What is the incidence of methotrexate or leflunomide discontinuation related to cytopenia, liver enzyme elevation or kidney function decline?
Alanine Transaminase
/ blood
Aspartate Aminotransferases
/ blood
Biomarkers
/ blood
Female
Humans
Immunosuppressive Agents
/ pharmacology
Incidence
Leflunomide
/ pharmacology
Liver Diseases
/ enzymology
Male
Methotrexate
/ pharmacology
Middle Aged
Renal Insufficiency
/ epidemiology
Rheumatic Diseases
/ drug therapy
Thrombocytopenia
/ epidemiology
United Kingdom
/ epidemiology
Withholding Treatment
autoimmune rheumatic diseases
blood-test monitoring
leflunomide
methotrexate
Journal
Rheumatology (Oxford, England)
ISSN: 1462-0332
Titre abrégé: Rheumatology (Oxford)
Pays: England
ID NLM: 100883501
Informations de publication
Date de publication:
01 12 2021
01 12 2021
Historique:
received:
19
10
2020
accepted:
05
03
2021
pubmed:
17
3
2021
medline:
30
12
2021
entrez:
16
3
2021
Statut:
ppublish
Résumé
To examine incidence of treatment changes due to abnormal blood-test results and, to explore rates of treatment changes due to liver, kidney and haematological blood-test abnormalities in autoimmune rheumatic diseases (AIRD) treated with low-dose MTX or LEF. Data for people with AIRDs prescribed MTX or LEF were extracted from the Clinical Practice Research Datalink. Participants were followed-up from first prescription of MTX or LEF in primary care. Primary outcome of interest was drug discontinuation, defined as a prescription gap of ≥90 days following an abnormal (or severely abnormal) blood-test result. Dose reduction was examined between consecutive prescriptions. Incidence rates per 1000 person-years were calculated. 15, 670 and 2,689 participants contributing 46, 571 and 4,558 person-years follow-up were included in MTX and LEF cohorts, respectively. The incidence of MTX and LEF discontinuation with abnormal (severely abnormal) blood-test was 42.24 (6.16) and 106.53 (9.42)/1000 person-years in year 1, and 22.44 (2.84) and 31.69 (4.40)/1000 person years, respectively, thereafter. The cumulative incidence of MTX and LEF discontinuation with abnormal (severely abnormal) blood tests was 1 in 24 (1 in 169), 1 in 9 (1 in 106) at 1 year; and 1 in 45 (1 in 352), 1 in 32 (1 in 227) per-year, respectively, thereafter. Raised liver enzymes were the commonest abnormality associated with drug discontinuation. MTX and LEF dose reduction incidence were comparable in year 1, however, thereafter MTX dose was reduced more often than LEF [16.60 (95% CI 13.05, 21.13) vs 8.10 (95% CI 4.97, 13.20)/1000 person-years]. MTX and LEF were discontinued for blood-test abnormalities after year 1 of treatment, however, discontinuations for severely abnormal results were uncommon.
Identifiants
pubmed: 33725120
pii: 6174126
doi: 10.1093/rheumatology/keab254
pmc: PMC8645271
doi:
Substances chimiques
Biomarkers
0
Immunosuppressive Agents
0
Aspartate Aminotransferases
EC 2.6.1.1
Alanine Transaminase
EC 2.6.1.2
Leflunomide
G162GK9U4W
Methotrexate
YL5FZ2Y5U1
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
5785-5794Subventions
Organisme : National Institute for Health Research
Organisme : NIHR
Organisme : Research for Patient Benefit Programme
ID : PB-PG-1217-20030
Organisme : NHS
Organisme : NIHR
Organisme : Department of Health and Social Care
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.
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