A 20-week multicenter observational before-after study was conducted to evaluate the efficacy and safety of Etanar® (Etveza) in patients with long-standing, multiple disease-modifying antirheumatic drugs (DMARDs)-resistant rheumatoid arthritis (RA) in a real-life setting. About 110 patients with active RA were initiated on Etanar® (Etveza) treatment (25 mg subcutaneous injection twice per week) despite treatment with DMARDs. The patients were followed for a period of 20 weeks. The demographics and clinical characteristics, like health assessment questionnaire (HAQ) and disease activity score (DAS28), were recorded every 4 weeks.
Table 1: Tenderness joint score and swollen joint score during follow-up
Significant improvement was observed in patients treated with Etanar® (Etveza) (P < 0.001,Table 1).
Etanar®(Etveza) may be effective in controlling disease activity in real-life patients with active RA where MTX and other DMARDS show poor responses. Etanar®(Etveza) is safe and well tolerated.
Rondon F, Bautista A, Salazar JC, Casas N, Santos P, Vargas F, et al. Etanar (Etveza) therapy in real-life patients with rheumatoid arthritis [abstract]. Arthritis Rheum. 2010;62(Suppl 10):1811.
The study aimed to compare the efficacy of two classical anti-tumor necrosis factor biologics (adalimumab, infliximab) and one Etanercept biosimilar in patients with long-standing rheumatoid arthritis (RA) in a real-life setting. A total of 158 patients with RA were assigned to receive adalimumab, infliximab, and Etanercept biosimilar Etanar® (Etveza).
According to the disease activity score (DAS28), the clinical follow-up was designed as follows:
The treatment was adjusted with DAS28 > 3.2 unless patient’s conditions did not permit it (treat-to-target strategy; T2T). The patients were divided into two groups: the remission-low disease activity (Rem/LDA) and moderate-severe disease activity (MDA/SDA). The median DAS28 and the disease activity were analyzed using t-student distribution and Pearson's statistics, respectively.
Table 1: Disease activity at the start and 24-month follow-up
Etanar® (Etveza)- Etanercept biosimilar is as effective as adalimumab and infliximab in controlling disease activity in patients with RA in a real-life setting with fewer adverse events. The implementation of T2T strategy is effective in patients with RA.
Santos-Moreno P, Saavedra-Martinez G, Villarreal L, Gomez D, Bello-Gualtero J, Giraldo V, et al. Etanar (Etveza) – A Etanercept biosimilar is as effective as adalimumab and infliximab in a cohort of real-life of patients with rheumatoid arthritis. Ann Rheum Dis. 2015;74:789–90.
Treatment with 25 mg subcutaneous Etanercept [Etanar® (Etveza) 25 mg: biologic type rhTNFR:Fc] twice per week in patients with active rheumatoid arthritis
A study was conducted to evaluate the clinical response of patients with rheumatoid arthritis treated with Etanar® (Etveza) (rhTNFR:Fc) at 12 month follow-up. A total of 105 patients with active rheumatoid arthritis were included in multicenter observational cohort study. The patients were treated with 25 mg subcutaneous Etanercept twice per week (Etanar® (Etveza) 25 mg approved for using in Colombia). The follow-up period of the study was 12 months, with assessments performed at weeks 12, 24, 36, and 48. The outcomes of the study included tender joint count (TJC), swollen joint count (SJC), health assessment questionnaire (HAQ), disease activity score 28 (DAS28), and American College of Rheumatology (ACR) response criteria (ACR20, ACR50, ACR70).
Figure 1: TJC and SJC at 12-month follow-up
The clinical response was defined by percentage improvement in disease activity (ACR-N criteria). The percentage of patients with at least a 20% improvement in the pain and edematous joint count, and in three of the five criteria (overall assessments by the doctor and patient, functional state, and erythrocyte sedimentation rate) were represented as ACR20. The threshold was also evaluated for 50% and 70% improvement (ACR50 and ACR70, respectively).
Figure 2: Percentage improvement with Etanercept at 12-month follow-up
Figure 3: DAS28 and HAQ at 12-month follow-up
Etanercept 25 mg twice a week shows significant clinical results with adequate disease control in a high percentage of patients with adequate safety.
Reference: Santos-Moreno PI, Sánchez G, Gomez D, Castro C. Clinical outcomes in a cohort of Colombian patients with rheumatoid arthritis treated with Etanar (Etveza), a new biologic type rhTNFR:Fc. Clin Exp Rheumatol. 2015 Nov-Dec;33(6):858–62.
Comparison of Etanercept [Etanar® (Etveza)], infliximab (Remecade®), and adalimumab (Humira®)
A observational retrospective cohort study was conducted to compare the clinical response and evaluate the adverse events in patients with rheumatoid arthritis treated with Etanercept, infliximab, or adalimumab at 36 months. A total of 307 patients with rheumatoid arthritis were assigned to receive subcutaneous Etanercept 25 mg twice a week (Etanar® (Etveza)), intravenous infliximab 3 mg/kg at weeks 0, 2, and 6 and then every 8 weeks (Remicade®), or subcutaneous adalimumab 40 mg every 2 weeks (Humira®). The follow-up period of the study was 36 months, with at least trimestral evaluations. The outcomes of the study included disease activity score 28 (DAS28) based on erythrocyte sedimentation rate for remission and low disease activity, health assessment questionnaire (HAQ), level of disability, and adverse events.
Figure 1: Median DAS28 from baseline to 36-month follow-up in the three treatment groups
Figure 2: Median HAQ from baseline to 36-month follow-up in the three treatment groups
Table 1: Level of disability during the 36-month follow-up in the three treatment groups
Table 2: Rates of adverse events in the three treatment groups during the follow-up
Etanercept, infliximab and adalimumab are effective therapeutic anti-tumor necrosis factor alternatives to reduce the disease severity levels and the degree of disability in patients with rheumatoid arthritis. Etanercept shows lower rate of adverse events as compared to infliximab and adalimumab.
Santos-Moreno P, Sánchez G, Gómez D, Bello-Gualtero J, Castro C. Direct comparative effectiveness among 3 anti-tumor necrosis factor biologics in a real-Life cohort of patients with rheumatoid arthritis. J Clin Rheumatol. 2016 Mar;22(2):57–62.