Table 1.
Demographics and baseline disease characteristics of patients with an MRI scan at both baseline and week 12 (or early discontinuation)
| Characteristics | Filgotinib (n = 48) | Placebo (n = 39) | All (N = 87) |
|---|---|---|---|
| Age, years, mean (s.d.) | 40.7 (11.47) | 41.9 (9.28) | 41.2 (10.50) |
| Male, n (%) | 37 (77.1) | 28 (71.8) | 65 (74.7) |
| Weight, kg, mean (s.d.) | 74.3 (11.36) | 76.4 (16.93) | 75.2 (14.08) |
| BMI, kg/m2, mean (s.d.) | 25.1 (3.53) | 25.9 (3.95) | 25.5 (3.72) |
| Time from symptom onset, years, mean (s.d.) | 7.0 (1.14) | 7.0 (1.35) | 7.0 (1.24) |
| HLA-B27 positivity, n (%) | 41 (95.3) | 33 (91.7) | 74 (93.7) |
| ASDAS, mean (s.d.) | 4.3 (0.57) | 4.1 (0.73) | 4.2 (0.64) |
| BASDAI, mean (s.d.) | 7.0 (1.14) | 7.0 (1.35) | 7.0 (1.23) |
| BASFI, mean (s.d.) | 7.0 (1.53) | 6.8 (1.59) | 6.9 (1.55) |
| BASMI, linear, mean (s.d.) | 4.9 (1.63) | 5.2 (1.69) | 5.1 (1.65) |
| hs-CRP, mg/l, mean (s.d.) | 19.8 (13.25) | 19.5 (16.73) | 19.7 (14.82) |
| hs-CRP ≥ ULN,an (%) | 35 (72.9) | 23 (59.0) | 58 (66.7) |
| MRI SPARCC spine, mean (s.d.) | 20.6 (20.54) | 16.4 (21.58) | 18.7 (20.99) |
| MRI SPARCC SI joint, mean (s.d.) | 7.7 (11.52) | 4.9 (6.40) | 6.4 (9.62) |
| Enthesitis at baseline,bn (%) | 39 (84.8) | 30 (76.9) | 69 (81.2) |
| Total SPARCC SSS ankylosis score at baseline,cn (%) | |||
| <10 | 59 (50.0) | 26 (44.8) | 55 (47.4) |
| 10–15 | 7 (12.1) | 7 (12.1) | 14 (12.1) |
| >15 | 20 (34.5) | 18 (31.0) | 38 (32.8) |
| SPARCC SSS erosion score (range 0–40), mean (s.d.) | 3.4 (5.34) | 2.6 (3.76) | 3.0 (4.69) |
| SPARCC SSS backfill score (range 0–20), mean (s.d.) | 1.0 (1.99) | 1.4 (2.59) | 1.2 (2.27) |
| SPARCC SSS ankylosis score (range 0–20), mean (s.d.) | 9.6 (8.15) | 9.8 (8.45) | 9.7 (8.24) |
| SPARCC SSS fat metaplasia score (range 0–40), mean (s.d.) | 4.2 (6.06) | 4.4 (5.44) | 4.3 (5.76) |
| MASES, mean (s.d.) | 4.2 (3.1) | 3.4 (3.2) | 3.8 (3.13) |
| csDMARD use, n (%) | 18 (37.5) | 16 (41.0) | 34 (39.1) |
| Methotrexate | 6 (12.5) | 3 (7.7) | 9 (10.3) |
| Sulfasalazine (oral) | 12 (25.0) | 13 (33.3) | 25 (28.7) |
| NSAID use, n (%) | 36 (75.0) | 25 (64.1) | 61 (70.1) |
| Glucocorticosteroid use, n (%) | 5 (10.4) | 8 (20.5) | 13 (14.9) |
| Previous TNF inhibitor therapy, n (%) | 4 (8.3) | 4 (10.3) | 8 (9.2) |
a
The ULN for hs-CRP is 10 mg/l.
b
Data shown for patients with one or more tender enthesis at baseline.
c
Data missing for two patients in the filgotinib 200 mg treatment group and seven patients on placebo. csDMARD: conventional synthetic DMARD; hs-CRP: high-sensitivity CRP; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; ULN: upper limit of normal.