Table 1B

Radiographic changes in TCZ clinical trials assessing joint damage

StudyPlacebo+MTX4 mg/kg+MTX8 mg/kg+MTX8 mg/kg mono-therapyDMARDsAssessment
LITHE†441.130.34*0.29*GTSS, mean change from baseline
SAMURAI†502.3 (1.5–3.2)**6.1 (4.2–8.0)vdH-TSS, mean (95%CI) change from baseline
ACT-RAY†460.08 (1.88)0.22*** (1.11)Change of GTSS at 6 months; mean (SD)
ACT-RAY†4792.4%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.