Demographic and clinical characteristics of the UC overall, UC advanced therapy, UC trial-similar, and Non-UC cohorts.
| UC overall (N = 32 170) | UC advanced therapy (N = 3332) | UC trial-similar (N = 1435) | Non-UC (N = 160 795) | |
| Demographics | ||||
| Age at index date, mean (SD) | 52.3 (17.9) | 45.0 (16.8) | 44.0 (16.6) | 52.3 (17.9) |
| Length of follow-up, years; mean (SD) | 2.8 (1.9) | 2.9 (2.0) | 2.7 (1.9) | 2.7 (2.0) |
| Sex, n (%) | ||||
| Female | 17 519 (54.5) | 1637 (49.1) | 696 (48.5) | 87 550 (54.4) |
| Male | 14 651 (45.5) | 1695 (50.9) | 739 (51.5) | 73 245 (45.6) |
| Race, n (%) | ||||
| White | 27 776 (86.3) | 2876 (86.3) | 1246 (86.8) | 138 865 (86.4) |
| Black | 2299 (7.1) | 164 (4.9) | 62 (4.3) | 11 480 (7.1) |
| Asian | 520 (1.6) | 68 (2.0) | 30 (2.1) | 2575 (1.6) |
| Other/Unknown | 1575 (4.9) | 224 (6.7) | 97 (6.8) | 7875 (4.9) |
| Baseline characteristics | ||||
| Charlson comorbidity index score (1 year prior to index date), mean (SD) | 1.0 (2.1) | 0.4 (1.4) | 0.1 (0.4) | 0.4 (1.2) |
| Medical history (1 year prior to index date), n (%) | ||||
| Diabetes (Type 1/Type 2) | 3368 (10.5) | 158 (4.7) | 23 (1.6) | 10 559 (6.6) |
| Pulmonary disease (COPD or asthma) | 3821 (11.9) | 186 (5.6) | 36 (2.5) | 8190 (5.1) |
| Chronic kidney disease | 1939 (6.0) | 54 (1.6) | 7 (0.5) | 3806 (2.4) |
| Nonalcoholic fatty liver disease | 652 (2.0) | 63 (1.9) | 11 (0.8) | 1132 (0.7) |
| Other immune diagnosis | 1081 (3.4) | 221 (6.6) | 75 (5.2) | 1695 (1.1) |
| Hypertension | 8808 (27.4) | 421 (12.6) | 95 (6.6) | 27 632 (17.2) |
| Hyperlipidemia | 7482 (23.3) | 372 (11.2) | 98 (6.8) | 21 190 (13.2) |
| Opportunistic infection | 1146 (3.6) | 87 (2.6) | 0 | 1789 (1.1) |
| Medical history (any time before index date), n (%) | ||||
| Extraintestinal manifestations | 4066 (12.6) | 367 (11.0) | 84 (5.9) | 4529 (2.8) |
| Malignancies (excluding NMSC) | 3703 (11.5) | 169 (5.1) | <5 (<0.4) | 6470 (4.0) |
| MACE (inpatient) | 2069 (6.4) | 70 (2.1) | 7 (0.5) | 3636 (2.3) |
| AV block | 388 (1.2) | 15 (0.5) | 0 | 650 (0.4) |
| Bradycardia | 1152 (3.6) | 43 (1.3) | 0 | 1995 (1.2) |
| Venous thromboembolism: PE | 411 (1.3) | 29 (0.9) | <5 (<0.4) | 472 (0.3) |
| Venous thromboembolism: DVT | 1291 (4.0) | 91 (2.7) | 17 (1.2) | 1418 (0.9) |
| Macular edema or retinopathy | 49 (0.2) | <5 (<0.4) | 0 | 66 (<0.1) |
| Medication history | ||||
| Prior conventional treatments (6 months prior to index date), n (%) | ||||
| Thiopurines | 1447 (4.5) | 233 (7.0) | 73 (5.1) | 70 (<0.1) |
| Oral CS | 21 970 (68.3) | 2321 (69.7) | 759 (52.9) | 29 530 (18.4) |
| Oral 5-ASA | 8448 (26.3) | 496 (14.9) | 142 (9.9) | 100 (0.1) |
| Prior conventional treatments (±30 days to index date), n (%) | ||||
| Thiopurines | 2247 (7.0) | 258 (7.7) | 85 (5.9) | 36 (<0.1) |
| Oral CS | 12 334 (38.3) | 1107 (33.2) | 307 (21.4) | 2258 (1.4) |
