Why carry out this study?
|
Patients with atopic dermatitis (AD) who are more severely affected and who cannot manage their disease with topical anti-inflammatory drugs require systemic therapy. |
Treatment patterns of systemic drug use (systemic corticosteroids, systemic immunosuppressants, and dupilumab), healthcare resource utilization and associated costs in patients with AD and systemic drug therapy initiation (aged ≥ 2 years) have not sufficiently been investigated under routine care conditions in Germany. |
What was learned from this study?
|
Despite unfavorable risk–benefit profile, treatment with systemic corticosteroids was common (even in non-adults), whereas other systemic drug therapy options were rarely used. |
Considering the observed treatment duration within this study, the use of systemic corticosteroids in most cases was no longer in line with European guideline recommendations. |
AD treated with systemic drugs resulted in substantial direct (€ 3677 per patient per year) and indirect costs due to AD (€ 6235 per adult patient per year) in Germany. |
Introduction
Methods
Data source
Study design
Inclusion and exclusion criteria
Assessment of patient characteristics
Assessment of treatment patterns
Assessment of HCRU and associated costs
Statistical analyses
Results
Patient characteristics
Female (n = 5762) | Male (n = 4213) | All (n = 9975) | ||||
---|---|---|---|---|---|---|
n | % | n | % | n | % | |
Age (years) | ||||||
2–11 | 846 | 14.7 | 1397 | 33.2 | 2243 | 22.5 |
12–17 | 210 | 3.6 | 207 | 4.9 | 417 | 4.2 |
18–29 | 695 | 12.1 | 373 | 8.9 | 1068 | 10.7 |
30–39 | 619 | 10.7 | 309 | 7.3 | 928 | 9.3 |
40–49 | 811 | 14.1 | 406 | 9.6 | 1217 | 12.2 |
50–59 | 1029 | 17.9 | 584 | 13.9 | 1613 | 16.2 |
60–69 | 755 | 13.1 | 407 | 9.7 | 1162 | 11.6 |
70–79 | 491 | 8.5 | 336 | 8.0 | 827 | 8.3 |
≥ 80 | 306 | 5.3 | 194 | 4.6 | 500 | 5.0 |
All | 5762 | 100.0 | 4213 | 100.0 | 9975 | 100.0 |
Mean (SD) | 43 | 23.7 | 34.8 | 27.0 | 39.6 | 25.5 |
Sex | ||||||
Female | 5762 | 57.8 | ||||
Male | 4213 | 42.2 | ||||
General comorbidity (ESC) | ||||||
0 diseases | 1205 | 20.9 | 1183 | 28.1 | 2388 | 23.9 |
1 disease | 1341 | 23.3 | 1281 | 30.4 | 2622 | 26.3 |
2 diseases | 1065 | 18.5 | 565 | 13.4 | 1630 | 16.3 |
3 diseases | 725 | 12.6 | 337 | 8.0 | 1062 | 10.6 |
4 diseases | 477 | 8.3 | 226 | 5.4 | 703 | 7.0 |
5 diseases | 327 | 5.7 | 183 | 4.3 | 510 | 5.1 |
≥ 6 diseases | 622 | 10.8 | 438 | 10.4 | 1060 | 10.6 |
Mean (SD) | 2.5 (2.5) | 2.1 (2.5) | 2.3 (2.5) | |||
Q1, Q3 | 1.0 | 3.0 | 0.0 | 3.0 | 1.0 | 3.0 |
Median | 2.0 | 1.0 | 1.0 | |||
Min, Max | 0.0 | 19.0 | 0.0 | 18.0 | 0.0 | 19.0 |
Specific comorbidity (top 10) | ||||||
Back pain | 2314 | 40.2 | 1149 | 27.3 | 3463 | 34.7 |
Acute upper respiratory infections | 1754 | 30.4 | 1472 | 34.9 | 3226 | 32.3 |
Bronchial asthma | 1822 | 31.6 | 1321 | 31.4 | 3143 | 31.5 |
Hypertension | 1816 | 31.5 | 1197 | 28.4 | 3013 | 30.2 |
Vasomotor and allergic rhinitis | 1727 | 30.0 | 1211 | 28.7 | 2938 | 29.5 |
