Table 1.
Event | Week |
||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 4 | 8 | 12 | 16 | 20 | 24 | 32 | 40 | 52 | LTE → | 56 | 64 | 76 | 88 | 100 | 112 | 124 | 136 | 148 | |
Treatment at randomization: Bari 4 mg (N =159) | |||||||||||||||||||||
Rescue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (3.1) | 7 (4.4) | 7 (4.4) | 7 (4.4) | Bari 4 mg Orig. group: Bari 4 mg | 14 (8.8) | 22 (13.8) | 24 (15.1) | 26 (16.4) | 28 (17.6) | 29 (18.2) | 29 (18.2) | 30 (18.9) | 31 (19.5) |
Discontinuation | 1 (0.6) | 1 (0.6) | 1 (0.6) | 3 (1.9) | 3 (1.9) | 6 (3.8) | 9 (5.7) | 13 (8.2) | 18 (11.3) | 20 (12.6) | 23 (14.5) | 23 (14.5) | 25 (15.7) | 27 (17.0) | 32 (20.1) | 33 (20.8) | 34 (21.4) | 35 (22.0) | 36 (22.6) | 37 (23.3) | |
Dose step-down to bari 2 mg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 (3.8) | 10 (6.3) | 13 (8.2) | 13 (8.2) | 14 (8.8) | 14 (8.8) | 15 (9.4) | 15 (9.4) | |
Treatment at randomization: Bari 4 mg + MTX (N =215) | |||||||||||||||||||||
Rescue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (1.9) | 5 (2.3) | 6 (2.8) | 6 (2.8) | Bari 4 mg Orig. group: Bari 4 mg + MTX | 12 (5.6) | 17 (7.9) | 20 (9.3) | 20 (9.3) | 22 (10.2) | 26 (12.1) | 27 (12.6) | 28 (13.0) | 28 (13.0) |
Discontinuation | 3 (1.4) | 7 (3.3) | 7 (3.3) | 12 (5.6) | 13 (6.0) | 18 (8.4) | 20 (9.3) | 22 (10.2) | 28 (13.0) | 35 (16.3) | 40 (18.6) | 44 (20.5) | 47 (21.9) | 51 (23.7) | 54 (25.1) | 55 (25.6) | 57 (26.5) | 62 (28.8) | 62 (28.8) | 65 (30.2) | |
Dose step-down to bari 2 mg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 (7.0) | 24 (11.2) | 25 (11.6) | 31 (14.4) | 34 (15.8) | 37 (17.2) | 38 (17.7) | 38 (17.7) | |
Treatment at randomization: MTX (N =210) | |||||||||||||||||||||
Rescue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 18 (8.6) | 24 (11.4) | 26 (12.4) | 26 (12.4) | Bari 4 mg Orig. group: MTX | 29 (13.8) | 33 (15.7) | 37 (17.6) | 37 (17.6) | 39 (18.6) | 39 (18.6) | 39 (18.6) | 41 (19.5) | 41 (19.5) |
Discontinuation | 3 (1.4) | 5 (2.4) | 6 (2.9) | 13 (6.2) | 16 (7.6) | 20 (9.5) | 25 (11.9) | 27 (12.9) | 32 (15.2) | 38 (18.1) | 45 (21.4) | 49 (23.3) | 52 (24.8) | 57 (27.1) | 58 (27.6) | 61 (29.0) | 64 (30.5) | 66 (31.4) | 69 (32.9) | 74 (35.2) | |
Dose step-down to bari 2 mg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 (7.1) | 21 (10.0) | 29 (13.8) | 31 (14.8) |
Data are reported as n (%) and include up to 96 additional weeks in RA-BEYOND. Bari, baricitinib; LTE, long-term extension; orig., original.