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.
