Table 2.
Summary of clinical efficacy at week 24* among efficacy-evaluable randomised patients receiving MTX at baseline†
| Golimumab | ||||
|---|---|---|---|---|
| Placebo | 50 mg | 100 mg | Combined | |
| Efficacy-evaluable randomised patients receiving study agent+MTX, n | 103 | 101 | 100 | 201 |
| ACR20 response | 15 (14.6%) | 36 (35.6%) | 46 (46.0%) | 82 (40.8%) |
| ACR50 response | 4 (3.9%) | 20 (19.8%) | 22 (22.0%) | 42 (20.9%) |
| ACR70 response | 3 (2.9%) | 12 (11.9%) | 11 (11.0%) | 23 (11.4%) |
| DAS28-CRP response‡ | 24 (23.3%) | 49 (48.5%) | 65 (65.0%) | 114 (56.7%) |
| DAS28-CRP score <2.6 | 2 (1.9%) | 12 (11.9%) | 14 (14.0%) | 26 (12.9%) |
| DAS28-ESR response‡ | 27 (26.2%) | 49 (48.5%) | 67 (67.0%) | 116 (57.7%) |
| DAS28-ESR score <2.6 | 1 (1.0%) | 11 (10.9%) | 16 (16.0%) | 27 (13.4%) |
| HAQ-DI ≥0.25-unit improvement | 35 (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.