Table 1.
Patients who discontinued study agent through week 252a
| Golimumab + MTX | ||||||
|---|---|---|---|---|---|---|
| Placebo + MTX | Golimumab 100 mg + placebo | 50 mg | 100 mg | Combined | Total | |
| Patients randomized, no. | 160 | 159 | 159 | 159 | 318 | 637 |
| Patients treated, no. | 160 | 157 | 158 | 159 | 317 | 634 |
| Patients who discontinued study agent | 50 (31.3) | 56 (35.7) | 49 (31.0) | 60 (37.7) | 109 (34.4) | 215 (33.9) |
| Reason for discontinuation | ||||||
| Initiated protocol‐prohibited medication(s) | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse event | 21 (13.1) | 32 (20.4) | 24 (15.2) | 34 (21.4) | 58 (18.3) | 111 (17.5) |
| Worsening of RA | 0 | 3 (1.9) | 0 | 1 (0.6) | 1 (0.3) | 4 (0.6) |
| Unsatisfactory therapeutic effect | 5 (3.1) | 6 (3.8) | 5 (3.2) | 7 (4.4) | 12 (3.8) | 23 (3.6) |
| Lost to followup | 3 (1.9) | 4 (2.5) | 7 (4.4) | 6 (3.8) | 13 (4.1) | 20 (3.2) |
| Death | 0 | 3 (1.9) | 3 (1.9) | 2 (1.3) | 5 (1.6) | 8 (1.3) |
| Other | 21 (13.1) | 11 (7.0) | 10 (6.3) | 11 (6.9) | 21 (6.6) | 53 (8.4) |
a
Values are the number (percentage) unless indicated otherwise. MTX = methotrexate; RA = rheumatoid arthritis.