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).
Br J Dermatol
; 179(6): 1297-1306, 2018 12.
Article
in En
| MEDLINE
| ID: mdl-29727479
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 primaryoutcomes:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Methotrexate
/
Cyclosporine
/
Cost-Benefit Analysis
/
Dermatitis, Atopic
/
Dermatologic Agents
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Health_economic_evaluation
Aspects:
Patient_preference
Limits:
Adolescent
/
Child
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Child, preschool
/
Female
/
Humans
/
Male
Language:
En
Journal:
Br J Dermatol
Year:
2018
Document type:
Article
Affiliation country: