Table 2.
Secondary outcome measures at week 24*
| Outcome measure | Control | Abatacept |
|---|---|---|
| Urinary protein-to-creatinine ratio, mean ± SD | 1.1 ± 1.2 | 1.1 ± 1.3 |
| Disappearance of anti-dsDNA antibody | 4/36 (11) | 9/38 (24) |
| Correction of low C3 concentration | 11/30 (37) | 14/38 (37) |
| Correction of low C4 concentration | 10/25 (40) | 17/32 (53) |
| Total BILAG score, mean ± SD | 3.4 ± 1.8 | 3.8 ± 3.0 |
| Patient’s global assessment, mean ± SD | 28 ± 25 | 18 ± 22 |
| SF-36, mean ± SD | ||
| Physical component score | 45.3 ± 11 | 45.3 ± 11 |
| Mental component score | 46.5 ± 11 | 45.9 ± 12 |
| Subjects with lupus flares | ||
| Renal flare | 3/68 (4.4) | 3/66 (4.5) |
| Nonrenal flare | 6/68 (9) | 8/66 (12) |
| Complete response by race/ethnicity | ||
| Race | ||
| White | 14/33 (42) | 12/34 (35) |
| African American | 4/25 (16) | 9/27 (33) |
| Asian | 1/3 (33) | 1/3 (33) |
| Mixed or undeclared | 2/7 (29) | 0/2 (0) |
| Ethnicity | ||
| Hispanic/Mestizo | 10/28 (36) | 8/25 (32) |
| Not Hispanic/Mestizo | 11/40 (28) | 14/41 (34) |
| Total response by race/ethnicity† | ||
| Race | ||
| White | 21/33 (64) | 22/34 (65) |
| African American | 14/25 (56) | 15/27 (56) |
| Asian | 2/3 (67) | 1/3 (33) |
| Mixed race or undeclared | 3/7 (43) | 1/2 (50) |
| Ethnicity | ||
| Hispanic/Mestizo | 16/28 (57) | 15/25 (60) |
| Not Hispanic/Mestizo | 24/40 (60) | 24/41 (59) |
Except where indicated otherwise, values are the number of patients/number evaluated (%). Values for urinary protein-to-creatinine ratio were compared using a 2-sided t-test from an analysis of covariance (ANCOVA) model on log(urinary protein-to-creatinine ratio) that was adjusted for log(baseline values). Values for disappearance of anti—double-stranded DNA (anti-dsDNA) antibody and lupus flares were compared using a 2-sided Pearson’s chi-square test. Values for total British Isles Lupus Assessment Group (BILAG) score were compared using a 2-sided t-test from an analysis of variance model. Values for patient’s global assessment and Short Form 36 (SF-36) were compared using actual values between experimental and control groups and a 2-sided t-test from an ANCOVA model that adjusts for baseline values. None of the differences were statistically significant.
Total response included patients in whom a complete response or a partial response was achieved.