Table 1.
Moderate SLE at baselinea | Severe SLE at baselinea | |||
---|---|---|---|---|
Patients initiating belimumab before IS use (N = 1909) |
Patients initiating belimumab after IS use (N = 3252) |
Patients initiating belimumab before IS use (N = 386) |
Patients initiating belimumab after IS use (N = 862) |
|
Age at index, years, mean ± SD [median] | 45.2 ± 12.9 [45.2] | 43.5 ± 12.9 [43.6] | 44.8 ± 13.4 [43.7] | 42.2 ± 13.8 [41.3] |
Gender, n (%) | ||||
Female | 1808 (94.7) | 3042 (93.5) | 352 (91.2) | 783 (90.8) |
Male | 101 (5.3) | 208 (6.4) | 34 (8.8) | 78 (9.0) |
Missing | 0 (0) | 2 (0.1) | 0 (0) | 1 (0.1) |
US geographic region, n (%) | ||||
Midwest | 277 (14.5) | 482 (14.8) | 55 (14.2) | 129 (15.0) |
Northeast | 463 (24.3) | 704 (21.6) | 84 (21.8) | 185 (21.5) |
South | 803 (42.1) | 1417 (43.6) | 178 (46.1) | 364 (42.2) |
West | 349 (18.3) | 628 (19.3) | 66 (17.1) | 175 (20.3) |
Unknown | 17 (0.9) | 21 (0.6) | 3 (0.8) | 9 (1.0) |
Insurance, n (%) | ||||
Commercial | 1284 (67.3) | 2081 (64.0) | 224 (58.0) | 475 (55.1) |
Medicare/Medicaid | 578 (30.3) | 1091 (33.5) | 153 (39.6) | 369 (42.8) |
Other | 47 (2.5) | 80 (2.5) | 9 (2.3) | 18 (2.1) |
Index year, n (%) | ||||
2017 | 214 (11.2) | 333 (10.2) | 33 (8.5) | 87 (10.1) |
2018 | 297 (15.6) | 568 (17.5) | 74 (19.2) | 157 (18.2) |
2019 | 358 (18.8) | 608 (18.7) | 65 (16.8) | 142 (16.5) |
2020 | 366 (19.2) | 568 (17.5) | 77 (19.9) | 145 (16.8) |
2021 | 486 (25.5) | 869 (26.7) | 99 (25.6) | 251 (29.1) |
2022 | 188 (9.8) | 306 (9.4) | 38 (9.8) | 80 (9.3) |
Proportion of patients with organ damage, n (%)b,c | ||||
Any | 1290 (67.6) | 2223 (68.4) | 324 (83.9) | 713 (82.7) |
Neuropsychiatric | 573 (30.0) | 862 (26.5) | 188 (48.7) | 351 (40.7) |
Ocular | 390 (20.4) | 618 (19.0) | 83 (21.5) | 189 (21.9) |
Diabetes | 319 (16.7) | 514 (15.8) | 81 (21.0) | 201 (23.3) |
Cardiovascular | 355 (18.6) | 631 (19.4) | 128 (33.2) | 323 (37.5) |
Musculoskeletal | 256 (13.4) | 401 (12.3) | 79 (20.5) | 169 (19.6) |
Renal | 123 (6.4) | 292 (9.0) | 50 (13.0) | 176 (20.4) |
SLE flaresc,d | ||||
Proportion of patients with ≥ 1 flare, n (%) | ||||
Mild | 1727 (90.5) | 3127 (96.2) | 365 (94.6) | 834 (96.8) |
Moderate | 1886 (98.8) | 3252 (100.0) | 361 (93.5) | 860 (99.8) |
Severe | 254 (13.3) | 490 (15.1) | 301 (78.0) | 724 (84.0) |
Number of flares by modified definition, mean ± SD [median] | 10.3 ± 6.2 [10.0] | 14.2 ± 6.9 [13.0] | 13.1 ± 8.2 [12.0] | 19.1 ± 11.7 [17.0] |
OGC use at indexe,f | ||||
ADD at index, mg, mean ± SD [median] | 3.1 ± 5.2 [1.1] | 3.9 ± 6.4 [1.5] | 6.7 ± 9.6 [3.1] | 9.5 ± 12.5 [5.0] |
Proportion of patients with ADD > 0 mg at index, n (%) | 1031 (54.0) | 1916 (58.9) | 264 (68.4) | 632 (73.3) |
Proportion of patients with ADD > 10 mg at index, n (%) | 168 (8.8) | 378 (11.6) | 94 (24.4) | 290 (33.6) |
All-cause HCRU, mean ± SD [median]c | ||||
Inpatient stays | 0.6 ± 1.4 [0.0] | 0.6 ± 1.3 [0.0] | 1.6 ± 2.6 [1.0] | 1.9 ± 2.8 [1.0] |
Emergency department visits | 1.1 ± 2.4 [0.0] | 1.2 ± 2.6 [0.0] | 2.5 ± 4.5 [1.0] | 2.5 ± 4.8 [1.0] |
ADD average daily dose, HCRU healthcare resource utilization, IS immunosuppressant, OGC oral glucocorticoid, SD standard deviation, SLE systemic lupus erythematosus
aPatients were classified into mutually exclusive groups of mild, moderate, or severe disease using a previously published algorithm, which is based on validated measures of SLE activity and the consensus of expert clinical opinion and considers medications of interest and HCRU associated with an SLE-related condition
bOrgan damage values are presented where ≥ 1 cohort had a proportion ≥ 20.0%
cEvaluated during the 24-month baseline period excluded the index date
dSLE flare episodes were identified and classified by severity on the basis of a previously published claims-based algorithm, which considers medications of interest and HCRU associated with an SLE diagnosis or SLE-related condition (also featured in the definition of moderate/severe baseline SLE)
ePrednisone equivalent dosage
fAverage daily dose of OGC at index is calculated as the average daily dose of OGC over the 3 month period prior to the index date