Table 2.
Efficacy outcomes at weeks 12 and 48
| Week 12 | Week 48 | ||||
|---|---|---|---|---|---|
| Placebo (n = 56) | IXE Q4W (n = 115) | IXE Q4W vs. placebo | IXE Q4W (n = 115) | ||
| Response n (%) | Response n (%) | P‐value | Difference vs. placebo (95% CI) | Response n (%) | |
| PASI 50 | 21 (38) | 106 (92) | < 0·001 | 54·7% (41·1–68·3) | 106 (92) |
| PASI 75 | 14 (25) | 102 (89) | < 0·001 | 63·7% (51·0–76·4) | 103 (90) |
| PASI 90 | 3 (5) | 90 (78) | < 0·001 | 72·9% (63·3–82·5) | 95 (83) |
| PASI 100 | 1 (2) | 57 (50) | < 0·001 | 47·8% (38·0–57·6) | 63 (55) |
| sPGA 0 or 1 | 6 (11) | 93 (81) | < 0·001 | 70·2% (59·3–81·0) | 93 (81) |
| sPGA 0 | 1 (2) | 60 (52) | < 0·001 | 50·4% (40·6–60·2) | 65 (57) |
| Itch NRS ≥ 4a | 8 (20) | 59 (71) | < 0·001 | 51·1% (35·3–66·9) | 65 (78) |
| CDLQI/DLQI 0 or 1b | 13 (23) | 74 (64) | < 0·001 | 41·1% (27·0–55·2) | 87 (76) |
| PatGA 0 or 1 | 9 (16) | 91 (79) | < 0·001 | 63·1% (50·9–75·2) | 99 (86) |
| NAPSI = 0c | 0 | 6 (18) | 0·317 | 17·6% (4·8–30·5) | 17 (50) |
| PSSI = 0d | 8 (16) | 70 (69) | < 0·001 | 52·6% (39·1–66·2) | 75 (74) |
| PPASI 100e | 1 (11) | 8 (47) | 0·098 | 35·9% (4·6–67·3) | 13 (76) |
| Clearance of genital psoriasisf | 5 (36) | 35 (85) | < 0·001 | 49·7% (22·3–77·0) | 37 (90) |
| Response, LSM CFB ± SD | Response, LSM CFB ± SD | P‐value | Difference vs. placebo, LSM difference ± SE | Response, LSM CFB ± SE | |
| Itch NRS | −0·43 ± 0·44 | −3·15 ± 0·40 | < 0·001 | −2·72 ± 0·33 | −3·46 ± 0·40 |
| NAPSIc | 0·17 ± 5·33 | −16·87 ± 3·11 | 0·005 | −17·04 ± 5·75 | −31·17 ± 2·18 |
| PSSId | −12·28 ± 2·57 | −27·64 ± 2·32 | < 0·001 | −15·36 ± 1·68 | −25·72 ± 1·30 |
| PPASIe | 6·89 ± 3·38 | −5·11 ± 2·15 | 0·006 | −12·01 ± 3·85 | −9·04 ± 0·26 |
Unless otherwise specified, values are presented as the number of responders (%). Categorical outcomes: Fisher's exact test with nonresponder imputation for handling missing data. Continuous outcomes: mixed model for repeated‐measures analysis. Type III tests for least‐squares means (LSMs) was used for treatment group comparisons. CDLQI, Children's Dermatology Life Quality Index; CFB, change from baseline; DLQI, Dermatology Life Quality Index; IXE, ixekizumab; NAPSI, Nail Psoriasis Severity Index; NRS, numerical rating scale; PASI, Psoriasis Area and Severity Index; PatGA, Patient's Global Assessment of Disease Severity; PPASI, Palmoplantar Psoriasis Area and Severity Index; PSSI, Psoriasis Scalp Severity Index; Q4W, every 4 weeks; sPGA, static Physician's Global Assessment. aAssessed for patients with baseline itch NRS ≥ 4. Placebo, n = 40; IXE Q4W, n = 83. bCDLQI was assessed for patients 6–16 years of age. DLQI was assessed for patients ≥ 17 years of age. cAssessed for patients with baseline NAPSI > 0. Placebo, n = 12; IXE Q4W, n = 34. dAssessed for patients with baseline PSSI > 0. Placebo, n = 50; IXE Q4W, n = 102. eAssessed for patients with baseline PPASI > 0. Placebo, n = 9; IXE Q4W, n = 17. fAssessed for patients with genital psoriasis at baseline.