Summary of clinical response to golimumab at weeks 52, 100 and 160 of the GO-AFTER trial
| Placebo* | Golimumab 50 mg† | Golimumab 100 mg | |
|---|---|---|---|
| Number of randomised patients | 150 | 147 | 148 |
| Golimumab-treated patients with ACR response data at: | |||
| Weeks 52 and 100 | 150 | 147 | 148 |
| Week 160‡ | 75 | 81 | 81 |
| ACR20 response | |||
| Week 52 | 58/150 (38.7%) | 59/147 (40.1%) | 77/148 (52.0%) |
| Week 100 | 57/150 (38.0%) | 64/147 (43.5%) | 66/148 (44.6%) |
| Week 160 | 47/75 (62.7%) | 54/81 (66.7%) | 46/81 (56.8%) |
| ACR50 response | |||
| Week 52 | 32/150 (21.3%) | 27/147 (18.4%) | 35/148 (23.6%) |
| Week 100 | 36/150 (24.0%) | 36/147 (24.5%) | 37/148 (25.0%) |
| Week 160 | 25/75 (33.3%) | 36/81 (44.4%) | 29/81 (35.8%) |
| ACR70 response | |||
| Week 52 | 11/150 (7.3%) | 10/147 (6.8%) | 17/148 (11.5%) |
| Week 100 | 14/150 (9.3%) | 18/147 (12.2%) | 20/148 (13.5%) |
| Week 160 | 13/75 (17.3%) | 12/81 (14.8%) | 19/81 (23.5%) |
| DAS28-ESR§ response (good/moderate)¶ | |||
| Week 52 | 73/106 (68.9%) | 78/113 (69.0%) | 78/108 (72.2%) |
| Week 100 | 70/89 (78.7%) | 77/95 (81.1%) | 79/102 (77.5%) |
| Week 160 | 51/71 (71.8%) | 67/80 (83.8%) | 55/77 (71.4%) |
| DAS28-ESR§ remission (<2.6)¶ | |||
| Week 52 | 9/106 (8.5%) | 16/114 (14.0%) | 24/109 (22.0%) |
| Week 100 | 15/89 (16.9%) | 15/96 (15.6%) | 23/104 (22.1%) |
| Week 160 | 12/71 (16.9%) | 10/80 (12.5%) | 17/79 (21.5%) |
| DAS28-CRP response (good/moderate) | |||
| Week 52 | 72/150 (48.0%) | 80/147 (54.4%) | 94/148 (63.5%) |
| Week 100 | 71/150 (47.3%) | 79/147 (53.7%) | 87/148 (58.8%) |
| Week 160¶ | 54/70 (77.1%) | 66/80 (82.5%) | 61/77 (79.2%) |
| DAS28-CRP <3.2¶ | |||
| Week 52 | 30/104 (28.8%) | 33/115 (28.7%) | 39/107 (36.4%) |
| Week 100 | 43/87 (49.4%) | 37/96 (38.5%) | 43/100 (43.0%) |
| Week 160 | 30/70 (42.9%) | 32/80 (40.0%) | 35/78 (44.9%) |
| DAS28-CRP remission (<2.6) | |||
| Week 52 | 12/150 (8.0%) | 13/147 (8.8%) | 27/148 (18.2%) |
| Week 100 | 20/150 (13.3%) | 21/147 (14.3%) | 27/148 (18.2%) |
| Week 160¶ | 16/70 (22.9%) | 22/80 (27.5%) | 21/78 (26.9%) |
| SDAI remission (≤3.3)¶ | |||
| Week 52 | 6/104 (5.8%) | 9/115 (7.8%) | 14/107 (13.1%) |
| Week 100 | 8/87 (9.2%) | 11/96 (11.5%) | 15/100 (15.0%) |
| Week 160 | 8/70 (11.4%) | 7/80 (8.8%) | 18/78 (23.1%) |
| SDAI score >3.3 and <11 (low disease activity)¶ | |||
| Week 52 | 23/104 (22.1%) | 23/115 (20.0%) | 25/107 (23.4%) |
| Week 100 | 38/87 (43.7%) | 26/96 (27.1%) | 28/100 (28.0%) |
| Week 160 | 24/70 (34.3%) | 23/80 (28.8%) | 20/78 (25.6%) |
| SDAI score ≥11 and <26 (moderate disease activity)¶ | |||
| Week 52 | 42/104 (40.4%) | 49/115 (42.6%) | 40/107 (37.4%) |
| Week 100 | 22/87 (25.3%) | 31/96 (32.3%) | 33/100 (33.0%) |
| Week 160 | 23/70 (32.9%) | 35/80 (43.8%) | 25/78 (32.1%) |
| SDAI score ≥26 (severe disease activity)¶ | |||
| Week 52 | 33/104 (31.7%) | 34/115 (29.6%) | 28/107 (26.2%) |
| Week 100 | 19/87 (21.8%) | 28/96 (29.2%) | 24/100 (24.0%) |
| Week 160 | 15/70 (21.4%) | 15/80 (18.8%) | 15/78 (19.2%) |
| HAQ improvement ≥0.25¶ | |||
| Week 52 | 58/108 (53.7%) | 65/116 (56.0%) | 74/116 (63.8%) |
| Week 100 | 51/92 (55.4%) | 59/97 (60.8%) | 62/104 (59.6%) |
| Week 160 | 44/75 (58.7%) | 53/81 (65.4%) | 51/80 (63.8%) |
Data presented are median (interquartile range) or number (%) of randomised patients. 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 Groups 1, 2 and 3, respectively.
↵§ ESR determinations were not available for all patients at all time points; therefore, DAS28-ESR scores were determined in fewer patients.
↵¶ Analysis based on observed data.
ACR, American College of Rheumatology; CRP, C reactive protein; DAS, Disease Activity Score; EE, early escaped; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; SDAI, Simplified Disease Activity Index.