Table 2.
Randomized clinical trials
| Study | N | Intervention | Duration of follow-up | Efficacy outcomes | Discontinuation rate | Immunogenicity | Safety | ||
|---|---|---|---|---|---|---|---|---|---|
| Published studies | |||||||||
|
Jørgensen KK et al., 2017, Norway (NOR-SWITCH study) |
N = 482 n = 155 CD n = 93 UC |
Maintenance on IFX Switch to CT-P13 |
52 weeks |
Disease worsening: CD: 21.2% in IFX, 36.5% CT-P13 UC: 9.1% IFX, 11.9% CT-P13 Risk difference: CD: -14.3% (-29.3–0.7) UC: -2.6% (-15.2–10.0) |
4% of the IFX group and 4% of the CT-P13 group at 52 weeks in the full analysis set | New ADA in 7% of the IFX group and 8% of CT-P13 switch group in the full analysis set | No significant differences in TEAEs, or serious TEAE | ||
| Abstracts | |||||||||
|
Jørgensen KK et al., 2017, Norway (NOR-SWITCH subgroup analysis) |
N = 481 n = 129 CD n = 75 UC |
Maintenance on IFX Switch to CT-P13 |
52 weeks |
CD PtGA: -0.65 (-1.22, -0.07) CD PGA: -0.42 (-0.85, 0.001) |
N/A | No significant difference in ADA, trough serum levels | No significant difference in AEs | ||
|
Jørgensen KK et al., 2017, Norway (NOR-SWITCH extension trial, subgroup analysis) |
N = 198 n = 124 CD n = 74 UC |
Maintenance on CT-P13 after DB phase Switch to CT-P13 after DB phase |
26 weeks |
Disease worsening: CD: 20.6% (13/63) maintenance, 13.1% (8/61) switch UC: 15.4% (6/39) maintenance; 2.9% (1/35) switch |
N/A | No significant difference in ADA, trough serum levels | No significant difference in AEs | ||
| Kim YH et al., 2017, International study | N = 220 CD |
Maintenance on IFX Maintenance on CT-P13 Switch to IFX at week 30 Switch to CT-P13 at week 30 |
54 weeks | No significant differences in CDAI-70 at week 54 | N/A | No significant difference in ADA | No significant difference in AEs, infection rates | ||
|
Volkers AG et al., 2017, Netherlands (SIMILAR trial) |
N = 47 n = 35 CD n = 12 UC |
Maintenance on IFX Switch to IFX biosimilar |
30 weeks | 1 patient on IFX biosimilar relapsed | N/A | N/A | No SAEs related to study drug | ||
ADA antidrug antibodies, AE adverse event, CD Crohn’s disease, CDAI Crohn’s Disease Activity Index, DB double-blind, IFX infliximab originator, N/A not available, PGA physician’s global assessment, PtGA patient’s global assessment, SAE severe adverse event, TEAE treatment-emergent adverse event, UC ulcerative colitis