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+PASI100102/283 (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
 PASI100170/283 (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
 MDA135/283 (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
 ACR20195/283 (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
 ACR7090/283 (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
 PASI75227/283 (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
 PASI90203/283 (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.