IR@PKUHSC  > 北京大学第一临床医学院  > 皮肤性病科
学科主题临床医学
Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial
Sigurgeirsson, Bardur1; Boznanski, Andrzej2; Todd, Gail3; Vertruyen, Andre4; Schuttelaar, Marie-Louise A.5; Zhu, Xuejun6; Schauer, Uwe7; Qaqundah, Paul8,9; Poulin, Yves10,11; Kristjansson, Sigurdur12; von Berg, Andrea13; Nieto, Antonio14; Boguniewicz, Mark15,16; Paller, Amy S.17,18; Dakovic, Rada19; Ring, Johannes20; Luger, Thomas21
刊名PEDIATRICS
2015-04-01
DOI10.1542/peds.2014-1990
135期:4页:597-606
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pediatrics
研究领域[WOS]Pediatrics
关键词[WOS]TOPICAL CALCINEURIN INHIBITORS ; QUALITY-OF-LIFE ; SDZ ASM 981 ; CREAM 1-PERCENT ; ANTIINFLAMMATORY DRUG ; INFANTS ; CHILDREN ; ECZEMA ; SKIN ; CHILDHOOD
英文摘要

BACKGROUND AND OBJECTIVES: Atopic dermatitis (AD) primarily affects infants and young children. Although topical corticosteroids (TCSs) are often prescribed, noncorticosteroid treatments are needed because compliance with TCSs is poor due to concerns about their side effects. In this longest and largest intervention study ever conducted in infants with mild-to-moderate AD, pimecrolimus 1% cream (PIM) was compared with TCSs.

METHODS: A total of 2418 infants were enrolled in this 5-year open-label study. Infants were randomized to PIM (n = 1205; with short-term TCSs for disease flares) or TCSs (n = 1213). The primary objective was to compare safety; the secondary objective was to document PIM′s long-term efficacy. Treatment success was defined as an Investigator′s Global Assessment score of 0 (clear) or 1 (almost clear).

RESULTS: Both PIM and TCSs had a rapid onset of action with >50% of patients achieving treatment success by week 3. After 5 years, >85% and 95% of patients in each group achieved overall and facial treatment success, respectively. The PIM group required substantially fewer steroid days than the TCS group (7 vs 178). The profile and frequency of adverse events was similar in the 2 groups; in both groups, there was no evidence for impairment of humoral or cellular immunity.

CONCLUSIONS: Long-term management of mild-to-moderate AD in infants with PIM or TCSs was safe without any effect on the immune system. PIM was steroid-sparing. The data suggest PIM had similar efficacy to TCS and support the use of PIM as a first-line treatment of mild-to-moderate AD in infants and children.

语种英语
WOS记录号WOS:000353726700047
资助机构Novartis Pharmaceuticals Corporation ; Meda Pharma GmbH Co. KG
引用统计
被引频次:36[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/56747
专题北京大学第一临床医学院_皮肤性病科
作者单位1.Wroclaw Med Univ, Dept Children Allergol & Cardiol, Wroclaw, Poland
2.Univ Cape Town, Dept Med, ZA-7925 Cape Town, South Africa
3.GZA Campus St Vincentius, Antwerp, Belgium
4.Univ Iceland, Dept Dermatol, Fac Med, Reykjavik, Iceland
5.Univ Groningen, Univ Med Ctr Groningen, Dept Dermatol, Groningen, Netherlands
6.Peking Univ, Hosp 1, Dept Dermatol, Beijing 100871, Peoples R China
7.Ruhr Univ Bochum, Klin Kinder & Jugendmed, Bochum, Germany
8.Pediat Care Med Grp, Huntington Beach, CA USA
9.Ruhr Univ Bochum, Bochum, Germany
10.Univ Laval, Hop Hotel Dieu Quebec, Dermatol Unit, Quebec City, PQ, Canada
11.Ctr Rech Dermatol Quebec Metropolitain, Quebec City, PQ, Canada
12.Landspitali Univ Hosp, Dept Pediat, Reykjavik, Iceland
13.Marien Hosp Wesel, Childrens Dept, Res Inst, Wesel, Germany
14.Childrens Hosp La Fe, Pediat Pulmonol & Allergy Unit, Valencia, Spain
15.Natl Jewish Hlth, Dept Pediat, Div Pediat Allergy Immunol, Denver, CO USA
16.Univ Colorado, Sch Med, Denver, CO USA
17.Northwestern Univ Feinberg, Sch Med, Dept Dermatol, Chicago, IL USA
18.Northwestern Univ Feinberg, Sch Med, Dept Pediat, Chicago, IL USA
19.Meda Pharma GmbH & Co KG, Bad Homburg, Germany
20.Tech Univ Munich, Dept Dermatol & Allergol Biederstein, Christine Kuhne Ctr Allergy Res & Educ, D-80290 Munich, Germany
21.Univ Munster, Dept Dermatol, D-48149 Munster, Germany
22.Hudlaeknastodin, IS-201 Kopavogur, Iceland
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GB/T 7714
Sigurgeirsson, Bardur,Boznanski, Andrzej,Todd, Gail,et al. Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial[J]. PEDIATRICS,2015,135(4):597-606.
APA Sigurgeirsson, Bardur.,Boznanski, Andrzej.,Todd, Gail.,Vertruyen, Andre.,Schuttelaar, Marie-Louise A..,...&Luger, Thomas.(2015).Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial.PEDIATRICS,135(4),597-606.
MLA Sigurgeirsson, Bardur,et al."Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial".PEDIATRICS 135.4(2015):597-606.
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