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)

TREAT Trial Investigators; A. D. Irvine; A. P. Jones; P. Beattie; S. Baron; F. Browne; F. Ashoor; L. O'Neill; A. Rosala-Hallas; T. Sach; C. Spowart; L. Taams; C. Walker; M. Wan; N. Webb; P. Williamson; C. Flohr

doi:10.1111/bjd.16717

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)

TREAT Trial Investigators, A. D. Irvine, A. P. Jones, P. Beattie, S. Baron, F. Browne, F. Ashoor, L. O'Neill, A. Rosala-Hallas, T. Sach, C. Spowart, L. Taams, C. Walker, M. Wan, N. Webb, P. Williamson, C. Flohr (Lead / Corresponding author)

Biological Chemistry and Drug Discovery

Research output: Contribution to journal › Article › peer-review

23 Citations (Scopus)

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.

Original language	English
Pages (from-to)	1297-1306
Number of pages	10
Journal	British Journal of Dermatology
Volume	179
Issue number	6
Early online date	28 Oct 2018
DOIs	https://doi.org/10.1111/bjd.16717
Publication status	Published - Dec 2018

ASJC Scopus subject areas

Dermatology

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TREAT Trial Investigators, Irvine, A. D., Jones, A. P., Beattie, P., Baron, S., Browne, F., Ashoor, F., O'Neill, L., Rosala-Hallas, A., Sach, T., Spowart, C., Taams, L., Walker, C., Wan, M., Webb, N., Williamson, P., & Flohr, C. (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), 1297-1306. https://doi.org/10.1111/bjd.16717

TREAT Trial Investigators ; Irvine, A. D. ; Jones, A. P. et al. / 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). In: British Journal of Dermatology. 2018 ; Vol. 179, No. 6. pp. 1297-1306.

@article{26082198dd384505af4876c6c6ea0aea,

title = "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)",

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{\textquoteright} 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.",

author = "{TREAT Trial Investigators} and Irvine, {A. D.} and Jones, {A. P.} and P. Beattie and S. Baron and F. Browne and F. Ashoor and L. O'Neill and A. Rosala-Hallas and T. Sach and C. Spowart and L. Taams and C. Walker and M. Wan and N. Webb and P. Williamson and C. Flohr and Alison Layton and Tim Burton and Michael Grainge and Michael Arden-Jones and Saskia King and Michael Perkin and Alain Taieb and Anthony Ormerod and Robert Chalmers and Xinxue Liu and Amina Ahmed and Farhiya Ashoor and Anna Rosala-Hallas and Amy Holton and Irvine, {A. D.} and Ashley Jones and Tracey Sach and Catherine Spowart and Mandy Wan and Charlotte Walker and Paula Williamson and Suzannah August and Paula Beattie and Sara Brown and Mike Cork and Ben Esdaile and Joanna Gach and Emma Howard and Tess McPherson and Donal O'Kane and Jane Ravenscroft and Robert Hearn and Graham Ogg and Irwin Mclean",

year = "2018",

month = dec,

doi = "10.1111/bjd.16717",

language = "English",

volume = "179",

pages = "1297--1306",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Wiley",

number = "6",

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TREAT Trial Investigators, Irvine, AD, Jones, AP, Beattie, P, Baron, S, Browne, F, Ashoor, F, O'Neill, L, Rosala-Hallas, A, Sach, T, Spowart, C, Taams, L, Walker, C, Wan, M, Webb, N, Williamson, P & Flohr, C 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, vol. 179, no. 6, pp. 1297-1306. https://doi.org/10.1111/bjd.16717

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). / TREAT Trial Investigators; Irvine, A. D.; Jones, A. P. et al.
In: British Journal of Dermatology, Vol. 179, No. 6, 12.2018, p. 1297-1306.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - the TREatment of severe Atopic eczema Trial (TREAT)

AU - TREAT Trial Investigators

AU - Irvine, A. D.

AU - Jones, A. P.

AU - Beattie, P.

AU - Baron, S.

AU - Browne, F.

AU - Ashoor, F.

AU - O'Neill, L.

AU - Rosala-Hallas, A.

AU - Sach, T.

AU - Spowart, C.

AU - Taams, L.

AU - Walker, C.

AU - Wan, M.

AU - Webb, N.

AU - Williamson, P.

AU - Flohr, C.

AU - Layton, Alison

AU - Burton, Tim

AU - Grainge, Michael

AU - Arden-Jones, Michael

AU - King, Saskia

AU - Perkin, Michael

AU - Taieb, Alain

AU - Ormerod, Anthony

AU - Chalmers, Robert

AU - Liu, Xinxue

AU - Ahmed, Amina

AU - Ashoor, Farhiya

AU - Rosala-Hallas, Anna

AU - Holton, Amy

AU - Irvine, A. D.

AU - Jones, Ashley

AU - Sach, Tracey

AU - Spowart, Catherine

AU - Wan, Mandy

AU - Walker, Charlotte

AU - Williamson, Paula

AU - August, Suzannah

AU - Beattie, Paula

AU - Brown, Sara

AU - Cork, Mike

AU - Esdaile, Ben

AU - Gach, Joanna

AU - Howard, Emma

AU - McPherson, Tess

AU - O'Kane, Donal

AU - Ravenscroft, Jane

AU - Hearn, Robert

AU - Ogg, Graham

AU - Mclean, Irwin

PY - 2018/12

Y1 - 2018/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85054878100&partnerID=8YFLogxK

U2 - 10.1111/bjd.16717

DO - 10.1111/bjd.16717

M3 - Article

C2 - 29727479

AN - SCOPUS:85054878100

SN - 0007-0963

VL - 179

SP - 1297

EP - 1306

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 6

ER -

TREAT Trial Investigators, Irvine AD, Jones AP, Beattie P, Baron S, Browne F et al. 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. 2018 Dec;179(6):1297-1306. Epub 2018 Oct 28. doi: 10.1111/bjd.16717

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)

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