A randomized, open-label, multicenter trial of topical tacrolimus for the treatment of pruritis in patients with atopic dermatitis

Abstract

Background: Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings.

Objective: To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy.

Methods: Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint.

Results: Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant.

Conclusion: Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.

Keywords: Atopic dermatitis; Maintenance therapy; Pruritis; Randomized trial; Tacrolimus.

Fig. 1

Flow diagram showing subjects' progress. Patients were advance-allocated after registration, received introduction therapy (add-on tacrolimus therapy), and the responders to the introduction therapy proceeded into maintenance therapy. There were several dropouts and one refusal during the study. VAS: visual analogue scale.

Fig. 2

Change in visual analogue scale (VAS)-itch score and disease severity after add-on tacrolimus therapy. (A) Pruritis (mean VAS-itch score - standard deviation) reduced after add-on topical tacrolimus therapy. (B) There was no statistical difference in mean VAS-itch score between responders and non-responders before the add-on therapy. (C) There was a significant decrease in VAS-itch score in responders after the add-on therapy. (D) SCORing Atopic Dermatitis (SCORAD) score reduced after the add-on topical tacrolimus therapy.

Fig. 3

Cumulative recurrence of pruritis in maintenance therapy. Tacrolimus monotherapy group (solid line) showed significantly much lower recurrence of pruritis compared to that of the emollient group (dotted line).

Fig. 4

Efficacy of tacrolimus monotherapy in maintenance therapy. The emollient group showed more pruritis than the tacrolimus monotherapy group at the end of maintenance therapy. VAS: visual analogue scale.

Fig. 5

Change of SCORing Atopic Dermatitis (SCORAD) in induction therapy between treatment-responding (blue circle) and non-responding patients (red circle) in induction therapy. Forty-three treatment-responding patients showed significantly reduced SCORAD compared to that of 7 non-responding patients in induction therapy as assessed by analysis of covariance (p=0.001).