Patient demographics and baseline characteristics—randomised population
| Sarilumab | |||||||
|---|---|---|---|---|---|---|---|
| Placebo (n=50) | 100 mg q2w (n=49) | 150 mg q2w (n=50) | 100 mg qw (n=52) | 200 mg q2w (n=50) | 150 mg qw (n=50) | All (n=301) | |
| Demographics | |||||||
| Age, years, mean (SD) | 40.3 (11.7) | 42.4 (10.8) | 43.0 (11.3) | 40.4 (11.5) | 37.2 (10.4) | 41.1 (11.1) | 40.7 (11.2) |
| Male, n (%) | 38 (76.0) | 30 (61.2) | 34 (68.0) | 37 (71.2) | 40 (80.0) | 39 (78.0) | 218 (72.4) |
| Caucasian/white, n (%) | 49 (98.0) | 49 (100) | 48 (96.0) | 49 (94.2) | 48 (96.0) | 49 (98.0) | 292 (97.0) |
| BMI (kg/m2), mean (SD) | 26.97 (5.30) | 26.12 (4.83) | 25.43 (3.93) | 27.31 (4.61) | 27.10 (5.24) | 26.88 (4.21) | 26.64 (4.72) |
| Region, n (%) | |||||||
| Western countries* | 39 (78.0) | 39 (79.6) | 40 (80.0) | 41 (78.8) | 39 (78.0) | 40 (80.0) | 238 (79.1) |
| RoW† | 11 (22.0) | 10 (20.4) | 10 (20.0) | 11 (21.2) | 11 (22.0) | 10 (20.0) | 63 (20.9) |
| HLA-B27 positive, % | 74.0 | 78.7 | 76.0 | 78.8 | 78.0 | 81.6 | 77.9 |
| Baseline characteristics | |||||||
| Duration of AS (years since diagnosis), mean (SD) | 9.45 (8.31) | 8.50 (10.30) | 8.55 (10.65) | 7.13 (7.96) | 7.13 (7.08) | 5.55 (5.31) | 7.71 (8.48) |
| Screening hs-CRP level, n (%) | |||||||
| ≤1.5 mg/dL | 28 (56.0%) | 27 (55.1%) | 27 (54.0%) | 29 (55.8%) | 28 (56.0%) | 27 (54.0%) | 166 (55.1%) |
| Number of prior DMARDs, n (%) | |||||||
| None | 41 (82.0) | 41 (83.7) | 39 (78.0) | 39 (75.0) | 40 (80.0) | 44 (88.0) | 244 (81.1%) |
| 1 | 8 (16.0) | 8 (16.3) | 11 (22.0) | 13 (25.0) | 10 (20.0) | 6 (12.0) | 56 (18.6%) |
| 2 | 1 (2.0) | 0 | 0 | 0 | 0 | 0 | 1 (0.3%) |
| History of smoking n (%) | 27 (54.0) | 30 (61.2) | 21 (42.0) | 27 (51.9) | 28 (56.0) | 31 (62.0) | 164 (54.5%) |
| Alcohol use, n (%) | 33 (66.0) | 36 (73.5) | 33 (66.0) | 33 (63.5) | 32 (64.0) | 36 (72.0) | 203 (67.4%) |
| ASAS individual core components (0–10 scale) | |||||||
| Back pain, mean (SD) | 6.62 (2.14) | 6.73 (1.88) | 6.60 (1.57) | 6.91 (1.70) | 6.90 (1.66) | 6.52 (1.63) | 6.72 (1.76) |
| Physical function, mean (SD) | 4.44 (1.63) | 4.24 (1.58) | 4.05 (1.45) | 4.25 (1.66) | 3.99 (1.68) | 3.95 (1.62) | 4.15 (1.60) |
| Patient global assessment, mean (SD) | 6.88 (1.97) | 6.82 (1.88) | 6.44 (1.75) | 6.94 (1.70) | 6.78 (1.67) | 6.48 (1.62) | 6.72 (1.76) |
| Inflammation, mean (SD) | 6.91 (2.12) | 6.21 (1.73) | 6.55 (1.56) | 6.49 (1.96) | 7.05 (1.82) | 6.26 (1.88) | 6.58 (1.87) |
| MRI (ASspiMRI) total score | |||||||
| Number | 49 | 48 | 50 | 52 | 49 | 50 | 298 |
| Mean (SD) | 8.8 (8.8) | 6.8 (7.6) | 7.8 (11.1) | 9.1 (11.0) | 9.2 (10.2) | 9.7 (9.7) | 8.6 (9.8) |
‘Inflammation’ represents mean of intensity and duration of morning stiffness from BASDAI. ‘Alcohol use’ is defined as any consumption of an alcoholic beverage that occurs at least monthly or more frequently (this is “daily”, “weekly”, or “monthly”)
*Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Spain, The Netherlands, USA.
†Lithuania, Poland, Turkey.
AS, ankylosing spondylitis; ASAS, Axial SpondyloArthritis international Society; ASspiMRI, Ankylosing Spondylitis spine MRI-active score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, Body Mass Index; DMARD, disease modifying anti-rheumatic drug; hs-CRP, high-sensitivity C-reactive protein; RoW, rest of world.