Table 2.
Results of efficacy
| Efficacy scores | Placebo group (n = 9) |
|
Secukinumab group (n = 11) |
|
|
Placebo vs. secukinumab |
||||
|---|---|---|---|---|---|---|---|---|---|---|
| Wk 16 mean | % change from baseline | Mean diff. (95% CI) baseline to Wk 16 | Adjusted p value | Wk 16 Mean | % change from baseline | Mean Diff. (95% CI) baseline to Wk 16 | Adjusted p value | Wk 16 mean diff. (95% CI) placebo vs. secukinumab | Adjusted p value | |
|
| ||||||||||
| IASI | 32 | − 11.8 | 4.3 (− 6.5 to 15.1) | 0.61 | 31.3 | − 7.3 | 2.4 (− 7.8 to 12.7) | 0.88 | 0.6 (− 11.6 to 12.9) | > 0.99 |
| IASI− E | 15 | − 17.5 | 3.2 (− 4.0 to 10.4) | 0.53 | 15.6 | − 7.7 | 1.3 (− 4.0 to 6.6) | 0.88 | − 0.6 (− 7.1 to 5.9) | 0.99 |
| IASI− S | 16.9 | − 6.2 | 1.1 (− 3.0 to 5.2) | 0.82 | 15.7 | − 6.8 | 1.1 (− 4.6 to 6.9) | 0.93 | 1.2 (− 5.7 to 8.1) | 0.96 |
| VIIS | 21.1 | − 11.6 | 2.8 (− 2.8 to 8.4) | 0.43 | 19.4 | − 10.2 | 2.2 (− 2.0 to 6.4) | 0.43 | 1.3 (− 4.4 to 7.8) | 0.85 |
| Bodemer Score | 45.7 | 12 | − 0.1 (− 11.3 to 11.1) | > 0.99 | 38 | − 6.5 | 2.6 (− 6.3 to 11.5) | 0.8 | 7.7 (− 2.4 to 17.8) | 0.17 |
| TEWL Arm | 32 | − 0.2 | 0.1 (− 12.1 to 12.2) | > 0.99 | 32.7 | 0 | 0.0 (− 10.1 to 10.1) | > 0.99 | − 0.7 (− 13.2 to 11.8) | > 0.99 |
| TEWL Buttock | 32.8 | 15.8 | − 4.5 (− 14.8 to 5.9) | 0.54 | 33.9 | 1.8 | − 0.6 (− 12.1 to 10.9) | > 0.99 | − 1.2 (− 15.9 to 13.6) | > 0.99 |
| DLQI | 9 | 14.1 | − 1.1 (− 5.8 to 3.5) | 0.87 | 9 | − 5.7 | 0.5 (− 2.8 to 3.9) | 0.96 | 0.0 (− 7.7 to 7.7) | > 0.99 |
| iQoL-32 | 61.7 | − 1.1 | 0.7 (− 13.5 to 14.9) | > 0.99 | 67.8 | − 7.7 | 5.6 (− 1.9 to 13.2) | 0.16 | − 6.2 (− 26.3 to 13.9) | 0.82 |
| 5-D Itch | 16.4 | − 3.9 | 0.7 (− 2.1 to 3.5) | 0.87 | 14.4 | − 4.8 | 0.7 (− 2.5 to 4.0) | 0.9 | 2.1 (− 2.3 to 6.5) | 0.52 |
| Itch NRS | 5.1 | − 6.1 | 0.3 (− 1.5 to 2.2) | 0.94 | 3.7 | − 5.1 | 0.2 (− 1.7 to 2.1) | 0.99 | 1.4 (− 1.4 to 4.2) | 0.5 |
| Pain NRS | 1.8 | 14.3 | − 0.2 (− 1.1 to 0.6) | 0.83 | 1.7 | − 38.7 | 1.1 (− 1.5 to 3.7) | 0.59 | 0.1 (− 2.0 to 2.1) | > 0.99 |
