Table 2.
Number (%) of patients who developed cross-reactive ADAs or NAbs per study weeka
| Visit | PLANETAS | PLANETRA | ||
|---|---|---|---|---|
| ADAs | NAbs | ADAs | NAbs | |
| CT-P13 treatment group | ||||
| Screeningb | – | – | – | – |
| Week 14 | 10/10 (100.0) | 9/9 (100.0) | 68/72 (94.4)c | 67/71 (94.4) |
| Week 30 | 30/31 (96.8) | 29/30 (96.7) | 120/126 (95.2) | 117/123 (95.1) |
| Week 54 | 25/25 (100.0) | 25/25 (100.0) | 120/125 (96.0) | 120/125 (96.0) |
| EOS | 38/38 (100.0) | 35/36 (97.2) | 150/151 (99.3) | 148/150 (98.7) |
| RP treatment group | ||||
| Screeningb | – | – | – | – |
| Week 14 | 13/13 (100.0) | 13/13 (100.0) | 66/69 (95.7)d | 63/66 (95.5) |
| Week 30 | 24/25 (96.0) | 23/24 (95.8) | 118/122 (96.7) | 117/122 (95.9) |
| Week 54 | 26/28 (92.9) | 26/28 (92.9) | 100/108 (92.6) | 96/104 (92.3) |
| EOS | 31/35 (88.6) | 31/35 (88.6) | 142/151 (94.0) | 139/148 (93.9) |
ADA antidrug antibody, EOS end of study, NAb neutralising antibody, RP reference product, TNF tumour necrosis factor
aAs a proportion of the total number of patients who developed ADAs or NAbs (cross-reactive and non-cross-reactive), respectively
bResults are not included for the screening visits because ADAs detected at this time point were non-specific, as patients were anti-TNF agent-naïve
cFour patients had developed CT-P13 ADAs that were not detected by Remicade-tagged assay
dThree patients had developed RP ADAs that were not detected by CT-P13-tagged assay