Table 1.
Demographic and Clinical Characteristics of Rituximab-Treated Persons With Multiple Sclerosis
| Total (n = 2,482) | Serious infections | Recurrent outpatient infections | |||||
| Yes (n = 155) | No (n = 2,327) | p Value | Yes (n = 700) | No (n = 1782) | p Value | ||
| Age, mean (SD), y | 43.0 (12.3) | 47.9 (12.5) | 42.7 (12.2) | <0.0001 | 44.4 (12.7) | 42.5 (12.1) | 0.0010 |
| Female, n (%) | 1785 (71.9) | 98 (63.2) | 1,687 (72.5) | 0.0129 | 571 (81.6) | 1,214 (68.1) | <0.0001 |
| Race and ethnicity, n (%) | 0.1821 | 0.0264 | |||||
| Asian/Pacific Islander | 70 (2.8) | 4 (2.6) | 66 (2.8) | 9 (1.3) | 61 (3.4) | ||
| Black | 409 (16.5) | 28 (18.1) | 381 (16.4) | 121 (17.3) | 288 (16.2) | ||
| Hispanic | 769 (31.0) | 36 (23.2) | 733 (31.5) | 211 (30.1) | 558 (31.3) | ||
| White | 1,234 (49.7) | 87 (56.1) | 1,147 (49.3) | 359 (51.3) | 875 (49.1) | ||
| Prior use of other DMTa, n (%) | 0.0273 | <0.0001 | |||||
| Highly effective | 448 (18.1) | 37 (23.9) | 411 (17.7) | 156 (22.3) | 292 (16.4) | ||
| Modestly effective | 930 (37.5) | 64 (41.3) | 866 (37.2) | 292 (41.7) | 638 (35.8) | ||
| None | 1,104 (44.5) | 54 (34.8) | 1,050 (45.1) | 252 (36.0) | 852 (47.8) | ||
| Advanced disability, n (%) | 735 (29.6) | 123 (79.4) | 612 (26.3) | <0.0001 | 302 (43.1) | 433 (24.3) | <0.0001 |
| Comorbidities, n (%) | |||||||
| Obesity | 1,149 (46.3) | 70 (45.2) | 1,079 (46.4) | 0.7704 | 358 (51.1) | 791 (44.4) | 0.0024 |
| Diabetes | 212 (8.5) | 18 (11.6) | 194 (8.3) | 0.1577 | 69 (9.9) | 143 (8.0) | 0.1416 |
| COPD | 216 (8.7) | 10 (6.5) | 206 (8.9) | 0.3045 | 76 (10.9) | 140 (7.9) | 0.0170 |
| Serious infection, n (%) | 155 (6.2) | — | — | 109 (15.6) | 46 (2.6) | <0.0001 | |
| Recurrent outpatient infections, n (%) | 700 (28.2) | 109 (70.3) | 591 (25.4) | <0.0001 | — | — | |
| Rituximab use characteristics | |||||||
| Cumulative dose, n (%), g | <0.0001 | <0.0001 | |||||
| ≤2 | 1,232 (49.6) | 24 (15.5) | 1,208 (51.9) | 170 (24.3) | 1,062 (59.6) | ||
| >2 and ≤4 | 691 (27.8) | 47 (30.3) | 644 (27.7) | 253 (36.1) | 438 (24.6) | ||
| >4 | 559 (22.5) | 84 (54.2) | 475 (20.4) | 277 (39.6) | 282 (15.8) | ||
| No. of infusions, median (IQR) | 4.0 (2.0, 6.0) | 6.0 (4.0, 8.0) | 3.0 (2.0, 6.0) | <0.0001 | 6.0 (4.0, 8.0) | 3.0 (2.0, 5.0) | <0.0001 |
| Duration of use, median (IQR), y | 2.4 (1.3, 3.9) | 4.1 (3.1, 5.8) | 2.3 (1.2, 3.7) | <0.0001 | 3.6 (2.5, 5.2) | 1.9 (1.0, 3.2) | <0.0001 |
| Average annual dose, g | 0.8205 | <0.0001 | |||||
| Mean (SD) | 1.8 (9.2) | 1.2 (0.6) | 1.8 (9.5) | 1.1 (0.6) | 2.1 (10.9) | ||
| Median (IQR) | 1.1 (0.8, 1.4) | 1.1 (0.9, 1.3) | 1.1 (0.8, 1.4) | 1.0 (0.8, 1.3) | 1.1 (0.9, 1.5) | ||
| IgG levels before infection/end of follow-up, n (%) | <0.0001 | <0.0001 | |||||
| ≥700 mg/dL | 2,234 (90.0) | 124 (80.0) | 2,110 (90.7) | 597 (85.3) | 1,637 (91.9) | ||
| ≥500 and <700 mg/dL | 221 (8.9) | 23 (14.8) | 198 (8.5) | 85 (12.1) | 136 (7.6) | ||
| ≥300 and <500 mg/dL | 24 (1.0) | 5 (3.2) | 19 (0.8) | 15 (2.1) | 9 (0.5) | ||
| <300 mg/dL | 3 (0.1) | 3 (1.9) | 0 (0.0) | 3 (0.4) | 0 (0.0) | ||
| Median (IQR) | 1,000.0 (842.0, 1,170.0) | 894.0 (743.0, 1,100.0) | 1,005.0 (850.0, 1,170.0) | <0.0001 | 940.6 (794.0, 1,140.0) | 1,020.0 (865.0, 1,189.0) | <0.0001 |
| Total follow-up time, n (%), y | <0.0001 | <0.0001 | |||||
| ≤2 | 1,016 (40.9) | 14 (9.0) | 1,002 (43.1) | 101 (14.4) | 915 (51.3) | ||
| >2 and ≤4 | 873 (35.2) | 57 (36.8) | 816 (35.1) | 294 (42.0) | 579 (32.5) | ||
| >4 | 593 (23.9) | 84 (54.2) | 509 (21.9) | 305 (43.6) | 288 (16.2) | ||
| Median (IQR), mo | 28.8 (15.6, 46.8) | 49.8 (36.8, 69.1) | 27.1 (14.9, 44.7) | <0.0001 | 43.5 (29.7, 62.3) | 23.0 (12.2, 38.7) | <0.0001 |
Abbreviations: COPD = chronic obstructive pulmonary disease; DMT = disease-modifying therapy; IgG = immunoglobulin G; IQR = interquartile range; RTX = rituximab.
a
Prior use is defined as within 12 mo before rituximab initiation.