Patient disposition through week 104
Placebo | Golimumab 50 mg | Golimumab 100 mg | |
---|---|---|---|
Randomised patients | 113 | 146 | 146 |
Treated patients | 113 | 146 | 146 |
Treatment received* | |||
Golimumab 50 mg | 102 (90.3%) | 146 (100.0%) | 0 (0.0%) |
Placebo → golimumab 50 mg in early escape (weeks 16–104) | 51 (50.0%) | 0 (0.0%) | 0 (0.0%) |
Dose escalated to 100 mg (weeks 52–104) | 13/51 | 0 | 0 |
Placebo → golimumab 50 mg in crossover (weeks 24–104) | 51 (50.0%) | 0 (0.0%) | 0 (0.0%) |
Dose escalated to 100 mg (weeks 52–104) | 14/51 | 0 | 0 |
Golimumab 50 mg only | 0 (0.0%) | 118 (80.8%) | 0 (0.0%) |
Dose escalated to 100 mg (weeks 52–104) | 0 | 28/118 | 0 |
Golimumab 50 mg →100 mg in early escape (weeks 16–104) | 0 (0.0%) | 28 (19.2%) | 0 (0.0%) |
Golimumab 100 mg | 25 (22.1%) | 56 (38.4%) | 146 (100.0%) |
Patients who discontinued study agent | 25 (22.1%) | 28 (19.2%) | 17 (11.6%) |
Initiated protocol-prohibited medication | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Adverse event | 9 (8.0%) | 8 (5.5%) | 10 (6.8%) |
Worsening of psoriatic arthritis | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Unsatisfactory therapeutic effect | 6 (5.3%) | 5 (3.4%) | 4 (2.7%) |
Lost to follow-up | 1 (0.9%) | 4 (2.7%) | 1 (0.7%) |
Death | 0 (0.0%) | 1 (0.7%) | 0 (0.0%) |
Other | 9 (8.0%) | 10 (6.8%) | 2 (1.4%) |
*Patients randomised to placebo who did not early escape and discontinued study agent prior to week 24 are excluded.