Week 24 Outcomes, % | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
DAS28 = 3.2 | DAS28 < 2.6 | CDAI = 10 | SDAI = 11 | |||||||||||||
≥ 50% SJC66 improvement by Week 8 | ||||||||||||||||
Sensitivity | Specificity | PPV | NPV | Sensitivity | Specificity | PPV | NPV | Sensitivity | Specificity | PPV | NPV | Sensitivity | Specificity | PPV | NPV | |
Placebo + DMARD | 69 | 63 | 9 | 98 | 80 | 63 | 4 | 99 | 70 | 66 | 19 | 95 | 70 | 66 | 19 | 95 |
TCZ 4 mg/kg + DMARD | 71 | 52 | 31 | 85 | 76 | 50 | 17 | 94 | 75 | 55 | 39 | 85 | 78 | 56 | 39 | 87 |
TCZ 8 mg/kg + DMARD | 68 | 56 | 51 | 72 | 71 | 53 | 35 | 84 | 75 | 56 | 44 | 83 | 75 | 57 | 46 | 82 |
Rapid3 at least moderate response by Week 8 | ||||||||||||||||
Placebo + DMARD | 67 | 52 | 6 | 97 | 75 | 51 | 3 | 99 | 65 | 52 | 14 | 93 | 64 | 52 | 13 | 93 |
TCZ 4 mg/kg + DMARD | 75 | 42 | 29 | 84 | 76 | 40 | 15 | 92 | 73 | 42 | 32 | 80 | 73 | 42 | 32 | 81 |
TCZ 8 mg/kg + DMARD | 78 | 41 | 47 | 73 | 80 | 38 | 31 | 84 | 78 | 38 | 37 | 79 | 77 | 39 | 38 | 77 |
CDAI: Clinical Disease Activity Index; DAS28: Disease Activity Score using 28 joints; DMARD-IR: DMARD inadequate response; NPV: negative predictive value; PPV: positive predictive value; RAPID3: Routine Assessment of Patient Index Data 3; SDAI: Simplified Disease Activity Index; SJC66: swollen joint count based on 66 joints; TCZ: tocilizumab.