Table 4.
Percentage agreement of immunogenicity testing between immunoassays in PLANETRA (safety population)
| Visit | Assay ADA-A vs. assay ADA-Ba | Assay NAb-A vs. assay NAb-Bb | ||
|---|---|---|---|---|
| PPAc (%) | NPAd (%) | PPAc (%) | NPAd (%) | |
| All patients (N = 602) | ||||
| Screening | 100.00 | 99.32 | 60.00 | 99.66 |
| Week 14 | 97.10 | 98.01 | 96.30 | 98.02 |
| Week 30 | 97.54 | 96.93 | 96.30 | 96.95 |
| Week 54 | 94.83 | 96.86 | 95.15 | 96.49 |
| EOS | 94.50 | 98.69 | 94.72 | 97.87 |
| CT-P13 treatment group (N = 302) | ||||
| Screening | 100.00 | 98.97 | 33.33 | 99.66 |
| Week 14 | 98.55 | 98.02 | 97.10 | 98.02 |
| Week 30 | 98.36 | 95.38 | 96.69 | 95.42 |
| Week 54 | 96.77 | 95.58 | 97.56 | 95.61 |
| EOS | 94.94 | 99.10 | 95.48 | 98.25 |
| RP treatment group (N = 300) | ||||
| Screening | 100.00 | 99.66 | 100.00 | 99.66 |
| Week 14 | 95.65 | 98.01 | 95.45 | 98.02 |
| Week 30 | 96.72 | 98.47 | 95.90 | 98.47 |
| Week 54 | 92.59 | 98.18 | 92.31 | 97.37 |
| EOS | 94.04 | 98.31 | 93.92 | 97.52 |
Results for ADA and NAb detection up to week 30 using assay ADA-A and assay NAb-A, respectively, have been published previously [17]
ADA antidrug antibody, EOS end of study, EU European Union, NAb neutralising antibody, NPA negative percentage agreement, PPA positive percentage agreement, RP reference product
aAssay ADA-A = ADA detection immunoassay with EU-approved Remicade tag; assay ADA-B = ADA detection immunoassay with CT-P13 tag
bAssay NAb-A = NAb detection immunoassay with EU-approved Remicade tag; assay NAb-B = NAb detection immunoassay with CT-P13 tag
cPPA = (number of patients with positive outcome for both Remicade- and CT-P13-tagged assays)/(number of patients with positive outcome for Remicade-tagged immunoassay) × 100
dNPA = (number of patients with negative outcome for both Remicade- and CT-P13-tagged assays)/(number of patients with negative outcome for Remicade-tagged immunoassay) × 100