Summary of clinical and radiographic efficacy at weeks 14 and 24: full analysis patient population*
| Week 14 | Week 24 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Group 1: Placebo+MTX | Group 2: Golimumab 50 mg+MTX | Group 3: Golimumab 100 mg+MTX | Combined groups 2 and 3 | Group 1: Placebo+MTX | Group 2: Golimumab 50 mg+MTX | Group 3: Golimumab 100 mg+MTX | Combined groups 2 and 3 | ||
| Number of patients | 88 | 86 | 87 | 173 | 88 | 86 | 87 | 173 | |
| ACR20 response (primary endpoint) | 24 (27.3%) | 62 (72.1%) | 65 (74.7%) | 127 (73.4%) | 29 (33.0%) | 61 (70.9%) | 65 (74.7%) | 126 (72.8%) | |
| p value† vs Group 1 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| ACR50 response | 8 (9.1%) | 37 (43.0%) | 33 (37.9%) | 70 (40.5%) | 13 (14.8%) | 36 (41.9%) | 42 (48.3%) | 78 (45.1%) | |
| p value† vs Group 1 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| ACR 70 response | 2 (2.3%) | 19 (22.1%) | 12 (13.8%) | 31 (17.9%) | 5 (5.7%) | 23 (26.7%) | 19 (21.8%) | 42 (24.3%) | |
| p value† vs Group 1 | <0.0001 | 0.0050 | 0.0003 | 0.0002 | 0.0019 | 0.0002 | |||
| ACR-N Index of Improvement | 12.94 (20.00) | 40.76 (30.20) | 39.99 (25.86) | 40.37 (28.02) | 16.78 (24.50) | 42.95 (32.80) | 45.37 (28.77) | 44.17 (30.78) | |
| 0.00 [0.0, 85.7] | 39.25 [0.0, 97.0] | 40.00 [0.0, 97.0] | 40.00 [0.0, 97.0] | 0.00 [0.0, 81.8] | 41.30 [0.0, 100.0] | 48.08 [0.0, 100.0] | 43.94 [0.0, 100.0] | ||
| p value‡ vs Group 1 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| DAS28(ESR) response§ | |||||||||
| Moderate | 32 (37.6%) | 66 (79.5%) | 71 (85.5%) | 137 (82.5%) | 41 (48.8%) | 68 (84.0%) | 74 (90.2%) | 142 (87.1%) | |
| p value† vs Group 1 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| Good | 10 (11.8%) | 35 (42.2%) | 26 (31.3%) | 61 (36.7%) | 11 (13.1%) | 38 (46.9%) | 36 (43.9%) | 74 (45.4%) | |
| p value† vs Group 1 | <0.0001 | 0.0020 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| DAS28(ESR) remission | 3 (3.4%) | 27 (31.4%) | 16 (18.4%) | 43 (24.9%) | 6 (6.8%) | 30 (34.9%) | 19 (21.8%) | 49 (28.3%) | |
| p value† vs Group 1 | <0.0001 | 0.0014 | <0.0001 | <0.0001 | 0.0045 | <0.0001 | |||
| Change in DAS28(ESR) score p value† vs Group 1 | −0.43 (1.20) | −1.98 (1.25) | −1.85 (1.00) | −1.91 (1.13) | −0.60 (1.38) | −2.05 (1.23) | −2.04 (1.10) | −2.05 (1.16) | |
| −0.55 [−2.9, 2.5] | −2.13 [−4.5, 0.9] | −1.70 [−5.0, −0.1] | −1.80 [−5.0, 0.9] | −0.69 [−3.3, 3.1] | −2.21 [−4.6, 0.7] | −1.92 [−4.2, 0.4] | −2.07 [−4.6, 0.7] | ||
| <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | ||||
| Improvement in HAQ-DI score | 0.07 (0.49) | 0.32 (0.40) | 0.39 (0.42) | 0.35 (0.41) | 0.03 (0.58) | 0.33 (0.42) | 0.45 (0.43) | 0.39 (0.43) | |
