Table 3.
Laboratory and clinical parameters from study enrollment to 24 months
| Study enrollment |
3 mos | 6mos | 9 mos | 12 mos | 15 mos | 18 mos | 24 mos | |
|---|---|---|---|---|---|---|---|---|
| Serum albumin (g/dL) (Ref range: 3.5–5.2) |
1.8±0.5 | 3.2±0.6 | 3.5±0.7 | 3.6±0.7 | 3.8±0.6 | 3.8±0.4 | 3.8±0.5 | 3.9±0.4 |
| Cholesterol (mg/dL)* | 267 ±97 | 215 ±61 | 201±59 | 191 ±52 | 189 ±54 | 162 ±23 | 184 ±34 | 172 ±47 |
| Serum IgG (mg/dL) (Ref range: 700–1600) |
465±146 | 720±109 | 844±133 | 820±172 | 862±206 | 1021±183 | 973±150 | 1009±117 |
| Serum IgM (mg/dL) (Ref range: 40–230) |
85.3±62.1 | 79.6±62.4 | 86.3±51.4 | 62±39.0 | 73.5±55.7 | 73.6±61.8 | 75.7±47.5 | 66.4±52.8 |
| WBC (K/µl) | 5.7±1.7 | 5.6±1.8 | 6.6±3.4 | 5.7±2.0 | 6.0±2.0 | 5.9±2.4 | 6.3±2.6 | 6.0±3.1 |
| Hemoglobin (g/dL) | 11.4±1.8 | 11.5±1.6 | 11.1±1.4 | 11.7±1.2 | 12.1±1.3 | 12.2±1.4 | 12.5±1.4 | 12.3±1.1 |
| CD19 (cells/µl)** (Ref range:61–321) |
184 (139– 230) |
0 (0–0) | 4 (2–57) | 0 (0–2) | 1 (0–5) | 3 (0–68) | 42 (15– 144) |
151 (37– 277) |
| Systolic blood pressure (mmHg) # |
125.3±17 | 133.5±14 | 133.7±11 | 123.2±11 | 124.2±15 | 115.0±13 | 114.4±11 | 116.9±10 |
| Diastolic blood pressure (mmHg) # |
75.6±9 | 79.7±8 | 77.0±7 | 72.4±8 | 69.5±10 | 64.5±6 | 69.2±11 | 67.4±7 |
Data are presented as mean ± SD with exception of CD19 counts which are presented as median (IQR)
12/13 patients on statin at initial evaluation
Median duration of CD19+ B cell depletion (defined as <5 cells/ul) was 172 days (range 99 days –254 days) after the first cycle of RTX. All patients received the second cycle of RTX between 6–8 months after the first cycle which was based on the timing of B cell repletion in each individual patient, as discussed in the Methods section.
new onset or worsening hypertension occurred in 54% of patients during treatment necessitating addition or dose escalation of anti-hypertensive medications (except RAAS antagonists) to maintain pre-enrollment blood pressure levels.