Table 2.
Endpoint/changes from baseline to endpoint measurements in patients, by race and treatment group
| Race |
||||||||
|---|---|---|---|---|---|---|---|---|
| Asian |
White |
Other |
Blacka |
|||||
| Characteristic | MMF (n = 62) | IVC (n = 61) | MMF (n = 75) | IVC (n = 72) | MMF (n = 22) | IVC (n = 32) | MMF (n = 26) | IVC (n = 20) |
| Change from baseline in urine P/Cr | −2.8 (4.58)b | −2.0 (2.82) | −1.9 (2.81)c | −2.3 (3.67)d | −2.8 (3.29)e | −1.0 (4.57)f | −2.3 (3.25) | −1.7 (1.61)g |
| Time to 50% reduction in 24-h urine protein, days | 56.0 (55.0, 83.0) | 83.0 (56.0, 111.0) | 84.0 (56.0, 112.0) | 91.0 (84.0, 138.0) | 56.0 (54.0, 84.0) | 112.0 (60.0, 113.0) | 113.0 (56.0, 162.0) | 60.0 (28.0, 111.0) |
| Change from baseline serum albumin concentration, g/l | 7.1 (6.92)h | 9.3 (6.82)i | 6.2 (6.76)j | 8.4 (7.72)c | 7.4 (4.98)e | 6.6 (6.79)k | 6.6 (5.36) | 6.5 (6.01)l |
| Patients with negative anti-dsDNA antibody binding level at endpoint | 27 (47.4) | 18 (31.0) | 23 (33.3) | 13 (19.7) | 7 (35.0) | 3 (10.0) | 11 (42.3) | 4 (23.5) |
| Patients with low (<90 mg/dl) C3 concentrations at endpoint | 25 (40.3) | 34 (55.7) | 31 (41.3) | 30 (41.2) | 8 (36.4) | 16 (50.0) | 6 (23.1) | 10 (50.0) |
| Patients with low (<16 mg/dl) C4 concentrations at endpoint | 9 (14.5) | 23 (37.7) | 29 (38.7) | 23 (31.9) | 4 (18.2) | 17 (53.1) | 5 (19.2) | 9 (45.0) |
| Change from baseline to endpoint in total SLEDAI score | −5.82 (7.87)h | −6.19 (6.93)m | −6.26 (12.45)j | −7.66 (7.58)c | −6.24 (10.44)e | −6.00 (9.89)k | −7.12 (6.92) | −5.33 (9.29)l |
Values are given as median (s.d.) for change in urine P/Cr, median (95% CI) for time to 50% reduction in 24-h urine protein, mean (s.d.) for change in serum albumin concentration and for change in SLEDAI score and n (%) for categorical values. Primary endpoint was the number and percentage of patients showing treatment response at 24 weeks. Response was defined as decrease in proteinuria or a decrease in urine P/Cr ratio by ≥50% in patients with sub-nephrotic proteinuria and stabilization or improvement of serum creatinine level. Secondary endpoints included change from baseline in serum creatinine, urine protein and serum albumin; immunological parameters (C3, C4 anti-dsDNA); and total SELENA–SLEDAI score. aBlack patients analysed separately here, rather than as part of the Other group; bn = 57; cn = 70; dn = 68; en = 21; fn = 30; gn = 17; hn = 60; in = 58; jn = 72; kn = 31; ln = 18; mn = 59.