials

Abstract

Introduction: Calcineurin inhibitors, novel topical immunomodulators, may constitute a superior alternative for glucocorticosteroids in atopic dermatitis (AD) topical treatment.

Aim: Determination of efficacy and safety of each topical calcineurin inhibitor (TCI) formulation, 0.3% or 0.1% tacrolimus and 1% pimecrolimus, for the treatment of moderate to severe AD in comparison with glucocorticosteroids.

Material and methods: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, GREAT database, trials registers and reference lists were searched up to February 2018. Randomised controlled trials of TCI, compared to corticosteroids (TCS), reporting efficacy or safety outcomes were selected. Quality of trials and evidence of each outcome were evaluated according to Cochrane Collaboration recommendations and tools. The primary outcomes were physician's global assessment of improvement and occurrence of adverse events (AEs).

Results: Fourteen trials involving 7376 children and adults with AD were included. Calcineurin inhibitors were significantly more effective than various potency TCS, neither least potent to lower mid-strength nor mid-strength to potent TCS (RR = 1.24, 95% CI: 1.06-1.44). The major AEs were skin burning and pruritus, their incidence was higher in TCI treatment (RR = 3.32, 95% CI: 2.90-3.80; RR = 1.59, 95% CI: 1.34-1.80).

Conclusions: Calcineurin inhibitors seem to be more effective and contrarily they elicit more AEs than TCS.

Keywords: atopic dermatitis; calcineurin inhibitors; corticosteroids; meta-analysis; tacrolimus.

Figure 1

Study flow diagram illustrating details of search strategy and study selection processes

Figure 2

Physician’s assessment of global response of improvement: clear or excellent. For citation references, see Table 1

Figure 3

Any adverse events. For citation references, see Table 1

Figure 4

Skin burning. For citation references, see Table 1

Figure 5

Pruritus. For citation references, see Table 1