|
| ||||||||||
| Efficacy scores | Placebo-first group—on open-label secukinumab (n = 9) | Secukinumab group (n = 11) | Placebo-first v. secukinumab | |||||||
| Wk 32 Mean | % change from Week 16 | Mean diff. (95% CI) week 16 to week 32 | Adjusted p value | Week 32 mean | % change from baseline | Mean diff. (95% CI) baseline to week 32 | Adjusted p value | Week 32 mean diff. (95% CI) Placebo-First vs. Secukinumab | Adjusted p value | |
| IASI | 30.3 | − 5.0 | 1.6 (− 6.9 to 10.1) | 0.93 | 28.3 | − 16.0 | 5.4 (− 0.9 to 11.7) | 0.1 | 2.0 (− 7.1 to 11.1) | 0.91 |
| IASI-E | 14.8 | − 1.5 | 0.2 (− 5.7 to 6.2) | 0.99 | 13.5 | − 20.0 | 3.4 (0.2 to 6.6) | 0.04* | 1.3 (− 2.7 to 5.3) | 0.78 |
| IASI-S | 15.5 | − 8.1 | 1.4 (− 1.8 to 4.5) | 0.54 | 14.9 | − 11.6 | 2.0 (− 1.8 to 5.7) | 0.43 | 0.6 (− 5.5 to 6.8) | 0.99 |
| VIIS | 21.3 | 1.3 | − 0.3 (− 5.5 to 4.9) | > 0.99 | 17.4 | − 19.2 | 4.1 (1.2 to 7.1) | 0.01* | 3.9 (− 1.2 to 9.0) | 0.16 |
| Bodemer Score | 41.5 | − 9.3 | 4.2 (− 4.0 to 12.4) | 0.41 | 37.1 | − 8.7 | 3.5 (− 6.2 to 13.3) | 0.69 | 4.4 (− 6.7 to 15.5) | 0.67 |
| TEWL Arm | 34.6 | 8.1 | − 2.6 (− 14.6 to 9.4) | 0.9 | 32.6 | − 0.4 | 0.1 (− 12.9 to 13.2) | > 0.99 | 2.0 (− 18.8 to 22.8) | 0.99 |
| TEWL Buttock | 34.5 | 5.3 | − 1.7 (− 13.9 to 10.4) | 0.97 | 32.2 | − 3.0 | 1.0 (− 10.9 to 12.9) | 0.99 | 2.2 (− 19.2 to 23.5) | 0.99 |
| DLQI | 8.4 | − 6.2 | 0.6 (− 2.5 to 3.6) | 0.94 | 7.7 | − 19.0 | 1.8 (− 6.2 to 10.0) | 0.9 | 0.7 (− 6.7 to 8.1) | 0.99 |
| iQoL-32 | 61.7 | 0 | 0.0 (− 4.9 to 4.9) | > 0.99 | 63.1 | − 14.1 | 10.4 (− 11.1 to 31.9) | 0.48 | − 1.4 (− 20.4 to 17.6) | > 0.99 |
| 5-D Itch | 16.8 | 2.1 | 0.3 (− 2.6 to 1.9) | 0.96 | 14.9 | − 1.2 | 0.2 (− 4.2 to 4.6) | > 0.99 | 1.9 (− 2.8 to 6.5) | 0.64 |
| Itch NRS | 4.8 | − 6.5 | 0.3 (− 0.4 to 1.0) | 0.48 | 4 | 2.6 | − 0.1 (− 3.5 to 3.3) | > 0.99 | 0.8 (− 2.2 to 3.8) | 0.87 |
| Pain NRS | 2.3 | 31.2 | − 0.6 (− 2.1 to 1.0) | 0.66 | 1.9 | − 32.3 | 0.9 (− 2.5 to 4.3) | 0.85 | 0.4 (− 2.4 to 3.2) | 0.97 |