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 | ||||
Yes | 14/49 (28.6) | 27/54 (50.0) | 21/52 (40.4) | 48/106 (45.3) |
No | 7/55 (12.7) | 18/49 (36.7) | 25/53 (47.2) | 43/102 (42.2) |
ACR20 by body weight | ||||
≤100 kg | 17/74 (23.0) | 32/74 (43.2) | 34/73 (46.6) | 66/147 (44.9) |
>100 kg | 4/30 (13.3) | 13/29 (44.8) | 12/31 (38.7) | 25/60 (41.7) |
ACR20 by anti-TNF use | ||||
Anti-TNF-naïve | 12/42 (28.6) | 23/43 (53.5) | 26/47 (55.3) | 49/90 (54.4) |
Anti-TNF-experienced | 9/62 (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 | ||||
Yes | 3/29 (10.3) | 19/39 (48.7) | 22/39 (56.4) | 41/78 (52.6) |
No | 1/51 (2.0) | 22/41 (53.7) | 23/42 (54.8) | 45/83 (54.2) |
PASI75 by body weight | ||||
≤100 kg | 4/54 (7.4) | 31/58 (53.4) | 32/57 (56.1) | 63/115 (54.8) |
>100 kg | 0/26 (0.0) | 10/22 (45.5) | 13/24 (54.2) | 23/46 (50.0) |
PASI75 by anti-TNF use | ||||
Anti-TNF-naïve | 3/30 (10.0) | 21/36 (58.3) | 25/40 (62.5) | 46/76 (60.5) |
Anti-TNF-experienced | 1/50 (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, N | 42 | 43 | 47 | 90 |
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, N | 62 | 60 | 58 | 118 |
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.