Rheumatoid arthritis

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 OpenPublished Randomised controlled trial

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 = 0.01
MTX
−0.39(−0.84 to 0.06)
P = 0.09

Further findings

OutcomeNSAIDMTXBaricitinibP value
DAS · 12 monthsMTX vs NSAID · across all three arms; non-significant1.6 (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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