| Oral 5-ASA | 19 131 (59.5) | 660 (19.8) | 205 (14.3) | 47 (<0.1) |
| Prior advanced treatments (± 30 days to index date), n (%) | ||||
| Adalimumab | 884 (2.7) | 884 (26.5) | 380 (26.5) | 46 (<0.1) |
| Infliximab | 1575 (4.9) | 1575 (47.3) | 608 (42.4) | 22 (<0.1) |
| Golimumab | 78 (0.2) | 78 (2.3) | 27 (1.9) | <5 (<0.4) |
| Vedolizumab | 695 (2.2) | 695 (20.9) | 363 (25.3) | <5 (<0.4) |
| Ustekinumab | 64 (0.2) | 64 (1.9) | 29 (2.0) | 0 |
| Tofacitinib | 77 (0.2) | 77 (2.3) | 36 (2.5) | <5 (<0.4) |
| Upadacitinib | 9 (< 0.1) | 9 (0.3) | 7 (0.5) | <5 (<0.4) |
| UC overall (N = 32 170) | UC advanced therapy (N = 3332) | UC trial-similar (N = 1435) | Non-UC (N = 160 795) | |
| Demographics | ||||
| Age at index date, mean (SD) | 52.3 (17.9) | 45.0 (16.8) | 44.0 (16.6) | 52.3 (17.9) |
| Length of follow-up, years; mean (SD) | 2.8 (1.9) | 2.9 (2.0) | 2.7 (1.9) | 2.7 (2.0) |
| Sex, n (%) | ||||
| Female | 17 519 (54.5) | 1637 (49.1) | 696 (48.5) | 87 550 (54.4) |
| Male | 14 651 (45.5) | 1695 (50.9) | 739 (51.5) | 73 245 (45.6) |
| Race, n (%) | ||||
| White | 27 776 (86.3) | 2876 (86.3) | 1246 (86.8) | 138 865 (86.4) |
| Black | 2299 (7.1) | 164 (4.9) | 62 (4.3) | 11 480 (7.1) |
| Asian | 520 (1.6) | 68 (2.0) | 30 (2.1) | 2575 (1.6) |
| Other/Unknown | 1575 (4.9) | 224 (6.7) | 97 (6.8) | 7875 (4.9) |
| Baseline characteristics | ||||
| Charlson comorbidity index score (1 year prior to index date), mean (SD) | 1.0 (2.1) | 0.4 (1.4) | 0.1 (0.4) | 0.4 (1.2) |
| Medical history (1 year prior to index date), n (%) | ||||
| Diabetes (Type 1/Type 2) | 3368 (10.5) | 158 (4.7) | 23 (1.6) | 10 559 (6.6) |
| Pulmonary disease (COPD or asthma) | 3821 (11.9) | 186 (5.6) | 36 (2.5) | 8190 (5.1) |
| Chronic kidney disease | 1939 (6.0) | 54 (1.6) | 7 (0.5) | 3806 (2.4) |
| Nonalcoholic fatty liver disease | 652 (2.0) | 63 (1.9) | 11 (0.8) | 1132 (0.7) |
| Other immune diagnosis | 1081 (3.4) | 221 (6.6) | 75 (5.2) | 1695 (1.1) |
| Hypertension | 8808 (27.4) | 421 (12.6) | 95 (6.6) | 27 632 (17.2) |
| Hyperlipidemia | 7482 (23.3) | 372 (11.2) | 98 (6.8) | 21 190 (13.2) |
| Opportunistic infection | 1146 (3.6) | 87 (2.6) | 0 | 1789 (1.1) |
| Medical history (any time before index date), n (%) | ||||
| Extraintestinal manifestations | 4066 (12.6) | 367 (11.0) | 84 (5.9) | 4529 (2.8) |
| Malignancies (excluding NMSC) | 3703 (11.5) | 169 (5.1) | <5 (<0.4) | 6470 (4.0) |
| MACE (inpatient) | 2069 (6.4) | 70 (2.1) | 7 (0.5) | 3636 (2.3) |
| AV block | 388 (1.2) | 15 (0.5) | 0 | 650 (0.4) |
| Bradycardia | 1152 (3.6) | 43 (1.3) | 0 | 1995 (1.2) |
| Venous thromboembolism: PE | 411 (1.3) | 29 (0.9) | <5 (<0.4) | 472 (0.3) |
| Venous thromboembolism: DVT | 1291 (4.0) | 91 (2.7) | 17 (1.2) | 1418 (0.9) |
| Macular edema or retinopathy | 49 (0.2) | <5 (<0.4) | 0 | 66 (<0.1) |
| Medication history | ||||
