Summary of patient characteristics and RA medications at baseline of the GO-AFTER trial
| Placebo* | Golimumab 50 mg† | Golimumab 100 mg | |
|---|---|---|---|
| Number of randomised patients | 155 | 153 | 153 |
| Female | 132 (85.2%) | 113 (73.9%) | 122 (79.7%) |
| Age | 54.8±13.07 (54.0) | 53.9±11.47 (55.0) | 53.7±12.26 (55.0) |
| Disease duration (years) | 12.4±9.58 (9.8) | 12.4±9.24 (9.6) | 10.6±7.90 (8.7) |
| CRP (mg/dl) | 2.1±3.16 (1.0) | 2.2±2.97 (0.8) | 2.1±3.38 (0.8) |
| ESR (mm/h) | 38.4±26.27 (32.0) | 35.2±26.98 (27.5) | 37.9±29.92 (30.0) |
| Number of swollen joints (0–66) | 17.5±11.76 (14.0) | 17.8±11.82 (14.0) | 15.4±9.49 (13.0) |
| Number of tender joints (0–68) | 30.0±17.56 (26.0) | 30.6±16.86 (27.0) | 29.1±16.69 (26.0) |
| HAQ score (0–3) | 1.6±0.6 (1.8) | 1.6±0.7 (1.60) | 1.5±0.6 (1.5) |
| DAS28-ESR score (0–10) | 6.2±1.19 (6.3) | 6.3±1.25 (6.3) | 6.1±1.24 (6.1) |
| DAS28-CRP score (0–10) | 5.1±0.99 (5.1) | 5.3±1.05 (5.4) | 5.1±0.92 (5.1) |
| SDAI score (0–100) | 40.9±14.59 (38.4) | 43.2±15.89 (42.1) | 40.7±13.88 (40.3) |
| Previous anti-TNF for RA | 155 (100.0%) | 153 (100.0%) | 153 (100.0%) |
| Adalimumab, by reason for d/c | 85 (54.8%) | 72 (47.1%) | 65 (42.5%) |
| Lack of efficacy | 53 (34.2%) | 44 (28.8%) | 40 (26.1%) |
| Intolerance | 3 (1.9%) | 9 (5.9%) | 10 (6.5%) |
| Other | 29 (18.7%) | 19 (12.4%) | 15 (9.8%) |
| Etanercept, by reason for d/c | 73 (47.1%) | 76 (49.7%) | 73 (47.7%) |
| Lack of efficacy | 40 (25.8%) | 49 (32.0%) | 40 (26.1%) |
| Intolerance | 11 (7.1%) | 4 (2.6%) | 10 (6.5%) |
| Other | 22 (14.2%) | 23 (15.0%) | 23 (15.0%) |
| Infliximab, by reason for d/c | 83 (53.5%) | 64 (41.8%) | 71 (46.4%) |
| Lack of efficacy | 48 (31.0%) | 33 (21.6%) | 36 (23.5%) |
| Intolerance | 14 (9.0%) | 9 (5.9%) | 16 (10.5%) |
| Other | 21 (13.5%) | 22 (14.4%) | 19 (12.4%) |
| Methotrexate use at baseline | 102 (65.8%) | 103 (67.8%) | 100 (65.8%) |
| Number of previous anti-TNF agents‡ | |||
|---|---|---|---|
| 1 previous anti-TNF (n=292) | 2 previous anti-TNFs (n=113) | 3 previous anti-TNFs (n=40) | |
| Reason for d/c through week 160 | |||
| AE | 34 (11.6%) | 18 (15.9%) | 11 (27.5%) |
| Death | 3 (1.0%) | 0 (0.0%) | 0 (0.0%) |
| Lost to follow-up | 5 (1.7%) | 2 (1.8%) | 0 (0.0%) |
| Other | 33 (11.3%) | 9 (8.0%) | 2 (5.0%) |
| Unsatisfactory therapeutic effect | 48 (16.4%) | 29 (25.7%) | 15 (37.5%) |
Data presented are mean ±SD (median) or number (%) of randomised patients.
↵* 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.
↵‡ Based on the 445 patients included in efficacy analyses after exclusion of 16 patients at one study site.
AE, adverse event; CRP, C reactive protein; DAS, Disease Activity Score; d/c, discontinuation; EE, early escaped; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; RA, rheumatoid arthritis; SDAI, Simplified Disease Activity Index; TNF, tumour necrosis factor.