Summary of efficacy findings. Efficacy data are summarized as number (%) of randomized patients achieving response at Week 48 of the main study or number (%) of patients participating at LTE-0 achieving response at LTE-14 and LTE-24. Data for Week 48 reflect the effects of IV 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 | 53 | 57 | 110 | 83 | 104 | 23 | 163 | 373 |
| ACR20 | |||||||||
| Wk 48 (IV)† | 28 (21.7) | 31 (24.2) | 34 (26.4) | 65 (25.3) | 58 (45.0) | 63 (49.2) | ND | ND | 121 (47.1) |
| p†† | 0.63 | 0.38 | 0.43 | < 0.001 | < 0.001 | < 0.001 | |||
| LTE-14 (SC)# | 2/3 (66.7) | 42/53 (79.2) | 43/57 (75.4) | 85/110 (77.3) | 62/83 (74.7) | 80/104 (76.9) | 13/23 (56.5) | 104/163 (63.8) | 259/373 (69.4) |
| LTE-24 (SC)# | 2/3 (66.7) | 29/40 (72.5) | 33/47 (70.2) | 62/87 (71.3) | 77/98 (78.6) | 88/113 (77.9) | 16/23 (69.6) | 106/165 (64.2) | 287/399 (71.9) |
| ACR50 | |||||||||
| Wk 48 (IV)† | 10 (7.8) | 15 (11.7) | 14 (10.9) | 29 (11.3) | 31 (24.0) | 42 (32.8) | ND | ND | 73 (28.4) |
| p†† | 0.28 | 0.38 | 0.27 | < 0.001 | < 0.001 | < 0.001 | |||
| LTE-14 (SC)# | 2/3 (66.7) | 25/53 (47.2) | 29/57 (50.9) | 54/110 (49.1) | 42/83 (50.6) | 54/104 (51.9) | 8/23 (34.8) | 55/163 (33.7) | 159/373 (42.6) |
| LTE-24 (SC)# | 2/3 (66.7) | 19/40 (47.5) | 20/47 (42.6) | 39/87 (44.8) | 51/98 (52.0) | 57/113 (50.4) | 9/23 (39.1) | 57/165 (34.5) | 174/399 (43.6) |
| ACR70 | |||||||||
| Wk 48 (IV)† | 2 (1.6) | 8 (6.3) | 7 (5.4) | 15 (5.8) | 10 (7.8) | 16 (12.5) | ND | ND | 26 (10.1) |
| p†† | 0.05 | 0.09 | 0.05 | 0.02 | < 0.001 | 0.01 | |||
| LTE-14 (SC)# | 2/3 (66.7) | 15/53 (28.3) | 13/57 (22.8) | 28/110 (25.5) | 26/83 (31.3) | 32/104 (30.8) | 5/23 (21.7) | 32/163 (19.6) | 95/373 (25.5) |
| LTE-24 (SC)# | 2/3 (66.7) | 9/40 (22.5) | 10/47 (21.3) | 19/87 (21.8) | 28/98 (28.6) | 30/113 (26.5) | 4/23 (17.4) | 34/165 (20.6) | 96/399 (24.1) |
| DAS28-CRP good/moderate response | |||||||||
| Wk 48 (IV)† | 44 (34.1) | 44 (34.4) | 51 (39.5) | 95 (37.0) | 75 (58.1) | 79 (61.7) | ND | ND | 154 (59.9) |
| p†† | 0.96 | 0.37 | 0.58 | < 0.001 | < 0.001 | < 0.001 | |||
| LTE-14 (SC)# | 3/3 (100.0) | 46/53 (86.8) | 51/57 (89.5) | 97/110 (88.2) | 72/82 (87.8) | 93/100 (93.0) | 18/23 (78.3) | 125/163 (76.7) | 308/368 (83.7) |
| LTE-24 (SC)# | 3/3 (100.0) | 34/40 (85.0) | 42/47 (89.4) | 76/87 (87.4) | 88/98 (89.8) | 102/113 (90.3) | 20/23 (87.0) | 121/163 (74.2) | 331/397 (83.4) |
| DAS28-CRP remission | |||||||||
| LTE-14 (SC)# | 2/3 (66.7) | 17/53 (32.1) | 9/57 (15.8) | 26/110 (23.6) | 24/82 (29.3) | 32/100 (32.0) | 5/23 (21.7) | 23/163 (14.1) | 84/368 (22.8) |
| LTE-24 (SC)# | 2/3 (66.7) | 10/40 (25.0) | 11/47 (23.4) | 21/87 (24.1) | 30/98 (30.6) | 37/113 (32.7) | 6/23 (26.1) | 34/163 (20.9) | 107/397 (27.0) |
| HAQ improvement ≥ 0.3 | |||||||||
| LTE-14 (SC)# | 2/3 (66.7) | 32/53 (60.4) | 34/57 (59.6) | 66/110 (60.0) | 55/84 (65.5) | 70/104 (67.3) | 13/23 (56.5) | 92/162 (56.8) | 230/373 (61.7) |
| LTE-24 (SC)# | 2/3 (66.7) | 23/40 (57.5) | 33/47 (70.2) | 56/87 (64.4) | 66/98 (67.3) | 69/113 (61.1) | 13/23 (56.5) | 91/164 (55.5) | 239/398 (60.1) |
↵* Excludes patients who started MTX after LTE-14.
↵** Includes patients who started and/or adjusted MTX dose after LTE-14.
↵† Among randomized patients in the Main Study.
↵†† For comparison versus placebo + MTX. All p values shown are nominal.
↵# Among randomized patients who remained in the study through the start of the LTE. 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; HAQ: Health Assessment Questionnaire-Disability Index; IV: intravenous; LTE: longterm extension; MTX: methotrexate; ND: not determined; SC: subcutaneous.