Effect on structural disease progression
| Placebo | IXEQ4W | IXEQ2W | Adalimumab 40 mg Q2W* | ||
|---|---|---|---|---|---|
| N=106 | N=107 | N=103 | N=101 | ||
| LS mean change from baseline mTSS (SE)† | Week 16 | 0.36 (0.07) | 0.13 (0.07)‡ | 0.06 (0.07)§ | 0.12 (0.08)‡ |
| Week 24 | 0.49 (0.09) | 0.17 (0.08)§ | 0.08 (0.08)¶ | 0.10 (0.09)¶ | |
| Percentage of patients with change in mTSS at week 24 | ≤0 | 72.0 | 83.0 | 83.5 | 91.6¶ |
| ≤0.5 | 77.4 | 89.0** | 94.8¶ | 95.8¶ | |
| ≤0.95 | 83.9 | 94.0‡ | 96.9§ | 95.8§ |
*The adalimumab 40 mg Q2W treatment arm served as active reference for comparison with placebo. The study was not powered to test equivalence or non-inferiority of ixekizumab versus adalimumab.
†Higher mTSS scores indicate more articular damage. The mean change from baseline at week 24 was assessed with a statistical significance threshold of p<0.025 in a hierarchical analysis; all other end points were assessed with a statistical significance threshold of p<0.05.
‡p≤0.025 vs placebo.
§p≤0.01 vs placebo.
¶p≤0.001 vs placebo.
**p<0.05 vs placebo.
IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; LS, least squares; mTSS, van der Heijde modified total Sharp score; Q2W, every 2 weeks.