Table 1.
Comparison of baseline characteristics for patients with inflammatory bowel disease (IBD) in the infliximab-dyyb group versus reference product (RP) infliximab group before propensity score matching (PSM) and after PSM
| Baseline characteristic | Infliximab-dyyb (n = 1409) | Before PSM | After PSM | |||
|---|---|---|---|---|---|---|
| RP infliximab (n = 2779) | P value | RP infliximab (n = 1409) | P value | |||
| Matched variables | Age, mean ± SD | 47.8 ± 16.9 | 42.6 ± 16.9 | < 0.01 | 47.5 ± 17.1 | 0.61 |
| Male | 727 (52) | 1340 (48) | 0.04 | 708 (50) | 0.47 | |
| White race | 940 (67) | 1886 (68) | 0.15 | 986 (70) | 0.06 | |
| CCI, median (IQR) | 0 (0.1) | 0 (0.1) | < 0.01 | 0 (0.1) | 0.55 | |
| Crohn’s disease | 728 (52) | 1528 (55) | 0.04 | 731 (52) | 0.91 | |
| Ulcerative colitis | 681 (48) | 1251 (45) | 678 (48) | |||
| Recent IBD-related surgery | 35 (2.5) | 56 (2.0) | 0.33 | 28 (2.0) | 0.37 | |
| Recent/concomitant IBD medication | ||||||
| Immunomodulator | 403 (29) | 899 (32) | 0.01 | 400 (28) | 0.90 | |
| Non-infliximab biologic or tofacitinib | 18 (1) | 133 (5) | < 0.01 | 27 (2) | 0.18 | |
| Dose at index date | ||||||
| < 300 mg | 29 (2) | 113 (4) | < 0.01 | 35 (2) | 0.70 | |
| 300–500 mg | 998 (71) | 2059 (74) | 1002 (71) | |||
| > 500 mg | 382 (27) | 607 (22) | 372 (26) | |||
| Unmatched variables | Length of IBD history (years), mean ± SD | 8.1 ± 5.8 | 5.7 ± 5.4 | < 0.01 | 7.0 ± 5.6 | < 0.01 |
| Infliximab use (years), mean ± SD | 3.3 ± 2.4 | 1.6 ± 1.9 | < 0.01 | 2.2 ± 2.0 | < 0.01 | |
| Currently or past history of smoking | 481 (34) | 988 (36) | 0.36 | 544 (39) | 0.01 | |
| Use of steroida | 60 (4) | 916 (33) | < 0.01 | 197 (14) | < 0.01 | |
| Recent/concomitant use of aminosalicylates | 299 (21) | 1069 (38) | < 0.01 | 359 (25) | < 0.02 | |
Values are n (%) unless otherwise stated
Immunomodulators included azathioprine, basiliximab, cyclosporine, hydroxychloroquine, mercaptopurine, methotrexate, mycophenolate, sirolimus, and tacrolimus
Non-infliximab biologics included abatacept, adalimumab, belatacept, belimumab, certolizumab, etanercept, glatiramer, golimumab, natalizumab, tocilizumab, ocrelizumab, ustekinumab, and vedolizumab
CCI Charlson Comorbidity Index, IQR interquartile range, SD standard deviation
aUse of steroids = a cumulative of > 1800 mg prednisone dose equivalents of systemic steroid within 6 months prior to index date