Table 2.
Study characteristics of RCTs
| Trial name | Population | Timepoint(s) eligible for ITC (weeks) | Randomized interventions | Sample size | Age, Mean (SD), years | Gender, male (%) | Mean symptom duration (Years) | Previous bDMARD treatment (%) | Elevated CRP (%) |
|---|---|---|---|---|---|---|---|---|---|
| ABILITY-1 [14] | bDMARD-naïve nr-axSpA | 12 | ADA 40 mg EOW | 91a | 37.6 (11.3) | 48 | 10.1 | 0 | 32.0 |
| PBO | 94a | 38.4 (10.4) | 43 | 10.1 | 0 | 39.0 | |||
| C-axSpAnd [11, 36]b | bDMARD-naïve nr-axSpA | 12, 16, 52c | CZP 200 mg Q2W | 152 | 37.2 (10.7) | 50 | 7.8 | 0 | 52.6 |
| PBO | 147 | 37.1 (10.9) | 49 | 8.0 | 0 | 51.7 | |||
| COAST-X [16] |
bDMARD-naïve nr-axSpA bDMARD-naïve nr-axSpA with symptom duration between > 3 months and < 5 years |
12 | IXE 80 mg Q4W | 96 | 40.9 (14.5) | 52 | 11.3 | 0 | 57.0 |
| IXE 80 mg Q2W | 102 | 40 (12) | 48 | 10.6 | 0 | 56.0 | |||
| PBO | 105 | 39.9 (12.4) | 42 | 10.1 | 0 | 54.0 | |||
| EMBARK [12] | bDMARD-naïve nr-axSpA with disease duration ≤ 5 years | 12 | ETN 50 mg QW | 106 | 31.9 (7.8) | 64.1 | 2.4 | 0 | 45.3 |
| PBO | 109 | 32.0 (7.8) | 56.9 | 2.5 | 0 | 40.4 | |||
| GO-AHEAD [13] | bDMARD-naïve nr-axSpA | 16, 52c | GOL 50 mg Q4W | 98 | 30.7 (7.1) | 62.2 | NRd | 0 | 40.8 |
| PBO | 100 | 31.7 (7.2) | 52.0 | 0 | 41.0 | ||||
| PREVENT [37] | nr-axSpA | 16 | SEC 150 mg (loading) | 185 | 39.1 (11.5) | 43.2 | 8.7 | 11.4 | 56.2 |
| SEC 150 mg (no loading) | 184 | 39.8 (11.7) | 45.7 | 8.6 | 9.8 | 58.2 | |||
| PBO | 186 | 39.3 (11.5) | 48.9 | 8.4 | 8.1 | 56.5 | |||
| RAPID-axSpA [15, 22]b | axSpA (bDMARD-naïve nr-axSpA patient characteristics shown here) | 12, 16 | CZP 200 mg Q2W | 42 | 36.2 (13.1) | 47.6 | Median: 8.3 | 0 | 35.7 |
| CZP 400 mg Q4W | 49 | 37.6 (11.0) | 51.0 | Median: 8.1 | 0 | 30.6 | |||
| PBO | 40 | 38.5 (12.1) | 47.5 | Median: 9.1 | 0 | 42.5 |
ADA adalimumab, AS ankylosing spondylitis, axSpA axial spondyloarthritis, bDMARD biologic disease-modifying anti-rheumatic drug, CRP c-reactive protein, CZP certolizumab pegol, EOW every other week, ETN etanercept, GOL golimumab, ITC indirect treatment comparison, IXE ixekizumab, NR not reported, nr-axSpA non-radiographic axial spondyloarthritis, PBO placebo, Q2W every other week, Q4W every four weeks, QW weekly, RCT randomized controlled trial, SD standard deviation, SEC secukinumab
aPer-protocol population analysis
bRAPID-axSpA (AS001) and C-axSpAnd trial data were provided by UCB
cPrimary publication
dAll patients had ≤ 5-year disease duration