to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate. Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months. Clinical efficacy results at 12 months: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration a: Patients who did not complete 12 months in the study were considered to be non-responders. b: Values for Disease Activity Score (DAS) are means. c: Remission is defined as DAS Pairwise comparison p-values:
† = p methotrexate and ϕ = p Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below). 19 Endpoint Methotrexate (n = 228) Etanercept (n = 223) Etanercept + Methotrexate (n = 231) ACR Responsesa ACR 20 58.8% 65.5% 74.5% †,ϕ ACR 50 36.4% 43.0% 63.2% †, ϕ ACR 70 16.7% 22.0% 39.8% †, ϕ DAS Baseline scoreb 5.5 5.7 5.5 Week 52 scoreb 3.0 3.0 2.3 †, ϕ Remissionc 14% 18% 37% †, ϕ HAQ Baseline 1.7 1.7 1.8 Week 52 1.1 1.0 0.8 †, ϕ