Table 3

Proportion of subjects treated with combination therapy or methotrexate monotherapy who progressed >0.5 on X-ray (vdHS) and MRI (RAMRIS erosion) and the estimated sample size (per group) to achieve statistical significance at 80% power

MRI progression (12 weeks)MRI progression (24 weeks)X-ray progression (52 weeks)
NoYesNoYesNoYes
All participants(N=190)(N=194)(N=420)
 MTX monotherapy4616 (26%)4717 (27%)9744 (31%)
 Combination MTX+GLM10919 (15%)11020 (15%)21366 (24%)
 p value0.070.060.1
 Estimated group N229196581
Synovitis >5(N=147)(N=152) 
 MTX monotherapy3015 (33%)3216 (33%) 
 Combination MTX+GLM8517 (17%)8618 (17%) 
 p Value0.020.03 
 Estimated group N117127 
Bone oedema >5(N=109)(N=110) 
 MTX monotherapy2011 (35%)2012 (38%) 
 Combination MTX+GLM6414 (18%)6513 (17%) 
 p Value0.050.02 
 Estimated group N11080 
  • GLM, golimumab; MTX, methotrexate; RAMRIS, rheumatoid arthritis MRI score; vdHS, van der Heijde-Sharp.