Table 1.
Demographics and baseline disease characteristics
| Patient characteristic | Dose received in preceding phase II trial | Total (N = 611) | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 116) | Peficitinib 25 mg (n = 112) | Peficitinib 50 mg (n = 124) | Peficitinib 100 mg (n = 128) | Peficitinib 150 mg (n = 131) | ||
| Prior trial participation, n (%) | ||||||
| ‘With MTX’ trial | 67 (57.8) | 61 (54.5) | 76 (61.3) | 77 (60.2) | 71 (54.2) | 352 (57.6) |
| ‘Without MTX’ trial | 49 (42.2) | 51 (45.5) | 48 (38.7) | 51 (39.8) | 60 (45.8) | 259 (42.4) |
| Female, n (%) | 99 (85.3) | 93 (83.0) | 102 (82.3) | 106 (82.8) | 104 (79.4) | 504 (82.5) |
| Age, mean (SD), years | 52.4 (12.1) | 52.2 (11.5) | 53.3 (11.5) | 54.5 (12.1) | 54.2 (12.4) | 53.4 (11.9) |
| BMI, mean (SD), kg/m2 | 28.6 (6.2) | 28.7 (6.1) | 29.0 (6.6) | 29.0 (7.0) | 28.2 (6.1) | 28.7 (6.4) |
| Hispanic or Latino, n (%) | 27 (23.3) | 34 (30.4) | 36 (29.0) | 36 (28.1) | 29 (22.1) | 162 (26.5) |
| RA duration, mean (SD), years | 8.4 (7.9) | 9.0 (7.2) | 8.4 (8.2) | 9.1 (8.4) | 8.8 (7.1) | 8.8 (7.8) |
| Prior bDMARD use, n (%) | 42 (36.2) | 39 (34.8) | 44 (35.5) | 44 (34.4) | 48 (36.6) | 217 (35.5) |
| Number of previous bDMARDs, n (%) | ||||||
| 1 | 15 (12.9) | 12 (10.7) | 19 (15.3) | 16 (12.5) | 17 (13.0) | 79 (12.9) |
| 2 | 11 (9.5) | 16 (14.3) | 14 (11.3) | 15 (11.7) | 16 (12.2) | 72 (11.8) |
| ≥ 3 | 16 (13.8) | 11 (9.8) | 11 (8.9) | 13 (10.2) | 15 (11.5) | 66 (10.8) |
| Prior anti-TNF use, n (%) | 39 (33.6) | 32 (28.6) | 41 (33.1) | 40 (31.3) | 38 (29.0) | 190 (31.1) |
| Concomitant MTX use, n (%) | 70 (60.3) | 62 (55.4) | 77 (62.1) | 80 (62.5) | 77 (58.8) | 366 (59.9) |
| Concomitant corticosteroids, n (%) | ||||||
| Prednisone | 27 (23.3) | 28 (25.0) | 40 (32.3) | 31 (24.2) | 34 (26.0) | 160 (26.2) |
| Methylprednisolone | 29 (25.0) | 27 (24.1) | 28 (22.6) | 37 (28.9) | 21 (16.0) | 142 (23.2) |
| Prednisolone | 3 (2.6) | 2 (1.8) | 3 (2.4) | 3 (2.3) | 2 (1.5) | 13 (2.1) |
| Dexamethasone | 2 (1.7) | 3 (2.7) | 2 (1.6) | 4 (3.1) | 1 (0.8) | 12 (2.0) |
| Beclometasone | 1 (0.9) | 1 (0.9) | 0 | 1 (0.8) | 0 | 3 (0.5) |
| Liothyronine | 1 (0.9) | 2 (1.8) | 0 | 0 | 0 | 3 (0.5) |
| Diprosan | 0 | 0 | 2 (1.6) | 0 | 0 | 2 (0.3) |
| Corticosteroidsa | 1 (0.9) | 0 | 0 | 0 | 0 | 1 (0.2) |
| Concomitant SSZ | 17 (14.7) | 9 (8.0) | 2 (1.6) | 9 (7.0) | 11 (8.4) | 48 (7.9) |
