Table 2: Pivotal clinical trials of tocilizumab.

Study Population Week at evaluation Treatment arms Patient number HAQ (% ≥MCID) Response rates (%), OR (95% CI) DAS28 remission rate (%), OR (95% CI) Conclusion
ACR20 ACR50 ACR70

ACT-RAY MTX-IR 24 W TCZ (8 mg/kg) + PBO 276 70 40 25 35 No difference of efficacy between TCZ and TCZ + MTX
TCZ (8 mg/kg) + MTX 277 72 46 25 40, 5.6
(−2.4–13.7)

ADACTA MTX-IR 24 W TCZ-IV (8 mg/kg/4 weeks) 163 65** 
2.0
(1.2–3.1)
47*** 
2.4
(1.5–3.9)
33** 
2.3
(1.3–3.8)
40**** 
5.7
(3.1–10.3)
TCZ is superior to ADA as monotherapy 
ADA-SC (40 mg/2 weeks) 162 49 28 18 11

MUSASHI MTX-IR24 W TCZ-IV (8 mg/kg/4 weeks) 173 68 89 67 41 62 Noninferiority of TCZ-SC to TCZ-IV
TCZ-SC (162 mg/2 weeks)173 57 79 63 37 50

SUMMACTA DMARDs-IR24 W TCZ-IV (8 mg/kg/4 weeks) + DMARD 631 67 73 48 27 36 Noninferiority of TCZ-SC to TCZ-IV 
TCZ-SC (162 mg/week) + DMARD 631 65 69 47 24 38

, , .
HAQ: health assessment questionnaire disability index; MCID: minimal clinical important difference; OR: odds ratio; CI: confidence interval; MTX: methotrexate; IR: inadequate response; TCZ: tocilizumab; PBO: placebo; IV: intravenous injection; ADA: adalimumab; SC: subcutaneous injection; DMARDs: disease-modifying antirheumatic drugs.