Disorders of refraction and accommodation | 1813 | 31.5 | 1116 | 26.5 | 2929 | 29.4 |
Other and unspecified dermatitis | 1447 | 25.1 | 984 | 23.4 | 2431 | 24.4 |
Disorders of lipoprotein metabolism and other lipidemias | 1282 | 22.2 | 848 | 20.1 | 2130 | 21.4 |
Somatoform disorders | 1266 | 22.0 | 465 | 11.0 | 1731 | 17.4 |
Acute bronchitis | * | * | 843 | 20.0 | 1670 | 16.7 |
Treatment patterns of systemic drug use
2–11 years (n = 2243) | 12–17 years (n = 417) | ≥ 18 years (n = 7315) | All (n = 9975) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Mean DDD | n | % | Mean DDD | n | % | Mean DDD | n | % | Mean DDD | |
Systemic drug therapy | ||||||||||||
Glucocorticoids | 2241 | 99.9 | 10.0 | 412 | 98.8 | 45.2 | 7245 | 99.0 | 84.8 | 9898 | 99.2 | 66.2 |
Azathioprine | 5 | 0.2 | 83.3 | 6 | 1.4 | 218.1 | 49 | 0.7 | 118.2 | 60 | 0.6 | 125.3 |
Cyclosporine | < 5 | – | – | < 5 | – | – | 45 | 0.6 | 95.1 | 51 | 0.5 | 93.9 |
Dupilumab | < 5 | – | – | < 5 | – | – | 26 | 0.4 | 212.1 | 28 | 0.3 | 205.1 |
Methotrexate | – | – | – | < 5 | – | – | < 5 | – | – | 5 | 0.1 | 72.0 |
Corticosteroids, fixed-dose combinations | – | – | – | – | – | – | 45 | 0.6 | 19.4 | 45 | 0.5 | 19.4 |
Phototherapy* | 0 | 0.0 | 5 | 1.2 | 277 | 3.8 | 282 | 2.8 |
Persistence of systemic drug therapy
n | Discontinuous users | Time to discontinuation | |||
---|---|---|---|---|---|
n | % | Mean | SD | ||
Index systemic drug therapy | |||||
Glucocorticoids, corticosteroids for systemic use | 9912 | 9605 | 96.9 | 46.3 | 58.4 |
Cyclosporine | 25 | 19 | 76.0 | 119.3 | 104.4 |
Azathioprine | 22 | 14 | 63.6 | 85.0 | 85.6 |
Methotrexate | < 5 | – | – | – | – |
All | 9963 | 9657 | 96.9 | 46.8 | 59.2 |
Concomitant topical drug therapy (TCS and/or TCI)
2–11 years (n = 2243) | 12–17 years (n = 417) | ≥ 18 years (n = 7315) | All (n = 9975) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Mean DDD | SD | n | % | Mean DDD | SD | n | % | Mean DDD | SD | n | % | Mean DDD | SD | |
Concomitant topical therapy | ||||||||||||||||
Neither TCI nor TCS | 1532 | 68.3 | 266 | 63.8 | 4024 | 55.0 | 5822 | 58.4 | ||||||||
TCS only | 602 | 26.8 | 40.7 | 55.5 | 112 | 26.9 | 59.3 | 68.3 | 2732 | 37.3 | 109.4 | 167.2 | 3446 | 34.5 | 95.8 | 153.5 |
TCI only | 31 | 1.4 | 25.9 | 32.3 | 11 | 2.6 | 29.3 | 43.1 | 137 | 1.9 | 22.9 | 24.0 | 179 | 1.8 | 23.8 | 26.9 |
TCI and TCS | ||||||||||||||||
TCI | 78 | 3.5 | 37.8 | 59.7 | 28 | 6.7 | 42.5 | 51.4 | 422 | 5.8 | 33.7 | 46.4 | 528 | 5.3 | 34.7 | 48.8 |
TCS | 78 | 3.5 | 96.6 | 144.1 | 28 | 6.7 | 246.1 | 338.3 | 422 | 5.8 | 156.3 | 276.0 | 528 | 5.3 | 152.3 | 265.9 |
HCRU and associated costs
2–11 years (n = 2243) | 12–17 years (n = 417) | ≥ 18 years (n = 7315) | All (n = 9975) | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Mean | SD | Min | Max | n | % | Mean | SD | Min | Max | n | % | Mean | SD | Min | Max | n | % | Mean | SD | Min | Max | |
Outpatient services | ||||||||||||||||||||||||
