Table 1. Included trials/treatments and important patient characteristics.
Study name or code | Interventions | Number randomised | Week of analysis (primary time point) | Mean age (years) | % Male | % Naïve | Mean disease duration (years) |
---|---|---|---|---|---|---|---|
Induction | |||||||
GEMINI 1 [29] | PBO | 149 | 6 | 41.2 | 62 | 51 | 7.1 |
VDZ 300 mg IV at week 0 and 2 and every 8 weeks thereafter | 225 | 6 | 40.1 | 59 | 58 | 6.1 | |
ULTRA 1 [44] | PBO | 130 | 8 | 38.4 | 63 | 100 | 5.4a |
ADA 160 mg SC at week 0, followed by 80 mg at week 2 and then 40 mg every other week | 130 | 8 | 37.9 | 64 | 100 | 6.1a | |
ULTRA 2 [45, 46] | PBO | 258 | 8 | 41.3 | 62 | 59 | 8.5 |
ADA 160 mg SC at week 0, followed by 80 mg at week 2 and then 40 mg every other week | 260 | 8 | 39.6 | 57 | 61 | 8.1 | |
ACT 1 [27] | PBO | 121 | 8 | 41.4 | 60 | 100 | 6.2 |
IFX 5 mg/kg IV at week 0, followed by 5 mg/kg at 2 and 6 weeks and every 8 weeks thereafter | 122 | 8 | 42.4 | 65 | 100 | 5.9 | |
ACT 2 [27] | PBO | 121 | 8 | 39.3 | 58 | 100 | 6.5 |
IFX 5 mg/kg IV at week 0, followed by 5 mg/kg at 2 and 6 weeks and every 8 weeks thereafter | 120 | 8 | 40.5 | 63 | 100 | 6.7 | |
PURSUIT-SC [47] | PBO | 331 | 6 | 39.0 | 53 | 100 | 6.0 |
GLM 200 mg SC at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks | 331 | 6 | 40.0 | 54 | 100 | 6.4 | |
Suzuki, 2014 [49] | PBO | 96 | 8 | 41.3 | 72.9 | 100 | 7.8 |
ADA 160 mg/80 mg | 90 | 8 | 42.5 | 67.8 | 100 | 7.8 | |
Maintenance | |||||||
GEMINI 1 [28, 29, 30, 32, 33, 34] | PBO | 126 | 52 | 40.3 | 55 | 63 | 7.8 |
VDZ 300 mg IV every 8 weeks | 122 | 52 | 41.0 | 57 | 59 | 6.2 | |
ULTRA 2 [45, 46] | PBO | 246b | 52 | 40.5 | 58 | 87 | NR |
ADA 40 mg SC every other week | 248b | 52 | 40.5 | 58 | 87 | NR | |
ACT 1 [27] | PBO | 121b | 54 | 41.4 | 60 | 100 | 6.2 |
IFX 5 mg/kg IV every 8 weeks | 122b | 54 | 42.4 | 65 | 100 | 5.9 | |
PURSUIT-M [48] | PBO | 156 | 54 | 40.2 | 48 | 100 | 6.9 |
GLM 100 mg every 4 weeks | 154 | 54 | 39.1 | 58 | 100 | 7.2 | |
Suzuki, 2014 [49] | PBO | 96b | 52 | NR | NR | 100 | NR |
ADA 40 mg SC every other week | 177b | 52 | NR | NR | 100 | NR |
ADA, adalimumab; GLM, golimumab; IFX, infliximab; IV, intravenously; NR, not reported; PBO, placebo; SC, subcutaneous; VDZ, vedolizumab.
a Median disease duration.
b These studies were not rerandomised at maintenance, so the number of patients who responded at the end of induction has been used in this table.