| Prior conventional treatments (6 months prior to index date), n (%) | ||||
| Thiopurines | 1447 (4.5) | 233 (7.0) | 73 (5.1) | 70 (<0.1) |
| Oral CS | 21 970 (68.3) | 2321 (69.7) | 759 (52.9) | 29 530 (18.4) |
| Oral 5-ASA | 8448 (26.3) | 496 (14.9) | 142 (9.9) | 100 (0.1) |
| Prior conventional treatments (±30 days to index date), n (%) | ||||
| Thiopurines | 2247 (7.0) | 258 (7.7) | 85 (5.9) | 36 (<0.1) |
| Oral CS | 12 334 (38.3) | 1107 (33.2) | 307 (21.4) | 2258 (1.4) |
| Oral 5-ASA | 19 131 (59.5) | 660 (19.8) | 205 (14.3) | 47 (<0.1) |
| Prior advanced treatments (± 30 days to index date), n (%) | ||||
| Adalimumab | 884 (2.7) | 884 (26.5) | 380 (26.5) | 46 (<0.1) |
| Infliximab | 1575 (4.9) | 1575 (47.3) | 608 (42.4) | 22 (<0.1) |
| Golimumab | 78 (0.2) | 78 (2.3) | 27 (1.9) | <5 (<0.4) |
| Vedolizumab | 695 (2.2) | 695 (20.9) | 363 (25.3) | <5 (<0.4) |
| Ustekinumab | 64 (0.2) | 64 (1.9) | 29 (2.0) | 0 |
| Tofacitinib | 77 (0.2) | 77 (2.3) | 36 (2.5) | <5 (<0.4) |
| Upadacitinib | 9 (< 0.1) | 9 (0.3) | 7 (0.5) | <5 (<0.4) |
Abbreviations: 5-ASA, 5-aminosalicylic acid; AV, atrioventricular; COPD, chronic obstructive pulmonary disease; CS, corticosteroids; DVT, deep vein thrombosis; MACE, major adverse cardiovascular event; n, number of patients; N, the number of patients in the group; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; UC, ulcerative colitis.
Demographic and clinical characteristics of the UC overall, UC advanced therapy, UC trial-similar, and Non-UC cohorts.
| UC overall (N = 32 170) | UC advanced therapy (N = 3332) | UC trial-similar (N = 1435) | Non-UC (N = 160 795) | |
| Demographics | ||||
| Age at index date, mean (SD) | 52.3 (17.9) | 45.0 (16.8) | 44.0 (16.6) | 52.3 (17.9) |
| Length of follow-up, years; mean (SD) | 2.8 (1.9) | 2.9 (2.0) | 2.7 (1.9) | 2.7 (2.0) |
| Sex, n (%) | ||||
| Female | 17 519 (54.5) | 1637 (49.1) | 696 (48.5) | 87 550 (54.4) |
| Male | 14 651 (45.5) | 1695 (50.9) | 739 (51.5) | 73 245 (45.6) |
| Race, n (%) | ||||
| White | 27 776 (86.3) | 2876 (86.3) | 1246 (86.8) | 138 865 (86.4) |
| Black | 2299 (7.1) | 164 (4.9) | 62 (4.3) | 11 480 (7.1) |
| Asian | 520 (1.6) | 68 (2.0) | 30 (2.1) | 2575 (1.6) |
| Other/Unknown | 1575 (4.9) | 224 (6.7) | 97 (6.8) | 7875 (4.9) |
| Baseline characteristics | ||||
| Charlson comorbidity index score (1 year prior to index date), mean (SD) | 1.0 (2.1) | 0.4 (1.4) | 0.1 (0.4) | 0.4 (1.2) |
| Medical history (1 year prior to index date), n (%) | ||||
| Diabetes (Type 1/Type 2) | 3368 (10.5) | 158 (4.7) | 23 (1.6) | 10 559 (6.6) |
| Pulmonary disease (COPD or asthma) | 3821 (11.9) | 186 (5.6) | 36 (2.5) | 8190 (5.1) |
| Chronic kidney disease | 1939 (6.0) | 54 (1.6) | 7 (0.5) | 3806 (2.4) |
| Nonalcoholic fatty liver disease | 652 (2.0) | 63 (1.9) | 11 (0.8) | 1132 (0.7) |
