TOPLINE:

Patients with recent-onset undifferentiated arthritis who received early baricitinib showed a greater improvement in disease activity at 3 months than those who received symptomatic therapy with non-steroidal anti-inflammatory drugs (NSAIDs), and methotrexate showed a similar but non-significant benefit; 12-month outcomes were favourable across the three treatments.

METHODOLOGY:

• Researchers conducted a single-blind randomised clinical trial (I CEA) to compare outcomes of early treatment with disease-modifying antirheumatic drugs (DMARDs) with those of symptomatic therapy in adults with recent-onset undifferentiated arthritis.
• The analysis included 85 DMARD-naive patients with undifferentiated arthritis affecting two or more joints (average age, 52 years; 61% women; median symptom duration, 4.4 months) from seven hospitals in Netherlands between December 2020 and November 2023.
• All patients received a single 40 mg glucocorticoid injection at baseline and were randomly assigned to receive NSAIDs (n = 29) at standard daily doses, methotrexate 15 mg/wk increased to 25 mg/wk within 4 weeks (n = 28), or baricitinib 4 mg/d (n = 28) for 3 months.
• The primary endpoint was a change in the Disease Activity Score (DAS; 44/53 joints) at 3 months compared with baseline. Secondary endpoints included the achievement of remission (DAS < 1.6) at 3, 6, 9, and 12 months; safety endpoints were also assessed.
• Patients were followed up for 12 months, including a 3-month intervention phase and a 9-month observational period with study visits every 3 months.

TAKEAWAY:

• At 3 months, patients who received baricitinib showed a significantly greater improvement in the DAS than those who received NSAIDs (adjusted mean change, -0.52; P = .01). Methotrexate treatment showed a statistically non-significant reduction of 0.39 points.
• Over 12 months, a repeated measures analysis showed that the mean predicted DAS reduced faster with methotrexate treatment (-0.27 points per week) and baricitinib treatment (-0.28 points per week; P < .05 for both) than with NSAID treatment. However, the single 12-month mean predicted DAS did not differ significantly across the three treatment groups.
• In an adjusted analysis, methotrexate was associated with a 1.9-fold higher chance of achieving remission at 12 months than NSAIDs (P = .04), whereas baricitinib showed no significant association.
• During the first 3 months, patients receiving baricitinib or methotrexate experienced significantly higher rates of adverse events than those receiving NSAIDs (incidence rate ratio, 1.2 for both; P < .001 for both).

IN PRACTICE:

"DMARD initiation should be weighed against the wishes and treatment goals of the patient and the risk of (S)AEs [serious adverse events]," the authors wrote.

SOURCE:

This study was led by Isabell S. Nevins, Leiden University Medical Center, Leiden, Netherlands. It was published online on May 28, 2026, in RMD Open.

LIMITATIONS:

Regulatory safety warnings prompted protocol changes and caused some patients assigned to receive baricitinib to stop treatment but stay in follow-up. Approximately 25% of participants did not adhere to their assigned treatment within the first 3 months.

DISCLOSURES:

This study received financial support from Eli Lilly. Some authors reported receiving research grants, consulting fees, speaker fees, or honoraria from multiple pharmaceutical and biopharmaceutical companies and organisations including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.