. 2014 Jan 12;2014:698313. doi: 10.1155/2014/698313

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
Study	Population	Week at evaluation	Treatment arms	Patient number	HAQ (% ≥MCID)	ACR20	ACR50	ACR70	DAS28 remission rate (%), OR (95% CI)	Conclusion
ACT-RAY	MTX-IR	24 W	TCZ (8 mg/kg) + PBO	276	Δ − 0.5	70	40	25	35	No difference of efficacy between TCZ and TCZ + MTX
ACT-RAY	MTX-IR	24 W	TCZ (8 mg/kg) + MTX	277	Δ − 0.5	72	46	25	40, 5.6 (−2.4–13.7)	No difference of efficacy between TCZ and TCZ + MTX

ADACTA	MTX-IR	24 W	TCZ-IV (8 mg/kg/4 weeks)	163	Δ − 0.7	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
ADACTA	MTX-IR	24 W	ADA-SC (40 mg/2 weeks)	162	Δ − 0.5	49	28	18	11	TCZ is superior to ADA as monotherapy

MUSASHI	MTX-IR	24 W	TCZ-IV (8 mg/kg/4 weeks)	173	68	89	67	41	62	Noninferiority of TCZ-SC to TCZ-IV
MUSASHI	MTX-IR	24 W	TCZ-SC (162 mg/2 weeks)	173	57	79	63	37	50	Noninferiority of TCZ-SC to TCZ-IV

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

**P < 0.01, ***P < 0.001, ****P < 0.0001.

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.