Variables | Placebo Wks 0–16, n = 51 | CNTO6785 | ||||
---|---|---|---|---|---|---|
Placebo to 200 mg, Wks 16–38, n = 48 | 15 mg, Wks 0–38, n = 52 | 50 mg, Wks 0–38, n = 51 | 100 mg, Wks 0–38, n = 51 | 200 mg, Wks 0–38, n = 52 | ||
TEAE, n (%) | 16 (31.4) | 23 (47.9) | 29 (55.8) | 32 (62.7) | 41 (80.4) | 29 (55.8) |
Treatment-emergent SAE, n (%) | 1 (2.0) | 1 (2.1) | 2 (3.8) | 2 (3.9) | 5 (9.8) | 0 |
Study agent discontinuation due to TEAE, n (%) | 0 | 0 | 2 (3.8) | 3 (5.9) | 3 (5.9) | 0 |
Deaths, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
TEAE of interest, n (%) | 10 (19.6) | 19 (39.6) | 22 (42.3) | 27 (52.9) | 28 (54.9) | 21 (40.4) |
Infections | 8 (15.7) | 12 (25.0) | 16 (30.8) | 19 (37.3) | 21 (41.2) | 12 (23.1) |
Injection site reactions | 1 (2.0) | 8 (16.7) | 9 (17.3) | 13 (25.5) | 12 (23.5) | 10 (19.2) |
Major adverse cardiovascular event | 0 | 0 | 1 (1.9) | 0 | 0 | 0 |
Malignancies | 0 | 0 | 0 | 1 (2.0) | 0 | 0 |
Neutropenia or leucopenia | 1 (2.0) | 2 (4.2) | 1 (1.9) | 2 (3.9) | 3 (5.9) | 2 (3.8) |
TEAE of interest included neutropenia; decreases of leukocytes; infections including active tuberculosis, opportunistic infection, Candida infection, injection site reaction, newly identified malignancies, allergic reactions, major adverse cardiovascular events; and selected treatment-related SAE. TEAE: treatment-emergent adverse events; SAE: serious adverse events.