TABLE 2.
Mean changes from baseline in individual efficacy indicators.
| Indicators a | HS016 (n = 416) | Adalimumab (n = 232) | p-value |
|---|---|---|---|
| ∆Total back pain score (0–10 cm NRS) | |||
| Week 2 | –1.98 ± 2.12 | –2.10 ± 2.03 | 0.494 |
| Week 10 b | –3.40 ± 2.30 | –3.80 ± 2.32 | 0.038 |
| Week 12 | –3.58 ± 2.28 | –3.96 ± 2.27 | 0.040 |
| Week 22 b | –4.15 ± 2.34 | –4.54 ± 2.25 | 0.038 |
| Week 24 | –4.25 ± 2.32 | –4.56 ± 2.26 | 0.111 |
| ∆Nocturnal back pain score (0–10 cm NRS) | |||
| Week 2 | –2.10 ± 2.27 | –2.21 ± 2.07 | 0.548 |
| Week 12 | –3.70 ± 2.43 | –4.07 ± 2.41 | 0.065 |
| Week 24 | –4.38 ± 2.41 | –4.63 ± 2.38 | 0.193 |
| ∆SJC (46 joints) | |||
| Week 2 | –0.10 ± 0.87 | –0.26 ± 2.04 | 0.159 |
| Week 12 | –0.16 ± 1.01 | –0.34 ± 2.26 | 0.184 |
| Week 24 | –0.18 ± 0.94 | –0.34 ± 2.30 | 0.200 |
| ∆MASES (range 0–13) | |||
| Week 2 | –0.80 ± 1.86 | –1.10 ± 1.94 | 0.054 |
| Week 12 | –1.32 ± 2.08 | –1.58 ± 2.29 | 0.142 |
| Week 24 | –1.41 ± 2.19 | –1.67 ± 2.40 | 0.162 |
| ∆PaGA of disease activity (0–10 cm NRS) | |||
| Week 2 | –1.83 ± 1.98 | –1.80 ± 2.03 | 0.865 |
| Week 12 | –3.28 ± 2.24 | –3.60 ± 2.42 | 0.088 |
| Week 24 | –3.89 ± 2.37 | –4.18 ± 2.38 | 0.137 |
| ∆PhGA of disease activity (0–10 cm NRS) | |||
| Week 2 | –1.59 ± 1.49 | –1.53 ± 1.49 | 0.628 |
| Week 12 | –3.28 ± 1.74 | –3.45 ± 1.74 | 0.243 |
| Week 24 | –3.99 ± 1.75 | –4.18 ± 1.84 | 0.190 |
| ∆BASDAI (0–10 cm NRS) | |||
| Week 2 | –1.71 ± 1.64 | –1.68 ± 1.54 | 0.843 |
| Week 12 | –3.31 ± 1.94 | –3.46 ± 1.97 | 0.353 |
| Week 24 | –3.91 ± 1.98 | –4.12 ± 1.94 | 0.202 |
| ∆BASFI (0–10 cm NRS) | |||
| Week 2 | –1.05 ± 1.73 | –1.05 ± 1.56 | 0.974 |
| Week 12 | –2.20 ± 2.08 | –2.27 ± 2.00 | 0.706 |
| Week 24 | –2.59 ± 2.23 | –2.66 ± 2.11 | 0.688 |
| ∆BASMIlin | |||
| Week 2 | –0.37 ± 0.55 | –0.33 ± 0.67 | 0.455 |
| Week 12 | –0.75 ± 0.79 | –0.69 ± 0.82 | 0.315 |
| Week 24 | –0.86 ± 0.91 | –0.85 ± 0.91 | 0.948 |
| ∆Chest expansion (cm) | |||
| Week 2 | 0.39 ± 1.64 | 0.37 ± 1.27 | 0.922 |
| Week 12 | 0.62 ± 1.88 | 0.59 ± 1.82 | 0.839 |
| Week 24 | 0.88 ± 2.10 | 0.78 ± 1.88 | 0.566 |
BASDAI, Bath ankylosing spondylitis disease activity index; BASFI, Bath ankylosing spondylitis functional index; BASMIlin, linear Bath ankylosing spondylitis metrology index; MASES, Maastricht ankylosing spondylitis enthesitis score; NRS, numerical rating scale; PaGA, Patient global assessment; PhGA, Physician global assessment; SJC, swollen joint count.
All data are presented as the means ± SDs, ∆ = values at each point-baseline.
This data have been added since they comprise the only significant differences between the groups within other time points than week 2, 12, and 24. An independent group t-test was utilized to identify any changes from baseline to week 2, week 12, and week 24 between the two groups. A two-sided p-value <0.05 was deemed significant.