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)


Irvine, AD, Jones, AP, Beattie, P, Baron, S, Browne, F, Ashoor, F, O'Neill, L, Rosala-Hallas, A ORCID: 0000-0001-8012-9995, Sach, T, Spowart, C et al (show 6 more authors) (2018) 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). BRITISH JOURNAL OF DERMATOLOGY, 179 (6). pp. 1297-1306.

[img] Text
A_randomised_controlled_trial_IRVINE_Publishedonline4May2018_GREEN_AAM.pdf - Author Accepted Manuscript
Download (499kB) | Preview

Abstract

<h4>Background</h4>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.<h4>Objectives</h4>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.<h4>Methods</h4>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<sup>-1</sup> per week) or CyA (4 mg kg<sup>-1</sup> per day).<h4>Results</h4>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.<h4>Conclusions</h4>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.

Item Type: Article
Uncontrolled Keywords: TREAT Trial Investigators, Humans, Dermatitis, Atopic, Methotrexate, Cyclosporine, Intermediate Filament Proteins, Dermatologic Agents, Treatment Outcome, Administration, Oral, Severity of Illness Index, Adolescent, Child, Child, Preschool, Cost-Benefit Analysis, Female, Male, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Pragmatic Clinical Trials as Topic, Filaggrin Proteins
Depositing User: Symplectic Admin
Date Deposited: 24 May 2019 13:16
Last Modified: 19 Jan 2023 00:43
DOI: 10.1111/bjd.16717
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3042794
Dimensions
Altmetric
CORE (COnnecting REpositories)