A randomized controlled trial protocol assessing the effectiveness, safety and cost-effectiveness of methotrexate vs. ciclosporin in the treatment of severe atopic eczema in children: the TREatment of severe Atopic eczema Trial (TREAT)

被引：13

作者：

Irvine, A. D. ^{[1
,2
,3
]}

Jones, A. P. ^{[4
]}

Beattie, P. ^{[5
]}

Baron, S. ^{[6
,7
]}

Browne, F. ^{[2
]}

Ashoor, F. ^{[4
]}

O'Neill, L. ^{[8
]}

Rosala-Hallas, A. ^{[4
]}

Sach, T. ^{[9
]}

Spowart, C. ^{[4
]}

Taams, L. ^{[10
]}

Walker, C. ^{[6
,7
]}

Wan, M. ^{[6
,7
]}

Webb, N. ^{[11
]}

Williamson, P. ^{[4
]}

Flohr, C. ^{[6
,7
]}

机构：

[1] Trinity Coll Dublin, Clin Med, Dublin, Ireland

[2] Our Ladys Children Hosp Crumlin, Paediat Dermatol, Dublin, Ireland

[3] Natl Childrens Res Ctr, Dublin, Ireland

[4] Univ Liverpool, Dept Biostat, Clin Trials Res Ctr, Liverpool, Merseyside, England

[5] Royal Hosp Children NHS Trust, Glasgow, Lanark, Scotland

[6] Guys & St Thomas NHS Fdn Trust, St Johns Inst Dermatol, Unit Population Based Dermatol Res, London, England

[7] Kings Coll London, London, England

[8] Trinity Coll Dublin, Biochem, Dublin, Ireland

[9] Univ East Anglia, Norwich Med Sch, Hlth Econ Grp, Norwich, Norfolk, England

[10] Kings Coll London, Ctr Mol & Cellular Biol Inflammat, London, England

[11] Manchester Royal Infirm, Renal Res Labs, Manchester, Lancs, England

来源：

BRITISH JOURNAL OF DERMATOLOGY | 2018年 / 179卷 / 06期

基金：

美国国家卫生研究院; 英国医学研究理事会;

关键词：

DERMATITIS; EFFICACY; DISEASE; AZATHIOPRINE; GUIDELINES; EXPERIENCE;

D O I：

10.1111/bjd.16717

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

Background Oral systemic immunomodulatory medication is regularly used off-licence in children with severe atopic eczema. However, there is no firm evidence regarding the effectiveness, safety, cost-effectiveness and impact on quality of life from an adequately powered randomized controlled trial (RCT) using systemic medication in children. Objectives Methods To assess whether there is a difference in the speed of onset, effectiveness, side-effect profile and reduction in flares post-treatment between ciclosporin (CyA) and methotrexate (MTX), and also the cost-effectiveness of the drugs. Treatment impact on quality of life will also be examined in addition to whether FLG genotype influences treatment response. In addition, the trial studies the immune-metabolic effects of CyA and MTX. Multicentre, parallel group, assessor-blind, pragmatic RCT of 36 weeks' duration with a 24-week follow-up period. In total, 102 children aged 2-16 years with moderate-to-severe atopic eczema, unresponsive to topical treatment will be randomized (1 : 1) to receive MTX (0 center dot 4 mg kg(-1) per week) or CyA (4 mg kg(-1) per day). Results Conclusions Appendix The trial has two primary outcomes: change from baseline to 12 weeks in Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) and time to first significant flare following treatment cessation. This trial addresses important therapeutic questions, highlighted in systematic reviews and treatment guidelines for atopic eczema. The trial design is pragmatic to reflect current clinical practice.

引用

页码：1297 / 1306

页数：10

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