Tocilizumab: pivotal randomised controlled trials in rheumatoid arthritis
| Study: Name/Author, PY | Previously failed | Comparators | Combi-nation | ACR20 | ACR50 | ACR70 | HAQ (% ≥MCID) | x-Ray | FU | |
|---|---|---|---|---|---|---|---|---|---|---|
| TCZ in combination therapy | OPTION 200811 | MTX | PL/TCZ 4/TCZ 8 | MTX | 26/48/59 | 11/31/44 | 2/12/22 | 47/61/59* | n.s. | 24 |
| TOWARD 200810 | DMARD | PL/TCZ 8 | DMARD | 25/61 | 9/38 | 3/21 | 34/60* | n.s. | 24 | |
| RADIATE 200819 | TNFi | PL/TCZ 4/TCZ 8 | MTX | 10/30/50 | 4/17/29 | 1/5/12 | Δ−0.4/−0.3/−0.1 | n.s. | 24 | |
| ROSE 201220 | DMARD | PL/TCZ 8 | DMARD | 11/30 | n.s. | n.s. | ||||
| LITHE 201113 | MTX | PL/TCZ 4/TCZ 8 | MTX | 25/47/56 | 10/29/36 | 4/16/20 | 53/60/63* | 1.1/0.3/0.3† | 52 | |
| NCT0010653518 | MTX | PL / TCZ 4/TCZ 8 | MTX | 27/51/56 | 10/25/32 | 2/11/13 | −0.3±0.5/−0.5±0.5/−0.5±0.6† | n.s. (yet) | 24 | |
| Lim 201219 | MTX | PL/TCZ 8 | MTX | 62/17 | 30/2 | 4/2 | n.s. | n.s. | 24 | |
| monotherapy versus Combination | CHARISMA 200615 | MTX | PL/2/4/8 TCZ-m vs. each dose TCZ-c+MTXHere: 4 m/4c//8m/8c | MTX | 61/63// 63/74 | 28/37// 41/53 | 6/12// 16/37 | n.s. | n.s. | 16 |
| ACT-RAY 201217 | MTX | TCZ 8 m/TCZ 8 | MTX | 71/72 | 41/45 | 26/25 | 33/33§ | 0.1(1.9)/0.2(1.1)§ | 24 | |
| NCT0089102022 | TNFi | TCZ 8 m / TCZ 4/TCZ 8 | DMARD | 48/45/50 | 25/24/27 | 7/9/10 | n.s. (yet) | n.s. (yet) | 24 | |
| TCZ monotherapy | Choy 20029 | DMARD | PL/single i.v. dose of 0.1/1/5/10 mg MRA | n.s. | n.s. | 2 | ||||
| Nishimoto 200416 | DMARD | PL/TCZ 4/TCZ 8 | 57/78 | 26/40 | 20/16 | n.s. | n.s. | 12 | ||
| AMBITION 20108 | (67% MTX-naïve pts.) | MTX/TCZ 8 | 52/70 (54/69) | 34/44 (33/45) | 15/28 (14/27) | Δ−0.5/−0.7 | n.s. | 24 | ||
| SATORI 200914 | MTX | MTX/TCZ 8 | 25/80 | 11/49 | 6/30 | 34/67%¶ | n.s. | 24 | ||
| SAMURAI 200712 | DMARD | DMARDs/TCZ 8 | 34/78 | 13/64 | 6/44 | 40/68%¶ | 6.1 (4.2–8.0)/2.3 (1.5–3.2)** | 52 |
ACR, American College of Rheumatology; DMARD, disease modifying antirheumatic drug; FU, follow-up (weeks); MCID, minimally clinical important difference; MTX, methotrexate; PL, placebo; PY, year of publication; TCZ, tocilizumab; TCZ-m, tocilizumab-monotherapy; TCZ-c, tocilizumab in combination therapy; TNFi, tumour necrosis factor inhibitor; TNFi, tumour necrosis factor inhibitor *MCID HAQ>0.3.
†total Genant-modified Sharp Score (GTSS), mean change from BL.
§GTSS, BL annualised progression rate; mean (SD).
¶MCID HAQ≥0.22; Δ mean change from BL; GTSS, total Genant modified Sharp Score.
**vdH-TSS, mean (95%CI) change from baseline TCZ doses are abbreviated with ‘8’=8 mg/kg 4 weekly and ‘4’=4 mg/kg 4 weekly.