Table 1.
Baseline demographics and clinical characteristics
| Placebo | Risankizumab | |||
| (n=40) | 18 mg (n=40) | 90 mg (n=39) | 180 mg (n=40) | |
| Age, years (SD) | 37.6 (11.0) | 38.0 (11.1) | 39.5 (10.8) | 40.6 (11.9) |
| Male, n (%) | 25 (63) | 28 (70) | 30 (77) | 30 (75) |
| Race, n (%) | ||||
| White | 19 (48) | 26 (65) | 28 (72) | 22 (55) |
| Asian | 20 (50) | 13 (33) | 11 (28) | 17 (43) |
| Other* | 1 (3) | 1 (3) | 0 | 1 (3) |
| Geographic region, n (%) | ||||
| Europe | 18 (45.0) | 23 (57.5) | 24 (61.5) | 20 (50.0) |
| Asia | 20 (50.0) | 13 (32.5) | 11 (28.2) | 17 (42.5) |
| USA | 2 (5.0) | 4 (10.0) | 4 (10.3) | 3 (7.5) |
| BMI, kg/m2 (SD) | 24.2 (4.3) | 26.2 (5.3) | 25.9 (4.6) | 25.8 (4.5) |
| HLA-B27 status, n (%) | ||||
| Positive | 26 (65) | 30 (75) | 30 (77) | 34 (85) |
| Missing | 4 (10) | 4 (10) | 4 (10) | 2 (5) |
| Duration of disease, years (SD) | 8.1 (8.2) | 7.4 (8.2) | 6.6 (8.8) | 10.2 (9.5) |
| ASAS core components on NRS† (SD) | ||||
| Patient global | 7.2 (2.0) | 7.2 (1.7) | 6.5 (1.7) | 6.8 (2.2) |
| Inflammation | 6.2 (2.2) | 6.4 (2.0) | 6.5 (1.8) | 6.0 (2.2) |
| Spinal pain | 6.8 (2.0) | 6.5 (1.8) | 6.3 (1.8) | 6.4 (1.9) |
| Physical function | 4.6 (2.3) | 4.9 (2.1) | 4.9 (1.9) | 4.5 (2.6) |
| ASDAS-CRP | 3.5 (3.0, 4.3) | 3.6 (2.9, 4.2) | 3.5 (2.9, 4.0) | 3.6 (2.8, 4.0) |
| BASDAI | 6.3 (5.1, 7.2) | 6.4 (5.1, 7.1) | 5.8 (4.8, 7.1) | 6.1 (4.3, 7.4) |
| BASMI | 3.0 (1.0, 4.5) | 2.0 (1.0, 3.0) | 3.0 (1.0, 4.0) | 3.0 (1.0, 5.0) |
| CRP level, mg/L | ||||
| <2.87 (ULN) | 10 (25) | 11 (27) | 5 (13) | 11 (27) |
| ≥2.87 | 30 (75) | 29 (73) | 34 (87) | 29 (73) |
| ≥2.87 to <8 | 14 (35) | 12 (30) | 20 (26) | 10 (25) |
| ≥8 to ≤15 | 9 (23) | 6 (15) | 5 (13) | 11 (28) |
| >15 | 7 (18) | 11 (28) | 9 (23) | 8 (20) |
| SPARCC SI joint, N median (IQR) | 14 | 9 | 14 | 16 |
| 0.8 (0.0–4.0) | 2.5 (2.0–15.5) | 1.5 (0.0–8.5) | 3.3 (0.8–7.3) | |
| SPARCC total spine, N median (IQR) | 14 | 9 | 14 | 16 |
| 11.3 (3.5–22.0) | 9.0 (4.5–24.0) | 11.3 (3.8–18.8) | 8.3 (0.8–27.5) | |
| Concomitant csDMARD‡ | 20 (50.0) | 8 (20.0) | 8 (20.5) | 20 (50.0) |
| Concomitant NSAIDs§ and/or paracetamol | 36 (90.0) | 35 (87.5) | 34 (87.2) | 33 (82.5) |
| Concomitant GCs | 3 (7.5) | 5 (12.5) | 2 (5.1) | 3 (7.5) |
Data are mean (SD), n (%) or median (IQR).
*Other includes black or African-American and American Indian or Alaska Native.
†Patients assessment of ASAS core components on NRS (0–10): patient global is based on global AS disease activity; inflammation is based on the mean of BASDAI questions 5 and 6 addressing the level of morning stiffness and duration; spinal pain is based on the mean of two questions; physical function is based on BASFI.
‡Concomitant csDMARDs include sulfasalazine, methotrexate, hydroxychloroquine and leflunomide.
§Concomitant NSAIDs include etoricoxib, celecoxib, meloxicam, diclofenac, diclofenac sodium, naproxen, ibuprofen, piroxicam, ketoprofen, indomethacin, aceclofenac, diclofenac resinate, etodolac, vimovo, acemetacin, morniflumate, naproxen sodium, phenylbutazone and sulindac.
AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis International Society; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score-CRP; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BMI, body mass index; CRP, C reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; GC, glucocorticoid; HLA, human leucocyte antigen; NRS, numerical rating scale; NSAID, non-steroidal anti-inflammatory drug; SI, sacroiliac; SPARCC, SpondyloArthritis Research Consortium of Canada; ULN, upper limit of normal.