Gaubitz M, et al. – The efficacy and safety of etanercept (ETN) monotherapy were compared with a combination therapy [methotrexate (MTX) + ETN] in rheumatoid arthritis. In investigations, ETN + MTX appeared marginally more effective than ETN monotherapy in some, but not all, outcomes measured.

• This analysis included patients who received either ETN alone or ETN + MTX during a 52–week prospective, observational study conducted at 329 German centers.
• The primary endpoint was “Funktionsfragebogen Hannover” (Hannover Functional Ability Questionnaire [FFbH]; low FFbH = worse function) functional remission at week 26 and week 52.
• The 28–joint count Disease Activity Score (DAS28), DAS28 remission (DAS28 < 2.6), and adverse events (Aes) were considered as the secondary endpoints.
• Participating centers applied ETN monotherapy in 43.1% of patients and ETN + MTX in 56.9%.
• A smaller proportion of patients achieved FFbH functional remission with ETN vs ETN + MTX (31.9%, 95% confidence interval [CI] 29.1–34.9% vs 39.8%, 37.2–42.5%, respectively; p < 0.001) at 26 weeks and at 52 weeks (38.4%, 35.1–41.7% vs 44.3%, 41.5–47.2%, respectively; p = 0.007).
• After 52 weeks, the mean DAS28 (±SD) decreased from 5.5 ± 1.3 to 3.4 ± 1.4 (ETN) vs 5.3 ± 1.3 to 3.2 ± 1.3 (ETN + MTX) and DAS28 remission was achieved by 32.5% (95% CI 29.0–36.1%) of patients with ETN vs 38.8% (35.8–41.9%; p = 0.007) with ETN + MTX.
• Overall, 20.6 (ETN) and 19.7% (ETN + MTX) of patients reported treatment–related AEs.
• Patients received ETN monotherapy almost as often as ETN + MTX.