Table 2.
Changes in urinary protein excretion (g per 24 hours) in individual patients from time of diagnosis to study enrollment to 24 months and percentages of remission achieved over time
| Patient number | Proteinuria (g/24 h) at time of diagnosis by renal biopsy (pre-enrollment) | Proteinuria (g/24 h) at start of protocol treatment (enrollment) | 3 mo | 6 mo | 9 mo | 12 mo | 15 mo | 18 mo | 24 mo |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 2.8 | 10.6 | 10.9 | 10.8 | 14.1 | 5.7 | 3.8 | 1.8 | 0.80 |
| 2 | 8.3 | 10.5 | 1.1 | 0.20 | 0.30 | 0.10 | 0.20 | 0.10 | 0.20 |
| 3 | 9.1 | 14.1 | 11.3 | 3.4 | 2.1 | 1.4 | 1.1 | 0.80 | 0.52 |
| 4 | 6.9 | 13.9 | 1.1 | 0.98 | 0.35 | 0.21 | 0.1 | 0.10 | 0.10 |
| 5 | 5.3 | 8.0 | 1.9 | 1.27 | 0.68 | 0.70 | 0.67 | 1.0 | 3.5 (R) |
| 6 | 7.0 | 9.8 | 7.2 | 5.9 | 2.1 | 7.4 (R) | 2.7 | 1.6 | 0.69 |
| 7 | 6.1 | 9.6 | 1.23 | 0.22 | 0.24 | 0.15 | 0.18 | 0.17 | 0.10 |
| 8 | 10.9 | 11.2 | 4.3 | 1.23 | 0.26 | 0.28 | 0.16 | 0.16 | 0.13 |
| 9 | 3.5 | 15.9 | 2.9 | 1.2 | 1.4 | 1.34 | 2.3 | 2.8 | 3.0 |
| 10 | 1.8 | 8.3 | 4.0 | 0.44 | 0.27 | 0.26 | 0.21 | 0.24 | 0.05 |
| 11 | 6.0 | 7.3 | 1.5 | 0.85 | 0.85 | 0.21 | 0.23 | 0.15 | 0.17 |
| 12 | 4.1 | 13.7 | 1.1 | 1.1 | 0.78 | 0.59 | 0.66 | 0.39 | 0.37 |
| 13 | 6.2 | 7.1 | 0.30 | 0.20 | 0.23 | 0.10 | 0.10 | 0.11 | 0.10 |
| Mean proteinuria, g/24 h (± SD) | 6±2.6 | 10.8±2.8 | 3.8±3.7 | 2.1±3.1 | 1.8±3.8 | 0.9±1.6 | 0.8±1.1 | 0.7±0.9 | 0.5±0.9 |
| % PR | - | - | 54% [25,81] | 62% [32,86] | 54% [25,81] | 31% [9,61] | 31% [9,61] | 38% [14,68] | 31% [9,61] |
| % CR | - | - | 7% [0.2,36] | 23% [5,54] | 38% [14,68] | 54% [25,81] | 54% [25,81] | 54% [25,81] | 54% [25,81] |
| Total remissions, % | - | - | 61% [32,86] | 85% [55,98] | 92% [64,100] | 85% [55,98] | 85% [55,98] | 92% [64,100] | 85% [55,98] |
Proteinuria values based on 24-hour urine collection. Individual patient values shown as well as mean values and percentages of remission at each time point with 95% confidence intervals. Mean proteinuria increased during the observation phase (period from diagnosis to enrollment) despite initiation and escalation of angiotensin antagonists. Initiation of protocol immunosuppressive drugs led to decrease in proteinuria at all time points. There were 2 relapses (R) during the trial period. After relapse, patients were treated off protocol with rituximab. Efficacy data from that point forward were not included in the analysis; their proteinuria values (i.e., mean proteinuria) are included in the table to show response. However, for purposes of calculating percentages of remissions, all patients are included in the denominator even if relapsed.
CR, complete remission; PR, partial remission.