Table 3.
Endpoint/changes from baseline to endpoint measurements in patients by geographical region and treatment
| Region |
||||||||
|---|---|---|---|---|---|---|---|---|
| Asia |
Latin America |
USA/Canada |
Rest of World |
|||||
| MMF (n = 57) | IVC (n = 60) | MMF (n = 56) | IVC (n = 50) | MMF (n = 37) | IVC (n = 38) | MMF (n = 35) | IVC (n = 37) | |
| Change in urine P/Cr | −2.9 (4.72)a | −2.0 (2.84)b | −2.0 (3.28)a | −1.1 (4.02)c | −1.9 (2.98)d | −2.5 (3.55)e | −2.4 (2.40) | −2.50 (3.23)f |
| 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, 114.0) | 113.0 (83.0, unknown) | 96.5 (56.0, 145.0) | 61.0 (55.0, 88.0) | 83.0 (54.0, 109.0) | 90.0 (79.0, 118.0) |
| Serum albumin change from baseline concentration, g/l | 6.8 (6.66)g | 9.4 (6.88)h | 5.8 (5.96)g | 4.6 (6.14) | 7.0 (7.03)e | 7.3 (6.62)d | 7.6 (6.18) | 12.2 (7.02)i |
| Patients with negative anti-dsDNA antibody binding level at endpoint | 26 (50) | 18 (31.6) | 14 (26.4) | 11 (22.4) | 15 (42.9) | 6 (17.6) | 13 (38.2) | 3 (9.7) |
| Patients with low (<90 mg/dl) C3 concentrations at endpoint | 23 (44.2) | 34 (59.6) | 25 (46.3) | 21 (43.8) | 9 (25.7) | 18 (52.9) | 13 (37.1) | 17 (48.6) |
| Patients with low (<16 mg/dl) C4 concentrations at endpoint | 8 (15.4) | 23 (40.4) | 23 (42.6) | 19 (40.4) | 7 (20.0) | 17 (50.0) | 13 (37.1) | 13 (37.1) |
| Change from baseline to endpoint in total SLEDAI score | −5.84 (7.80)g | −6.14 (6.98)j | −3.85 (12.91)a | −4.48 (7.32) | −7.97 (7.61)i | −9.26 (8.46)d | −8.69 (10.08) | −8.00 (9.20)i |
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 and anti-dsDNA) and total SELENA–SLEDAI score. an = 53; bn = 57; cn = 49; dn = 34; en = 35; fn = 32; gn = 55; hn = 57; in = 36; jn = 58.