Clinical outcomes at the end of years 1 and 2 (intent-to-treat population)
| Year 1 | Year 2 | ||||
|---|---|---|---|---|---|
| Clinical outcomes | SC Abatacept+MTX | Adalimumab+MTX | SC Abatacept+MTX | Adalimumab+MTX | |
| ACR responses (%) (95% CI) | ACR 20 | 64.8 (59.5 to 70.0) | 63.4 (58.2 to 68.6) | 59.7 (54.4 to 65.1) | 60.1 (54.8 to 65.4) |
| ACR 50 | 46.2 (40.7 to 51.7) | 46.0 (40.6 to 51.4) | 44.7 (39.2 to 50.1) | 46.6 (41.2 to 52.0) | |
| ACR 70 | 29.2 (24.2 to 34.2) | 26.2 (21.5 to 31.0) | 31.1 (26.0 to 36.2) | 29.3 (24.3 to 34.2) | |
| ACR 90 | 10.4 (7.0 to 13.7) | 6.4 (3.8 to 9.1) | 14.5 (10.6 to 18.3) | 8.2 (5.3 to 11.2) | |
| HAQ-DI response* (%) (95% CI) | 60.4 (55.0 to 65.8) | 57.0 (51.7 to 62.4) | 54.1 (48.6 to 59.6) | 48.8 (43.4 to 54.2) | |
| DAS28 | Mean change in DAS28-CRP† (95% CI) | −2.30 (0.08) (−2.45 to −2.15) | −2.27 (0.08) (−2.42 to −2.12) | −2.35 (0.08) (−2.51 to −2.19) | −2.33 (0.08) (−2.50 to −2.17) |
| LDAS (%)‡ (95% CI) | 59.3 (53.5 to 65.1) | 61.4 (55.6 to 67.3) | 65.3 (59.5 to 71.2) | 68.0 (62.2 to 73.9) | |
| Remission (%) (95% CI) | 43.3 (37.4 to 49.1) | 41.9 (36.0 to 47.9) | 50.6 (44.4 to 56.8) | 53.3 (47.0 to 59.5) | |
| CDAI | LDAS (95% CI) | 61.0 (55.3 to 66.8) | 61.8 (56.0 to 67.6) | 65.6 (59.7 to 71.5) | 67.6 (61.8 to 73.5) |
| Remission (95% CI) | 23.5 (18.5 to 28.5) | 24.0 (18.8 to 29.1) | 32.0 (26.2 to 37.8) | 30.3 (24.6 to 36.1) | |
| SDAI | LDAS (95% CI) | 62.2 (56.5 to 67.9) | 63.5 (57.7 to 69.3) | 65.2 (59.3 to 71.1) | 69.1 (63.3 to 74.9) |
| Remission (95% CI) | 23.3 (18.3 to 28.3) | 24.8 (19.6 to 30.0) | 31.2 (25.5 to 36.9) | 32.5 (26.6 to 38.4) | |
*HAQ response is defined as an improvement of at least 0.3 units from baseline in the HAQ-DI.
†Adjusted mean change from baseline (SE).
‡Proportion of subjects in low disease activity (LDAS) or remission.
ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; DAS28, Disease Activity Score for 28-joint counts; HAQ-DI, Health Assessment Questionnaire–Disability Index; MTX, methotrexate; SC, Subcutaneous; SDAI, Simplified Disease Activity Index.