Efficacy measures at week 52 (except where otherwise indicated) by early escape status
| Group 1: placebo+MTX → golimumab 50 mg+MTX* | Group 2: golimumab 100 mg+placebo | Group 3: golimumab 50 mg+MTX | Group 4: golimumab 100 mg+MTX | |||||
|---|---|---|---|---|---|---|---|---|
| Early escape (weeks 16–52) | Crossover (weeks 24–52) | 100 mg+ placebo only | Early escape (weeks 16–52) 100 mg → 100 mg+ MTX | 50 mg+ MTX only | Early escape (weeks 16–52) 50 mg+ MTX → 100 mg+MTX | 100 mg+ MTX only | Early escape (weeks 16–52) 100 mg+ MTX → 100 mg+MTX | |
| Patients (n) | 42 | 82 | 97 | 36 | 74 | 15 | 75 | 14 |
| Patients with evaluable data for ACR calculation (n) | 39 | 81 | 87 | 31 | 70 | 15 | 65 | 14 |
| ACR20 (%) | 23 (59.0) | 58 (71.6) | 60 (69.0) | 15 (48.4) | 58 (82.9) | 6 (40.0) | 45 (69.2) | 7 (50.0) |
| ACR50 (%) | 12 (30.8) | 37 (45.7) | 38 (43.7) | 7 (22.6) | 40 (57.1) | 2 (13.3) | 36 (55.4) | 4 (28.6) |
| ACR70 (%) | 7 (17.9) | 20 (24.7) | 23 (26.4) | 4 (12.9) | 22 (31.4) | 0 (0) | 29 (44.6) | 1 (7.1) |
| ACR-N | 25.0 (−10.1, 64.3) | 46.2 (14.3, 69.7) | 33.3 (15.2, 72.0) | 13.8 (0.0, 47.5) | 54.4 (27.3, 76.5) | 6.7 (−16.7, 25.0) | 56.0 (7.7, 81.5) | 31.5 (6.3, 55.0) |
| % Reduction in swollen joints | 69.2 (20.0, 85.7) | 85.7 (60.0, 100) | 80.0 (63.6, 100) | 75.3 (20.7, 100) | 84.9 (62.5, 100) | 36.4 (17.6, 54.5) | 94.4 (73.3, 100) | 56.3 (48.0, 81.4) |
| % Reduction in tender joints | 40.0 (17.2, 80.0) | 76.5 (52.2, 93.3) | 84.0 (62.1, 93.8) | 57.1 (37.0, 84.4) | 80.8 (55.9, 100) | 26.5 (0, 73.9) | 85.7 (70.3, 100) | 62.5 (37.9, 73.7) |
| Patients with zero tender and swollen joints at week 24 (%) | 0 (0) | 2 (2.4) | 9 (9.8) | 0 (0) | 8 (11.0) | 0 (0) | 7 (9.6) | 0 (0) |
| Patients with zero tender and swollen joints at week 52 (%) | 2 (5.1) | 10 (12.3) | 14 (16.1) | 1 (3.1) | 15 (21.4) | 0 (0) | 16 (24.6) | 0 (0) |
| CRP (mg/dl) | 20.0 (0.0, 70.0) | 40.0 (0.0, 68.4) | 25.0 (0.0, 66.7) | 32.5 (0.0, 76.4) | 35.7 (0.0, 77.8) | 56.4 (0.0, 87.1) | 50.0 (0.0, 81.3) | 52.7 (12.5, 78.9) |
| HAQ-DI (actual improvement) | 0.25 (0.00, 0.75) | 0.38 (0.13, 0.88) | 0.38 (0.00, 1.00) | 0.38 (0.00, 0.63) | 0.63 (0.25, 0.88) | 0.38 (0.13, 1.00) | 0.50 (0.25, 1.0) | 0.25 (−0.25, 0.50) |
| Patients with HAQ-DI improvement ≥0.25 (%) | 22 (56.4) | 55 (67.9) | 53 (60.9) | 17 (54.8) | 53 (76.8) | 11 (73.3) | 51 (78.5) | 7 (53.8) |
| EULAR (DAS28 using ESR) responders (%) | 25 (64.1) | 68 (84.0) | 75 (86.2) | 23 (74.2) | 63 (92.6) | 10 (66.7) | 55 (88.7) | 11 (84.6) |
| EULAR (DAS28 using CRP) responders (%) | 26 (66.7) | 69 (86.3) | 79 (91.9) | 23 (74.2) | 64 (91.4) | 13 (92.9) | 58 (89.2) | 11 (91.7) |
| DAS28 (using ESR) low disease activity (≤3.2) (%) | 9 (23.1) | 32 (39.5) | 30 (34.5) | 7 (22.6) | 33 (48.5) | 2 (13.3) | 36 (57.1) | 4 (30.8) |
| DAS28 (using CRP) low disease activity (≤3.2) (%) | 19 (48.7) | 59 (73.8) | 56 (65.1) | 19 (61.3) | 49 (70.0) | 5 (35.7) | 47 (72.3) | 3 (25.0) |
| DAS28 (using ESR) remission (≤2.6) (%) | 7 (17.9) | 21 (25.9) | 20 (23.0) | 2 (6.5) | 25 (36.8) | 1 (6.7) | 24 (38.1) | 2 (15.4) |
| DAS28 (using CRP) remission (≤2.6) (%) | 11 (28.2) | 41 (51.3) | 38 (44.2) | 12 (38.7) | 43 (61.4) | 4 (28.6) | 39 (60.0) | 3 (25.0) |
Values are median (interquartile range) percentage improvement from baseline to week 52 for continuous outcomes (except where otherwise indicated) or n (%) of patients achieving the endpoint at week 52 for ordinal outcomes (except where otherwise indicated).
↵* Only patients who were eligible to receiv at least one dose of golimumab (to early escape or crossover) are included. Patients who discontinued the study before week 16 received placebo injections only. One patient who discontinued study treatment before week 16 returned for study visits, had evaluable data for efficacy and met the criteria for early escape at week 16. This patient did not receive golimumab but was considered to have entered early escape in the efficacy analysis.
ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, 28-count disease activity score; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ-DI, health assessment questionnaire disability index; MTX, methotrexate.