Two recent studies have shown that tacrolimus 0.03% ointment is effective for second-line treatment of moderate to severe atopic dermatitis in children not responding adequately to topical corticosteroids, said principal investigator Nejib Doss, MD, head, department of dermatology, Military Hospital of Tunis, Tunis, Tunisia.

Dr. Doss and colleagues therefore conducted their international, randomised, double-blind, noninferiority study, to directly compare tacrolimus 0.03% (Protopic®) with fluticasone 0.005% in this paediatric population, with the main exclusion criteria being acne or rosacea, superinfection of eczema, ulcer of the skin, or infection with herpes, varicella zona, or molluscum contagiosum.

The 473 patients (age range 2-15 years) of the full analysis set were randomised to receive either tacrolimus or fluticasone. The tacrolimus arm consisted of 236 children (male, 48%) and the fluticasone arm had 237 patients (male, 47%).

The disease characteristics across these 2 treatment groups were well balanced for mean disease duration and median duration of current flare up. The treatments that these patients had received during the previous 12 months included a range of topical steroids. "Intensive use of potent topical corticosteroids before the trial was high, illustrating the severity of the disease in this patient population." Dr. Doss said in his presentation on May 18^th.

After treatment twice daily for 3 weeks with either tacrolimus or fluticasone, the primary endpoint was 60% or greater reduction in modified Eczema Area and Severity Index (mEASI) at day 21. After this, patients continued on a once-a-day application of the same study drug for a further 3 weeks, until the end of the study.

The various secondary endpoints included physicians'/patients' global assessment of clinical response, patients' assessment of severity of pruritis, and quality of sleep and safety of use.

Of the 371 patients who received at least 1 dose of study medication, the response rates for the tacrolimus and fluticasone groups were 86.3% and 91.5%, respectively. The criteria for noninferiority were met here, with a difference in response (tacrolimus vs fluticasone) of -5.2%, and the corresponding 95% confidence interval (CI) of -11.8% (P =.0024)

Dr. Doss indicated that the robustness of these findings were also demonstrated for the full analysis set, with noninferiority also seen (tacrolimus, 84.3%; fluticasone 89.5%; P =.0012).

There were no significant differences between the 2 groups, except for pruritis, in terms of secondary endpoints in the full analysis set (tacrolimus, -84.0%; fluticasone, -91.5%; P =.008).

For the safety analysis, the 2 treatment groups showed similar safety profiles, with the only significant difference seen during the first 3 weeks of the trial arising from the known transient burning sensation associated with the application site for tacrolimus. Application site adverse events occurred in 18.0% and 11.3% of patients at day 21, respectively (P =.038)

"This study demonstrates the marked efficacy of tacrolimus as second-line treatment in children with atopic dermatitis, with an efficacy comparable to a potent topical corticosteroid," Dr. Doss said.


[Presentation title: Efficacy and Safety of Tacrolimus 0.03% Ointment (Protopic®) Versus Potent Corticosteroid Ointment as Second-Line Treatment in Children With Moderate to Severe Atopic Dermatitis. Abstract FC4.]

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