Table 4.
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.