Table 3.
Week 52 efficacy overview (intent-to-treat population)
| Efficacy outcomes | Ixekizumab Q4W (N = 122) | Ixekizumab Q2W (N = 123) | ||
|---|---|---|---|---|
| Responder rate [n/N (%)] | NRI | MI | NRI | MI |
| ACR20 | 75/122 (61.5) | 100/122 (83.6) | 63/123 (51.2) | 92/123 (75.4) |
| ACR50 | 51/122 (41.8) | 64/122 (53.4) | 41/123 (33.3) | 50/123 (40.6) |
| ACR70 | 32/122 (26.2) | 38/122 (31.6) | 22/123 (17.9) | 24/123 (20.4) |
| HAQ-DI MCIDa | 48/104 (46.2) | 63/104 (60.9) | 38/108 (35.2) | 58/108 (53.8) |
| Minimal disease activity | 42/122 (34.4) | 46/122 (37.6) | 29/123 (23.6) | 35/123 (28.7) |
| Low disease activityb | 65/122 (53.3) | 78/122 (64.0) | 46/123 (37.4) | 58/123 (47.4) |
| Remissionc | 23/122 (18.9) | 25/122 (20.3) | 14/123 (11.4) | 15/123 (12.0) |
| LDI-B = 0d | 21/28 (75.0) | 22/28 (81.4) | 11/20 (55.0) | 13/20 (68.5) |
| LEI = 0e | 32/68 (47.1) | 44/68 (64.5) | 30/84 (35.7) | 45/84 (53.4) |
| PASI75f | 41/68 (60.3) | 55/68 (81.3) | 37/68 (54.4) | 57/68 (83.1) |
| PASI90f | 34/68 (50.0) | 45/68 (65.8) | 27/68 (39.7) | 42/68 (61.8) |
| PASI100f | 27/68 (39.7) | 35/68 (52.1) | 24/68 (35.3) | 35/68 (52.0) |
| sPGA (0)g | 26/60 (43.3) | 33/60 (54.7) | 27/62 (43.5) | 36/62 (58.3) |
| NAPSI (0)h | 41/89 (46.1) | 53/89 (59.1) | 24/74 (32.4) | 35/74 (47.5) |
| Mean change from baseline | mBOCF (s.d.) | MI (s.e.) | mBOCF (s.d.) | MI (s.e.) |
| DAS28-CRP | −2.6 (1.3) | −2.5 (0.1) | −2.3 (1.1) | −2.0 (0.1) |
| DAPSAi | −30.9 (27.6) | −36.6 (2.0) | −31.2 (26.4) | −35.7 (2.4) |
| HAQ-DI | −0.4 (0.5) | −0.5 (<0.1) | −0.4 (0.5) | −0.4 (0.1) |
| SF-36 PCS Score | 7.4 (8.9) | 7.6 (0.8) | 7.1 (10.0) | 7.6 (0.9) |
| SF-36 MCS Score | 4.1 (11.1) | 4.5 (1.0) | 3.4 (9.4) | 3.6 (1.0) |
| LDI-Bd | −29.1 (34.5) | −24.4 (4.0) | −50.7 (32.9) | −46.1 (7.9) |
| LEIe | −1.8 (1.9) | −2.0 (0.2) | −1.6 (2.1) | −2.0 (0.2) |
| NAPSIh | −15.2 (19.7) | −15.7 (2.1) | −14.4 (19.0) | −16.7 (2.5) |
Baseline HAQ-DI score ≥0.35.
≤14 DAPSA score.
≤4 DAPSA score.
Baseline LDI-B > 0.
Baseline LEI > 0.
Baseline body surface area ≥3%.
Baseline sPGA ≥ 3.
Baseline fingernail psoriasis present.
Baseline mean DAPSA scores were 49.6 (IXEQ4W) and 52.9 (IXEQ2W). DAPSA: Disease Activity in PsA; DAS-28-CRP: 28-joint DAS using CRP; HAQ-DI: HAQ-Disability Index; LDI-B: Leeds Dactylitis Index-Basic; LEI: Leeds Enthesitis Index; mBOCF: modified baseline observation carried forward; MCID: minimal clinically important difference; MCS/PCS: mental or physical component summary; MI: multiple imputation; NAPSI: Nail Psoriasis Severity Index; NRI: non-responder imputation; PASI: Psoriasis Area and Severity Index; Q4W/Q2W: 80 mg every 4 or 2 weeks; SF-36: Short Form (36 Items) Health Survey; sPGA: static physician global assessment of psoriasis.