| 0.13 [−1.8, 1.8] | 0.25 [−0.6, 1.4] | 0.25 [−0.4, 2.0] | 0.25 [−0.6, 2.0] | 0.00 [−1.8, 2.1] | 0.25 [−0.4, 1.6] | 0.38 [−0.4, 2.0] | 0.25 [−0.4, 2.0] | ||
| p value¶ vs Group 1 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.0001 | |||
| Patients achieving HAQ score <0.5 p value† vs Group 1 | 26 (29.5%) | 30 (34.9%) | 50 (57.5%) | 80 (46.2%) | 27 (30.7%) | 35 (40.7%) | 54 (62.1%) | 89 (51.4%) | |
| 0.4511 | 0.0002 | 0.0094 | 0.1678 | <0.0001 | 0.0014 | ||||
| Change from baseline in vdH-S score | |||||||||
| Total vdH-S score | 2.51 (5.52) | 1.05 (3.71) | 0.33 (2.66) | 0.69 (3.23) | |||||
| – | – | – | – | 0.25 [−8.5, 33.5] | 0.00 [−6.3, 22.5] | 0.00 [−3.5, 19.0] | 0.00 [−6.3, 22.5] | ||
| p value¶ vs Group 1 | 0.0203 | 0.0006 | 0.0009 | ||||||
| Erosion score | N=84 | N=81 | N=82 | N=163 | |||||
| – | – | – | – | 1.66 (3.73) | 0.54 (1.62) | 0.03 (1.44) | 0.28 (1.55) | ||
| 0.00 [−2.5, 22.5] | 0.00 [−2.5, 8.0] | 0.00 [−3.5, 9.0] | 0.00 [−3.5, 9.0] | ||||||
| p value¶ vs Group 1 | 0.0044 | <0.0001 | <0.0001 | ||||||
| JSN score | N=84 | N=81 | N=82 | N=163 | |||||
| – | – | – | – | 0.83 (2.31) | 0.71 (2.91) | 0.29 (1.49) | 0.50 (2.31) | ||
| 0.00 [−6.5, 11.0] | 0.00 [−2.5, 22.0] | 0.00 [−2.0, 10.0] | 0.00 [−2.5, 22.0] | ||||||
| p value¶ vs Group 1 | 0.7293 | 0.1335 | 0.2836 | ||||||
| Change in vdH-S score <0 p value† vs Group 1 | – | – | – | – | 44 (50.0%) | 51 (59.3%) | 61 (70.1%) | 112 (64.7%) | |
| 0.2179 | 0.0066 | 0.0217 | |||||||
| Change in vdH-S >SDC (3.23) p value† vs Group 1 | – | – | – | – | 19 (21.6%) | 14 (16.3%) | 5 (5.7%) | 19 (11.0%) | |
| 0.3715 | 0.0023 | 0.0216 | |||||||
Values are number (%) of patients or mean (SD), median [range].
↵* The full analysis patient population excluded patients who did not meet the study eligibility criteria, who did not receive study treatment and/or who had no efficacy data, following randomisation. With the exception of vdH-S scores, which were not determined at week 16, patients who qualified for early escape were grouped according to randomised treatment group and had week 24 data replaced with week 16 data.
↵† Based on the χ2 test.
↵‡ Based on analysis of variance with treatment as a factor.
↵§ For DAS 28 (ESR) response, the numbers of patients evaluated at week 14/24 are 85/84 in Group 1, 83/81 in Group 2, 83/82 in Group 3 and 166/163 in combined Groups 2 and 3.
↵¶ Based on analysis of covariance on least squares mean and two-sided 95% confidence intervals with treatment as a factor and with baseline value as covariates.
ACR, American College of Rheumatology; DAS 28 (ESR), disease activity score using 28-joint count and erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; JSN, joint space narrowing; MTX, methotrexate; SDC, smallest detectable change; vdH-S, van der Heijde-modified Sharp score.