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. 2018 Oct;24(10):10.18553/jmcp.2018.24.10.952. doi: 10.18553/jmcp.2018.24.10.952

Table 4.

Etanercept Biosimilar Switching Discontinuations and ADEs48-50

Author (Year) Injection Site Reaction n/N (%) ADA Development n/N (%) Discontinuation, Any n/N (%) Discontinuation, ADE n/N (%) Discontinuation, Lack of Efficacy n/N (%)
Double-blinded studies
  Griffiths et al. (2017)a,48 - 0/100b (0.0)
1/96 (1.0)c
11/100 (11.0)b
5/96 (5.2)c
2/100 (2.0)b
5/96 (5.2)c
2/100 (2.0)b
-
  Gerdes et al. (2017)49 72/196 (36.7) 0/196 (0.0) - 6/196 (3.1) -
Open-label studies
  Emery et al. (2017)50 0/119 (0.0) 1/119 (0.8) 6/119 (5.0) 2/119 (1.7) -

aResults reported after second treatment period.

bPatients receiving GP2015 for period 1 then switched to etanercept→GP2015→etanercept, which continued into extension.

cPatients receiving etanercept for period 1 then switched to GP2015→etanercept→GP2015, which continued into extension.

ADA = antidrug antibody; ADE = adverse drug event.