Table 2

Summary of primary and major secondary efficacy endpoints at week 24 among randomised patients

Placebo
(N=104)
UST 45 mg
(N=103)
UST 90 mg
(N=105)
Combined UST
(N=208)
ACR20 response (1° endpoint)  Difference (CI)21 (20.2)45 (43.7)***
23.5 (11.2 to 35.8)
46 (43.8)***
23.6 (11.4 to 35.8)
91 (43.8)***
ACR20 by MTX use
 Yes14/49 (28.6)27/54 (50.0)21/52 (40.4)48/106 (45.3)
 No7/55 (12.7)18/49 (36.7)25/53 (47.2)43/102 (42.2)
ACR20 by body weight
 ≤100 kg17/74 (23.0)32/74 (43.2)34/73 (46.6)66/147 (44.9)
 >100 kg4/30 (13.3)13/29 (44.8)12/31 (38.7)25/60 (41.7)
ACR20 by anti-TNF use
 Anti-TNF-naïve12/42 (28.6)23/43 (53.5)26/47 (55.3)49/90 (54.4)
 Anti-TNF-experienced9/62 (14.5)22/60 (36.7)20/58 (34.5)42/118 (35.6)
ACR50 response (major 2° endpoint)7 (6.7)18 (17.5)*24 (22.9)**42 (20.2)**
 Difference (CI)10.7 (2.0 to 19.5)16.1 (6.8 to 25.5)
ACR70 response (major 2° endpoint)3 (2.9)7 (6.8)9 (8.6)16 (7.7)
 Difference (CI)3.9 (−1.9 to 9.7)5.7 (−0.6 to 11.9)
PASI75 response† (major 2° endpoint)4/80 (5.0)41/80 (51.3)***45/81 (55.6)***86/161 (53.4)***
 Difference (CI)46.3 (34.3 to 58.2)50.6 (38.7 to 62.4)
PASI75 by MTX use
 Yes3/29 (10.3)19/39 (48.7)22/39 (56.4)41/78 (52.6)
 No1/51 (2.0)22/41 (53.7)23/42 (54.8)45/83 (54.2)
PASI75 by body weight
 ≤100 kg4/54 (7.4)31/58 (53.4)32/57 (56.1)63/115 (54.8)
 >100 kg0/26 (0.0)10/22 (45.5)13/24 (54.2)23/46 (50.0)
PASI75 by anti-TNF use
 Anti-TNF-naïve3/30 (10.0)21/36 (58.3)25/40 (62.5)46/76 (60.5)
 Anti-TNF-experienced1/50 (2.0)20/44 (45.5)20/41 (48.8)40/85 (47.1)
HAQ-DI score
 Change from baseline (major 2° endpoint)0.00 (−0.13 to 0.13)−0.13 (−0.38 to 0.00)**−0.25 (−0.50 to 0.00)***−0.25 (−0.38 to 0.00)***
 Difference (CI)0.13 (0.00 to 0.30)0.25 (0.10 to 0.30)
HAQ-DI change from baseline
 Anti-TNF-naïve, N42434790
0.00 (−0.25 to 0.25)−0.25 (−0.50 to 0.00)−0.25 (−0.50 to 0.00)−0.25 (−0.50 to 0.00)
 Anti-TNF-experienced, N626058118
0.00 (−0.13 to 0.13)−0.13 (−0.38 to 0.00)−0.19 (−0.38 to 0.00)−0.13 (−0.38 to 0.00)
  • Data are reported as n (%), n/N (%) or median (IQR).

  • *, ** and *** indicate p<0.05, 0.01 and 0.001, respectively, versus placebo.

  • †Among patient with ≥3% BSA psoriasis involvement at baseline.

  • ACR, American College of Rheumatology; BSA, body surface area; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; TNF, tumour necrosis factor-α; UST, ustekinumab.