Elsevier

The Journal of Pediatrics

Volume 142, Issue 2, February 2003, Pages 155-162
The Journal of Pediatrics

Original Articles
Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants,☆☆

https://doi.org/10.1067/mpd.2003.65Get rights and content

Abstract

Objective The safety and efficacy of a 1% cream formulation of pimecrolimus, a selective, nonsteroid immunomodulator, was studied in infants with atopic dermatitis (AD). Methods During a 6-week double-blind phase, 186 infants with mild/moderate AD were randomly assigned to twice-daily pimecrolimus cream 1% or vehicle. All patients were subsequently treated with open-label pimecrolimus for 20 weeks. Results At the end of the double-blind phase, 54.5% and 23.8% of patients in the pimecrolimus and vehicle groups, respectively, were clear or almost clear of AD (P <.001). Similar improvements were observed in the Eczema Area and Severity Index, pruritus assessment, and the care giver's assessment. By the first return visit, 69.9% and 36.5% of pimecrolimus and vehicle-treated patients, respectively, achieved absent or mild pruritus. Efficacy during the double-blind phase was maintained throughout the open-label phase. Vehicle-treated patients transferring to open-label pimecrolimus rapidly achieved disease control comparable to those receiving continuous pimecrolimus. There were no significant differences between groups in application site reactions or skin infections. Most adverse events were mild or moderate and unrelated to treatment. Conclusions Pimecrolimus was safe in infants with AD, with rapid and sustained efficacy. Pimecrolimus holds promise as a valuable new treatment option for the youngest patients with AD. (J Pediatr 2003;142:155-62)

Section snippets

Study design and patients

Enrolled subjects met the following inclusion criteria: age, 3 to 23 months; written consent of legal guardian; clear diagnosis of AD,22 affecting ≥5% of total body surface area and with a baseline Investigator's Global Assessment (IGA) of 2 (mild) or 3 (moderate), based on the degree of erythema and infiltration/papulation. The following were reasons for exclusion: immunocompromised subject, other concurrent or active skin disease or viral skin infections, or a known hypersensitivity to study

Patients

A total of 186 patients were randomly assigned to receive either pimecrolimus cream 1% bid (n = 123) or corresponding vehicle (n = 63). There were no clinically or statistically significant demographic differences between the two groups (Table I).Baseline disease severity was similar for the two groups (Table I). In total, 109 (88.6%) patients in the pimecrolimus group completed the 6-week, double-blind phase, compared with 33 (52.4%) in the vehicle group. Eight (6.5%) patients in the

Discussion

This study demonstrates that pimecrolimus cream 1% is highly effective and safe for the treatment of mild to moderate AD in infants. In the 6-week double-blind phase, 70% of patients with moderate AD showed improvement, and >65% of patients with mild AD improved. The majority of patients receiving pimecrolimus quickly achieved clear or almost clear status. Clinically relevant improvements in AD were demonstrated at the first return visit on day 8, with statistically significant differences

Acknowledgements

We thank all participating investigators, including A. Halbert (Australia); F. F. Alonso, S. Pereira, M. C. Pires (Brazil); C. Lynde, K. Papp (Canada); K. Deichmann, H. Hamm, P. Höger (Germany); M. Groenewald, P. Jeena, D. Patel, N. L. Raboobee, S. Reyneke (South Africa); M. Casado, J. Escudero, and J.-M. Hernanz-Hermosa (Spain). In addition, we also thank Simon Hedgecock, Francois Langlo, and Michael Graeber of Novartis Pharma AG, Basel, Switzerland.

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    Supported by a research grant from Novartis Pharmaceuticals Corp.

    ☆☆

    Reprint requests: Vincent C. Ho, MD, Department of Medicine, Division of Dermatology, University of British Columbia, 835 West 10th Avenue, Vancouver, BC V5Z 4E8, Canada.

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