Radiographic changes in TCZ clinical trials assessing joint damage
| Study | Placebo+MTX | 4 mg/kg+MTX | 8 mg/kg+MTX | 8 mg/kg mono-therapy | DMARDs | Assessment |
|---|---|---|---|---|---|---|
| LITHE†44 | 1.13 | 0.34* | 0.29* | GTSS, mean change from baseline | ||
| SAMURAI†50 | 2.3 (1.5–3.2)** | 6.1 (4.2–8.0) | vdH-TSS, mean (95%CI) change from baseline | |||
| ACT-RAY†46 | 0.08 (1.88) | 0.22*** (1.11) | Change of GTSS at 6 months; mean (SD) | |||
| ACT-RAY†47 | 92.4% | 85.5%**** | No radiographic progression at 1 year |
*p<0.0001; **p<0.001; ***p=0.26; ****p=0.007; using as a cutoff the smallest detectable change of the Genant modified Sharp score of 1.5 (a relatively high value as a cutoff for non-progression; data on lower values, such as 0 or 0.25 are awaited).
†The LITHE and SAMURAI data, including p values, relate to 1 year study results; for ACT-RAY, data shown reflect 6-month analyses which showed no significant differences between TCZ monotherapy and combination with MTX.
DMARDs, disease modifying antirheumatic drugs; GTSS, Genant-modified total Sharp score; MTX, methotrexate; TCZ, tocilizumab; vdH-TSS, van der Heijde modified total Sharp score.