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Wednesday, September 13th, 2017
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 [F] Diseases Research  / PubMed Research Articles  /
Influence of High-Dose Folic Acid on Methotrexate Efficacies and Safety in Japanese Rheumatoid Arthritis Patients.




Drug research 2017 Sep 12; ()


Kameyama S1; Kase Y2; Kurihara S3; Yoshida F4; Noda M5; Iiduka T6; Horiguchi M7; Sugiyama K8; Hirano T9;

Author Information
  • 1Department of Clinical Pharmacology, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
  • 2Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 3Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 4Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 5Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 6Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 7Bohsei Pharmacy, Isehara, Kanagawa, Japan.
  • 8Department of Clinical Pharmacology, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
  • 9Department of Clinical Pharmacology, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.


Backgrounds Folic acid dose at ≦5 mg/week has been recommended for rheumatoid arthritis (RA) patients to decrease risk of methotrexate adverse effects. However, higher doses of folic acid is used in some cases. We examined the influence of high-dose folic acid on methotrexate efficacies and safety in Japanese RA patients. Methods 502 RA patients of four hospitals prescribed methotrexate and folic acid were included. These patients were divided into two subgroups according to the threshold of folic acid dose by 5 mg/week. Basic patient characteristics, methotrexate doses, and the efficacies or adverse effects of methotrexate were retrospectively compared between the two patient subgroups. Results The frequency of folic acid use at doses higher than 5 mg/week was significantly different between the four hospitals (P<0.001). The prevalence of methotrexate adverse effects was not significantly different between the patients taking folic acid less and more than 5 mg/week. However, in the lower dose methotrexate subgroup (≦8 mg/week), the prevalence of patients exhibiting abnormal serum ALT concentrations in the patients using higher (>5 mg/week) dose of folic acid was significantly higher than that in the lower (≦5 mg/week) folic acid-treated subgroup (P=0.029). Folic acid dose between patients taking methotrexate less and more than 8 mg/week was not significantly different. Major conclusion Folic acid dose was dependent on the hospitals, while efficacies and hepatotoxicity of methotrexate was not basically different between patients taking less and more than 5 mg/week of folic acid.

© Georg Thieme Verlag KG Stuttgart · New York.




Publication Type: Journal Article

This article is licensed under the the National Library of Medicine License. It uses material from the PubMed National Library of Medicine Data.

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