Table 2.
Clinical efficacy, patient‐reported outcomes, and radiographic results at week 256 using the ITT analysisa
| Golimumab + MTX | ||||||
|---|---|---|---|---|---|---|
| Placebo + MTX | Golimumab 100 mg + placebo | 50 mg | 100 mg | Combined | Total | |
| Clinical efficacyb | ||||||
| Patients randomized, no. | 160 | 159 | 159 | 159 | 318 | 637 |
| ACR20 | 109 (68.1) | 117 (73.6) | 114 (71.7) | 124 (78.0) | 238 (74.8) | 464 (72.8) |
| ACR50 | 80 (50.0) | 83 (52.2) | 88 (55.3) | 97 (61.0) | 185 (58.2) | 348 (54.6) |
| ACR70 | 61 (38.1) | 59 (37.1) | 57 (35.8) | 65 (40.9) | 122 (38.4) | 242 (38.0) |
| DAS28‐CRP responsec | 128 (80.0) | 138 (86.8) | 131 (82.4) | 139 (87.4) | 270 (84.9) | 536 (84.1) |
| DAS28‐CRP <2.6 | 67 (41.9) | 65 (40.9) | 70 (44.0) | 74 (46.5) | 144 (45.3) | 276 (43.3) |
| DAS28‐CRP ≤3.2 | 86 (53.8) | 90 (56.6) | 91 (57.2) | 94 (59.1) | 185 (58.2) | 361 (56.7) |
| SDAI ≤3.3 | 47 (29.4) | 40 (25.2) | 42 (26.4) | 46 (28.9) | 88 (27.7) | 175 (27.5) |
| CDAI ≤2.8 | 51 (31.9) | 40 (25.2) | 44 (27.7) | 49 (30.8) | 93 (29.2) | 184 (28.9) |
| Boolean remission | 30 (18.8) | 32 (20.1) | 38 (23.9) | 35 (22.0) | 73 (23.0) | 135 (21.2) |
| Improvement from baseline in HAQ DI, mean ± SD | 0.68 ± 0.69 | 0.70 ± 0.74 | 0.65 ± 0.70 | 0.80 ± 0.72 | 0.72 ± 0.71 | 0.70 ± 0.71 |
| Patients with improvement in HAQ DI ≥0.25 | 120 (75.0) | 111 (69.8) | 110 (69.2) | 122 (76.7) | 232 (73.0) | 463 (72.7) |
| Patients with HAQ DI ≤0.5 | 61 (38.1) | 62 (39.0) | 72 (45.3) | 79 (49.7) | 151 (47.5) | 274 (43.0) |
| Radiographic results | ||||||
| SHS change from baseline, mean ± SDd | ||||||
| At week 208 | 2.18 ± 6.53 | 1.74 ± 6.71 | 0.68 ± 3.59 | 0.54 ± 2.72 | 0.61 ± 3.19 | 1.29 ± 5.23 |
| At week 256 | 2.28 ± 6.65 | 1.81 ± 6.82 | 0.72 ± 3.67 | 0.60 ± 2.86 | 0.66 ± 3.30 | 1.36 ± 5.34 |
| SHS change from week 104, mean ± SDd | ||||||
| At week 208 | 0.68 ± 3.19 | 0.79 ± 4.39 | 0.43 ± 1.82 | 0.57 ± 2.36 | 0.50 ± 2.10 | 0.62 ± 3.08 |
| At week 256 | 0.78 ± 3.40 | 0.87 ± 4.64 | 0.47 ± 2.05 | 0.64 ± 2.64 | 0.55 ± 2.35 | 0.69 ± 3.31 |
| Patients with change in total SHS ≤0 at week 256 | 65 (54.2) | 64 (56.6) | 75 (62.5) | 73 (65.2) | 148 (63.8) | 277 (59.6) |
| Patients with change in total SHS ≤0.5 at week 256 | 78 (65.0) | 82 (72.6) | 92 (76.7) | 89 (79.5) | 181 (78.0) | 341 (73.3) |
| Estimated annual rate of progression at baseline, mean ± SD | 8.44 ± 19.37 | 8.32 ± 27.49 | 9.75 ± 24.86 | 6.76 ± 14.73 | 8.31 ± 20.61 | 8.34 ± 22.14 |
| Estimated annual rate of progression at week 256, mean ± SD | 0.46 ± 1.34 | 0.36 ± 1.36 | 0.14 ± 0.74 | 0.12 ± 0.57 | 0.13 ± 0.66 | 0.27 ± 1.07 |
Values are the number (percentage) unless indicated otherwise. ITT = intent‐to‐treat; MTX = methotrexate; ACR20/50/70 = American College of Rheumatology criteria for 20%/50%/70% improvement; DAS28‐CRP = Disease Activity Score in 28 joints using the C‐reactive protein level; SDAI = Simplified Disease Activity Index; CDAI = Clinical Disease Activity Index; HAQ = Health Assessment Questionnaire; DI = disability index; SHS = modified Sharp/van der Heijde score.
Modified ITT analysis in which the following rules were applied: 1) missing baseline values for continuous variables were replaced with the median value, and last observation carried forward methodology was applied to missing postbaseline values, and 2) patients who discontinued study agent due to unsatisfactory therapeutic effect were considered to be nonresponders.
Good or moderate response as defined by the European League Against Rheumatism 14.
Includes patients who had an SHS at weeks 0 and 104 and at least 1 score after week 104.