Sequential corticosteroid/TCI regimen provides rapid, durable AD control

October 1, 2004

The results showed the sequential approach was safe and very effective for controlling AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology, Children's Hospital, San Diego, and clinical professor of pediatrics and medicine (dermatology), University of California San Diego School of Medicine.

Open study Dr. Eichenfield and colleagues investigated the efficacy and safety of this combination regimen in a 13 week, open study that enrolled 15 patients ages 2 to 16 years old. All participants began treatment of affected skin sites with a "run-in" course of triamcinolone 0.1 percent ointment twice daily, and after three to five days, switched to topical calcineurin inhibitor (TCI) treatment with tacrolimus 0.03 percent ointment.

Shown safe The results showed the sequential approach was safe and very effective for controlling AD.

Run-in treatment with the corticosteroid rapidly reduced disease severity and also appeared to have a benefit for minimizing stinging and burning with the initiation of tacrolimus. Continued treatment with the TCI over the next several weeks was associated with further improvement that was maintained over the longer term with intermittent use as needed.

"The initial studies with tacrolimus established its efficacy and safety as short-term monotherapy for acute atopic dermatitis," he says. "However, over the several years since it has been on the market, there has clearly been an evolution in how it is being used. Some of the most commonly asked questions regarding TCIs in general relate to how they might be used together with topical corticosteroids. There are many possible ways to combine these agents, and the results of this small trial demonstrate the value of this sequential approach."

He adds, "We studied tacrolimus 0.03 percent so that our treatment would not be 'off-label.' Our results, showing that maintenance of efficacy with prolonged use of the lower potency formulation of tacrolimus, are consistent with the findings from two long-term phase 3 studies that investigated the 0.1 percent product."

Eligibility Patients with any severity of AD were eligible for participation in the study if they had at least 10 percent body surface area (BSA) involvement. Concomitant use of any emollients was allowed, and children were permitted to continue existing oral antihistamine therapy without any changes in dosage or dosing frequency as well as inhaled steroids for comorbid asthma. However, other systemic or topical steroids were prohibited unless deemed necessary by the investigator.

Patients with any significant disease other than atopic dermatitis, active skin infection or history of tacrolimus ointment use during the preceding 30 days were excluded from the study.

Efficacy measures Efficacy measures included assessments of changes in the six-point Investigator's Global Atopic Dermatitis Assessment (IGADA) score (0 = clear, 5 = very severe), percent involvement of BSA, and the 4-point Pruritus Severity Index (PSI) (0 = none, 3 = severe). The mean IGADA score at baseline was 3.1 (moderate), was reduced to 2.4 after the short course of triamcinolone ointment. It continued to decrease throughout the rest of the study, falling to 2.2 at the end of week five and to 2.0 at study conclusion.