Clinical efficacy and radiographic results† through week 24
| Placebo-controlled period | Placebo crossover period | |||||
|---|---|---|---|---|---|---|
| Week 14 | Week 24 | |||||
| Group 1: Placebo (n=105) | Group 2: Golimumab 50 mg (n=101) | Group 3: Golimumab 100 mg (n=102) | Group 1: Placebo→Golimumab 50 mg (n=105) | Group 2: Golimumab 50 mg (n=101‡) | Group 3: Golimumab 100 mg (n=102) | |
| Clinical efficacy results | ||||||
| ACR20 response | 20 (19.0) | 51 (50.5) | 60 (58.8) | 18 (17.1) | 47 (46.5) | 71 (69.6) |
| p<0.0001 | p<0.0001 | p<0.0001 | p<0.0001 | |||
| ACR50 response | 6 (5.7) | 29 (28.7) | 33 (32.4) | 8 (7.6) | 28 (27.7) | 43 (42.2) |
| p<0.0001 | p<0.0001 | p=0.0001 | p<0.0001 | |||
| ACR70 response | 1 (1.0) | 13 (12.9) | 12 (11.8) | 2 (1.9) | 17 (16.8) | 22 (21.6) |
| p=0.0007 | p=0.0013 | p=0.0002 | p<0.0001 | |||
| ACR90 response | 0 (0.0) | 3 (3.0) | 2 (2.0) | 0 | 5 (5.0) | 3 (2.9) |
| p=0.0752 | p=0.1493 | p=0.021 | p=0.0767 | |||
| ACR-N | 9.1 (4.3 to 14.0) | 30.5 (25.6, 35.5) | 33.0 (28.1, 38.0) | 9.3 (3.9, 14.7) | 30.9 (25.4, 36.4) | 40.0 (34.6, 45.5) |
| p<0.0001 | p<0.0001 | p<0.0001 | p<0.0001 | |||
| DAS28-ESR | ||||||
| Change from baseline | n=94 | n=97 | n=100 | n=91 | n=93 | n=100 |
| −0.3 (−0.6 to −0.1) | −1.5 (−1.8, −1.3) | −1.9 (−2.1 to −1.7) | −1.5 (−1.8, −1.2) | −1.6 (−1.9 to −1.4) | −1.9 (−2.1, −1.6) | |
| p<0.0001 | p<0.0001 | |||||
| Moderate response | n=93 | n=97 | n=100 | n=91 | n=93 | n=100 |
| 27 (29.0) | 69 (71.1) | 74 (74.0) | 56 (61.5) | 65 (69.9) | 78 (78.0) | |
| p<0.0001 | p<0.0001 | |||||
| Good response | n=93 | n=97 | n=100 | n=91 | n=93 | n=100 |
| 4 (4.3) | 23 (23.7) | 32 (32.0) | 21 (23.1) | 21 (22.6) | 31 (31.0) | |
| p=0.0001 | p<0.0001 | |||||
| Remission | n=94 | n=97 | n=100 | n=92 | n=93 | n=100 |
| 2 (2.1) | 13 (13.4) | 23 (23.0) | 8 (8.7) | 16 (17.2) | 19 (19.0) | |
| p=0.0025 | p<0.0001 | |||||
| HAQ-DI | ||||||
| Change from baseline | −0.03 (−0.12 to 0.06) | 0.24 (0.15 to 0.34) | 0.33 (0.24 to 0.42) | −0.03 (−0.13 to 0.07) | 0.23 (0.13 to 0.33) | 0.33 (0.23 to 0.43) |
| p<0.0001 | p<0.0001 | p=0.0003 | p<0.0001 | |||
| Radiographic results | ||||||
| vdH–S score, baseline | ||||||
| Total | – | – | – | 56.1 (62.2) | 43.8 (50.6) | 56.9 (57.0) |
| Joint space narrowing | – | – | – | 25.9 (30.2) | 19.9 (24.0) | 25.3 (26.2) |
| Erosion | – | – | – | 30.2 (33.8) | 23.9 (28.3) | 31.7 (33.0) |
| vdH–S score, change from baseline to week 24 | ||||||
| Total | n=105 | n=100 | n=102 | |||
| 2.6 (4.7) | 1.9 (4.1) | 2.1 (10.4) | ||||
| 1.0 (−2.5 to 29.8) | 0.5 (−1.8 to 23.0) | 0.0 (−2.5 to 102.5) | ||||
| p=0.5091* | p=0.6573* | |||||
| p=0.1802** | p=0.0043** | |||||
| Joint space narrowing | n=92 | n=93 | n=99 | |||
| 0.9 (1.9) | 1.0 (2.8) | 1.0 (5.1) | ||||
| 0.0 (−1.0 to 9.5) | 0.0 (−1.5 to 17.5) | 0.0 (−2.0 to 48.5) | ||||
| p=0.7530* | p=0.9353* | |||||
| p=0.3373** | p=0.0832** | |||||
| Erosion | n=92 | n=93 | n=99 | |||
| 1.3 (2.5) | 1.0 (2.1) | 1.1 (5.7) | ||||
| 0.5 (−2.5 to 14.5) | 0.5 (−1.5 to 11.5) | 0.0 (−2.5 to 54.0) | ||||
| p=0.6272* | p=0.7614* | |||||
| p=0.5895** | p=0.0316** | |||||
*p Values based on analysis of covariance on least-squares mean and two-sided 95% CIs with treatment and baseline value as covariates.
**p Values based on analysis of variance on van der Waerden normal scores.
†Clinical efficacy data are presented as n (%) or least-squares mean (95% CI). Radiographic data are presented as mean (SD) and median (range).
‡Data from one patient who discontinued the study before week 24 were included in these analyses because the timing of the study termination visit fell within the prespecified time period for week 24 data collection.
ACR20/50/70/90, 20%/50%/70%/90% improvement in the American College of Rheumatology criteria; ACR-N, American College of Rheumatology index of improvement; DAS28-ESR, 28-joint Disease Activity Score using erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; vdH–S, van der Heijde/Sharp.