Table 2.
Efficacy outcome variables
| Variable | NIAT-Rituximab Group, n=37 | NIAT Group, n=38 | P Value |
|---|---|---|---|
| Remission, complete and partiala | 13 (35.1; 19.7 to 50.5) | 8 (21.1; 8.1 to 34.0) | 0.21 |
| Protein-to-creatinine ratio, mg/g | |||
| Baseline | 7680.0 (4584.3–10,399.0) | 7195.1 (5363.1–8965.1) | |
| 3 mo | 4814.4 (3205.5–7398.6) | 4832.1 (2424.9–7911.9) | 0.94b |
| 6 mo | 3531.2 (1796.6–6469.4) | 5265.8 (2500.1–7690.7) | 0.18b |
| Serum albumin level, g/L | |||
| Baseline | 22 (18–25) | 22 (20–26) | |
| 3 mo | 27 (21–31) | 23 (19–27) | 0.10b |
| 6 mo | 30 (26–34) | 24 (20–29) | 0.029b |
| Serum creatinine, μmol/L | |||
| Baseline | 98.1 (82.2–122.9) | 91.1 (74.3–122.0) | |
| 3 mo | 94.6 (78.7–114.0) | 100.8 (81.3–115.8) | 0.88b |
| 6 mo | 94.6 (75.1–130.8) | 97.2 (76.0–126.4) | 0.67b |
| eGFR, ml/min per 1.73 m2 | |||
| Baseline | 66.7 (55.4–82.5) | 72.7 (58.1–88.6) | |
| 3 mo | 66.7 (57.2–87.1) | 68.9 (45.7–89.7) | 0.95b |
| 6 mo | 65.6 (51.0–89.0) | 72.5 (52.4–89.7) | 0.75b |
| PLA2R-Ab–positive patients, ELISA | |||
| Baseline | 27 (73.0) | 28 (73.7) | |
| Day 8 | 18 (52.9) | 17 (68.0) | 0.25c |
| 3 mo | 11 (31.4) | 25 (83.3) | <0.001c |
| 6 mo | 13 (36.1) | 24 (75.0) | 0.001c |
| PLA2R-Ab–depleted patients | |||
| 3 mo | 14/25 (56.0) | 1/23 (4.3) | <0.001b |
| 6 mo | 13/26 (50.0) | 3/25 (12.0) | 0.004b |
| PLA2R-Ab titer (all patients), RU/ml | |||
| Baseline | 40.5 (0.0–275.5) | 43.3 (0.0–457.5) | |
| Day 8 | 27.1 (0.0–126.1) | 65.5 (0.0–345.5) | 0.24c |
| 3 mo | 0.0 (0.0–49.1) | 54.6 (16.5–278.4) | <0.001c |
| 6 mo | 0.0 (0.0–34.0) | 45.7 (7.6–262.2) | 0.002c |
| PLA2R-Ab titer (positive patients),d RU/ml | |||
| Baseline | 102.5 (36.1–672.5) | 199.5 (24.2–491.4) | |
| Day 8 | 63.2 (12.9–382.0) | 163.5 (34.7–438.5) | 0.41c |
| 3 mo | 0.0 (0.0–60.5) | 77.5 (30.3–325.9) | 0.003c |
| 6 mo | 8.3 (0.0–73.5) | 62.9 (16.6–449.3) | 0.01c |
| Post hoc composite end point at 6 mo | 15 (40.5; 24.7 to 56.4) | 5 (13.2; 2.4 to 23.9) | <0.01 |
| CD19, per mm3e | |||
| 3 mo | 11 (2.0–22.0) | NA | |
| 6 mo | 61 (34.0–100) | NA |
Data are shown as n (%), n (%; 95% CI), or median (IQR). eGFR was calculated according to the MDRD equation. NA, not available.
a
Complete and partial remissions were defined according to 2012 KDIGO criteria on the basis of proteinuria; composite end point was defined as reduction of proteinuria >50% and increase of serum albumin >30%.
b
P value <0.03 indicates statistical significance (Bonferroni correction).
c
P value <0.02 indicates statistical significance (Bonferroni correction).
d
Patients with at least one positive detection of PLA2R-Ab at any time.
e
Normal range (100–500/mm3).