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Weekly split‐dose regimen for oral methotrexate reduced polyglutamation in red blood cells in patients with rheumatoid arthritis compared with single‐dose regimen: Results from a multicentered randomized control trial
Author(s) -
Nagaoka Shouhei,
Katayama Kou,
Kasama Tsuyoshi,
Sato Masao,
Ohno Shigeru,
Amasaki Yoshiharu,
Kataoka Hiroshi,
Furusaki Akira,
Kon Yujiro,
Okamoto Masahiro,
Sasano Minoru,
Sagawa Akira
Publication year - 2020
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.13931
Subject(s) - medicine , adverse effect , regimen , methotrexate , rheumatoid arthritis , incidence (geometry) , clinical endpoint , gastroenterology , dosing , randomized controlled trial , dose , physics , optics
Abstract Aims We compared the incidence of adverse events between single and divided‐dose regimens of methotrexate (MTX) by using a multicenter randomized controlled trial. Methods Eighty‐nine patients with insufficient control on MTX 8 mg/wk were randomly assigned into single‐dose (39 patients) or triple dose (39 patients) groups. The MTX dose for all patients was gradually increased to 16 mg/wk. The primary endpoint was the occurrence of liver dysfunction during the observation period (20 weeks). Results There were no differences in baseline data and MTX dose at Week 20 between groups. There was no significant difference in the incidence of liver dysfunction between groups (single dose, 3 [7.7%] patients vs. triple dose, 5 [13.2%] patients; P = .455). The incidence of adverse event increased in triple dose (single dose, 12 [30.8%] patients vs. triple dose, 20 [51.3%]), but the difference was not significant ( P = .066). There was no significant difference in disease activity between groups, although MTX‐triglutamate (PG3), MTX‐PG4, and MTX‐PG5 were significantly higher in the single dose group. Conclusions Weekly split dosing reduced the polyglutamation of MTX. There was no significant difference in efficacy and safety between the 2 groups.