Induction of Cure in Early Arthritis (I CEA): results of a randomised clinical trial to compare three treatment strategies in recent onset undifferentiated arthritis
Authors' conclusion
In patients with UA, early DMARD treatment led to greater improvement in disease activity over 3 months compared with NSAIDs, with the improvement for baricitinib reaching statistical significance. Over 12 months, disease activity was not significantly different across treatment arms, with overall favourable outcomes.
Study context
- Population
- Patients with early DMARD-naïve undifferentiated arthritis (arthritis ≥2 joints, not fulfilling American College of Rheumatology (ACR)/EULAR 2010 RA criteria), all receiving a GC injection (40 mg intra-articular or intramuscular)
- Participants
- 29 / 28 / 28
- Comparison
- Baricitinib or methotrexate (MTX) vs non-steroidal anti-inflammatory drugs (NSAIDs) for 3 months after GC injection in early undifferentiated arthritis (UA)
- NSAIDn = 29reference
- MTXn = 28
- Baricitinibn = 28
- Primary endpoint
- DAS (44/53 joints) improvement
- Follow-up
- 3 months
Methodological detailsmulticentre, single-blinded, 3-month RCT followed by 9-month observational period
- Multicentre
- Single-blinded
- 3-month RCT followed by 9-month observational period
Primary result
As reported in the abstract
Adjusted mean change in DAS
Each group vs NSAIDAdjusted mean change in DAS (95% CI)P value
Baricitinib
−0.52(−0.93 to −0.11)
P = 0.01MTX
−0.39(−0.84 to 0.06)
P = 0.09Further findings
| Outcome | NSAID | MTX | Baricitinib | P value |
|---|---|---|---|---|
| DAS · 12 monthsMTX vs NSAID · across all three arms; non-significant | 1.6 (SD 0.9) | 1.3 (SD 0.7) | 1.7 (SD 0.9) | P = 0.38 |
Safety
Severe adverse events
- Incidence rates remained low across all treatment arms
Original publication
Induction of Cure in Early Arthritis (I CEA): results of a randomised clinical trial to compare three treatment strategies in recent onset undifferentiated arthritis. RMD Open. Published 28 May 2026. doi:10. 1136/ rmdopen-2026-006828
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