Rheumatoid arthritis

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 RheumatolPublished Pilot study

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

OutcomeValues
Withdrawal because of adverse eventsSTEP-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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