| Other immune diagnosis | 1081 (3.4) | 221 (6.6) | 75 (5.2) | 1695 (1.1) |
| Hypertension | 8808 (27.4) | 421 (12.6) | 95 (6.6) | 27 632 (17.2) |
| Hyperlipidemia | 7482 (23.3) | 372 (11.2) | 98 (6.8) | 21 190 (13.2) |
| Opportunistic infection | 1146 (3.6) | 87 (2.6) | 0 | 1789 (1.1) |
| Medical history (any time before index date), n (%) | ||||
| Extraintestinal manifestations | 4066 (12.6) | 367 (11.0) | 84 (5.9) | 4529 (2.8) |
| Malignancies (excluding NMSC) | 3703 (11.5) | 169 (5.1) | <5 (<0.4) | 6470 (4.0) |
| MACE (inpatient) | 2069 (6.4) | 70 (2.1) | 7 (0.5) | 3636 (2.3) |
| AV block | 388 (1.2) | 15 (0.5) | 0 | 650 (0.4) |
| Bradycardia | 1152 (3.6) | 43 (1.3) | 0 | 1995 (1.2) |
| Venous thromboembolism: PE | 411 (1.3) | 29 (0.9) | <5 (<0.4) | 472 (0.3) |
| Venous thromboembolism: DVT | 1291 (4.0) | 91 (2.7) | 17 (1.2) | 1418 (0.9) |
| Macular edema or retinopathy | 49 (0.2) | <5 (<0.4) | 0 | 66 (<0.1) |
| Medication history | ||||
| Prior conventional treatments (6 months prior to index date), n (%) | ||||
| Thiopurines | 1447 (4.5) | 233 (7.0) | 73 (5.1) | 70 (<0.1) |
| Oral CS | 21 970 (68.3) | 2321 (69.7) | 759 (52.9) | 29 530 (18.4) |
| Oral 5-ASA | 8448 (26.3) | 496 (14.9) | 142 (9.9) | 100 (0.1) |
| Prior conventional treatments (±30 days to index date), n (%) | ||||
| Thiopurines | 2247 (7.0) | 258 (7.7) | 85 (5.9) | 36 (<0.1) |
| Oral CS | 12 334 (38.3) | 1107 (33.2) | 307 (21.4) | 2258 (1.4) |
| Oral 5-ASA | 19 131 (59.5) | 660 (19.8) | 205 (14.3) | 47 (<0.1) |
| Prior advanced treatments (± 30 days to index date), n (%) | ||||
| Adalimumab | 884 (2.7) | 884 (26.5) | 380 (26.5) | 46 (<0.1) |
| Infliximab | 1575 (4.9) | 1575 (47.3) | 608 (42.4) | 22 (<0.1) |
| Golimumab | 78 (0.2) | 78 (2.3) | 27 (1.9) | <5 (<0.4) |
| Vedolizumab | 695 (2.2) | 695 (20.9) | 363 (25.3) | <5 (<0.4) |
| Ustekinumab | 64 (0.2) | 64 (1.9) | 29 (2.0) | 0 |
| Tofacitinib | 77 (0.2) | 77 (2.3) | 36 (2.5) | <5 (<0.4) |
| Upadacitinib | 9 (< 0.1) | 9 (0.3) | 7 (0.5) | <5 (<0.4) |
| UC overall (N = 32 170) | UC advanced therapy (N = 3332) | UC trial-similar (N = 1435) | Non-UC (N = 160 795) | |
| Demographics | ||||
| Age at index date, mean (SD) | 52.3 (17.9) | 45.0 (16.8) | 44.0 (16.6) | 52.3 (17.9) |
| Length of follow-up, years; mean (SD) | 2.8 (1.9) | 2.9 (2.0) | 2.7 (1.9) | 2.7 (2.0) |
| Sex, n (%) | ||||
| Female | 17 519 (54.5) | 1637 (49.1) | 696 (48.5) | 87 550 (54.4) |
| Male | 14 651 (45.5) | 1695 (50.9) | 739 (51.5) | 73 245 (45.6) |
| Race, n (%) | ||||
| White | 27 776 (86.3) | 2876 (86.3) | 1246 (86.8) | 138 865 (86.4) |
| Black | 2299 (7.1) | 164 (4.9) | 62 (4.3) | 11 480 (7.1) |
| Asian | 520 (1.6) | 68 (2.0) | 30 (2.1) | 2575 (1.6) |
| Other/Unknown | 1575 (4.9) | 224 (6.7) | 97 (6.8) | 7875 (4.9) |
| Baseline characteristics | ||||
| Charlson comorbidity index score (1 year prior to index date), mean (SD) | 1.0 (2.1) | 0.4 (1.4) | 0.1 (0.4) | 0.4 (1.2) |
