Sustained clinical response to golimumab in the GO-AFTER trial
| Placebo* | Golimumab 50 mg† | Golimumab 100 mg | |
|---|---|---|---|
| Number of randomised patients | 150 | 147 | 148 |
| Golimumab-treated patients with response data at: | |||
| Weeks 52 and 100 | 150 | 147 | 148 |
| Week 160‡ | 75 | 81 | 81 |
| ACR20 response at both week 24 and week 100§¶ | 38/54 (70.4%) | 40/55 (72.7%) | |
| ACR20 response relative to dose escalation (50→100 mg) among patients with ample data¶ | |||
| Previous to dose escalation | 43/117 (36.8%) | ||
| 12 weeks after dose escalation | 48/100 (48.0%) | ||
| 24 weeks after dose escalation | 36/69 (52.2%) | ||
| ACR50 response at both week 24 and week 100§¶ | 20/25 (80.0%) | 15/26 (57.7%) | |
| ACR50 response relative to dose escalation (50→100 mg) among patients with ample data¶ | |||
| Previous to dose escalation | 9/117 (7.7%) | ||
| 12 weeks after dose escalation | 21/100 (21.0%) | ||
| 24 weeks after dose escalation | 18/69 (26.1%) | ||
| ACR70 response at both week 24 and week 100 | 10/14 (71.4%) | 6/11 (54.5%) | |
| DAS28-ESR** response at both week 24 and week 100 | 55/67 (82.1%) | 63/77 (81.8%) | |
| DAS28-ESR** response relative to dose escalation (50→100 mg) among patients with ample data¶ | |||
| Previous to dose escalation | 17/35 (48.6%) | ||
| 12 weeks after dose escalation | 19/30 (63.3%) | ||
| 24 weeks after dose escalation | 21/29 (72.4%) | ||
| DAS28-CRP response at both week 24 and week 100 | 55/71 (77.5%) | 62/74 (83.8%) | |
| DAS28-CRP response relative to dose escalation (50→100 mg) among patients with ample data¶ | |||
| Previous to dose escalation | 63/113 (55.8%) | ||
| 12 weeks after dose escalation | 65/98 (66.3%) | ||
| 24 weeks after dose escalation | 46/66 (69.7%) | ||
| HAQ improvement ≥0.25 at both week 24 and week 100¶ | 55/68 (80.9%) | 55/73 (75.3%) | |
Data presented are median (interquartile range) or number (%) of randomised patients with sufficient data. Efficacy data pertaining to 16 patients (5, 6 and 5 patients randomised to placebo, golimumab 50 mg and golimumab 100 mg, respectively) at site 7465 were excluded due to violations at the study site identified during the sponsor's standard audit processes.
↵* Includes patients who EE at week 16 or crossed over at week 24 to receive golimumab 50 mg or dose escalated after the week 24 database lock to receive golimumab 100 mg.
↵† Includes patients who EE at week 16 or dose escalated after the week 24 database lock to receive golimumab 100 mg.
↵‡ By week 160, only 75, 81 and 81 patients had ACR response data in the placebo, golimumab 50 mg and golimumab 100 mg groups.
↵§ Based on the week 24 responders who remained in the trial at week 100 for response rates at weeks 52, 100 and 160, respectively.
↵¶ Analysis based on observed data.
↵** ESR determinations were not available for all patients at all time points; therefore, DAS28-ESR scores were determined in fewer patients.
ACR, American College of Rheumatology; CRP, C reactive protein; DAS, Disease Activity Score; EE, early escaped; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire.