Table 2

Summary of clinical efficacy at week 24* among efficacy-evaluable randomised patients receiving MTX at baseline

 Golimumab
Placebo50 mg100 mgCombined
Efficacy-evaluable randomised patients receiving study agent+MTX, n103101100201
ACR20 response15 (14.6%)36 (35.6%)46 (46.0%)82 (40.8%)
ACR50 response4 (3.9%)20 (19.8%)22 (22.0%)42 (20.9%)
ACR70 response3 (2.9%)12 (11.9%)11 (11.0%)23 (11.4%)
DAS28-CRP response24 (23.3%)49 (48.5%)65 (65.0%)114 (56.7%)
DAS28-CRP score <2.62 (1.9%)12 (11.9%)14 (14.0%)26 (12.9%)
DAS28-ESR response27 (26.2%)49 (48.5%)67 (67.0%)116 (57.7%)
DAS28-ESR score <2.61 (1.0%)11 (10.9%)16 (16.0%)27 (13.4%)
HAQ-DI ≥0.25-unit improvement35 (34.0%)48 (47.5%)54 (54.0%)102 (50.7%)
  • Data presented are number (%) of patients unless otherwise noted.

  • *For patients who early escaped, efficacy data from week 16 were carried forward for analysis at week 24.

  • †Excludes patients from a single site due to violations at the study site identified during the Sponsor's standard audit processes. These violations were not confirmed until after the initial publication of trial results, thus resulting in minor numerical differences in response rates between the initial report20 and the current paper regarding patients treated with golimumab+MTX.

  • ‡DAS28-CRP/ESR score indicating a ‘good’ or ‘moderate’ response.

  • ACR20, ACR 50, ACR70, at least 20%, 50%, or 70% improvement according to the American College of Rheumatology response criteria; CRP, C reactive protein; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate.