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Rheumatoid arthritis: very early versus delayed etanercept and methotrexate

The Very Early Versus Delayed Etanercept in Patients With RA (VEDERA) trial has failed to show that the effect of first-line etanercept+methotrexate (ETN+MTX) over treat-to-target MTX (MTX-TT) in very early rheumatoid arthritis (ERA) is higher than previously reported.

VEDERA sought to confirm in very ERA a greater superiority (30%) of first-line ETN+MTX over MTX-TT than previously reported in ERA (14%) and to explore whether ETN following initial MTX secures a comparable response to first-line ETN+MTX.

The pragmatic, open-label, randomised controlled trial included treatment-naïve patients with ERA (≤12 months symptom) having Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2 and positive rheumatoid factor (RF) and anticitrullinated peptide antibody and if RF and ACPA are negative, grade ≥1 in at least one joint confirmed using ultrasound power Doppler (PD).

Subjects (n=120) were randomised to ETN+MTX (n=60) or MTX-TT (n=60) and escalated to ETN if week 24 DAS28-ESR ≥2.6 and intramuscular corticosteroids.

Remission rates with ETN+MTX versus MTX-TT, respectively, were 38 per cent versus 33 per cent at week 24 and 52 per cent versus 38 per cent at week 48 (OR, 1.6, 95% CI, 0.8-3.5; P=.211).

Greater sustained DAS28-ESR remission was observed with ETN+MTX versus MTX-TT (42% and 27%, respectively; P=.035).

PD was fully suppressed by week 48 in over 90 per cent in each arm.

Planned exploratory analysis revealed OR of 2.84 (95% CI, 0.84-9.60) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.

The authors concluded that the results do not demonstrate a larger effect in very ERA compared with remission rates typically reported with first-line tumour necrosis factor inhibitor+MTX versus MTX-TT.


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