Summary of clinical and radiographic response through Week 104. Data shown are change from baseline or number (%) of patients with response unless noted otherwise. Data are summarized by randomized treatment group.
| Group 1 Placebo + MTX1 | Group 2 Golimumab 100 mg + Placebo2 | Group 3 Golimumab 50 mg + MTX3 | Group 4 Golimumab 100 mg + MTX | Combined Golimumab + MTX | |
|---|---|---|---|---|---|
| Randomized patients | 133 | 133 | 89 | 89 | 178 |
| ACR20 response | 68/104 (65.4%) | 74/106 (69.8%) | 62/83 (74.7%) | 48/67 (71.6%) | 110/150 (73.3%) |
| At Wk 52 and Wk 104 | 57/73 (78.1%) | 59/69 (85.5%) | 52/63 (82.5%) | 40/46 (87.0%) | 92/109 (84.4%) |
| ACR50 response | 38/104 (36.5%) | 49/106 (46.2%) | 50/83 (60.2%) | 34/67 (50.7%) | 84/150 (56.0%) |
| At Wk 52 and Wk 104 | 28/47 (59.6%) | 32/41 (78.0%) | 32/41 (78.0%) | 27/35 (77.1%) | 59/76 (77.6%) |
| ACR70 response | 24/104 (23.1%) | 33/106 (31.1%) | 26/83 (31.3%) | 24/67 (35.8%) | 50/150 (33.3%) |
| At Wk 52 and Wk 104 | 16/25 (64.0%) | 16/23 (69.6%) | 17/21 (81.0%) | 20/28 (71.4%) | 37/49 (75.5%) |
| Swollen joint count | |||||
| Median (IQR) joint count | 2.0 (0.0, 5.0) | 2.0 (0.0, 6.0) | 2.0 (0.0, 6.0) | 1.0 (0.0, 4.0) | 1.5 (0.0, 4.0) |
| Median (IQR) change | −8.5 (−13.0, −5.5) | −8.0 (−14.0, −5.0) | −9.0 (−19.0, −5.0) | −10.0 (−15.0, −5.0) | −10.0 (−15.0, −5.0) |
| Tender joint count | |||||
| Median joint count | 3.0 (1.0, 9.5) | 3.0 (1.0, 9.0) | 3.0 (0.0, 12.0) | 2.0 (0.0, 9.0) | 3.0 (0.0, 9.0) |
| Median (IQR) change | −15.0 (−23.0, −7.5) | −17.0 (−26.0, −7.0) | −17.0 (−30.0, −8.0) | −16.0 (−27.0, −10.0) | −16.5 (−28.0, −8.0) |
| DAS28-CRP | |||||
| Median (IQR) score | 3.0 (1.9, 3.9) | 3.0 (2.1, 3.9) | 2.7 (1.9, 4.1) | 2.5 (1.8, 3.8) | 2.7 (1.9, 3.9) |
| Median (IQR) change | −2.1 (−3.1, −1.3) | −2.1 (−3.2, −1.6) | −2.5 (−3.4, −1.5) | −2.6 (−3.3, −1.9) | −2.6 (−3.4, −1.7) |
| Responder (Good + Moderate) | 89/102 (87.3%) | 91/105 (86.7%) | 73/83 (88.0%) | 61/67 (91.0%) | 134/150 (89.3%) |
| At Wk 52 and 104 | 77/82 (93.9%) | 80/90 (88.9%) | 68/75 (90.7%) | 56/59 (94.9%) | 124/134 (92.5%) |
| Remission (< 2.6) | 42/102 (41.2%) | 43/105 (41.0%) | 39/83 (47.0%) | 35/67 (52.2%) | 74/150 (49.3%) |
| At Wk 52 and Wk 104 | 22/31 (71.0%) | 22/32 (68.8%) | 24/34 (70.6%) | 25/33 (75.8%) | 49/67 (73.1%) |
| HAQ-DI score | |||||
| Median (IQR) score | 0.9 (0.3, 1.4) | 0.5 (0.1, 1.1) | 0.5 (0.3, 1.4) | 0.6 (0.3, 1.3) | 0.6 (0.3, 1.4) |
| Median (IQR) change | 0.4 (0.0, 0.7) | 0.5 (0.1, 1.0) | 0.6 (0.1, 1.0) | 0.4 (0.1, 0.9) | 0.5 (0.1, 0.9) |
| ≥ 0.25–unit improvement | 64/104 (61.5%) | 75/106 (70.8%) | 60/83 (72.3%) | 49/67 (73.1%) | 109/150 (72.7%) |
| At Wk 24 and Wk 104 | 43/47 (91.5%) | 50/57 (87.7%) | 52/60 (86.7%) | 53/60 (88.3%) | 105/120 (87.5%) |
| At Wk 52 and Wk 104 | 56/68 (82.4%) | 60/64 (93.8%) | 57/63 (90.5%) | 46/50 (92.0%) | 103/113 (91.2%) |
| SHS-Total4,5 | |||||
| Mean (SD) change to Wk 104 | 1.15 (4.41) | 1.87 (5.77) | 0.51 (3.32) | 0.54 (3.49) | 0.52 (3.39) |
| No radiographic progression* at Wk 52 | 60/105 (57.1%) | 60/106 (56.6%) | 51/81 (63.0%) | 44/66 (66.7%) | 95/147 (64.6%) |
| No radiographic progression at Wk 104* | 54/106 (50.9%) | 56/108 (51.9%) | 56/83 (67.5%) | 46/69 (66.7%) | 102/152 (67.1%) |
↵1 Includes patients who escaped early at Week 16 or crossed over at Week 24 to receive golimumab 50 mg + MTX or whose doses were escalated after Week 52 to receive golimumab 100 mg + MTX.
↵2 Includes patients who escaped early at Week 16 to receive golimumab 100 mg + MTX or added MTX after Week 52.
↵3 Includes patients who escaped early at Week 16 or whose doses were escalated after Week 52 to receive golimumab 100 mg + MTX.
↵4 Includes patients with baseline SHS and ≥ 1 SHS after Week 52.
↵5 Missing imputation rules were applied. Within type (erosion, joint space narrowing) and region (hand, foot), if ≥ 50% of joint scores were imputed with worst-case scores because of procedure or injection, then change from baseline of this subscore was imputed with worst change score of type-by-region subscores among all other patients.
↵* Change in SHS ≤ 0. ACR: American College of Rheumatology; CRP: C-reactive protein; DAS28: Disease Activity Score using 28-joint count; HAQ-DI: Health Assessment Questionnaire (Disability Index); IQR: interquartile range; MTX: methotrexate; SHS: Sharp/van der Heijde Score.