Etanercept is a
bio-pharmaceutical product obtained through the recombinant DNA technology.
A biosimilar of etanercept, LBEC0101 posesses an
equivalent properties to etanercept (ETN-RP) in terms of clinical efficacy and
safety.
Etanercept is a bio-pharmaceutical product obtained through the recombinant DNA technology. It consists of disulfide bond-linked chain of fusion protein and is mainly used for the treatment of autoimmune disorder. It works by interfering with tumor necrosis factor (TNF) and acts as a TNF inhibitor which is major contributor in the inflammatory disorders like rheumatoid arthritis (RA) and psoriasis. Etanercept acts by inhibiting the TNF-α receptors by binding with the TNF receptor and blocking its interaction with the cell surface. In Japan and Korea etanercept is named as ETN-RP which is approved drug for the treatment of various inflammatory disorders like RA, psoriatic arthritis, and axial spondyloarthritis. LBEC0101 is a biosimilar product to ETN-RP. The similarities between these two products with respect to its structural and functional properties and biological activities has been demonstrated by in vitro and in vivo studies such as a TNF-α binding affinity study. Moreover, for the clinical development of LBEC0101, a phase I pharmacokinetic (PK) study on healthy male volunteers was conducted and showed equivalent result to ETN-RP. The present study compared the efficacy and safety of LBEC0101 and ETN-RP as an ancillary therapy to methotrexate (MTX) in patients with active RA and has poor responses to previous MTX treatment.
Rationale behind the research:
The biologicals used for the tretment of RA are highly expensive e.g. ENT-RP approx. cost is £204 721
Therefore, this study used a biosimilar named as LBEC0101 which shown to have similar outcomes as of ENT-RP
Objective:
To evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active RA despite MXT treatment.
Study outcomes measures:
Primary Endpoints: Change from the baseline DAS28-ESR at week 24
Secondary Endpoints:
Time period:
Efficacy: Baseline, week 12, week 24, week 52
Study Outcomes
Figure 1A: DAS28-ESR change from baseline (PPS-24w and FAS).
Figure 1B:
Mean±SD of DAS28-ESR at baseline, week 12, week 24 and week 52
Figure 2. ACR20 response rates (A). The between-group difference in ACR20. (B,C) The ACR50 and ACR70 response rates.
In conclusion, LBEC0101 was shown to be equivalent to ETN-RP in terms of clinical efficacy and safety. The study results were found to be more consistent than previous clinical studies on ETN-RP. ACR20 response rates of the LBEC0101 were quiet similar to ETN-RP. The safety profile of LBEC0101 was also comparable to ETN-RP; however, fewer injection site reactions and ADAs were observed in the LBEC0101 group.
Since the present study was the first clinical trial of LBEC0101 for RA conducted in Asia (Japan and Korea), the extent of the findings may be limited to the Asian population.
The results from the present study may have some important cost implications in the treatment of patients with RA as the findings from the study suggest LBEC0101 as a cheap but similarly effective alternative to the expensive treatment (ETN-RP).
Annals of the rheumatic diseases. 2017 Dec 19
Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate
Matsuno H et al.
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