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Br J Dermatol. 2018 Dec;179(6):1297-1306. doi: 10.1111/bjd.16717. Epub 2018 Oct 28.

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).

Author information

1
Clinical Medicine, Trinity College Dublin, Dublin, Ireland.
2
Paediatric Dermatology, Our Lady's Children Hospital Crumlin, Dublin, Ireland.
3
National Children's Research Centre, Crumlin, Dublin, Ireland.
4
Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, U.K.
5
Royal Hospital for Children NHS Trust, Glasgow, U.K.
6
Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, U.K.
7
Biochemistry, Trinity College Dublin, Dublin, Ireland.
8
Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, U.K.
9
Centre for Molecular and Cellular Biology of Inflammation, King's College London, London, U.K.
10
Renal Research Laboratories, Manchester Royal Infirmary, Manchester, U.K.

Abstract

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:

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.

METHODS:

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 (0·4 mg kg-1 per week) or CyA (4 mg kg-1 per day).

RESULTS:

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.

CONCLUSIONS:

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.

PMID:
29727479
DOI:
10.1111/bjd.16717

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