Efficacy endpoints at Week 52 (EPP), including radiographic progression. Data are mean change from baseline (SD), unless otherwise specified.
| Variables | PBO/IXEQ4W | ADA/IXEQ4W | IXEQ4W/IXEQ4W | PBO/IXEQ2W | ADA/IXEQ2W | IXEQ2W/IXEQ2W | Total IXEQ4W | Total IXEQ2W |
|---|---|---|---|---|---|---|---|---|
| ACR20*, n/N (%) | 26/45 (57.8) | 34/49 (69.4) | 67/97 (69.1) | 33/46 (71.7) | 28/48 (58.3) | 66/96 (68.8) | 127/191 (66.5) | 127/190 (66.8) |
| ACR50*, n/N (%) | 19/45 (42.2) | 29/49 (59.2) | 53/97 (54.6) | 21/46 (45.7) | 21/48 (43.8) | 51/96 (53.1) | 101/191 (52.9) | 93/190 (48.9) |
| ACR70*, n/N (%) | 9/45 (20.0) | 17/49 (34.7) | 38/97 (39.2) | 14/46 (30.4) | 14/48 (29.2) | 38/96 (39.6) | 64/191 (33.5) | 66/190 (34.7) |
| HAQ-DI, mBOCF | −0.38 (0.53) | −0.47 (0.48) | −0.53 (0.56) | −0.42 (0.60) | −0.42 (0.47) | −0.55 (0.52) | −0.48 (0.53) | −0.48 (0.53) |
| ≥ 0.35 HAQ-DI improvement*, n/N (%) | 16/37 (43.2) | 26/43 (60.5) | 52/91 (57.1) | 16/40 (40.0) | 20/42 (47.6) | 48/84 (57.1) | 94/171 (55.0) | 84/166 (50.6) |
| DAS28-CRP, mBOCF | −1.9 (1.2) | −2.2 (1.3) | −2.3 (1.3) | −2.1 (1.1) | −2.1 (0.9) | −2.4 (1.3) | −2.2 (1.3) | −2.2 (1.2) |
| PsARC*, n/N (%) | 26/45 (57.8) | 34/49 (69.4) | 65/97 (67.0) | 34/46 (73.9) | 30/48 (62.5) | 62/96 (64.6) | 125/191 (65.4) | 126/190 (66.3) |
| LEI, mBOCF | −1.1 (2.2) | −2.0 (1.9) | −1.9 (1.7) | −1.7 (2.0) | −1.1 (2.3) | −1.8 (1.6) | −1.8 (1.8) | −1.6 (1.9) |
| LEI = 0*, n/N (%) | 9/22 (40.9) | 14/28 (50.0) | 36/65 (55.4) | 11/26 (42.3) | 6/23 (26.1) | 26/52 (50.0) | 59/115 (51.3) | 43/101 (42.6) |
| LDI-B, mBOCF | −47.7 (62.6) | −96.5 (125.5) | −57.9 (103.9) | −21.3 (21.7) | −93.1 (102.5) | −43.4 (55.5) | −61.9 (100.2) | −45.3 (63.0) |
| LDI-B = 0*, n/N (%) | 7/10 (70.0) | 6/8 (75.0) | 30/35 (85.7) | 8/14 (57.1) | 7/10 (70.0) | 21/24 (87.5) | 43/53 (81.1) | 36/48 (75.0) |
| Prespecified mTSS, linear extrapolationa,c | ||||||||
| Mx | 31 | 36 | 80 | 37 | 34 | 80 | 147 | 151 |
| Mean (SD) | 0.27 (0.84) | 0.32 (1.02) | 0.54 (2.12) | 0.41 (0.81) | −0.03 (0.39) | 0.09 (0.95) | 0.43 (1.69) | 0.14 (0.83) |
| Posthoc mTSS, linear extrapolationb,c | ||||||||
| Mx | 44 | 47 | 97 | 45 | 45 | 96 | 188 | 186 |
| Mean (SD) | 0.25 (0.79) | 0.24 (0.90) | 0.47 (1.94) | 0.51 (1.10) | 0.06 (0.54) | 0.09 (0.88) | 0.36 (1.51) | 0.18 (0.89) |
| Posthoc mTSS ≤ 0, observed, n/Nx (%)b | 29/34 (85.3) | 35/40 (87.5) | 68/81 (84.0) | 22/35 (62.9) | 29/35 (82.9) | 70/83 (84.3) | 132/155 (85.2) | 121/153 (79.1) |
| Posthoc mTSS ≤ 0.5, observed, n/Nx (%)b | 32/34 (94.1) | 35/40 (87.5) | 72/81 (88.9) | 23/35 (65.7) | 32/35 (91.4) | 75/83 (90.4) | 139/191 (89.7) | 130/153 (85.0) |
| Posthoc mTSS ≤ 1.32, SDC, observed, n/Nx (%)b | 33/34 (97.1) | 36/40 (90.0) | 75/81 (92.6) | 30/35 (85.7) | 34/35 (97.1) | 77/83 (92.8) | 144/155 (92.9) | 141/153 (92.2) |
| PASI 75*, n/N (%) | 19/31 (61.3) | 22/34 (64.7) | 52/66 (78.8) | 19/29 (65.5) | 22/33 (66.7) | 45/55 (81.8) | 93/131 (71.0) | 86/117 (73.5) |
| PASI 90*, n/N (%) | 16/31 (51.6) | 17/34 (50.0) | 44/66 (66.7) | 18/29 (62.1) | 17/33 (51.5) | 43/55 (78.2) | 77/131 (58.8) | 78/117 (66.7) |
| PASI 100*, n/N (%) | 15/31 (48.4) | 12/34 (35.3) | 37/66 (56.1) | 13/29 (44.8) | 15/33 (45.5) | 37/55 (67.3) | 64/131 (48.9) | 65/117 (55.6) |
| NAPSI, mBOCF | −10.5 (13.5) | −16.8 (19.0) | −16.5 (18.5) | −12.8 (13.9) | −10.4 (11.3) | −21.6 (20.6) | −15.1 (17.6) | −16.6 (17.8) |
| NAPSI = 0*, n/N (%) | 10/31 (32.3) | 13/33 (39.4) | 30/64 (46.9) | 12/35 (34.3) | 16/35 (45.7) | 28/69 (40.6) | 53/128 (41.4) | 56/139 (40.3) |
↵* Nonresponder imputation.
↵a mTSS values were excluded from the summary if radiographs were not taken at the scheduled visit.
↵b All available mTSS values were interpolated.
↵c Any missing data were imputed using linear extrapolation. ADA: adalimumab; ACR: American College of Rheumatology; DAS28-CRP: 28-joint Disease Activity Score using C-reactive protein; EPP: extension period population; HAQ-DI: Health Assessment Questionnaire–Disability Index; IXEQ2W: 80 mg ixekizumab once every 2 weeks; IXEQ4W: 80 mg ixekizumab once every 4 weeks; LDI-B: Leeds Dactylitis Index–Basic; LEI: Leeds Enthesitis Index; mBOCF: modified baseline observation carried forward; mTSS: van der Heijde modified total Sharp score; Mx: no. patients with nonmissing or imputed data; NAPSI: Nail Psoriasis Severity Index; Nx: no. patients with nonmissing data; PASI: Psoriasis Area and Severity Index; PBO: placebo; PsARC: Psoriatic Arthritis Response Criteria; SDC: smallest detectable change.