RA-BEGIN (0–52 weeks)a | RA-BEAMa | RA-BUILD (0–24 weeks)a | RA-BEACON (0–24 weeks)a | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0–24 weeks | 0–52 weeksb | |||||||||||||
MTX (N = 210) | BARI 4 mg (N = 159) | MTX+ BARI 4 mg (N = 215) | PBO (N = 488) | BARI 4 mg (N = 487) | ADA (N = 330) | BARI 4 mg (N = 487) | ADA (N = 330) | PBO (N = 228) | BARI 2 mg (N = 229) | BARI 4 mg (N = 227) | PBO (N = 176) | BARI 2 mg (N = 174) | BARI 4 mg (N = 177) | |
Initiated interruptions (n) | 46 | 21 | 66 | 80 | 69 | 36 | 119 | 58 | 38 | 33 | 48 | 25 | 54 | 52 |
Study drug ever restarted | 42 (91.3) | 18 (85.7) | 60 (90.9) | 67 (83.8) | 62 (89.9) | 30 (83.3) | 106 (89.1) | 47 (81.0) | 33 (86.8) | 25 (75.8) | 41 (85.4) | 21 (84.0) | 47 (87.0) | 48 (92.3) |
Restarted during LTE | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 1 | 1 | 3 | 4 | 4 |
Total temporary interruptions (n) during studyc | 42 | 17 | 60 | 67 | 62 | 30 | 103 | 46 | 32 | 24 | 40 | 18 | 43 | 44 |
Patients with ≥ 1 interruption, n (%) | 31 (14.8) | 15 (9.4) | 48 (22.3) | 54 (11.1) | 50 (10.3) | 28 (8.5) | 75 (15.4) | 40 (12.1) | 29 (12.7) | 21 (9.2) | 34 (15.0) | 15 (8.5) | 31 (17.8) | 32 (18.1) |
Number of interruptions per interrupted patient, mean (SD) | 1.4 (0.6) | 1.1 (0.4) | 1.3 (0.4) | 1.2 (0.5) | 1.2 (0.4) | 1.1 (0.3) | 1.4 (0.6) | 1.2 (0.4) | 1.1 (0.4) | 1.1 (0.4) | 1.2 (0.4) | 1.2 (0.6) | 1.4 (0.6) | 1.4 (0.7) |
Time from first dose to first interruption, mean (SD), days | 120.7 (100.9) | 134.4 (113.5) | 146.6 (97.9) | 68.9 (43.0) | 70.6 (48.6) | 73.2 (49.4) | 126.9 (93.4) | 112.3 (74.0) | 53.1 (40.1) | 41.0 (39.3) | 53.6 (37.7) | 64.4 (39.1) | 63.1 (46.1) | 59.2 (43.1) |
Duration of individual interruptions, mean (SD), days | 16.3 (16.7) | 15.0 (14.9) | 17.5 (16.3) | 11.7 (13.2) | 11.4 (9.4) | 19.4 (24.6) | 15.1 (15.7) | 23.1 (29.1) | 11.6 (10.2) | 12.3 (12.6) | 10.7 (9.8) | 16.8 (10.0) | 12.9 (19.2) | 12.6 (9.5) |
Reason for interruptions, n (%) | ||||||||||||||
Adverse event | 36 (85.7) | 14 (82.4) | 53 (88.3) | 53 (79.1) | 57 (91.9) | 28 (93.3) | 95 (92.2) | 43 (93.5) | 26 (81.3) | 19 (79.2) | 32 (80.0) | 15 (83.3) | 36 (83.7) | 38 (86.4) |
AE reported as an abnormal lab resultd | 9 (25.0) | 0 | 9 (17.0) | 6 (11.3) | 9 (15.8) | 7 (25.0) | – | – | 2 (7.7) | 1 (5.3) | 0 | 1 (6.7) | 1 (2.8) | 1 (2.6) |
Abnormal laboratory result | 6 (14.3) | 3 (17.6) | 6 (10.0) | 11 (16.4) | 3 (4.8) | 0 | 6 (5.8) | 0 | 4 (12.5) | 5 (20.8) | 6 (15.0) | 2 (11.1) | 4 (9.3) | 4 (9.1) |
Investigator decision | 0 | 0 | 1 (1.7) | 3 (4.5) | 2 (3.2) | 2 (6.7) | 2 (1.9) | 3 (6.5) | 2 (6.3) | 0 | 2 (5.0) | 1 (5.6) | 3 (7.0) | 1 (2.3) |