title: Functional interpretation of metabolomics data as a new method for predicting long-term side effects: treatment of atopic dermatitis in infants.
abstract: Topical steroids are used for the treatment of primary atopic dermatitis (AD); however, their associated risk of serious complications is great due to the presence of vulnerable lesions in young children with AD. Topical calcineurin inhibitors (TCIs) are steroid-free, anti-inflammatory agents used for topical AD therapy. However, their use is prohibited in infants <2 years of age because of their carcinogenic potential. We conducted a randomized, double-blind trial to evaluate the efficacy of TCIs as a secondary AD treatment for children <2 years of age by comparing 1% pimecrolimus cream with 0.05% desonide cream. We performed urinary metabolomics to predict long-term side effects. The 1% pimecrolimus cream displayed similar efficacy and exceptional safety compared with the 0.05% desonide cream. Metabolomics-based long-term toxicity tests effectively predicted long-term side effects using short-term clinical models. This applicable method for the functional interpretation of metabolomics data sets the foundation for future studies involving the prediction of the toxicity and systemic reactions caused by long-term medication administration.
authors.affiliation: College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Seul Ji
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, College of Medicine, Chungbuk National University, 52 Naesudong-ro, Heungdeok-gu, Cheongju 361-763, Korea.
authors.forename: Sung-il
authors.initials: SI
authors.lastname: Woo
authors.affiliation: Department of Statistics, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Soo Hyun
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Dong Kyu
authors.initials: DK
authors.lastname: Lim
authors.affiliation: College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Hong
authors.affiliation: College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Jeong Hill
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Statistics, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Johan
authors.initials: J
authors.lastname: Lim
authors.affiliation: Department of Internal Medicine, College of Medicine, Chungbuk National University, 52 Naesudong-ro, Heungdeok-gu, Cheongju 361-763, Korea.
authors.forename: Mi-kyeong
authors.initials: MK
authors.lastname: Kim
authors.affiliation: College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 151-742, Korea.
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Kwon
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003876:Dermatitis, Atopic / Q000188:drug therapy / Q000652:urine; D003898:Desonide / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D055432:Metabolomics; D011237:Predictive Value of Tests; D063465:Skin Cream / Q000008:administration & dosage* / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C117268:pimecrolimus; D003898:Desonide; D016559:Tacrolimus