Table 1.
Demographic and clinical characteristics of study participants
| Characteristic | Total | Ofatumumab | Rituximab | P value |
|---|---|---|---|---|
| n=140 | n=70 | n=70 | ||
| Male/female, n | 96/44 | 44/26 | 52/18 | 0.15 |
| Age at onset, yrs | 3 (2–4) | 3 (2–4) | 3 (2–5) | 0.74 |
| Age at enrolment, yrs | 11 (6–16) | 10 (6–16) | 11 (5–15) | |
| Body weight, kg | 41 (21) | 40 (20) | 42 (21) | 0.50 |
| Height, m | 136 (25) | 135 (23) | 137 (26) | 0.69 |
| Body mass index, kg/m2 | 20 (17–24) | 19 (16–24) | 20 (17–23) | 0.61 |
| Body surface area, m2 | 1.2 (0.8–1.5) | 1.2 (0.8–1.5) | 1.3 (0.9–1.6) | 0.65 |
| Systolic blood pressure, mmHg | 110 (12) | 109 (11) | 111 (12) | 0.36 |
| Diastolic blood pressure, mmHg | 68 (10) | 67 (10) | 69 (11) | 0.25 |
| Hemoglobin, g/dl | 14 (13–14) | 13 (12–14) | 14 (13–15) | 0.17 |
| Platelets × 1000, per mcl | 302(254–384) | 310(262–385) | 291(250–382) | 0.49 |
| White blood cells × 1000, per mcl | 10 (8–13) | 11 (8–13) | 10 (8–13) | 0.90 |
| Polymorphonuclear cells × 1000, per mcl | 5 (3–7) | 5 (3–7) | 5 (3–7) | 0.65 |
| Lymphocytes × 1000, per mcl | 4 (3–5) | 4 (3–5) | 4 (2–5) | 0.09 |
| Serum creatinine, mg/dl | 0.5 (0.2) | 0.5 (0.2) | 0.5 (0.2) | 0.33 |
| Estimated GFR, ml/min per 1.73 m2 | 146 (33) | 147 (31) | 144 (34) | 0.65 |
| Proteinuria, mg/day | 80 (60–120) | 80 (60–130) | 75 (50–120) | 0.15 |
| Urine protein/creatinine, mg/mg | 0.12 (0.08–0.18) | 0.13 (0.09–0.18) | 0.11 (0.07–0.17) | 0.16 |
| Serum albumin, g/dl | 4 (1) | 4 (1) | 4 (1) | 0.67 |
| Total cholesterol, mg/dl | 214 (77) | 220 (85) | 208 (70) | 0.37 |
| Previous RTX n (%) | 64(46%) | 31(44%) | 33(47%) | 0.50 |
| Infusions, n | 0(0–2) | 0(0–2) | 0(0–2) | 0.69 |
| Previous MMF, n (%) | 29(21) | 14(20) | 15(21) | 0.26 |
| Prednisone, n (%) | 140 (100) | 70 (100) | 70 (100) | 0.90 |
| mg/kg | 0.55 (0.31–0.94) | 0.54 (0.35–0.94) | 0.56 (0.26–0.85) | 0.071 |
| Cyclosporine, n (%) | 96 (69) | 49 (35) | 47 (34) | 0.65 |
| Tacrolimus, n (%) | 43 (31) | 19 (14) | 24 (17) | 0.29 |
Data are presented as mean (SD) or median (interquartile range) for continuous measures, and n (%) for categorical measures. Prednisone, cyclosporin, and tacrolimus indicate the number (% of total) receiving oral treatment to maintain remission; mg/kg indicates the limit of steroid dependence that is the mi nimum dose of prednisone that allowed remission during the run-in month. RTX, rituximab; MMF, mycofenolatemofetil.