Table 1 Patient demographics, baseline disease characteristics, and prior DMARD exposure
Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | |||||||
|---|---|---|---|---|---|---|---|---|---|
Non-MTX csDMARD-IRa (n = 208) | MTX-IRb (n = 1147) | bDMARD-IR (n = 270) | Non-MTX csDMARD-IRa (n = 247) | MTX-IRb (n = 1192) | bDMARD-IR (n = 289) | Non-MTX csDMARD-IRa (n = 82) | MTX-IRb (n = 774) | bDMARD-IR (n = 223) | |
Age, years | |||||||||
Mean (SD) | 50.3 (11.9) | 52.5 (11.8) | 54.6 (11.1) | 50.7 (12.4) | 52.3 (11.6) | 54.6 (10.8) | 49.7 (11.7) | 52.3 (12.1) | 53.7 (12.0) |
Median (range) | 51.0 (18–76) | 53.0 (18–86) | 55.0 (20–83) | 51.0 (18–80) | 53.0 (18–85) | 56.0 (21–84) | 50.0 (18–73) | 54.0 (18–81) | 54.0 (20–82) |
Female, n (%) | 167 (80.3) | 967 (84.3) | 227 (84.1) | 211 (85.4) | 1004 (84.2) | 236 (81.7) | 69 (84.1) | 638 (82.4) | 179 (80.3) |
RA duration, years | |||||||||
Mean (SD) | 5.2 (7.1) | 8.1 (7.5) | 12.0 (8.9) | 6.7 (7.7) | 8.1 (7.8) | 12.2 (8.5) | 7.2 (7.7) | 8.6 (8.2) | 11.6 (8.8) |
Median (range) | 2.0 (0.0–34.0) | 5.6 (0.1–46.0) | 10.0 (0.9–55.0) | 3.3 (0.1–34.0) | 5.6 (0.1–49.0) | 10.8 (0.4–45.0) | 4.5 (0.1–36.0) | 6.0 (0.3–49.4) | 9.8 (0.3–47.0) |
DAS28-4(ESR), mean (SD) | 6.5 (0.9) | 6.4 (1.0) | 6.5 (1.0) | 6.4 (0.9) | 6.4 (1.0) | 6.4 (1.0) | 6.2 (0.8) | 6.3 (1.0) | 6.4 (1.1) |
HAQ-DI score, mean (SD) | 1.5 (0.6) | 1.4 (0.7) | 1.6 (0.6) | 1.4 (0.7) | 1.4 (0.7) | 1.5 (0.6) | 1.4 (0.7) | 1.4 (0.7) | 1.6 (0.6) |
Concomitant corticosteroid use, n (%) | 132 (63.5) | 775 (67.6) | 196 (72.6) | 150 (60.7) | 773 (64.8) | 217 (75.1) | 43 (52.4) | 508 (65.6) | 161 (72.2) |
Corticosteroid dose, mg | |||||||||
Mean (SD) | 4.0 (3.9) | 4.0 (3.9) | 4.5 (4.1) | 4.6 (13.9) | 3.9 (4.0) | 4.4 (3.9) | 3.1 (4.1) | 3.7 (3.8) | 4.6 (4.0) |
Prior treatment with specific csDMARDs, n (%) | |||||||||
Chloroquine | 41 (19.7) | 165 (14.4) | 9 (3.3) | 47 (19.0) | 163 (13.7) | 16 (5.5) | 7 (8.5) | 103 (13.3) | 7 (3.1) |
Hydroxychloroquine | 78 (37.5) | 255 (22.2) | 54 (20.0) | 101 (40.9) | 271 (22.7) | 63 (21.8) | 21 (25.6) | 165 (21.3) | 38 (17.0) |
Leflunomide | 45 (21.6) | 256 (22.3) | 70 (25.9) | 46 (18.6) | 237 (19.9) | 75 (26.0) | 13 (15.9) | 146 (18.9) | 44 (19.7) |
MTX | 13 (6.3) | 1147 (100.0) | 260 (96.3) | 17 (6.9) | 1192 (100.0) | 271 (93.8) | 9 (11.0) | 774 (100.0) | 216 (96.9) |
Sulfasalazine | 69 (33.2) | 289 (25.2) | 52 (19.3) | 79 (32.0) | 333 (27.9) | 55 (19.0) | 19 (23.2) | 212 (27.4) | 34 (15.3) |
Other | 14 (6.7) | 131 (11.4) | 29 (10.7) | 18 (7.3) | 114 (9.6) | 36 (12.5) | 11 (13.4) | 88 (11.4) | 16 (7.2) |
Number of failed bDMARDs, n (%) | |||||||||
1 | NA | NA | 168 (62.2) | NA | NA | 183 (63.3) | NA | NA | 137 (61.4) |
2 | NA | NA | 81 (30.0) | NA | NA | 65 (22.5) | NA | NA | 66 (29.6) |
≥ 3 | NA | NA | 21 (7.8) | NA | NA | 41 (14.2) | NA | NA | 20 (9.0) |
Type of failed bDMARD, n (%) | |||||||||
TNFi | NA | NA | 234 (86.7) | NA | NA | 244 (84.4) | NA | NA | 195 (87.4) |
Non-TNFi | NA | NA | 15 (5.6) | NA | NA | 8 (2.8) | NA | NA | 10 (4.5) |
Both TNFi and non-TNFi | NA | NA | 21 (7.8) | NA | NA | 37 (12.8) | NA | NA | 18 (8.1) |
RA duration in patients with bDMARD failure, years | |||||||||
1 failed bDMARD | |||||||||
Mean (SD) | NA | NA | 11.6 (8.5) | NA | NA | 11.8 (8.3) | NA | NA | 11.1 (8.7) |
Median (range) | NA | NA | 9.7 (1.0–38.0) | NA | NA | 10.6 (0.6–40.0) | NA | NA | 9.0 (0.3–47.0) |
≥ 2 failed bDMARDs | |||||||||
Mean (SD) | NA | NA | 12.6 (9.6) | NA | NA | 12.7 (8.9) | NA | NA | 12.4 (9.0) |
Median (range) | NA | NA | 10.3 (0.9–55.0) | NA | NA | 11.0 (0.4–45.0) | NA | NA | 11.0 (1.1–39.0) |