Summary of clinical efficacy (randomised patients)
| Capsular summary of clinical efficacy to week 246 | ||
|---|---|---|
| Placebo+MTX | Golimumab 2 mg/kg+MTX | |
| Randomised patients (n) | 197 | 395 |
| Primary endpoint: ACR20 response at week 14 (n (%)) | 49/197 (24.9) | 231/395 (58.5) |
| p Value vs placebo+MTX | <0.001 | |
| Major secondary endpoints reported previously | ||
| EULAR moderate/good (DAS28-CRP) response at week 14 (n (%)) | 79/197 (40.1) | 321/395 (81.3) |
| p Value vs placebo+MTX | <0.001 | |
| ACR50 response at week 24 (n (%)) | 26/197 (13.2) | 138/395 (34.9) |
| p Value vs placebo+MTX | <0.001 | |
| Improvement from baseline in HAQ-DI score at week 14 (mean±SD) | 0.19±0.56 | 0.50±0.58 |
| Median (IQ range) | 0.13 (−0.13, 0.50) | 0.50 (0.13, 0.88) |
| p Value vs placebo+MTX | <0.001 | |
| Clinical efficacy to week 52 | |||
|---|---|---|---|
| Placebo→Golimumab 2 mg/kg+MTX | Golimumab 2 mg/kg+MTX | All patients | |
| Randomised patients (n) | 197 | 395 | 592 |
| ACR response at week 52 (n (%)) | |||
| ACR20 | 121 (61.4) | 260 (65.8) | 381 (64.4) |
| ACR50 | 62 (31.5) | 153 (38.7) | 215 (36.3) |
| ACR70 | 29 (14.7) | 72 (18.2) | 101 (17.1) |
| Maintenance of ACR response from week 24 to week 52 (n (%)) | |||
| ACR20 | 53/63 (84.1) | 201/245 (82.0) | 254/308 (82.5) |
| ACR50 | 22/26 (84.6) | 99/138 (71.7) | 121/164 (73.8) |
| ACR70 | 5/8 (62.5) | 42/69 (60.9) | 47/77 (61.0) |
| ACR response at week 52 among week 24 non-responders (n (%)) | |||
| ACR20 | 68/128 (53.1) | 55/137 (40.1) | 123/265 (46.4) |
| ACR50 | 40/165 (24.2) | 54/244 (22.1) | 94/409 (23.0) |
| ACR70 | 24/183 (13.1) | 30/313 (9.6) | 54/496 (10.9) |
| DAS28–CRP moderate/good response (n (%)) | |||
| At week 52 | 149 (75.6) | 321 (81.3) | 470 (79.4) |
| Maintenance from week 24 to week 52 | 83/89 (93.3) | 279/317 (88.0) | 362/406 (89.2) |
| HAQ-DI improvement ≥0.25 units (n (%)) | |||
| At week 52 | 123 (62.4) | 253 (64.1) | 376 (63.5) |
| Maintenance from week 24 to week 52 | 80/88 (90.9) | 217/260 (83.5) | 297/348 (85.3) |
| CDAI score | |||
| Improvement from baseline (mean±SD) | 20.9±15.1 | 22.3±14.1 | 21.8±14.4 |
| Median (IQ range) | 19.5 (11.1, 32.4) | 23.1 (12.9, 31.2) | 22.1 (12.3, 31.3) |
| Disease activity (n (%)) | |||
| Remission (≤2.8) | 15 (7.6) | 33 (8.4) | 48 (8.1) |
| Low (>2.8 and <10) | 54 (27.4) | 114 (28.9) | 168 (28.4) |
| Moderate (≥10 and <22) | 73 (37.1) | 140 (35.4) | 213 (36.0) |
| High (≥22) | 55 (27.9) | 108 (27.3) | 163 (27.5) |
| SDAI score | |||
| Improvement from baseline (mean±SD) | 21.7±15.63 | 23.7±15.15 | 23.0±15.33 |
| Median (IQ range) | 20.3 (12.0, 33.8) | 24.3 (14.2, 33.1) | 22.9 (12.9, 33.3) |
| Disease activity (n (%)) | |||
| Remission (≤3.3) | 16 (8.1) | 36 (9.1) | 52 (8.8) |
| Low (>3.3 and <11) | 55 (27.9) | 114 (28.9) | 169 (28.5) |
| Moderate (≥11 and <26) | 74 (37.6) | 153 (38.7) | 227 (38.3) |
| High (≥26) | 52 (26.4) | 92 (23.3) | 144 (24.3) |
ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, 28 joint Disease Activity Score; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; SDAI, Simplified Disease Activity Index.