Table 2.
Efficacy and health outcomes at week 24
| IXE (n=283) | ADA (n=283) | Treatment difference IXE versus ADA (95% CI) |
IXE versus ADA P value |
|
| Primary endpoint | ||||
| ACR50+PASI100 | 102/283 (36.0) 30.4% to 41.6% |
79/283 (27.9) 22.7% to 33.1% |
8.1% (0.5% to 15.8%) |
0.036 |
| Major secondary endpoints | ||||
| ACR50* | 143/283 (50.5) 44.7% to 56.4% |
132/283 (46.6) 40.8% to 52.5% |
3.9% (-4.3% to 12.1%) |
0.338 |
| PASI100 | 170/283 (60.1) 54.4% to 65.8% |
132/283 (46.6) 40.8% to 52.5% |
13.4% (5.3% to 21.6%) |
0.001 |
| PsA endpoints | ||||
| MDA | 135/283 (47.7) 41.9% to 53.5% |
100/283 (35.3) 29.8% to 40.9% |
12.4% (4.3% to 20.4%) |
0.003 |
| VLDA† | 49/283 (17.3) 12.9% to 21.7% |
29/283 (10.2) 6.7% to 13.8% |
7.1% (1.4% to 12.7%) |
0.015 |
| DAPSA remission (≤4)† | 75/283 (26.5) 21.4% to 31.6% |
51/283 (18.0) 13.5% to 22.5% |
8.5% (1.7% to 15.3%) |
0.016 |
| DAPSA low disease activity or remission (≤14)† | 174/283 (61.5) 55.8% to 67.2% |
171/283 (60.4) 54.7% to 66.1% |
1.1% (-7.0% to 9.1%) |
0.737 |
| DAPSA, LSM change from baseline (SE)† | −31.74 (0.94) | −30.10 (0.94) | −1.64 (-3.94 to 0.66) |
0.161 |
| PASDAS low disease activity (≤3.2)† | 164/283 (58.0) 52.2% to 63.7% |
147/283 (51.9) 46.1% to 57.8% |
6.0% (-2.2% to 14.2%) |
0.153 |
| PASDAS near remission (≤1.9)† | 82/283 (29.0) 23.7% to 34.3% |
55/283 (19.4) 14.8% to 24.0% |
9.5% (2.5% to 16.6%) |
0.009 |
| PASDAS, LSM change from baseline (SE)† | −3.08 (0.10) | −2.94 (0.10) | −0.14 (-0.38 to 0.10) |
0.260 |
| mCPDAI, LSM change from baseline (SE) | −3.98 (0.14) | −3.46 (0.13) | −0.53 (-0.85 to −0.20) |
0.002 |
| ACR20 | 195/283 (68.9) 63.5% to 74.3% |
204/283 (72.1) 66.9% to 77.3% |
−3.2% (-10.7% to 4.3%) |
0.403 |
| ACR70 | 90/283 (31.8) 26.4% to 37.2% |
73/283 (25.8) 20.7% to 30.9% |
6.0% (-1.4% to 13.5%) |
0.111 |
| SPARCC Enthesitis Index=0‡ | 107/189 (56.6) 49.5% to 63.7% |
77/171 (45.0) 37.6% to 52.5% |
11.6% (1.3% to 21.9%) |
0.019 |
| LEI=0§ | 95/159 (59.7) 52.1% to 67.4% |
81/147 (55.1) 47.1% to 63.1% |
4.6% (-6.4% to 15.7%) |
0.432 |
| LDI-B=0¶ | 37/42 (88.1) 78.3% to 97.9% |
54/58 (93.1) 86.6% to 99.6% |
−5.0% (-16.8% to 6.8%) |
0.658 |
| Skin and nail psoriasis endpoints | ||||
| PASI75 | 227/283 (80.2) 75.6% to 84.9% |
195/283 (68.9) 63.5% to 74.3% |
11.3% (4.2% to 18.4%) |
0.002 |
| PASI90 | 203/283 (71.7) 66.5% to 77.0% |
158/283 (55.8) 50.0% to 61.6% |
15.9% (8.1% to 23.7%) |
<0.001 |
| NAPSI fingernails=0** | 111/191 (58.1) 51.1% to 65.1% |
88/177 (49.7) 42.4% to 57.1% |
8.4% (-1.8% to 18.6%) |
0.082 |
| NAPSI, LSM change from baseline (SE) | −15.89 (0.82) | −12.53 (0.82) | −3.37 (-5.40 to −1.33) |
0.001 |
| Quality of life endpoints | ||||
| HAQ-DI ≥0.35†† | 168/252 (66.7) 60.8% to 72.5% |
166/254 (65.4) 59.5% to 71.2% |
1.3% (-6.9% to 9.6%) |
0.741 |
| DLQI (0, 1) | 174/283 (61.5) 55.8% to 67.2% |
147/283 (51.9) 46.1% to 57.8% |
9.5% (1.4% to 17.7%) |
0.020 |
Unless otherwise indicated, values are presented as n/N (%), 95% CI.
*The treatment difference of IXE minus ADA was 3.9% (95% CI −4.3% to 12.1%). The lower bound of the 95% CI (−4.3%) was greater than −12%, thus meeting noninferiority criteria.
†Post hoc analysis.
‡Assessed for patients with SPARCC Enthesitis Index score >0 at baseline.
§Assessed for patients with LEI score >0 at baseline.
¶Assessed for patients with LDI-B score >0 at baseline.
**Assessed for patients with NAPSI fingernails score >0 at baseline.
††Assessed for patients with HAQ-DI score ≥0.35 at baseline. A response of ≥0.35 change from baseline is the minimal clinically important difference in HAQ-DI.
ACR, American College of Rheumatology; ADA, adalimumab; DAPSA, Disease Activity in Psoriatic Arthritis; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire–Disability Index; IXE, ixekizumab; LDI-B, Leeds Dactylitis Index–Basic; LEI, Leeds Enthesitis Index; LSM, least squares mean; mCPDAI, modified Composite Psoriatic Disease Activity Index; MDA, minimal disease activity; NAPSI, Nail Psoriasis Area and Severity Index; PASDAS, psoriatic arthritis disease activity score; PASI, Psoriasis Area and Severity Index; SPARCC, Spondyloarthritis Research Consortium of Canada; VLDA, very low disease activity.