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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)

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)
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)

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.

administration, oral, adolescent, child, child, preschool, cost-benefit analysis, cyclosporine/administration & dosage, dermatitis, atopic/diagnosis, dermatologic agents/administration & dosage, female, filaggrin proteins, humans, intermediate filament proteins/genetics, male, methotrexate/administration & dosage, multicenter studies as topic, pragmatic clinical trials as topic, randomized controlled trials as topic, severity of illness index, treatment outcome
0007-0963
1297-1306
Irvine, A.D.
6bc03e6e-41ca-4da7-a95b-2ee6c57f3a16
Jones, A.P.
9fe04f0a-e581-41e8-a636-da83ba8ea499
Beattie, P.
a5aadc6d-405f-44b1-8e35-a3e6209bf24d
Baron, S.
41a9fe36-6e67-4411-9012-8be4a82b2e12
Browne, F.
ba1f01a4-f1d3-42b9-9d1d-e8e851b08d1b
Ashoor, F
5678d633-a3a6-4a3a-a403-d3ecab846954
O'Neill, L.
2e84215b-fb32-49bc-a525-6a00816d13f5
Rosala-Hallas, A.
89c3e087-20b8-4d1e-bb66-f2d9df724aa8
Sach, T.
5c09256f-ebed-4d14-853a-181f6c92d6f2
Spowart, C.
b521faf2-e900-4115-8d91-e5e588e30a6e
Taams, L.
8c778c8c-98c3-4f92-9abe-b81fc44eb7c3
Walker, C.
ec9818bd-8f4f-4665-aabb-e825da839223
Wan, M.
1faaebc2-7161-4636-baeb-0314b6386d44
Webb, N.
bc12a662-decb-4a1a-8962-f5a76859826c
Williamson, P.
91fc4c52-327a-4482-8e60-b8e86002d8ff
Flohr, C.
2cd7a518-1a24-4fc7-b099-2a032fdf2068
TREAT Trial Investigators
Irvine, A.D.
6bc03e6e-41ca-4da7-a95b-2ee6c57f3a16
Jones, A.P.
9fe04f0a-e581-41e8-a636-da83ba8ea499
Beattie, P.
a5aadc6d-405f-44b1-8e35-a3e6209bf24d
Baron, S.
41a9fe36-6e67-4411-9012-8be4a82b2e12
Browne, F.
ba1f01a4-f1d3-42b9-9d1d-e8e851b08d1b
Ashoor, F
5678d633-a3a6-4a3a-a403-d3ecab846954
O'Neill, L.
2e84215b-fb32-49bc-a525-6a00816d13f5
Rosala-Hallas, A.
89c3e087-20b8-4d1e-bb66-f2d9df724aa8
Sach, T.
5c09256f-ebed-4d14-853a-181f6c92d6f2
Spowart, C.
b521faf2-e900-4115-8d91-e5e588e30a6e
Taams, L.
8c778c8c-98c3-4f92-9abe-b81fc44eb7c3
Walker, C.
ec9818bd-8f4f-4665-aabb-e825da839223
Wan, M.
1faaebc2-7161-4636-baeb-0314b6386d44
Webb, N.
bc12a662-decb-4a1a-8962-f5a76859826c
Williamson, P.
91fc4c52-327a-4482-8e60-b8e86002d8ff
Flohr, C.
2cd7a518-1a24-4fc7-b099-2a032fdf2068

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. and Flohr, C. , TREAT Trial Investigators (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. (doi:10.1111/bjd.16717).

Record type: Article

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.

This record has no associated files available for download.

More information

Accepted/In Press date: 23 April 2018
Published date: 1 December 2018
Additional Information: © 2018 British Association of Dermatologists.
Keywords: administration, oral, adolescent, child, child, preschool, cost-benefit analysis, cyclosporine/administration & dosage, dermatitis, atopic/diagnosis, dermatologic agents/administration & dosage, female, filaggrin proteins, humans, intermediate filament proteins/genetics, male, methotrexate/administration & dosage, multicenter studies as topic, pragmatic clinical trials as topic, randomized controlled trials as topic, severity of illness index, treatment outcome

Identifiers

Local EPrints ID: 478825
URI: http://eprints.soton.ac.uk/id/eprint/478825
DOI: doi:10.1111/bjd.16717
ISSN: 0007-0963
PURE UUID: 4e467729-dbea-41f5-84ed-ac17a8fecbb9
ORCID for T. Sach: ORCID iD orcid.org/0000-0002-8098-9220

Catalogue record

Date deposited: 11 Jul 2023 16:56
Last modified: 17 Mar 2024 04:19

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Contributors

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

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