This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via ISI Web of Science (33)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Whalley, D.
Right arrow Articles by van Assche, D.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Whalley, D.
Right arrow Articles by van Assche, D.
Related Collections
Right arrow Allergy & Dermatology

PEDIATRICS Vol. 110 No. 6 December 2002, pp. 1133-1136

The Benefit of Pimecrolimus (Elidel, SDZ ASM 981) on Parents’ Quality of Life in the Treatment of Pediatric Atopic Dermatitis

Diane Whalley, BSc*, Jasper Huels, PhD{ddagger}, Stephen P. McKenna, PhD* and Daniel van Assche, PhD{ddagger}

* Galen Research, Manchester, United Kingdom
{ddagger} Novartis Pharma AG, Basel, Switzerland

--> Objective. Two 26-week US clinical trials of identical design were conducted to evaluate the efficacy and safety of pimecrolimus (Elidel, SDZ ASM 981) cream 1% in pediatric atopic dermatitis (AD). A secondary aim of both trials, and the focus of this article, was to evaluate the quality-of-life (QoL) impact of pimecrolimus compared with its vehicle.

Methods. A 6-week randomized, double-blind treatment phase was followed by a 20-week open-label phase during which all patients received pimecrolimus (403 patients 2 to 17 years old with mild to moderate AD; 267 randomized to pimecrolimus and 136 to vehicle). QoL analyses were conducted on the intention-to-treat data and included patients 8 years old or younger. QoL was evaluated with the Parent’s Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) at baseline, 6 weeks, and 6 months. The PIQoL-AD is a 28-item measure completed by the parents of children with AD (0 to 8 years old).

Results. PIQoL-AD scores were available for 241 cases at baseline (158 pimecrolimus, 83 vehicle), 193 at 6 weeks (132 pimecrolimus, 61 vehicle), and 161 at 6 months (113 pimecrolimus, 48 vehicle). Improvement in parents’ QoL was seen for both groups between baseline and 6 weeks and 6 months. Analysis of covariance on PIQoL-AD scores at 6 weeks showed statistically significant superiority of pimecrolimus compared with vehicle. After all patients were switched to receive pimecrolimus at week 6, mean PIQoL-AD scores were the same across both groups at 6 months. Positive but low levels of association were observed between changes in PIQoL-AD scores and changes in severity of AD (Investigator’s Global Assessment and parent-perceived severity of pruritus).

Conclusion. The results showed that pimecrolimus had a beneficial effect on parents’ QoL in pediatric AD.

Key Words: clinical trials • atopic dermatitis • eczema • child • quality of life • SDZ ASM 981 • PIQoL-AD

Abbreviations: AD, atopic dermatitis • QoL, quality of life • PIQoL-AD, Parent’s Index of Quality of Life-Atopic Dermatitis • IGA, Investigator’s Global Assessment

Received for publication Sep 7, 2001; Accepted Jun 20, 2002.




This article has been cited by other articles:


Home page
 BMJHome page
D. M Ashcroft, P. Dimmock, R. Garside, K. Stein, and H. C Williams
Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials
BMJ, March 5, 2005; 330(7490): 516.
[Abstract] [Full Text] [PDF]

Home page
 EDUCATION AND PRACTICEHome page
S Conroy
NEW PRODUCTS FOR ECZEMA
Arch. Dis. Child. Ed. Pract., June 1, 2004; 89(1): ep23 - ep26.
[Full Text] [PDF]