| Concomitant anti-malarial | 7 (6.0) | 18 (16.1) | 13 (10.5) | 15 (11.7) | 10 (7.6) | 63 (10.3) |
| Geographic region, n (%) | ||||||
| North America | 48 (41.4) | 46 (41.1) | 54 (43.5) | 52 (40.6) | 56 (42.7) | 256 (41.9) |
| Europe | 51 (44.0) | 47 (42.0) | 49 (39.5) | 56 (43.8) | 55 (42.0) | 258 (42.2) |
| Latin America | 17 (14.7) | 19 (17.0) | 21 (16.9) | 20 (15.6) | 20 (15.3) | 97 (15.9) |
| Baseline disease activity, mean (SD) | ||||||
| SDAI | 24.7 (16.7) | 26.1 (16.7) | 20.3 (15.4) | 20.3 (16.6) | 19.3 (17.3) | 22.0 (16.7) |
| CDAI | 23.4 (16.2) | 25.0 (16.3) | 19.4 (14.9) | 19.3 (16.1) | 18.5 (16.9) | 21.0 (16.2) |
| TJC68 | 14.2 (13.1) | 14.9 (14.0) | 11.3 (12.6) | 12.3 (13.3) | 12.0 (15.2) | 12.9 (13.7) |
| SJC66 | 7.7 (9.0) | 8.5 (8.4) | 5.7 (6.9) | 6.4 (7.6) | 5.9 (7.8) | 6.8 (8.0) |
| CRP, mg/dl | 1.3 (1.6) | 1.1 (1.3) | 1.0 (1.3) | 1.0 (1.5) | 0.8 (1.3) | 1.0 (1.4) |
| ESR, mm/h | 31.9 (21.5) | 31.1 (19.1) | 32.0 (24.1) | 27.2 (19.0) | 23.5 (19.5) | 29.0 (20.9) |
| SGAP (100 mm VAS) | 48.7 (28.0) | 49.5 (27.1) | 41.5 (28.2) | 37.8 (27.0) | 37.2 (26.1) | 42.6 (27.7) |
| SGA (100 mm VAS) | 48.6 (26.7) | 50.7 (25.9) | 41.0 (26.8) | 38.6 (26.9) | 37.1 (25.5) | 42.8 (26.8) |
| PGA (100 mm VAS) | 39.2 (25.5) | 40.3 (26.3) | 30.7 (24.0) | 29.3 (24.4) | 28.0 (25.1) | 33.2 (25.5) |
| HAQ-DI | 1.2 (0.7) | 1.2 (0.7) | 1.1 (0.7) | 1.0 (0.7) | 1.0 (0.7) | 1.1 (0.7) |
| DAS28(ESR) | 5.0 (1.5) | 5.1 (1.6) | 4.6 (1.6) | 4.4 (1.7) | 4.2 (1.7) | 4.6 (1.7) |
| DAS28(CRP) | 4.4 (1.5) | 4.5 (1.6) | 4.0 (1.5) | 3.9 (1.6) | 3.8 (1.5) | 4.1 (1.6) |
Baseline characteristics were measured at baseline for this LTE study
bDMARD biological disease-modifying anti-rheumatic drug; BMI body mass index; CDAI Clinical Disease Activity Index; CRP C-reactive protein; DAS28 disease activity score in 28 joints; ESR erythrocyte sedimentation rate; HAQ-DI Health Assessment Questionnaire-Disability Index; MTX methotrexate; SD standard deviation; SDAI Simplified Disease Activity Index; SGA subject global assessment; SGAP subject global assessment of arthritis pain; PGA physician global assessment; RA rheumatoid arthritis; SJC swollen joint count; SSZ sulfasalazine; TJC tender joint count; TNF tumor necrosis factor; VAS visual analog scale
aOne patient that previously received placebo in their preceding phase II trial was recorded as having received concomitant corticosteroids during this study; it is unknown which corticosteroid was administered