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Survival and safety of infliximab bio-original and infliximab biosimilar (CT-P13) in usual rheumatology care


1, 2, 3, 4, 5, 6, 7, 8

 

  1. Academic Rheumatology Department, King's College London; and Rheumatology Department, Wittington, London, UK.
  2. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  3. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  4. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  5. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  6. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  7. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland.
  8. Department of Medicine, Jyväskylä Central Hospital, Jyväskylä, Finland. tuulikki.sokka-isler@ksshp.fi

CER11045
2019 Vol.37, N°1
PI 0055, PF 0059
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PMID: 29998827 [PubMed]

Received: 12/12/2017
Accepted : 10/04/2018
In Press: 07/06/2018
Published: 18/01/2019

Abstract

OBJECTIVES:
Reports to-date indicate similarity between infliximab biosimilar (IB) and infliximab bio-original (IO) in clinical efficacy and safety. This study examines the survival of IB and IO using routinely collected data over a 2-year period.
METHODS:
Routinely collected clinical data inputted directly in an electronic database at a large rheumatology centre were analysed. Adult patients taking IO or IB for any rheumatological diagnosis were included. Kaplan-Meier survival analyses were used to examine IB and IO survival, with a sub-group analysis among those starting infliximab from 2008 onwards.
RESULTS:
Out of 395 patients analysed, 53% (n=209) were female; the majority had rheumatoid arthritis (31%) followed by spondyloarthritis (28%). Ninety-nine patients had IB as the first infliximab drug. Patients who started on IB vs. IO as their first infliximab product, had better survival over the first 2 years (log rank=0.001). Discontinuation due to inefficacy was much commoner in IO versus IB users (18 vs. 5%). In patients switching from IO to IB, drug survival was better versus those receiving IB as the first infliximab drug (log rank=0.073).
CONCLUSIONS:
IB was well-tolerated and comparable to IO, with no additional safety signals identified. The results suggest superior survival of IB over IO over the first 2 years.

Rheumatology Article