Placebo | Ustekinumab | All | |||
45 mg | 90 mg | Combined | Patients | ||
Allpatients(N) | 84 | 66 | 73 | 139 | 223 |
Male | 42 (50.0) | 37 (56.1) | 48 (65.8) | 85 (61.2) | 127 (57.0) |
Age (years) | 47.01 (12.87) | 45.56 (11.62) | 45.67 (11.66) | 45.62 (11.60) | 46.14 (12.09) |
Body-mass index (kg/m2) | 28.96 (6.35) | 28.06 (5.16) | 28.69 (5.58) | 28.39 (5.38) | 28.60 (5.76) |
Duration of disease (years) | |||||
PsA | 7.11 (8.80) | 6.28 (6.77) | 6.48 (6.36) | 6.39 (6.54) | 6.66 (7.46) |
Psoriasis | 15.95 (12.82) | 14.58 (10.97) | 16.64 (12.34) | 15.66 (11.71) | 15.77 (12.12) |
Patient with ≥3% BSA psoriasis | 63 (75.0) | 57 (86.4) | 59 (80.8) | 116 (83.5) | 179 (80.3) |
PASI score (0–72) | 14.46 (12.53) | 15.11 (13.58) | 13.86 (10.22) | 14.48 (11.95) | 14.47 (12.12) |
DLQI score (0–30) | 13.13 (8.01) | 12.54 (7.13) | 11.75 (7.08) | 12.14 (7.09) | 12.49 (7.42) |
Swollen joint count (0–66) | 15.79 (11.02) | 12.76 (7.93) | 12.38 (8.99) | 12.56 (8.48) | 13.78 (9.62) |
Tender joint count (0–68) | 25.04 (14.85) | 24.33 (15.50) | 21.16 (12.92) | 22.67 (14.24) | 23.56 (14.48) |
Spondylitis-related activity (0–10) | |||||
BASDAI total neck/back/hip pain | 6.14 (2.74) | 6.62 (2.31) | 6.84 (2.15) | 6.74 (2.22) | 6.51 (2.44) |
mBASDAI (excl. peripheral) | 6.27 (1.84) | 6.52 (1.71) | 6.56 (1.63) | 6.54 (1.66) | 6.44 (1.73) |
BASDAI | 6.37 (1.74) | 6.57 (1.62) | 6.60 (1.60) | 6.59 (1.61) | 6.51 (1.66) |
ASDAS-CRP | 3.68 (0.88) | 3.86 (0.91) | 3.90 (0.87) | 3.88 (0.89) | 3.81 (0.89) |
CRP (mg/L) | 18.57 (25.72) | 20.30 (23.19) | 20.63 (20.74) | 20.47 (21.85) | 19.76 (23.35) |
HAQ-DI score (0–3) | 1.36 (0.63) | 1.33 (0.60) | 1.22 (0.66) | 1.27 (0.63) | 1.30 (0.63) |
DAS28-CRP | 5.25 (1.11) | 5.27 (0.98) | 5.11 (0.90) | 5.18 (0.94) | 5.21 (1.01) |
Dactylitis in ≥1 digit | 43 (51.2) | 38 (57.6) | 30 (41.1) | 68 (48.9) | 111 (49.8) |
Dactylitis score (0–60) | 9.88 (12.21) | 8.05 (11.00) | 6.70 (5.99) | 7.46 (9.10) | 8.40 (10.43) |
Enthesitis | 66 (78.6) | 56 (84.8) | 57 (78.1) | 113 (81.3) | 179 (80.3) |
Enthesitis score (0–15) | 5.23 (4.18) | 5.04 (2.99) | 6.54 (4.15) | 5.80 (3.68) | 5.59 (3.87) |
Methotrexate | 33 (39.3) | 33 (50.0) | 41 (56.2) | 74 (53.2) | 107 (48.0) |
Mean dose (SD) (mg/week) | 15.83 (4.87) | 14.09 (4.18) | 14.82 (3.97) | 14.49 (4.05) | 14.91 (4.34) |
Corticosteroids | 16 (19.0) | 17 (25.8) | 14 (19.2) | 31 (22.3) | 47 (21.1) |
Mean dose (SD) (mg/day) | 6.84 (2.23) | 7.71 (2.78) | 6.54 (2.76) | 7.18 (2.79) | 7.06 (2.59) |
