Table 2

Sustained efficacy outcomes

Group 1: placebo+MTX → golimumab 50 mg+MTXGroup 2: golimumab 100 mg+placeboGroup 3: golimumab 50 mg+MTXGroup 4: golimumab 100 mg+MTX
ITT responder analysis*
 ACR20 (%)29/37 (78.4)37/47 (78.7)48/53 (90.6)41/53 (77.4)
 ACR50 (%)13/18 (72.2)18/26 (69.2)26/33 (78.8)25/29 (86.2)
 ACR70 (%)6/7 (85.7)9/15 (60.0)14/18 (77.8)10/13 (76.9)
Sustained clinical response
 ACR20 (%)53/114 (46.5)50/109 (45.9)47/81 (58.0)40/74 (54.1)
 ACR50 (%)21/114 (18.4)23/109 (21.1)26/81 (32.1)22/74 (29.7)
 ACR70 (%)5/114 (4.4)11/109 (10.1)10/81 (12.3)12/74 (16.2)
Sustained DAS28 (using CRP) remission (%)21/109 (19.3)25/104 (24.0)28/76 (36.8)29/68 (42.6)
  • * Of the patients who met the ACR20, ACR50 or ACR70 response criteria at week 24 according to the ITT analysis, the proportions of patients who also met that response criteria at week 52 according to the ITT analysis.

  • ACR20, ACR50 or ACR70 response for six consecutive visits between weeks 4 and 52. Observed data were evaluated without imputation.

  • DAS28 less than 2.6 for six consecutive visits between weeks 4 and 52. DAS28 was calculated using CRP; ESR was not collected at every visit so DAS28 could not be calculated using ESR. Observed data were evaluated without imputation.

  • ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, 28-count disease activity score; ESR, erythrocyte sedimentation rate; ITT, intention-to-treat; MTX, methotrexate.