Tacrolimus Ointment: Advancing the Treatment of Atopic Dermatitis
The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis,☆☆,,★★,

https://doi.org/10.1067/mjd.2001.109814Get rights and content

Abstract

Background: Atopic dermatitis can have detrimental effects on health-related quality of life (QOL). Objective: Our purpose was to examine the QOL impact of tacrolimus ointment in patients with atopic dermatitis. Methods: The Dermatology Life Quality Index (DLQI), Children's DLQI (CDLQI), and Toddler QOL Survey were used to assess QOL in adults (16 years or older), children (5-15 years), and toddlers (2-4 years) enrolled in 12-week, randomized, double-blind studies comparing two concentrations of tacrolimus ointment (0.03% and 0.1%) versus vehicle ointment for treatment of atopic dermatitis. QOL was assessed at baseline, week 3, and week 12/early discontinuation. Results: Of the 985 patients enrolled, 91.5% had evaluable QOL data. Among adults, both tacrolimus ointment groups experienced improved QOL relative to the vehicle control group for all QOL scales (P < .001). Among children and toddlers, both tacrolimus ointment groups demonstrated significant QOL improvements relative to the vehicle control group (P < .05) for all but the Personal Relationships scale in the 0.03% tacrolimus ointment group among children. Conclusion: Tacrolimus ointment is associated with significant QOL benefits in adults, children, and toddlers with atopic dermatitis. (J Am Acad Dermatol 2001;44:S65-72.)

Section snippets

Study design

The QOL evaluations were conducted during 3 phase 3, randomized, double-blind, multicenter studies. The studies compared two concentrations of topical tacrolimus ointment (0.03% and 0.1%) with a vehicle control ointment in adult and pediatric patients with moderate to severe atopic dermatitis based on criteria developed by Rajka and Langland.15 The study drug was administered for up to 12 weeks or until 1 week after the affected areas defined for treatment at baseline were completely cleared,

Patient population

A total of 985 patients enrolled in the clinical studies. Between 90% and 94% of patients within each age group completed both a baseline and at least one subsequent QOL assessment and thus were included in the treatment effects analysis. Sample sizes in each age group included 579 adults, 178 children, and 145 toddlers. Baseline demographics and clinical severity were comparable across treatment groups in each age group. The average ages for the adults, children, and toddlers were 39 years, 9

Discussion

The findings from the analysis of the QOL data obtained from 3 prospective, randomized, double-blind, multicenter studies demonstrated that topical tacrolimus ointment is associated with significant QOL benefits in adult and pediatric patients with atopic dermatitis. The QOL benefits were observed across all QOL categories measured, including symptoms, feelings, daily activities, sleep, and treatment impact.

In each age group, the improvements associated with tacrolimus ointment were quite

Conclusions

This study demonstrated that atopic dermatitis can be quite burdensome on patients' QOL and that topical tacrolimus ointment is associated with significant QOL improvements in both adult and pediatric patients with atopic dermatitis. More than 60% of adults, children, and toddlers receiving tacrolimus ointment improved in areas in which atopic dermatitis has the most impact, including itchiness/pain, self-consciousness, being upset/sad, working/studying, and sleeping. QOL benefits of tacrolimus

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Supported by an educational grant from Fujisawa Healthcare, Inc, Deerfield, Illinois.

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This article is part of a supplement sponsored by Fujisawa Healthcare, Inc.

Dr Drake's and Dr Breneman's institutions have received grant support from Fujisawa. Ms Prendergast, Dr Lawrence, Ms Maher, and Mr Matoi are employees of Fujisawa Healthcare, Inc. Dr Korman and Ms Beusterien are consultants for Fujisawa.

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Reprint requests: Lynn A. Drake, MD, Department of Dermatology, Massachusetts General Hospital, 40 Blossom Street—BAR604, Boston, MA 02114-2696.

J Am Acad Dermatol 2001;44:S65-72.

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