No. of contacts | 2242 | 100.0 | 14.1 | 9.1 | 1.0 | 116.0 | 417 | 100.0 | 17.1 | 13.4 | 1.0 | 98.0 | 7306 | 99.9 | 30.8 | 23.9 | 1.0 | 392.0 | 9965 | 99.9 | 26.4 | 22.3 | 1.0 | 392.0 |
Phototherapy* | 0 | 0.0 | < 5 | – | 226 | 3.1 | 230 | 2.3 | ||||||||||||||||
Hospitalizations | ||||||||||||||||||||||||
No. of admissions | 319 | 14.2 | 1.4 | 1.0 | 1.0 | 14.0 | 73 | 17.5 | 1.7 | 1.5 | 1.0 | 9.0 | 2138 | 29.2 | 1.8 | 1.6 | 1.0 | 22.0 | 2530 | 25.4 | 1.7 | 1.5 | 1.0 | 22.0 |
No. of days | 319 | 14.2 | 6.5 | 16.5 | 1.0 | 212.0 | 73 | 17.5 | 14.1 | 25.4 | 1.0 | 137.0 | 2138 | 29.2 | 13.8 | 21.7 | 1.0 | 303.0 | 2530 | 25.4 | 13.0 | 21.7 | 1.0 | 303.0 |
No. of admissions due to AD | 12 | 0.5 | 1.4 | 0.9 | 1.0 | 4.0 | 5 | 1.2 | 1.8 | 0.8 | 1.0 | 3.0 | 77 | 1.1 | 1.2 | 0.5 | 1.0 | 4.0 | 94 | 0.9 | 1.2 | 0.6 | 1.0 | 4.0 |
No. of days due to AD | 12 | 0.5 | 9.3 | 7.6 | 1.0 | 27.0 | 5 | 1.2 | 16.4 | 14.4 | 3.0 | 40.0 | 77 | 1.1 | 14.2 | 16.2 | 3.0 | 103.0 | 94 | 0.9 | 13.7 | 15.3 | 1.0 | 103.0 |
Sick leave (adults, n = 6127) | ||||||||||||||||||||||||
No. of sick leave | 2648 | 43.2 | 2.8 | 2.2 | 1.0 | 48.0 | ||||||||||||||||||
No. of days | 2648 | 43.2 | 33.5 | 49.1 | 1.0 | 365.0 | ||||||||||||||||||
No. of sick leave due to AD | 200 | 3.3 | 1.2 | 0.5 | 1.0 | 5.0 | ||||||||||||||||||
No. of days due to AD | 200 | 3.3 | 24.0 | 48.7 | 1.0 | 359.0 |
2–11 years (n = 2243) | 12–17 years (n = 417) | ≥ 18 years (n = 7315) | All (n = 9975) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n | % | Mean cost [€] | Sum [€] | n | % | Mean cost [€] | Sum [€] | n | % | Mean cost [€] | Sum [€] | n | % | Mean cost [€] | Sum [€] | |
Outpatient services | ||||||||||||||||
Any contact | 2242 | 100.0 | 507 | 1,136,386 | 417 | 100.0 | 610 | 254,199 | 7306 | 99.9 | 1096 | 8,005,964 | 9965 | 99.9 | 943 | 9,396,549 |
Phototherapy* | 0 | 0.0 | – | – | < 5 | – | – | – | 226 | 3.1 | 102 | 23,090 | 230 | 2.3 | 101 | 23,300 |
Hospitalizations | ||||||||||||||||
Any admission | 319 | 14.2 | 2291 | 730,958 | 73 | 17.5 | 5.082 | 370,993 | 2138 | 29.2 | 6391 | 13,664,133 | 2530 | 25.4 | 5836 | 14,766,085 |
Admission due to AD | 12 | 0.5 | 3681 | 44,176 | 5 | 1.2 | 4.796 | 23,979 | 77 | 1.1 | 3333 | 256,611 | 94 | 0.9 | 3455 | 324,767 |
Medication | ||||||||||||||||
Any drug therapy | 2243 | 100.0 | 372 | 834,169 | 417 | 100.0 | 857 | 357,428 | 7315 | 100.0 | 1524 | 11,147,820 | 9975 | 100.0 | 1237 | 12,339,417 |
AD-related systemic drugs | 2243 | 100.0 | 32 | 72,662 | 416 | 99.8 | 36 | 14,840 | 7302 | 99.8 | 68 | 497,104 | 9961 | 99.9 | 59 | 584,606 |
Other AD-related drugs (excl. systemic drugs) | 1454 | 64.8 | 38 | 55,917 | 221 | 53.0 | 65 | 14,282 | 4026 | 55.0 | 71 | 286,048 | 5701 | 57.2 | 62 | 356,247 |
Concomitant use of TCI and TCS | 4153 | 41.6 | 46 | 191,298 | ||||||||||||
Sickness benefits | ||||||||||||||||
Any sickness benefit | 0 | 0.0 | – | – | < 5 | – | – | – | 341 | 5.6 | 5026 | 1,713,841 | ||||
Due to AD | 0 | 0.0 | – | – | 0 | 0.0 | – | – | 22 | 0.4 | 6235 | 137,167 |