Mean disease activity at key study visits
| Baseline | Week 2 | Week 12 | Week 24 | Week 52 | |
|---|---|---|---|---|---|
| DAS28(ESR) | |||||
| PBO+MTX (SD) | 6.80 (0.91) | 5.91 (1.28) | 4.43 (1.46) | 4.07 (1.44) | 3.77 (1.68) |
| CZP+MTX (SD) | 6.70 (0.89) | 5.06 (1.27) | 3.88 (1.44) | 3.54 (1.47) | 3.11 (1.58) |
| p Value (CFB) | − | <0.001 | <0.001 | <0.001 | <0.001 |
| CDAI | |||||
| PBO+MTX (SD) | 42.64 (12.87) | 31.52 (14.85) | 17.20 (13.69) | 14.11 (12.99) | 13.08 (13.72) |
| CZP+MTX (SD) | 41.28 (12.52) | 23.74 (12.87) | 13.33 (11.99) | 10.79 (11.27) | 8.71 (11.65) |
| p Value (CFB) | − | <0.001 | <0.001 | 0.001 | <0.001 |
| SDAI | |||||
| PBO+MTX (SD) | 44.79 (13.91) | 33.38 (15.84) | 18.32 (14.39) | 15.08 (13.65) | 14.05 (14.29) |
| CZP+MTX (SD) | 43.46 (13.56) | 24.41 (13.08) | 14.10 (12.63) | 11.55 (12.00) | 9.43 (12.41) |
| p Value (CFB) | − | <0.001 | <0.001 | <0.001 | <0.001 |
| TJC | |||||
| PBO+MTX (SD) | 16.22 (6.45) | 12.37 (7.28) | 6.20 (6.32) | 5.08 (6.09) | 4.76 (6.10) |
| CZP+MTX (SD) | 15.61 (6.48) | 9.21 (6.76) | 5.13 (5.86) | 4.08 (5.63) | 3.27 (5.39) |
| p Value (CFB) | − | <0.001 | 0.055 | 0.060 | 0.002 |
| SJC | |||||
| PBO+MTX (SD) | 13.04 (5.64) | 8.99 (6.02) | 5.09 (5.38) | 3.89 (4.58) | 3.60 (4.51) |
| CZP+MTX (SD) | 12.37 (5.48) | 6.77 (4.86) | 3.25 (4.24) | 2.61 (3.83) | 2.06 (3.94) |
| p Value (CFB) | − | <0.001 | <0.001 | <0.001 | <0.001 |
| ESR* | |||||
| PBO+MTX (min, max) | 44.00 (10.0, 135.0) | 41.00 (4.0, 140.0) | 30.00 (1.0, 100.0) | 30.00 (2.0, 137.0) | 21.50 (2.0, 110.0) |
| CZP+MTX (min, max) | 42.00 (2.0, 150.0) | 29.00 (1.0, 130.0) | 22.00 (0.0, 150.0) | 20.00 (0.0, 150.0) | 17.00 (0.0, 150.0) |
| p Value (CFB) | − | <0.001 | <0.001 | <0.001 | <0.001 |
| CRP* | |||||
| PBO+MTX (min, max) | 10.51 (0.3, 243.2) | 8.35 (0.3, 231.2) | 4.69 (0.2, 157.8) | 3.74 (0.2, 157.8) | 3.96 (0.2, 157.8) |
| CZP+MTX (min, max) | 11.14 (0.2, 231.1) | 2.17 (0.1, 237.2) | 2.33 (0.1, 170.6) | 2.05 (0.2, 251.8) | 2.07 (0.1, 251.8) |
| p Value (CFB) | − | <0.001 | <0.001 | <0.001 | <0.001 |
*Median values; PBO+MTX n=213, CZP+MTX n=655; p values are nominal and describe the difference in CFB between the two study arms at each study visit; LOCF; FAS.
CFB, change from baseline; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; CZP, certolizumab pegol; ESR, erythrocyte sedimentation rate; FAS, full analysis set; LOCF, last observation carried forward; MTX, methotrexate; PBO, placebo; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count.