Table 4.
Changes from baseline in Work Productivity and Activity Index for Spondyloarthritis scores at weeks 16 and 52 for biologic disease-modifying antirheumatic drugs-naïve patients (COAST-V study)
| Absenteeisma | |||||
|---|---|---|---|---|---|
| PBO (N = 87) | ADA (N = 90) | IXE Q4W (N = 81) | IXE Q2W (N = 83) | ||
| Week 16b | Nx | 50 | 65 | 57 | 49 |
| LSM (SE) | − 1.3 (2.3) | − 1.2 (2.0) | 1.2 (2.2) | − 6.7 (2.3) | |
| Mean (SD) | − 1.0 (13.8) | − 4.1 (23.9) | 1.7 (17.6) | − 8.7 (23.0) | |
| Week 52 | PBO/IXE (N = 86) | ADA/IXE (N = 86) | IXE Q4W/IXE Q4W (N = 78) | IXE Q2W/IXE Q2W (N = 79) | |
| Nx | 49 | 63 | 58 | 52 | |
| Mean (SD) | − 3.9 (12.5) | − 9.6 (27.3) | − 4.9 (14.5) | − 10.7 (25.1) | |
| Presenteeisma | |||||
|---|---|---|---|---|---|
| Week 16b | PBO (N = 87) | ADA (N = 90) | IXE Q4W (N = 81) | IXE Q2W (N = 83) | |
| Nx | 50 | 60 | 55 | 47 | |
| LSM (SE) | − 17.7 (3.1) | − 20.9 (2.8) | − 22.7 (2.9) | − 23.3 (3.1) | |
| Mean (SD) | − 21.4 (23.2) | − 20.0 (23.2) | − 24.6 (24.9) | − 24.8 (19.7) | |
| Week 52 | PBO/IXE (N = 86) | ADA/IXE (N = 86) | IXE Q4W/IXE Q4W (N = 78) | IXE Q2W/IXE Q2W (N = 79) | |
| Nx | 49 | 59 | 57 | 49 | |
| Mean (SD) | − 31.6 (26.2) | − 20.2 (24.9) | − 30.5 (27.7) | − 28.8 (22.7) | |
| Overall work impairmenta | |||||
|---|---|---|---|---|---|
| Week 16b | PBO (N = 87) | ADA (N = 90) | IXE Q4W (N = 81) | IXE Q2W (N = 83) | |
| Nx | 50 | 60 | 55 | 47 | |
| LSM (SE) | − 17.8 (3.3) | − 21.4 (2.9) | − 21.4 (3.1) | − 24.1 (3.3) | |
| Mean (SD) | − 21.7 (24.5) | − 20.7 (24.2) | − 23.6 (25.3) | − 26.1 (21.5) | |
| Week 52 | PBO/IXE (N = 86) | ADA/IXE (N = 86) | IXE Q4W/IXE Q4W (N = 78) | IXE Q2W/IXE Q2W (N = 79) | |
| Nx | 49 | 59 | 57 | 49 | |
| Mean (SD) | − 31.9 (26.3) | − 20.0 (26.2) | − 31.6 (28.4) | − 29.8 (23.9) | |
| Activity impairment | |||||
|---|---|---|---|---|---|
| Week 16b | PBO (N = 87) | ADA (N = 90) | IXE Q4W (N = 81) | IXE Q2W (N = 83) | |
| Nx | 86 | 88 | 80 | 83 | |
| LSM (SE) | − 14.1 (2.3) | − 21.1 (2.2)* | − 23.0 (2.4)‡ | − 23.4 (2.3)‡ | |
| Mean (SD) | − 16.4 (20.6) | − 20.9 (23.0) | − 23.7 (24.6) | − 25.2 (20.6) | |
| Week 52 | PBO/IXE (N = 86) | ADA/IXE (N = 86) | IXE Q4W/IXE Q4W (N = 78) | IXE Q2W/IXE Q2W (N = 79) | |
| Nx | 85 | 85 | 78 | 79 | |
| Mean (SD) | − 25.6 (24.7) | − 25.8 (25.3) | − 29.1 (27.6) | − 28.7 (23.7) | |
LSM (SE) is from analysis of covariance (ANCOVA), with missing data imputed via modified baseline observation carried forward (mBOCF). Mean (SD) at week 16 is from observed data from the blind-dose extended treatment group. Mean (SD) at week 52 is presented with missing data imputed via mBOCF
ADA 40 mg adalimumab every 2 weeks, ANCOVA analysis of covariance, IXE Q2W 80 mg ixekizumab every 2 weeks, IXE Q4W 80 mg ixekizumab every 4 weeks, LSM least squares mean, mBOCF modified baseline observation carried forward, N number of patients in the treatment group, Nx number of patients in the analysis subgroup, PBO placebo
p values were from ANCOVA (treatment vs. placebo) for week 16. *p < 0.05, ‡p < 0.01, †p < 0.001
aAbsenteeism, presenteeism, and overall work impairment were measured in patients reporting part- or full-time work
bAt week 16, patients receiving placebo (PBO) (COAST-V, COAST-W) or adalimumab (ADA) (COAST-V) were switched to ixekizumab (IXE) Q4W or Q2W. Data for IXE Q4W and IXE Q2W were combined for the PBO/IXE and ADA/IXE groups