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SAT0360 Etanar – A Etanercept Biosimilar is as Effective as Adalimumab and Infliximab in a Cohort of Real-Life of Patients with Rheumatoid Arthritis
  1. P. Santos-Moreno1,
  2. G. Saavedra-Martinez2,
  3. L. Villarreal3,
  4. D. Gomez1,
  5. J. Bello-Gualtero1,
  6. V. Giraldo4,
  7. P. Martinez4,
  8. A. Sanchez4,
  9. M. Sanchez4,
  10. E. Uribe4,
  11. M. Boon4
  1. 1Rheumatology
  2. 2Epidemiology
  3. 3Psychology
  4. 4Internal medicine, Biomab, Center For Rheumatoid Arthritis, Bogota, Bogota, Colombia

Abstract

Background Clinical 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.

Objectives The 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.

Methods A 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.

Results 158 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.

Conclusions This 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 RA.

Disclosure of Interest None declared

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