Table 2

Efficacy and health outcomes at Wk52

IXE (n=283)ADA (n=283)Treatment difference IXE vs ADA (95% CI)IXE vs ADA p value
ACR50+PASI100 n (%)111 (39.2) (33.5 to 44.9)74 (26.1) (21.0 to 31.3)13.1 (5.4 to 20.7)<0.001
ACR50141 (49.8) (44.0 to 55.6)141 (49.8) (44.0 to 55.6)0.0 (–8.2 to 8.2)0.924
PASI100182 (64.3) (58.7 to 69.9)117 (41.3) (35.6 to 47.1)23.0 (15.0 to 31.0)<0.001
PsA end points
 ACR20197 (69.6) (64.3 to 75.0)195 (68.9) (63.5 to 74.3)0.7 (–6.9 to 8.3)0.791
 ACR70100 (35.3) (29.8 to 40.9)97 (34.3) (28.7 to 39.8)1.1 (–6.8 to 8.9)0.733
 MDA134 (47.3) (41.5 to 53.2)116 (41.0) (35.3 to 46.7)6.4 (–1.8 to 14.5)0.108
 VLDA*66 (23.3) (18.4 to 28.2)54 (19.1) (14.5 to 23.7)4.2 (–2.5 to 11.0)0.189
 DAPSA remission (≤4)*85 (30.0) (24.7 to 35.4)80 (28.3) (23.0 to 33.5)1.8 (–5.7 to 9.3)0.579
 DAPSA low disease activity or remission (≤14)*174 (61.5) (55.8 to 67.2)166 (58.7) (52.9 to 64.4)2.8 (–5.2 to 10.9)0.428
 DAPSA, LSM change from baseline (SE)−33.8 (0.9)−32.4 (0.9)−1.4 (–3.7 to 0.9)0.219
 mCPDAI, LSM change from baseline (SE)−4.4 (0.1)−3.9 (0.1)−0.5 (–0.8 to –0.2)0.004
 SPARCC Enthesitis Index=0†107 (56.6) (49.5 to 63.7)83 (48.5) (41.0 to 56.0)8.1 (–2.2 to 18.4)0.097
 LEI=0‡98 (61.6) (54.1 to 69.2)84 (57.1) (49.1 to 65.1)4.5 (–6.5 to 15.5)0.392
 LDI-B=0§35 (83.3) (72.1 to 94.6)47 (81.0) (70.9 to 91.1)2.3 (–12.8 to 17.4)0.620
 PASI75222 (78.4) (73.7 to 83.2)194 (68.6) (63.1 to 74.0)9.9 (2.7 to 17.1)0.008
 PASI90206 (72.8) (67.6 to 78.0)153 (54.1) (48.3 to 59.9)18.7 (10.9 to 26.5)<0.001
 NAPSI fingernails=0¶129 (67.5) (60.9 to 74.2)104 (58.8) (51.5 to 66.0)8.8 (–1.1 to 18.6)0.060
 NAPSI, LSM change from baseline (SE)169 (0.7)154 (0.7)−2.7 (–4.6 to –0.8)0.005
Quality-of-life end points
 HAQ-DI improvement by ≥0.35**168 (66.7) (60.8 to 72.5)164 (64.6) (58.7 to 70.4)2.1 (–6.2 to 10.4)0.605
 DLQI (0–1)167 (59.0) (53.3 to 64.7)138 (48.8) (42.9 to 54.6)10.2 (2.1 to 18.4)0.014
 SF-36 PCS change from baseline10.1 (0.5)9.6 (0.5)0.5 (0.7)0.439
  • Unless otherwise indicated, values are presented as n (%), 95% CI.

  • *Post hoc analysis.

  • †Assessed for patients with SPARCC Enthisitis 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.

  • 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; NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PsA, psoriatic arthritis; SF-36, Medical Outcomes Study 36-Item Short Form Health Survey; SPARCC, Spondyloarthritis Research Consortium of Canada; VLDA, Very Low Disease Activity.