Table 3.
ACR responses in MTX/placebo-controlled trials (percentage of patients).
| Response rate week 24 | AMBITION MTX naïve | LITHE Inadequate response to MTX | OPTION Inadequate response to MTX | TOWARD Inadequate response to DMARD | RADIATE Inadequate response to TNF blocking agent | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MTX | TCZ 8 mg/kg | Placebo + MTX | TCZ 4 mg/kg + MTX | TCZ 8 mg/kg + MTX | Placebo + MTX | TCZ 4 mg/kg + MTX | TCZ 8 mg/kg + MTX | Placebo +DMARDs | TCZ 8 mg/kg +DMARDs | Placebo + MTX | TCZ 4 mg/kg + MTX | TCZ 8 mg/kg + MTX | |
| N = 284 | N = 286 | N = 393 | N = 399 | N = 398 | N = 204 | N = 213 | N = 205 | N = 413 | N = 803 | N = 158 | N = 161 | N = 170 | |
| ACR20 | |||||||||||||
| 53% | 70%*** | 27% | 51% | 56%*** | 27% | 48% | 59%*** | 25% | 61%*** | 10% | 30% | 50%*** | |
| ACR50 | |||||||||||||
| 34% | 44%** | 10% | 25% | 32%*** | 11% | 32% | 44%*** | 9% | 38%*** | 4% | 17% | 29%*** | |
| ACR70 | |||||||||||||
| 15% | 28%** | 2% | 11% | 13%*** | 2% | 12% | 22%*** | 3% | 21%*** | 1% | 5% | 12%** | |
MTX, methotrexate; TCZ, tocilizumab; TNF, tumor necrosis factor; DMARD, disease-modifying antirheumatic drug; ACR, American College of Rheumatology.
*
p < 0.05, tocilizumab versus placebo + MTX/DMARD.
**
p < 0.01, tocilizumab versus placebo + MTX/DMARD.
***
p < 0.0001, tocilizumab versus placebo + MTX/DMARD.