HLA-B27+patients* (N) | 13 | 13 | 14 | 27 | 40/158 (25.3) |
Age | |||||
<45 years | 7 (53.8) | 9 (69.2) | 8 (57.1) | 17 (63.0) | 24 (60.0) |
≥45 years | 6 (46.2) | 4 (30.8) | 6 (42.9) | 10 (37.0) | 16 (40.0) |
Spondylitis-related activity (0–10) | |||||
BASDAI total neck/back/hip pain | 5.54 (2.32) | 7.55 (2.29) | 7.40 (1.85) | 7.47 (2.03) | 6.88 (2.28) |
mBASDAI (excl. peripheral) | 5.99 (1.33) | 7.16 (1.78) | 7.02 (1.55) | 7.09 (1.63) | 6.75 (1.61) |
BASDAI | 6.18 (1.31) | 7.12 (1.66) | 6.97 (1.59) | 7.04 (1.59) | 6.78 (1.55) |
ASDAS-CRP | 3.76 (0.82) | 4.55 (0.95) | 4.09 (0.79) | 4.31 (0.88) | 4.14 (0.89) |
<45 years | 3.85 (0.68) | 4.85 (0.67) | 3.97 (0.84) | 4.44 (0.86) | 4.27 (0.84) |
≥45 years | 3.64 (1.05) | 3.87 (1.23) | 4.25 (0.76) | 4.10 (0.93) | 3.95 (0.96) |
CRP (mg/L) | 26.30 (46.20) | 42.46 (38.05) | 20.60 (22.22) | 31.12 (32.23) | 29.56 (36.80) |
HLA-B27–patients* (N) | 47 | 32 | 39 | 71 | 118/158 (74.7) |
Age | |||||
<45 years | 19 (40.4) | 11 (34.4) | 22 (56.4) | 33 (46.5) | 52 (44.1) |
≥45 years | 28 (59.6) | 21 (65.6) | 17 (43.6) | 38 (53.5) | 66 (55.9) |
Spondylitis-related activity (0–10) | |||||
BASDAI total neck/back/hip pain | 6.20 (2.76) | 6.53 (2.28) | 6.76 (2.03) | 6.66 (2.13) | 6.48 (2.40) |
mBASDAI (excl. peripheral) | 6.29 (1.87) | 6.42 (1.93) | 6.63 (1.66) | 6.54 (1.77) | 6.44 (1.81) |
BASDAI | 6.41 (1.72) | 6.45 (1.83) | 6.67 (1.63) | 6.57 (1.71) | 6.51 (1.71) |
ASDAS-CRP | 3.67 (0.83) | 3.64 (0.87) | 3.88 (0.84) | 3.78 (0.86) | 3.74 (0.84) |
<45 years | 3.68 (0.98) | 3.95 (1.10) | 3.81 (0.69) | 3.86 (0.82) | 3.79 (0.88) |
≥45 years | 3.67 (0.73) | 3.49 (0.71) | 3.97 (1.02) | 3.71 (0.89) | 3.69 (0.82) |
CRP (mg/L) | 17.24 (20.63) | 12.60 (9.77) | 19.61 (18.74) | 16.45 (15.66) | 16.76 (17.73) |
*Does not include three patients with testing for whom the HLA-B27 genotype could not be determined.
ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score incorporating C-reactive protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; CRP, C-reactive protein; DAS28-CRP, disease activity score 28-CRP; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire Disability Index; HLA-B27, human-leucocyte-antigen B27 allele; mBASDAI, modified Bath Ankylosing Spondylitis Disease Activity Index; PA-PRS, peripheral arthritis and physician-reported spondylitis; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; TNFi, tumour necrosis factor-inhibitor.