Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial
Authors' conclusion
The MIRACLE trial demonstrated that higher total MTX-PGs concentration in erythrocytes is related to the higher efficacy and lower safety of MTX.
Study context
- Population
- MTX-naïve patients with RA initiating oral MTX, increased to maximum tolerated dose by week 12MTX-naïve
- Participants
- 300 patients
- Comparison
- Association of erythrocyte methotrexate-polyglutamates (MTX-PGs) concentration with MTX efficacy and safety
Methodological detailsprospective interventional clinical trial, MTX-PGs measured in erythrocytes by liquid chromatography-tandem mass spectrometry
- Prospective interventional clinical trial
- MTX-PGs measured in erythrocytes by liquid chromatography-tandem mass spectrometry
Primary result
As reported in the abstract
Total MTX-PGs concentration in erythrocytes · week 24
Total MTX-PGs concentration, mean (SD)
110.5 (SD 43.8) nmol/L
MTX dose
12.6 (3.0) mg/week (0.23 (0.07) mg/kg/week)
Further findings
Determinants of total MTX-PGs concentration
- Significantly elevated by lower eGFR, serum albumin and BMI
Safety
Hepatotoxicity
- Related to higher MTX-PGs concentration regardless of adalimumab use
Original publication
Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial. Ann Rheum Dis. Published 2 January 2025. doi:10.
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