Table 2.
Structural lesion change according to sex in patients with axial spondyloarthritis, baseline to week 104
| Structural lesion | Study cohort | Sex | Lesion decreased n/N (%) | Lesion increased n/N (%) | Net % patients with decrease within study cohort (95% CI) | P value for lesion decrease vs increase | P value for difference in sex (both studies pooled) | P value for difference in study (both sexes pooled) | P value for difference in sex (by study) | P value for difference in study (by sex) |
| Erosion |
Etanercept (EMBARK) |
Male | 39/105 (37.1) | 6/105 (5.7) | 31.4% (21.3, 41.6) | < 0.001 | 0.048 | 0.03 | 0.02 | 0.02 |
| Female | 7/58 (12.1) | 1/58 (1.7) | 10.3% (− 3.3, 24.0) | 0.14 | 0.38 | |||||
|
Control (DESIR) |
Male | 10/45 (22.2) | 6/45 (13.3) | 8.9% (− 6.6, 24.4) | 0.26 | 0.47 | ||||
| Female | 4/31 (12.9) | 4/31 (12.9) | 0% (− 18.7, 18.7) | 1.0 | ||||||
| Structural lesion | Study cohort | Lesion increased n/N (%) | Lesion decreased n/N (%) | Net % patients with increase within study cohort (95% CI) | P value for lesion increase vs decrease | P value for difference in sex (both studies pooled) | P value for difference in study (both sexes pooled) | P value for difference in sex (by study) | P value for difference in study (by sex) | |
| Backfill |
Etanercept (EMBARK) |
Male | 24/105 (22.9) | 1/105 (1.0) | 21.9% (14.6, 29.2) | < 0.001 | 0.03 | 0.50 | 0.008 | 0.21 |
| Female | 3/58 (5.2) | 0/58 (0) | 5.2% (− 4.6, 15.0) | 0.30 | 0.88 | |||||
|
Control (DESIR) |
Male | 8/45 (17.8) | 2/45 (4.4) | 13.3% (2.2, 24.5) | 0.02 | 0.44 | ||||
| Female | 2/31 (6.5) | 0/31 (0) | 6.5% (− 7.0, 19.9) | 0.35 | ||||||
| Fat metaplasia |
Etanercept (EMBARK) |
Male | 13/105 (12.4) | 2/105 (1.9) | 10.5% (4.7, 16.2) | < 0.001 | 0.03 | 0.61 | 0.07 | 0.59 |
| Female | 1/58 (1.7) | 0/58 (0) | 1.7% (− 6.0, 9.5) | 0.66 | 0.82 | |||||
|
Control (DESIR) |
Male | 6/45 (13.3) | 0/45 (0) | 13.3% (4.6, 22.1) | 0.003 | 0.15 | ||||
| Female | 1/31 (3.2) | 0/31 (0) | 3.2% (− 7.4, 13.8) | 0.55 | ||||||
| Ankylosis |
Etanercept (EMBARK) |
Male | 2/105 (1.9) | 1/105 (1.0) | 1.0% (− 1.8, 3.7) | 0.50 | 0.24 | 0.47 | 0.26 | 0.62 |
| Female | 0/58 (0) | 1/58 (1.7) | − 1.7% (− 5.5, 2.0) | 0.37 | 0.59 | |||||
|
Control (DESIR) |
Male | 1/45 (2.2) | 0/45 (0) | 2.2% (− 2.0, 6.5) | 0.31 | 0.51 | ||||
| Female | 0/31 (0) | 0/31 (0) | 0% (− 5.1, 5.1) | 1.0 |