TABLE 2.
Baseline Demographics and Clinical Measurements of RBZ- and AFL-Treated Patients with DME
| Characteristic | Treatment-Naive DME | Previously Treated DME | ||||||
|---|---|---|---|---|---|---|---|---|
| ≥ 6 Months of Follow-up | ≥ 12 Months of Follow-up | ≥ 6 Months of Follow-up | ≥ 12 Months of Follow-up | |||||
| RBZ (n = 507) | AFL (n = 681) | RBZ (n = 326) | AFL (n = 382) | RBZ (n = 53) | AFL (n = 223) | RBZ (n = 24) | AFL (n = 122) | |
| Patient demographicsa | ||||||||
| Age, years, mean (SD) | 62.1 (11.2) | 63.4 (10.8) | 62.3 (11.5) | 64.1 (11.2) | 60.5 (9.1) | 61.4 (10.4) | 61.2 (9.7) | 62.0 (10.8) |
| Female, n (%) | 242 (47.7) | 280 (41.1) | 156 (47.9) | 159 (41.6) | 21 (39.6) | 105 (47.1) | 10 (41.7) | 53 (43.4) |
| Index year, n (%) | ||||||||
| 2014 | 177 (34.9) | 53 (7.8) | 145 (44.5) | 48 (12.6) | 2 (3.8) | 9 (4.0) | 1 (4.2) | 8 (6.6) |
| 2015 | 215 (42.4) | 381 (55.9) | 181 (55.5) | 334 (87.4) | 33 (62.3) | 130 (58.3) | 23 (95.8) | 114 (93.4) |
| 2016 | 115 (22.7) | 247 (36.3) | 0 (0) | 0 (0) | 18 (34.0) | 84 (37.7) | 0 (0) | 0 (0) |
| Geographic region, n (%) | ||||||||
| Northeast | 131 (25.8) | 224 (32.9) | 88 (27.0) | 136 (35.6) | 16 (30.2) | 62 (27.8) | 9 (37.5) | 29 (23.8) |
| Midwest | 132 (26.0) | 204 (30.0) | 83 (25.5) | 119 (31.2) | 8 (15.1) | 48 (21.5) | 1 (4.2) | 31 (25.4) |
| South | 205 (40.4) | 211 (31.0) | 128 (39.3) | 102 (26.7) | 22 (41.5) | 87 (39.0) | 10 (41.7) | 49 (40.2) |
| West | 39 (7.7) | 41 (6.0) | 27 (8.3) | 24 (6.3) | 6 (11.3) | 26 (11.7) | 4 (16.7) | 13 (10.7) |
| Unknown | 0 (0) | 1 (0.1) | 0 (0) | 1 (0.3) | 1 (1.9) | 0 (0) | 0 (0) | 0 (0) |
| Population density, n (%) | ||||||||
| Urban | 441 (87.0) | 584 (85.8) | 284 (87.1) | 332 (86.9) | 48 (90.6) | 197 (88.3) | 22 (91.7) | 112 (91.8) |
| Rural | 66 (13.0) | 96 (14.1) | 42 (12.9) | 49 (12.8) | 4 (7.5) | 26 (11.7) | 2 (8.3) | 10 (8.2) |
| Unknown | 0 (0) | 1 (0.1) | 0 (0) | 1 (0.3) | 1 (1.9) | 0 (0) | 0 (0) | 0 (0) |
| Health plan type, n (%) | ||||||||
| FFS | 85 (16.8) | 135 (19.8) | 59 (18.1) | 80 (20.9) | 3 (5.7) | 35 (15.7) | 0 (0) | 26 (21.3) |
| HMO | 33 (6.5) | 52 (7.6) | 19 (5.8) | 30 (7.9) | 5 (9.4) | 19 (8.5) | 0 (0) | 8 (6.6) |
| POS | 39 (7.7) | 37 (5.4) | 25 (7.7) | 18 (4.7) | 2 (3.8) | 17 (7.6) | 1 (4.2) | 6 (4.9) |
| PPO | 288 (56.8) | 388 (57.0) | 180 (55.2) | 217 (56.8) | 38 (71.7) | 127 (57.0) | 19 (79.2) | 68 (55.7) |
| Other | 62 (12.2) | 69 (10.1) | 43 (13.2) | 37 (9.7) | 5 (9.4) | 25 (11.2) | 4 (16.7) | 14 (11.5) |
| Primary payer type, n (%) | ||||||||
| Commercial | 303 (59.8) | 379 (55.7) | 190 (58.3) | 199 (52.1) | 40 (75.5) | 156 (70.0) | 17 (70.8) | 80 (65.6) |
| Medicare | 204 (40.2) | 302 (44.3) | 136 (41.7) | 183 (47.9) | 13 (24.5) | 67 (30.0) | 7 (29.2) | 42 (34.4) |
| Median household income, USD, mean (SD) | 48,273 (17,691) | 47,763 (15,088) | 48,621 (17,688) | 47,887 (14,973) | 46,382 (13,827) | 47,652 (17,013) | 47,382 (14,664) | 48,242 (16,592) |
| Clinical measurementsb | ||||||||
| Nonophthalmic comorbidities and medications, n (%) | ||||||||
| Nonmelanoma cancer | 32 (6.3) | 36 (5.3) | 19 (5.8) | 21 (5.5) | 3 (5.7) | 17 (7.6) | 1 (4.2) | 13 (10.7) |
