Summary of clinical response relative to the start of the LTE. Efficacy data are summarized as number (%) of randomized patients who were still participating at LTE-0 by response status at LTE-0, LTE-14, and LTE-24. Data for LTE-0 reflect the effects of intravenous golimumab during the main study.
| Placebo Plus MTX | Golimumab Only* | Golimumab Plus MTX | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 2 mg/kg | 4 mg/kg | Combined | 2 mg/kg** | 4 mg/kg** | EE/DRA to 2 mg/kg | EE/DRA to 4 mg/kg | Combined | ||
| Pts randomized | 129 | 128 | 129 | 257 | 129 | 128 | — | — | 257 |
| Pts randomized and still participating at LTE-0 | 3 | 59 | 63 | 122 | 82 | 104 | 24 | 173 | 383 |
| ACR 20 | |||||||||
| Responder at LTE-0 (IV) and Responder at: | 1 (33.3) | 31 (52.5) | 32 (50.8) | 63 (51.6) | 56 (68.3) | 65 (62.5) | 14 (58.3) | 86 (49.7) | 221 (57.7) |
| LTE-14 (SC) | 1 (100.0) | 25 (80.6) | 29 (90.6) | 54 (85.7) | 49 (87.5) | 60 (92.3) | 8 (57.1) | 70 (81.4) | 187 (84.6) |
| LTE-24 (SC) | 1 (100.0) | 27 (87.1) | 26 (81.3) | 53 (84.1) | 48 (85.7) | 59 (90.8) | 11 (78.6) | 73 (84.9) | 191 (86.4) |
| Nonresponder at LTE-0 (IV) and Responder at: | 2 (66.7) | 28 (47.5) | 31 (49.2) | 59 (48.4) | 26 (31.7) | 39 (37.5) | 10 (41.7) | 87 (50.3) | 162 (42.3) |
| LTE-14 (SC) | 1 (50.0) | 20 (71.4) | 16 (51.6) | 36 (61.0) | 10 (38.5) | 18 (46.2) | 5 (50.0) | 34 (39.1) | 67 (41.4) |
| LTE-24 (SC) | 1 (50.0) | 18 (64.3) | 14 (45.2) | 32 (54.2) | 13 (50.0) | 22 (56.4) | 5 (50.0) | 33 (37.9) | 73 (45.1) |
| ACR 50 | |||||||||
| Responder at LTE-0 (IV) and Responder at: | 0 (0.0) | 20 (33.9) | 16 (25.4) | 36 (29.5) | 36 (43.9) | 39 (37.5) | 5 (20.8) | 42 (24.3) | 122 (31.7) |
| LTE-14 (SC) | 0 (0.0) | 15 (75.0) | 12 (75.0) | 27 (75.0) | 31 (86.1) | 35 (89.7) | 3 (60.0) | 32 (76.2) | 101 (82.8) |
| LTE-24 (SC) | 0 (0.0) | 14 (70.0) | 11 (68.8) | 25 (69.4) | 28 (77.8) | 32 (82.1) | 4 (80.0) | 28 (66.7) | 92 (75.4) |
| Nonresponder at LTE-0 (IV) and Responder at: | 3 (100.0) | 39 (66.1) | 47 (74.6) | 86 (70.5) | 46 (56.1) | 65 (62.5) | 19 (79.2) | 131 (75.7) | 261 (68.3) |
| LTE-14 (SC) | 2 (66.7) | 12 (30.8) | 19 (40.4) | 31 (36.0) | 9 (19.6) | 17 (26.2) | 5 (26.3) | 23 (17.6) | 54 (20.7) |
| LTE-24 (SC) | 2 (66.7) | 15 (38.5) | 15 (31.9) | 30 (34.9) | 13 (28.3) | 19 (29.2) | 5 (26.3) | 29 (22.1) | 66 (25.3) |
| DAS28-CRP | |||||||||
| Good/moderate | |||||||||
| Responder at LTE-0 (IV) and Responder at: | 3 (100.0) | 42 (71.2) | 41 (65.1) | 83 (68.0) | 67 (81.7) | 81 (77.9) | 17 (70.8) | 115 (66.5) | 280 (73.1) |
| LTE-14 (SC) | 3 (100.0) | 40 (95.2) | 37 (90.2) | 77 (92.8) | 57 (85.1) | 76 (93.8) | 15 (88.2) | 102 (88.7) | 250 (89.3) |
| LTE-24 (SC) | 3 (100.0) | 38 (90.5) | 35 (85.4) | 73 (88.0) | 63 (94.0) | 78 (96.3) | 16 (94.1) | 101 (87.8) | 258 (92.1) |
| Nonresponder at LTE-0 (IV) and Responder at: | 0 (0.0) | 17 (28.8) | 22 (34.9) | 39 (32.0) | 13 (15.9) | 23 (22.1) | 7 (29.2) | 57 (32.9) | 100 (26.1) |
| LTE-14 (SC) | 0 (0.0) | 11 (64.7) | 16 (72.7) | 27 (69.2) | 9 (69.2) | 15 (65.2) | 3 (42.9) | 23 (40.4) | 50 (50.0) |
| LTE-24 (SC) | 0 (0.0) | 13 (76.5) | 18 (81.8) | 31 (79.5) | 7 (53.8) | 13 (56.5) | 4 (57.1) | 20 (35.1) | 44 (44.0) |
↵* Excludes patients who started MTX after LTE-14.
↵** Includes patients who started and/or adjusted MTX dose after LTE-14. ACR 20/50/70: 20%/50%/70% improvement in American College of Rheumatology response criteria; CRP: C-reactive protein; DAS28: 28-joint Disease Activity Score; DRA: dose regimen adjustment at Week 24; EE: early escape at Week 16; IV: intravenous; LTE: longterm extension; MTX: methotrexate; SC: subcutaneous.