SAT0360 Etanar – A Etanercept Biosimilar is as Effective as Adalimumab and Infliximab in a Cohort of Real-Life of Patients with Rheumatoid Arthritis

Abstract

BackgroundClinical response in patients with rheumatoid arthritis (RA) using biologics is well-known. However, there is no direct comparison between biologics in cohorts of patients with RA in real-life settings, which could have implications in treatment decisions and health economics.ObjectivesThe aim of this study was to describe a direct comparison in effectiveness between two classical antiTNF biologics (Adalimumab, Infliximab) and one Etanercept biosimilar in patients with long-standing RA in a cohort of real-life.MethodsA descriptive cross-sectional study was performed. Were included 158 patients with at least 6 visits to rheumatologist in last 24 months in a specialized in RA center. Clinical follow-up was designed by the authors according to DAS28 as follows: every 3-5 weeks (DAS28 >5.1), every 7-9 weeks (DAS28 ≥3.1 and ≤5.1), and every 11-13 weeks (DAS28 <3.1). Therapy had to be adjusted with DAS28 >3.2 unless patient's conditions don't permit it; we considered this follow-up type as implementation of a T2T strategy. We divided patients in two groups: remission-low disease activity (Rem/LDA) patients and moderate-severe disease activity (MDA/SDA) patients and the aim of the study was to look at what percentage of patients who were MDA/SDA disease activity reached a low disease activity or remission. 158 patients with RA and using Adalimumab, Infliximab and Etanercept biosimilar (Etanar® CP Guojian Pharmaceutical Co Ltd, China) were involved. The Etanercept biosimilar was approved for using in Colombia since 2007. Descriptive epidemiology was done, the medians were analyzed using t-Student assuming normality for DAS28 distribution and disease activity was analyzed using Pearson's statistics.Results158 patients were included in this study, 125 (79.1%) women and 33 (20.9%) men. Average age was 59±10 y/o with disease duration of 11 years (0.5-47). 158 patients with diagnosis of RA using Adalimumab, Etanercept and Infliximab were involved: Adalimumab 61 (38.6%), Etanercept 25 mg 62 (39.2%), and Infliximab 35 (22.2%). At 24 months was observed an increase in percentage of patients in remission and a decrease in percentage of patients in MDA/SDA disease activity statistically significant. for Adalimumab at beginning DAS28-3.6 and 24 months later 2.6; for Etanercept biosimilar at beginning DAS28-3.6 and 24 months later 2.6 and for Infliximab at beginnng DAS28-3.6 and 24 months later 2.6. There were not statistically significant differences between analyzed biologics. On the other hand, there were fewer adverse events with Etanercept-biosimilar than Adalimumab and Infliximab; it was statistically significant.ConclusionsThis study shows that the Etanercept biosimilar is as effective as 2 other traditional anti-TNF biological for disease activity control in patients with rheumatoid arthritis in a real-life setting with fewer adverse events, which could have implications in treatment decisions and health economics. On the other hand the study proves effectiveness of implementation of a T2T strategy in patients with ...

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

“…S2). The modified Downs and Black instrument was used to assess the quality of the 22 identified abstracts for original studies [39, 63–83], with scores of fair quality (3–4) for four studies [39, 66, 70, 76], good quality (5–8) for seven studies [63, 65, 67, 68, 73, 77, 79], and excellent quality (9–12) for 11 studies [64, 69, 71, 72, 74, 75, 78, 80–83] (ESM Fig. S3).…”

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence

“…Yisaipu ® ( Shanghai CP Guojian Pharmaceutical Co. ) An observational retrospective cohort study was performed in 158 patients with active RA treated with Yisaipu ® (etanercept intended copy) ( n   =  62), adalimumab ( n  = 61), or infliximab ( n   =  35) [126]. Similar decreases in Disease Activity Score in 28 joints (DAS28) were seen at 24 months.…”

“…For this reason, the Downs and Black instrument was adapted to assess the quality of the 22 identified abstracts for additional original studies (Tables 1, 2, 3, 4, 5, 6, ESM Fig. S5) [26, 41, 47, 48, 98, 63, 46, 119, 122, 103, 81, 74, 79, 82, 124, 125, 126, 130, 128, 104, 50, 34]. The average score for the abstract publications was 7.8 out of a possible 12 points.…”

“…The average score for the abstract publications was 7.8 out of a possible 12 points. The total score was fair quality (3–4) for four studies [81, 74, 125, 130], good quality (5–8) for seven studies [48, 122, 79, 82, 126, 128, 104], and excellent quality (9–12) for 11 studies [26, 41, 47, 98, 63, 45, 119, 103, 124, 50, 34]. The majority of the studies published as conference abstracts were of good or excellent quality (81.8%).…”

“…In Colombia, Yisaipu ® is marketed under the brand name Etanar ® . At the time of this review, only one limited clinical trial (not an equivalence study comparing Yisaipu ® with etanercept) had been reported [48, 126, 127]. Finally, at the time that this analysis was completed, there was only one study that assessed the efficacy and safety of intended copy Infinitam ® , which is currently marketed in Mexico [124].…”