STEp-down approach in MEthotrexate use for the Treatment of Rheumatoid Arthritis (STEMETRA): a pilot study demonstrating efficacy and safety of short-term, high dose methotrexate
Authors' conclusion
In this study, the step-down MTX approach was effective in inducing remission in most of the patients enrolled, without increasing the risk of adverse events.
Study context
- Population
- Rheumatoid arthritis (RA) patients naive to any disease specific therapy10 concluded the study
- Participants
- 15 participants
- Comparison
- Step-down sc methotrexate (MTX): 50 mg/week for 4 weeks, then reduced to 15 mg/week over 12 weeks
- STEP-DOWN MTXn = 15
- Outcome
- DAS28(CRP), mean
- Follow-up
- Week 16
Methodological detailsopen-label, monocentric, 16-week, One patient lost to follow-up after week 12
- Open-label
- Monocentric
- 16-week
- One patient lost to follow-up after week 12
Main finding
As reported in the abstract
Mean DAS28(CRP) at baseline
5.6
±0.37 SE
Mean DAS28(CRP) at week 16
1.6
±0.41SE
Further findings
ACR70 response and remission among patients who concluded the study · week 16
- ACR70 response and remission
- 7 out of 10
- Moderate disease activity
- 3
Safety
| Outcome | Values |
|---|---|
| Withdrawal because of adverse events | STEP-DOWN MTX 4 events |
Original publication
STEp-down approach in MEthotrexate use for the Treatment of Rheumatoid Arthritis (STEMETRA): a pilot study demonstrating efficacy and safety of short-term, high dose methotrexate. Clin Exp Rheumatol. Published 4 September 2023. doi:10. 55563/ clinexprheumatol/ kv54k5
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