Interleukin 6 and Rheumatoid Arthritis

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	Δ−0.5	70	40	25	35	No difference of efficacy between TCZ and TCZ + MTX
			TCZ (8 mg/kg) + MTX	277	Δ−0.5	72	46	25	40, 5.6; (−2.4–13.7)
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
			ADA-SC (40 mg/2 weeks)	162	Δ−0.5	49	28	18	11
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
			TCZ-SC (162 mg/2 weeks)	173	57	79	63	37	50
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
			TCZ-SC (162 mg/week) + DMARD	631	65	69	47	24	38

^∗∗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.