| Dyslipidemia | 419 (82.6) | 551 (80.9) | 264 (81.0) | 300 (78.5) | 46 (86.8) | 178 (79.8) | 20 (83.3) | 99 (81.1) |
| NSAIDs | 81 (16.0) | 86 (12.6) | 53 (16.3) | 48 (12.6) | 8 (15.1) | 24 (10.8) | 5 (20.8) | 12 (9.8) |
| Glucocorticoids | 74 (14.6) | 100 (14.7) | 49 (15.0) | 66 (17.3) | 6 (11.3) | 26 (11.7) | 2 (8.3) | 17 (13.9) |
| Diabetes (type 1 or 2) | 500 (98.6) | 676 (99.3) | 323 (99.1) | 378 (99.0) | 52 (98.1) | 223 (100) | 23 (95.8) | 122 (100) |
| Ophthalmic comorbidities and treatments, n (%) | ||||||||
| Cataracts | 202 (39.8) | 291 (42.7) | 134 (41.1) | 156 (40.8) | 25 (47.2) | 97 (43.5) | 13 (54.2) | 47 (38.5) |
| Glaucoma | 90 (17.8) | 161 (23.6) | 70 (21.5) | 91 (23.8) | 10 (18.9) | 40 (17.9) | 3 (12.5) | 21 (17.2) |
| Cataract surgery | 61 (12.0) | 85 (12.5) | 43 (13.2) | 53 (13.9) | 8 (15.1) | 24 (10.8) | 5 (20.8) | 13 (10.7) |
| Intravitreal steroid injection | 10 (2.0) | 20 (2.9) | 8 (2.5) | 13 (3.4) | 3 (5.7) | 12 (5.4) | 1 (4.2) | 7 (5.7) |
| Health status indices, mean (SD) | ||||||||
| Deyo Charlson Comorbidity Index | 4.0 (2.0) | 4.0 (1.8) | 4.1 (2.0) | 4.1 (1.8) | 4.0 (1.8) | 3.9 (1.7) | 3.3 (1.6) | 4.1 (2.0) |
| Unique ICD-9/10-CM diagnoses | 20.7 (13.5) | 20.9 (14.0) | 19.6 (12.4) | 18.8 (11.9) | 23.6 (16.0) | 18.9 (11.1) | 20.3 (13.1) | 18.7 (11.1) |
| Unique National Drug Code numbers | 17.4 (9.5) | 16.0 (9.6) | 17.4 (9.4) | 16.0 (9.3) | 19.7 (9.4) | 15.4 (8.8) | 19.3 (9.7) | 16.1 (9.8) |
| Total health care expenditure, USD | 34,596 (69,816) | 37,110 (76,856) | 35,226 (76,991) | 38,724 (75,452) | 49,671 (83,217) | 41,184 (95,272) | 34,169 (31,497) | 37,680 (61,027) |
| Median total health care expenditure, USD | 16,155 | 16,696 | 15,726 | 16,539 | 23,331 | 18,363 | 24,837 | 18,619 |
| Unadjusted frequency and cost of anti-VEGF injectionsc | ||||||||
| Injection frequency, mean (SD) | 2.60 (1.62) | 2.92 (1.61) | 3.15 (2.55) | 3.80 (2.58) | 2.94 (1.74) | 3.09 (1.65) | 3.38 (2.55) | 4.29 (2.89) |
| P value | < 0.001 | < 0.001 | 0.56 | 0.15 | ||||
| Injection cost, USD, mean (SD) | 3,376 (2,526) | 5,929 (3,966) | 4,145 (3,830) | 7,627 (5,496) | 3,711 (2,282) | 6,815 (5,001) | 4,011 (3,138) | 9,424 (8,259) |
| P value | < 0.001 | < 0.001 | < 0.001 | 0.002 | ||||
aPatient demographics were measured at the index date for each anti-VEGF treatment exposure.
bClinical measurements were measured during the 12-month baseline period for each anti-VEGF treatment exposure.
cUnadjusted injection frequencies and costs were measured over the specified length of follow-up (6 and 12 months). In patients with > 6 and > 12 months of follow-up, data were censored after the first 6 and 12 months, respectively.
AFL = aflibercept; DME = diabetic macular edema; FFS = fee-for-service; HMO = health maintenance organization; ICD-9/10-CM = International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification; NSAID = nonsteroidal anti-inflammatory drug; POS = point-of-service; PPO = preferred provider organization; RBZ = ranibizumab; SD = standard deviation; USD = U.S. dollars; VEGF = vascular endothelial growth factor.