Trial reportClinical rheumatology2026
Effect of different folic acid doses on methotrexate-related toxicity and its association with erythrocyte methotrexate-polyglutamates in patients with rheumatic diseases: a single-center exploratory randomized controlled trial.
Trial report in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
introductionFolic acid is routinely co-administered with methotrexate (MTX) to reduce toxicity; however, the optimal dose remains unclear. This study investigated whether increasing the weekly folic acid dose from 5 to 10 mg reduces MTX-related toxicity in patients receiving stable-dose MTX therapy.
methodsIn this single-center, open-label, randomized controlled trial, 44 patients with rheumatic diseases on stable-dose MTX either received 10 mg (ARM-1) or 5 mg (ARM-2) of folic acid per week for 12 weeks. Liver damage, other MTX-related toxicities, and erythrocyte MTX-polyglutamate (MTX-PG) concentrations were compared between groups using logistic regression analysis or analysis of covariance. Japan Registry of Clinical Trials (number: jRCT1061230085).
resultsForty-two patients completed the study. The presence of liver damage at Day 84 did not differ significantly between the two groups (OR 0.41, 95% CI, 0.01-5.75, p = 0.506). Adjusted mean differences in aspartate transaminase and alanine transaminase at Day 84 between the groups were - 0.33 U/L (95% CI, - 2.68 to 2.02; p = 0.779) and - 0.44 U/L (95% CI, - 5.39 to 4.51; p = 0.859). Comparison of outcomes between groups at Day 84 showed no significant differences in any outcomes, except for fatigue severity (adjusted mean difference, - 0.87; 95% CI, - 1.71 to - 0.04; p = 0.041). Baseline fatigue was associated with baseline MTX-PG2 or MTX-PG1-2 concentrations (OR, 1.06; p = 0.049 or OR, 1.03; p = 0.040, respectively).
conclusionsIncreasing folic acid dose to 10 mg/week showed little effect on reducing MTX-related toxicity, although it may improve fatigue in selected patients. Key Points • Increasing the weekly folic acid dose from 5 mg to 10 mg showed no additional benefit in reducing methotrexate-related toxicity in patients on stable-dose MTX. • Higher-dose folic acid was associated with improved fatigue severity, indicating a potential therapeutic option for patients who develop fatigue.
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