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Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants.
J Pediatr 2003; 142(2):155-62JPed

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.

Authors+Show Affiliations

Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12584537

Citation

Ho, Vincent C., et al. "Safety and Efficacy of Nonsteroid Pimecrolimus Cream 1% in the Treatment of Atopic Dermatitis in Infants." The Journal of Pediatrics, vol. 142, no. 2, 2003, pp. 155-62.
Ho VC, Gupta A, Kaufmann R, et al. Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. J Pediatr. 2003;142(2):155-62.
Ho, V. C., Gupta, A., Kaufmann, R., Todd, G., Vanaclocha, F., Takaoka, R., ... Cherill, R. (2003). Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. The Journal of Pediatrics, 142(2), pp. 155-62.
Ho VC, et al. Safety and Efficacy of Nonsteroid Pimecrolimus Cream 1% in the Treatment of Atopic Dermatitis in Infants. J Pediatr. 2003;142(2):155-62. PubMed PMID: 12584537.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. AU - Ho,Vincent C, AU - Gupta,Aditya, AU - Kaufmann,Roland, AU - Todd,Gail, AU - Vanaclocha,Francisco, AU - Takaoka,Roberto, AU - Fölster-Holst,Regina, AU - Potter,Paul, AU - Marshall,Katherine, AU - Thurston,Mark, AU - Bush,Christopher, AU - Cherill,Robert, PY - 2003/2/14/pubmed PY - 2003/3/22/medline PY - 2003/2/14/entrez SP - 155 EP - 62 JF - The Journal of pediatrics JO - J. Pediatr. VL - 142 IS - 2 N2 - 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. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/12584537/Safety_and_efficacy_of_nonsteroid_pimecrolimus_cream_1_in_the_treatment_of_atopic_dermatitis_in_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(02)40267-3 DB - PRIME DP - Unbound Medicine ER -