| Medical history (1 year prior to index date), n (%) | ||||
| Diabetes (Type 1/Type 2) | 3368 (10.5) | 158 (4.7) | 23 (1.6) | 10 559 (6.6) |
| Pulmonary disease (COPD or asthma) | 3821 (11.9) | 186 (5.6) | 36 (2.5) | 8190 (5.1) |
| Chronic kidney disease | 1939 (6.0) | 54 (1.6) | 7 (0.5) | 3806 (2.4) |
| Nonalcoholic fatty liver disease | 652 (2.0) | 63 (1.9) | 11 (0.8) | 1132 (0.7) |
| Other immune diagnosis | 1081 (3.4) | 221 (6.6) | 75 (5.2) | 1695 (1.1) |
| Hypertension | 8808 (27.4) | 421 (12.6) | 95 (6.6) | 27 632 (17.2) |
| Hyperlipidemia | 7482 (23.3) | 372 (11.2) | 98 (6.8) | 21 190 (13.2) |
| Opportunistic infection | 1146 (3.6) | 87 (2.6) | 0 | 1789 (1.1) |
| Medical history (any time before index date), n (%) | ||||
| Extraintestinal manifestations | 4066 (12.6) | 367 (11.0) | 84 (5.9) | 4529 (2.8) |
| Malignancies (excluding NMSC) | 3703 (11.5) | 169 (5.1) | <5 (<0.4) | 6470 (4.0) |
| MACE (inpatient) | 2069 (6.4) | 70 (2.1) | 7 (0.5) | 3636 (2.3) |
| AV block | 388 (1.2) | 15 (0.5) | 0 | 650 (0.4) |
| Bradycardia | 1152 (3.6) | 43 (1.3) | 0 | 1995 (1.2) |
| Venous thromboembolism: PE | 411 (1.3) | 29 (0.9) | <5 (<0.4) | 472 (0.3) |
| Venous thromboembolism: DVT | 1291 (4.0) | 91 (2.7) | 17 (1.2) | 1418 (0.9) |
| Macular edema or retinopathy | 49 (0.2) | <5 (<0.4) | 0 | 66 (<0.1) |
| Medication history | ||||
| Prior conventional treatments (6 months prior to index date), n (%) | ||||
| Thiopurines | 1447 (4.5) | 233 (7.0) | 73 (5.1) | 70 (<0.1) |
| Oral CS | 21 970 (68.3) | 2321 (69.7) | 759 (52.9) | 29 530 (18.4) |
| Oral 5-ASA | 8448 (26.3) | 496 (14.9) | 142 (9.9) | 100 (0.1) |
| Prior conventional treatments (±30 days to index date), n (%) | ||||
| Thiopurines | 2247 (7.0) | 258 (7.7) | 85 (5.9) | 36 (<0.1) |
| Oral CS | 12 334 (38.3) | 1107 (33.2) | 307 (21.4) | 2258 (1.4) |
| Oral 5-ASA | 19 131 (59.5) | 660 (19.8) | 205 (14.3) | 47 (<0.1) |
| Prior advanced treatments (± 30 days to index date), n (%) | ||||
| Adalimumab | 884 (2.7) | 884 (26.5) | 380 (26.5) | 46 (<0.1) |
| Infliximab | 1575 (4.9) | 1575 (47.3) | 608 (42.4) | 22 (<0.1) |
| Golimumab | 78 (0.2) | 78 (2.3) | 27 (1.9) | <5 (<0.4) |
| Vedolizumab | 695 (2.2) | 695 (20.9) | 363 (25.3) | <5 (<0.4) |
| Ustekinumab | 64 (0.2) | 64 (1.9) | 29 (2.0) | 0 |
| Tofacitinib | 77 (0.2) | 77 (2.3) | 36 (2.5) | <5 (<0.4) |
| Upadacitinib | 9 (< 0.1) | 9 (0.3) | 7 (0.5) | <5 (<0.4) |
Abbreviations: 5-ASA, 5-aminosalicylic acid; AV, atrioventricular; COPD, chronic obstructive pulmonary disease; CS, corticosteroids; DVT, deep vein thrombosis; MACE, major adverse cardiovascular event; n, number of patients; N, the number of patients in the group; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; UC, ulcerative colitis.
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