Table 2.
Sociodemographic and clinical characteristics of the overall CD and UC study population (FAS) and suboptimal control and optimal control subgroups
| Crohn’s disease (FAS) | Ulcerative colitis (FAS) | |||
|---|---|---|---|---|
| Patient characteristics | Suboptimal control (N = 104) |
Optimal control (N = 92) |
Suboptimal control (N = 83) |
Optimal control (N = 117) |
| Age at index (years)a | ||||
| Mean (SD) | 47.8 (13.6) | 50.6 (15.4) | 48.7 (14.5) | 50.6 (14.1) |
| Sex, n (%) | ||||
| Female | 60 (57.7) | 37 (40.2) | 53 (63.9) | 49 (41.9) |
| Male | 44 (42.3) | 55 (59.8) | 30 (35.7) | 68 (58.6) |
| BMI (kg/m2) | ||||
| N* | 74 | 68 | 52 | 75 |
| Mean (SD) | 25.9 (5.1) | 26.0 (5.2) | 25.9 (4.7) | 26.0 (4.1) |
| Age at diagnosis (years)b | ||||
| Mean (SD) | 33.4 (13.24) | 39.8 (17.1) | 37.3 (13.7) | 38.4 (13.5) |
| Duration of disease (years)c | ||||
| Mean (SD) | 16.4 (10.0) | 12.8 (8.3) | 13.4 (8.9) | 14.2 (9.2) |
| Active nicotine consumption, n (%) | ||||
| Yes | 29 (27.9) | 14 (15.2) | 12 (14.5) | 7 (6.0) |
| No or unknown | 75 (72.1) | 78 (84.9) | 71 (85.5) | 110 (94.0) |
| Treatment phase, n (%) | ||||
| Short-term | 1 (0.9) | 10 (10.8) | 2 (2.4) | 12 (10.3) |
| Intermediate-term | 4 (3.9) | 9 (9.7) | 2 (2.4) | 3(2.5) |
| Long-term | 99 (95.2) | 73 79.3) | 79 (95.2) | 102 (87.2) |
| Current CD/UC specific treatments, n (%) | ||||
| Yes | 97 (93.3) | 73 (79.3) | 81 (97.6) | 106 (90.6) |
| No | 7 (6.7) | 19 (20.7) | 2 (2.4) | 11 (9.4) |
| Current*, n (%) | ||||
| TIMd,e | 69 (66.3) | 52 (56.5) | 43 (51.8) | 36 (31) |
| First line | 40 (38.5) | 32 (34.8) | 28 (33.7) | 20 (17.1) |
| Second line | 16 (15.4) | 6 (6.5) | 17 (20.5) | 12 (10.3) |
| Third line or more | 8 (7.7) | 2 (2.2) | 7 (8.4) | 3 (2.6) |
| TIM naivef | 44 (42.3) | 29 (31.5) | 65 (78.3) | 89 (76.1) |
| Other | 18 (12.5) | 16 (17.4) | 11 (16.) | 24 (20.5) |
| Steroid overuse | ||||
| Current prednisolone used at ≥ 10 mg/d for > 6 weeks, n (%)g | 2 (1.9) | 0 (0.0) | 1 (1.2) | 2 (1.7) |
| Patient received more than one steroid course in the last 12 months, n (%)h | ||||
| Yes | 13 (12.5) | 3 (3.3) | 24 (28.9) | 5 (4.3) |
| No | 91 (87.5) | 89 (96.7) | 59 (71.1) | 112 (95.7) |
Patients may be receiving TIM, non-TIM, and other treatments simultaneously. Data reflect patients who have at least one of the treatments on the index date
BMI body mass index, CD Crohn´s disease, FAS full analysis set, HBI Harvey Bradshaw index, N total number of patients in this group, N* number of patients for whom information was available, SD standard deviation, UC ulcerative colitis
aNote: Age was based on index date and year of birth
bYear of diagnosis minus year of birth + 1, where year of birth = year of index minus – age at index
cYear of index minus year of diagnosis + 1d year of onset minus year of birth + 1
dIncludes TIM first-time users, total number of patients with at least one TIM. Patients currently not on TIM but previously on TIM were 20 (10 in suboptimal control and 10 in optimal control) in CD and 5 (4 in suboptimal control and 1 in optimal control) in UC
eIncludes anti-TNFs, vedolizumab, ustekinumab, tofacitinib
fTIM naive included: systemic steroids, budesonide, thiopurines, methotrexate (CD only), oral 5-ASA (UC only)
gSteroid overuse was not counted as a red flag indicative of suboptimal control if treatment was adjusted at index date
hSteroid overuse was not counted as a red flag indicative of suboptimal control if treatment was adjusted in the meantime due to steroid overuse, unless an additional course of steroids was given after treatment adjustment
*Patients and percentages may add up to more than 100% as patients may receive more than one treatment