Effects of Low-dose Methotrexate With Methimazole in Patients With Graves’ Disease: Results of a Randomized Clinical Trial
An erratum to this article was published (J Clin Endocrinol Metab, 21 Jan 2025 ↗)
Authors' conclusion
Supplemental MTX with MMI resulted in a higher discontinuation rate and improvement in decreased TRAb levels to homeostatic levels faster than methimazole treatment alone at months 12 to 18.
Study context
- Population
- Untreated hyperthyroid patients with Graves' disease (GD); academic endocrine outpatient clinic
- Participants
- 153 patients
- Comparison
- Methotrexate (MTX) 10 mg/w with mg/w with methimazole (MMI) vs MMI only
- Primary endpoint
- Discontinuation rate
- Follow-up
- Month 18
Methodological detailsprospective, open-label, supplementation controlled
- Prospective
- Open-label
- Supplementation controlled
Primary result
As reported in the abstract
95% CI 1.011–3.815; P = 0.045
Further findings
Discontinuation rate · month 15
(95% CI 1.020–3.922) · P = 0.043
| Outcome | MTX + MMI | MMI | P value |
|---|---|---|---|
| Decrease in TRAb levels · baseline to month 6 | 67.22% (range 43.12–80.32) | 54.85% (range 33.18–73.76) | P = 0.039 |
| Decrease in TRAb levels · month 9 | 77.79% (range 62.27–88.18) | 69.55% (range 50.50–83.22) | P = 0.035 |
| Decrease in TRAb levels · month 9Months 15-18 | P < 0.01 in 15-18 months |
Decrease in thyrotropin-related antibodies (TRAb) levels · month 9
- Significant difference in TRAb levels between groups at 9 to 18 months
FT3, FT4 and TSH
- No significant differences between the 2 groups
Safety
Events
| Outcome | MTX + MMI | MMI | P value |
|---|---|---|---|
| Serious drug-related adverse events | 0 | 0 | P = 0.771 |
Original publication
Effects of Low-dose Methotrexate With Methimazole in Patients With Graves’ Disease: Results of a Randomized Clinical Trial. J Clin Endocrinol Metab. Published 12 July 2024. doi:10.
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