Table 1.
Patient characteristic | Tofacitinib 2 mg BID, | Tofacitinib 5 mg BID, | Tofacitinib 10 mg BID, | Placebo |
---|---|---|---|---|
n = 42 | n = 44 | n = 44 | n = 34 | |
Gender, male, n (%) | 27 (64.3) | 32 (72.7) | 31 (70.5) | 24 (70.6) |
Age, mean (s.d.), years | 41.1 (11.9) | 41.2 (10.3) | 39.5 (11.0) | 41.5 (13.4) |
Race, white, n (%) | 30 (71.4) | 35 (79.5) | 35 (79.5) | 28 (82.4) |
HLA-B27+, n (%) | 37 (88.1) | 38 (86.4) | 42 (95.5) | 28 (82.4) |
BMI, mean (s.d.), kg/m2 | 25.6 (4.9) | 26.2 (5.0) | 25.5 (3.8) | 27.2 (6.3) |
Disease duration since diagnosis, median, years | 4.4 | 3.5 | 1.9 | 3.2 |
Concomitant csDMARDs, n (%) | 20 (47.6) | 14 (31.8) | 13 (29.5) | 10 (29.4) |
hsCRP ≥ULN 0.287 mg/dl, n (%) | 30 (71.4) | 35 (79.5) | 32 (72.7) | 24 (70.6) |
hsCRP ≥ULN 0.5 mg/dl, n (%) | 26 (61.9) | 30 (68.2) | 28 (63.6) | 18 (52.9) |
ASDAS, mean (s.d.) | 3.6 (0.8) | 3.7 (0.9) | 3.7 (0.8) | 3.7 (0.8) |
BASDAI, mean (s.d.) | 6.5 (1.3) | 6.4 (1.7) | 6.6 (1.4) | 6.7 (1.6) |
BASFI, mean (s.d.) | 5.4 (1.8) | 5.8 (2.3) | 5.6 (2.5) | 5.5 (2.5) |
SPARCC SI joint score, mean (s.d.) | 13.3 (15.4) | 12.7 (15.4) | 11.4 (15.0) | 8.0 (13.5) |
SPARCC spine score, mean (s.d.) | 14.9 (15.7) | 19.2 (18.7) | 17.3 (21.2) | 16.1 (18.5) |
Week 12 or study withdrawal. BID: twice daily; csDMARD: conventional synthetic DMARD; hsCRP: high-sensitivity CRP; SPARCC: SPondyloArthritis Research Consortium of Canada; ULN: upper limit of normal.