Risk of haematological events and preventive effect of folic acid in methotrexate users with chronic kidney disease and rheumatoid arthritis: Analysis of the Japanese Adverse Drug Event Report database.
chronic kidney disease
folic acid
haematological toxicity
methotrexate
rheumatoid arthritis
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
revised:
05
11
2020
received:
06
09
2020
accepted:
08
11
2020
pubmed:
13
11
2020
medline:
21
9
2021
entrez:
12
11
2020
Statut:
ppublish
Résumé
Although methotrexate (MTX) for rheumatoid arthritis (RA) sometimes causes severe haematological toxicities in users with chronic kidney disease (CKD), data are limited regarding the risk of these events and the preventive effect of folic acid. This study evaluated the risk of haematological toxicities and the efficacy of folic acid in MTX users with CKD using the Japanese Adverse Drug Event Report. In total, 5,648 oral MTX users with RA were identified, including 630 with haematological toxicities. MTX users with CKD had significantly increased risk of haematological toxicities compared with those without CKD when folic acid was not used (OR 3.72; 95% CI 2.87-4.81; P < 0.01). Multivariate logistic analysis showed that the risk of haematological toxicities was significantly decreased by only folic acid (OR 0.16; 95% CI 0.04-0.62; P < 0.01). This result provides useful information for preventing severe haematological toxicities in MTX users with CKD and RA.
Substances chimiques
Antirheumatic Agents
0
Folic Acid
935E97BOY8
Methotrexate
YL5FZ2Y5U1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2286-2289Informations de copyright
© 2020 British Pharmacological Society.
Références
Goodman SM, Cronstein BN, Bykerk VP. Outcomes related to methotrexate dose and route of administration in patients with rheumatoid arthritis: a systematic literature review. Clin Exp Rheumatol. 2015;33(2):272-278.
Fleischmann R. Safety and efficacy of disease-modifying antirheumatic agents in rheumatoid arthritis and juvenile rheumatoid arthritis. Expert Opin Drug Saf. 2003;2(4):347-365.
Strang A, Pullar T. Methotrexate toxicity induced by acute renal failure. J R Soc Med. 2004;97(11):536-537.
Al-Hasani, Roussou E. Methotrexate for rheumatoid arthritis patients who are on hemodialysis. Rheumatol Int. 2011;31(12):1545-1547.
Saisho K, Yoshikawa N, Sugata K, Hamada H, Tohma S. Prevalence of chronic kidney disease and administration of RA-related drugs in patients with RA: the NinJa 2012 study in Japan. Mod Rheumatol. 2016;26(3):331-335.
Tonelli M, Riella MC. World Kidney Day 2014: CKD and the aging population. Am J Kidney Dis. 2014;63(3):349-353.
Shea B, Swinden MV, Ghogomu ET, et al. Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis. J Rheumatol. 2014;41(6):1049-1060.
Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519-523.
Howard SC, McCormick J, Pui C, Buddington RK, Harvey RD. Preventing and managing toxicities of high-dose methotrexate. Oncologist. 2016;21(12):1471-1482.
Berthelot JM, Maugars Y, Hamidou M, et al. Pancytopenia and severe cytopenia induced by low-dose methotrexate. Eight case-reports and a review of one hundred cases from the literature (with twenty-four deaths). Rev Rhum. 1995;62(7-8):477-486.
Yazici Y, Sokka T, Kautiainen H, Swearingen C, Kulman I, Pincus T. Long term safety of methotrexate in routine clinical care: discontinuation is unusual and rarely the result of laboratory abnormalities. Ann Rheum Dis. 2005;64(2):207-211.
The US Food and Drug Administration. Methotrexate tablets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf. Accessed October 29, 2020.
Bourré-Tessier J, Haraoui B. Methotrexate drug interactions in the treatment of rheumatoid arthritis: a systematic review. J Rheumatol. 2010;37(7):1416-1421.