Table 2.
Participant characteristics at randomization
| Overall | Prednisone continuation | Prednisone withdrawal | |
|---|---|---|---|
| (n=15) | (n=8) | (n=7) | |
| Age (yr), mean (sd) | 34.2 (11.2) | 39.2 (12.8) | 28.4 (5.6) |
| Female gender, n (%) | 13 (86.7) | 6 (75) | 7 (100) |
| On steroids >12 months, n (%) | 10 (77) | 7 (88) | 3 (60) |
| Duration from biopsy to enrollment (days), median (25th to 75th percentile) | 342 (463) | 495 (497) | 331 (548) |
| Serum creatinine (umol/L), mean (sd) | 82.9 (45.4) | 85.9 (34.5) | 79.4 (58.4) |
| Proteinuria (g/mmol), mean (sd) | 0.07 (0.07) | 0.06 (0.07) | 0.09 (0.07) |
| Hemoglobin A1c (%), mean (sd) | 5.08 (0.62) | 4.8 (0.87) | 5.3 (0.2) |
| Blood Pressure, mmHg (sd) | |||
| Systolic | 118.3 (16.3) | 125.5 (18.1) | 110 (9.4) |
| Diastolic | 73.1 (10.4) | 76.3 (10.7) | 69.4 (9.5) |
| Renal Biopsy Class, n (%)a | |||
| III | 4 (29) | 3 (43) | 1 (14) |
| IV | 10 (71) | 4 (57) | 6 (86) |
| V | 8 (57) | 3 (43) | 5 (71) |
| Complete remissionb, n (%) | 9 (60) | 7 (88) | 2 (29) |
| SLEDAI total scorec, mean (sd) | 1.3 (2.9) | 0.25 (0.7) | 2.57 (3.9) |
| SLICC/ACR indexd, mean (sd) | 0.5 (0.9) | 0.75 (1.2) | 0.29 (0.5) |
| Prednisone dose (mg/day), mean (sd) | 8.1 (1.9) | 8.8 (1.6) | 7.5 (2.04) |
| Baseline Cytotoxic Use | |||
| Cyclophosphamide, n (%) | 0 | 0 | 0 |
| Mycophenolate, n (%) | 9 (60) | 4 (50) | 5 (71) |
| Azathioprine, n (%) | 4 (27) | 3 (38) | 1 (14) |
| None, n (%) | 2 (13) | 1 (12.5) | 1 (14) |
aISN/RPS International Society of Nephrology/Renal Pathology Society.
bComplete remission was defined as having a) less than 0.3 g/day proteinuria, b) normal urine sediment, c) normal serum albumin concentration and d) creatinine value less than 15% above baseline. Partial remission was defined as having a) 0.3 to 2.9 g/day proteinuria, b) serum albumin at least 30 g/L and c) stable renal function.
cSLEDAI, Systemic Lupus Erythematosus Activity Index.
dSLICC/ACR, Systemic Lupus International Collaborative Clinics/American College of Rheumatology.