Table 1.

Performance characteristics of early response criteria for disease activity outcomes at Week 24 (DMARD-IR population).

Week 24 Outcomes, %
DAS28 = 3.2DAS28 < 2.6CDAI = 10SDAI = 11
≥ 50% SJC66 improvement by Week 8
SensitivitySpecificityPPVNPVSensitivitySpecificityPPVNPVSensitivitySpecificityPPVNPVSensitivitySpecificityPPVNPV
Placebo + DMARD696399880634997066199570661995
TCZ 4 mg/kg + DMARD71523185765017947555398578563987
TCZ 8 mg/kg + DMARD68565172715335847556448375574682
Rapid3 at least moderate response by Week 8
Placebo + DMARD675269775513996552149364521393
TCZ 4 mg/kg + DMARD75422984764015927342328073423281
TCZ 8 mg/kg + DMARD78414773803831847838377977393877
  • 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.