TABLE 2.
Characteristics of Patients with a Rituximab Infusion by Indication Approval Status (N = 1,674)
| Characteristic | Approved Indication (n = 1,111) | Off-Label Indication (n = 563) | P Value |
|---|---|---|---|
| Mean age (SD)a | 64.4 (14.0) | 48.0 (14.3) | < 0.001 |
| Female, n (%) | 565 (50.9) | 200 (35.5) | < 0.001 |
| Race, n (%) | < 0.001 | ||
| White | 885 (79.7) | 406 (72.1) | |
| Other | 109 (9.8) | 95 (16.9) | |
| Unknown/undeclared | 117 (10.5) | 62 (11.0) | |
| Hispanic ethnicity, n (%) | 119 (10.7) | 79 (14.0) | 0.047 |
| Comorbidities, n (%)b | |||
| Chronic pulmonary disease | 266 (23.9) | 85 (15.1) | < 0.001 |
| Congestive heart failure | 84 (7.6) | 17 (3.0) | 0.002 |
| Diabetes | 183 (16.5) | 55 (9.8) | 0.002 |
| Liver disease | 106 (9.5) | 28 (5.0) | 0.001 |
| Malignancy | 842 (75.9) | 31 (5.5) | < 0.001 |
| Renal disease | 208 (18.7) | 74 (13.1) | 0.004 |
| Rheumatologic disease | 172 (15.5) | 36 (6.4) | < 0.001 |
| Mean Charlson Comorbidity Index score (SD) | 3.4 (2.5) | 1.0 (1.7) | < 0.001 |
| Mean chronic disease score (SD) | 5.1 (3.8) | 3.4 (3.6) | < 0.001 |
| Benefit design, n (%) | |||
| Medicaid beneficiary | 38 (3.4) | 39 (6.9) | 0.001 |
| Medicare beneficiary | 653 (58.8) | 142 (25.2) | < 0.001 |
| High deductible health plan | 43 (3.9) | 41 (7.3) | 0.003 |
aAs of index infusion date.
bDiagnosed during the 6 months before first infusion date.
SD = standard deviation.