Table 1: Randomized phase III controlled trials of tocilizumab.
(a) Clinical efficacy of tocilizumab (Tocilizumab combination therapy)

Study Population Week at evaluation Treatment arms Patient number HAQ (% ≥MCID) Response rates (%), OR (95% CI)DAS28 < 2.6 remission rate (%), OR (95% CI)
ACR20ACR50ACR70

TOWARD DMARDs-IR 24 W TCZ (8 mg/kg) + DMARDs 803 60****61****38****21****30****, 13.8
DMARDs 4133425 9 3 3

RADIATE Anti-TNF-IR 24 W TCZ (4 mg/kg) + MTX 161 30***17****5 8, 4.3
TCZ (8 mg/kg) + MTX 170 50***29****12****30***, 21
MTX 158 10 4 12

OPTION MTX-IR 24 W TCZ (4 mg/kg) + MTX 214 48****, 2.6 (1.7–3.9) 31****, 3.8 (2.3–6.5) 12****, 7.0 (2.4–20.4) 13***, 18.8 (2.5–142)
TCZ (8 mg/kg) + MTX 205 59****, 4.0 (2.6–6.1) 44****, 6.6 (3.9–11.2) 22****, 14.2 (5.0–40.4) 27****, 45 (6.1–332)
MTX 204 26 11 2 1

LITHE MTX-IR 52 W TCZ (4 mg/kg) + MTX 399 60 47*29*16*30*, 4.92
TCZ (8 mg/kg) + MTX 398 63*56****36****20****47****, 10.2
MTX 393 53 25 10 4 8

(b) Tocilizumab monotherapy

StudyPopulationWeek at evaluationTreatment armsPatient numberHAQ (% ≥MCID)Response rates (%), OR (95% CI)DAS28 < 2.6 remission rate (%), OR (95% CI)
ACR20 ACR50ACR70

AMBITION MTX, anti-TNF naïve 24 WTCZ (8 mg/kg) 286 70***44**28***34n.d., 5.83 (3.27–10.4)
MTX 284 53 34 15 12

SAMURAI DMARDs-IR 52 WTCZ (8 mg/kg) 157 68***78***64***44***59***, 46.5
DMARDs 145 40 34 13 6 3

SATORI MTX-IR 24 WTCZ (8 mg/kg) 61 67****80***49n.d.30n.d.43***, 37.0
MTX 64 34 25 11 6 2

, , , .
HAQ: health assessment questionnaire disability index; MCID: minimal clinical important difference; OR: odds ratio; CI: confidence interval; DMARDs: disease-modifying antirheumatic drugs; IR: inadequate response; TCZ: tocilizumab; TNF: tumor necrosis factor; MTX: methotrexate; n.d.: not described.
(c) Efficacy of tocilizumab in protection of radiographic progression of joints

Study Radiographic assessment Week at evaluation Treatment arms Proportion without progression TSS ≦ 0 Change in score (95% CI)
Total score Erosion score JSN score

SAMURAI van der Heijde-modified Sharp score 52 W TCZ (8 mg/kg) 56**2.3**, (1.5–3.2) 0.9***, (0.3–1.4) 1.5*, (0.9–2.1)
DMARDs 396.1 (4.2–8.0) 3.2 (2.1–4.3) 2.9 (2.0–3.8)

LITHE Genant-modified Sharp score 52 W TCZ (4 mg/kg) + MTX 81****0.34****0.21*0.13*
TCZ (8 mg/kg) + MTX 84****0.29****0.17****0.12**
MTX 671.130.710.42

, , , .
TSS: total Sharp score; CI: confidence interval; TCZ: tocilizumab; DMARDs: disease-modifying antirheumatic drugs; JSN: joint space narrowing; MTX: methotrexate.