Table 1 Study population demographic and clinical data
From: Rituximab-associated Hypogammaglobulinemia in pediatric patients with autoimmune diseases
| SLE | Autoimmune CNS diseases | ANCA associated vasculitis | Miscellaneous | P-value* | |
|---|---|---|---|---|---|
| Number of subjects | 22 | 14 | 10 | 17 | |
| Gender (Female / Male) | 19 / 3 | 12/2 | 9 / 1 | 14 / 3 | 0.957 |
| Race (White / Hispanic / African American / Others) | 11 / 7 / 4 / 0 | 9 / 2 / 2 / 1 | 7 / 3 / 0 / 0 | 6 / 4 / 6 / 1 | 0.382 |
| Age in years (mean ± SD / median) | 15.0 ± 2.5 / 15.9 | 10.3 ± 6.1 / 12.4 | 15.6 ± 2.0 / 15.5 | 13.6 ± 4.4 / 14.0 | 0.026 |
| Baseline IgG level mg/dL (mean ± SD / median) | 1259 ± 348 / 1210 | 924 ± 385 / 876 | 1149 ± 428 / 889 | 1456 ± 618 / 1430 | 0.099 |
| Baseline IgA level mg/dL (mean ± SD / median) | 264 ± 296 / 160 | 113 ± 88 / 91 | 171 ± 142 / 100 | 224 ± 127 / 204 | 0.063 |
| Baseline IgM level mg/dL (mean ± SD / median) | 137 ± 51 / 107 | 105 ± 65 / 100 | 129 ± 109 / 103 | 189 ± 66 / 185 | 0.045 |
| Baseline B cell count cell/uL (mean ± SD / median) | 371 ± 391 / 239 | 683 ± 773 / 335 | 471 ± 395 / 304 | 748 ± 741/ 343 | 0.231 |
| Number of subjects who received IVIG trial prior to Rituximab | 0 (0%) | 7 (50%) | 0 (0%) | 0 (0%) | < 0.001 |
| Number of Rituximab courses ⁑ (mean ± SD / median) | 1.6 ± 0.8 / 1 | 2.4 ± 1.2 / 2 | 2.5 ± 1.5 / 2.5 | 1.5 ± 0.7 / 2 | 0.128 |
| Number of subjects received steroid | 22 (100%) | 13 (93%) | 10 (100%) | 15 (88.2%) | 0.306 |
| Number of subjects received cyclophosphamide | 3 (14%) | 6 (43%) | 4 (40%) | 2 (12%) | 0.077 |
| Number of subjects received Hydroxychloroquine | 22 (100%) | 0 (0%) | 0 (0%) | 7 (41%) | < 0.001 |
| Number of subjects received DMARDs (Mycophenolate, Azathioprine, Methotrexate, cyclosporine or cyclophosphamide) prior to Rituximab | 8 (37%) | 2 (14.3%) | 2 (20%) | 15 (88%) | < 0.001 |
| Number of subjects received DMARDs (Mycophenolate, Azathioprine, Methotrexate, cyclosporine or cyclophosphamide) after Rituximab | 14 (64%) | 11 (78%) | 8 (80%) | 17 (100%) | 0.051 |
| Number of subjects received biologics (abatacept, TNF inhibitor or tocilizumab) prior to Rituximab | 0 (0%) | 0 (0%) | 0 (0%) | 5 (29%) | 0.002 |
| Number of subjects received biologics (abatacept, TNF inhibitor or tocilizumab) after to Rituximab | 3 (13.6%) | 0 (0%) | 0 (0%) | 6 (35%) | 0.090 |
| Number of subjects with hypogammaglobulinemia post Rituximab | 10 (46%) | 10 (71%) | 6 (60%) | 2 (12%) | 0.006 |
| Median IgG nider of subjects with hypogammaglobulinemia post Rituximab | 412 ± 192 / 525 | 358 ± 125 / 344 | 437 ± 142 / 443 | 485 ± 63 / 485 | 0.489 |
| Severity of hypogammaglobulinemia post Rituximab (normal / mild / moderate / severe) | 12 / 6 / 2 / 2 | 4 / 6 / 4 / 0 | 4 / 4 / 2 / 0 | 15 / 2 / 0 / 0 | 0.035 |
| Number of subjects with persistent hypogammaglobulinemia (> 6 month) | 5 (22%) | 8 (57%) | 3 (30%) | 1 (6%) | 0.014 |
| Onset of hypogammaglobulinemia post Rituximab in months (median) | 4.2 ± 3.8 / 3 | 9.1 ± 7.7 / 6 | 4.2 ± 3.4 / 3 | 4.5 ± 2.1 / 4.5 | 0.327 |
| Number of subjects with frequent or severe infections | 1 (4%) | 5 (35%) | 1 (10%) | 0 (0%) | 0.009 |
| Number of subjects on IVIG replacement for recurrent infection | 1 (4%) | 3 (21%) | 0 (0%) | 0 (0%) | 0.063 |