Comparison of the efficacy and safety of methotrexate alone or in combination with leflunomide in the treatment of juvenile idiopathic arthritis: a double-blind, placebo-controlled, randomized trial.
disease-modifying antirheumatic drugs
juvenile idiopathic arthritis
leflunomide
methotrexate
Journal
Reumatologia
ISSN: 0034-6233
Titre abrégé: Reumatologia
Pays: Poland
ID NLM: 20130190R
Informations de publication
Date de publication:
2023
2023
Historique:
received:
14
04
2022
accepted:
05
02
2023
medline:
1
4
2023
entrez:
31
3
2023
pubmed:
1
4
2023
Statut:
ppublish
Résumé
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disorder in children. Although methotrexate (MTX) is the first line disease-modifying antirheumatic drug for JIA, many patients do not respond well or cannot tolerate MTX. The aim of this study was to compare the effect of combination therapy of MTX and leflunomide (LFN) with MTX in patients who do not respond to MTX. Eighteen patients (2-20 years old) with polyarticular, oligoarticular or extended oligoarticular subtypes of JIA who did not respond to conventional JIA therapy participated in this double-blind, placebo-controlled, randomized trial. The intervention group received LFN and MTX for 3 months while the control group received oral placebo and MTX at a similar dose to the intervention group. Response to treatment was assessed every 4 weeks using the American College of Rheumatology Pediatric criteria (ACRPed) scale. Clinical criteria, including number of active joints and restricted joints, physician and patient global assessment, Childhood Health Assessment Questionnaire (CHAQ38) score, and serum erythrocyte sedimentation ratelevel, did not differ significantly between groups at baseline and at the end of the 4 The results of this study showed that combining LFN with MTX does not improve clinical outcomes of JIA and may increase side effects in patients who do not respond to MTX.
Identifiants
pubmed: 36998586
doi: 10.5114/reum/161317
pii: 161317
pmc: PMC10044028
doi:
Types de publication
Journal Article
Langues
eng
Pagination
4-12Informations de copyright
Copyright: © 2023 Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie.
Déclaration de conflit d'intérêts
Funding for this study was provided entirely by the first author’s faculty scholarship. This study was supported by Research Project No. 900527 as an MD student dissertation (No. 6935), and was registered on the clinicaltrials.gov website with registration code NCT02024334. The authors declare no conflict of interest.
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