Proportion of patients with DAS28 (CRP) remission and MRI non-progression per MRI pathology over time (ITT population)
| Patients with DAS28 (CRP) remission* and MRI non-progression† | ||||||
|---|---|---|---|---|---|---|
| MRI pathology | Study time point (months) | Abatacept plus MTX (n=119) | Abatacept monotherapy (n=116) | MTX (n=116) | Abatacept plus MTX vs MTX estimate of difference (95% CI) | Abatacept monotherapy vs MTX estimate of difference (95% CI) |
| Synovitis—n‡ (%) (95% CI)§ | 6 | 44 (37.0) (28.30 to 45.65) | 32 (27.6) (19.45 to 35.72) | 28 (24.1) (16.35 to 31.93) | 12.84 (0.33 to 25.34); p=0.046 | 3.45 (−8.67 to 15.57); p=0.653 |
| 12 | 59 (49.6) (40.60 to 58.56) | 43 (37.1) (28.28 to 45.86) | 41 (35.3) (26.65 to 44.04) | 14.24 (0.88 to 27.59); p=0.038 | 1.72 (−11.50 to 14.95); p=0.891 | |
| 18 | 18 (15.1) (8.69 to 21.56) | 11 (9.5) (4.15 to 14.81) | 9 (7.8) (2.89 to 12.63) | 7.37 (−1.55 to 16.29); p=0.117 | 1.72 (−6.36 to 9.81); p=0.815 | |
| Osteitis—n‡ (%) (95% CI)§ | 6 | 43 (36.1) (27.50 to 44.77) | 32 (27.6) (19.45 to 35.72) | 27 (23.3) (15.6 to 30.97) | 12.86 (0.45 to 25.27); p=0.044 | 4.31 (−7.75 to 16.37); p=0.546 |
| 12 | 58 (48.7) (36.76 to 57.72) | 42 (36.2) (27.46 to 44.95) | 41 (35.3) (26.65 to 44.04) | 13.39 (0.04 to 26.75); p=0.052 | 0.86 (−12.34 to 14.06); p=1.000 | |
| 18 | 18 (15.1) (8.69 to 21.56) | 12 (10.3) (4.80 to 15.89) | 9 (7.8) (2.89 to 12.63) | 7.37 (−1.55 to 16.29); p=0.117 | 2.59 (−5.65 to 10.82); 0.647 | |
| Erosion—n‡ (%) (95% CI)§ | 6 | 38 (31.9) (23.56 to 40.31) | 30 (25.9) (17.89 to 33.83) | 23 (19.8) (12.57 to 27.08) | 12.11 (0.17 to 24.04); p=0.049 | 6.03 (−5.60 to 17.67); p=0.348 |
| 12 | 51 (42.9) (33.97 to 51.75) | 36 (31.0) (22.62 to 39.45) | 33 (28.4) (20.24 to 36.66) | 14.41 (1.46 to 27.36); p=0.030 | 2.59 (−10.04 to 15.21); p=0.774 | |
| 18 | 15 (12.6) (6.64 to 18.57) | 11 (9.5) (4.15 to 14.81) | 8 (6.9) (2.29 to 11.51) | 5.71 (−2.68 to 14.10); p=0.210 | 2.59 (−5.32 to 10.50); p=0.632 | |
*DAS-defined remission was defined as DAS28 (CRP) <2.6.
†MRI non-progression was defined as change from baseline ≤smallest detectable change. Smallest detectable change values used for non-progression: synovitis (2.01), osteitis (2.81) and erosion (2.29).
‡n=number of patients with DAS28 (CRP) remission and MRI non-progression.
§Normal approximation is used if the number of DAS28 (CRP) remission and MRI non-progression for all treatment arms was at least 5; otherwise an exact method was used.
CRP, C reactive protein; DAS, Disease Activity Score; ITT, intention-to-treat; MTX, methotrexate.