Copyright
©The Author(s) 2021.
World J Clin Cases. Dec 26, 2021; 9(36): 11285-11299
Published online Dec 26, 2021. doi: 10.12998/wjcc.v9.i36.11285
Published online Dec 26, 2021. doi: 10.12998/wjcc.v9.i36.11285
Table 1 Variables collected at baseline and during follow-up visits
| Variable | Baseline | Follow-up |
| Demographic data | ||
| Date of birth | X | - |
| Gender | X | - |
| Smoking habit | X | - |
| Disease data | ||
| Date of diagnosis | X | - |
| IBD type (Crohn’s disease, ulcerative colitis) | X | - |
| Montreal classification | X | - |
| Type of fistula (perianal, entero-enteral, enterovesical, enterovaginal, enterocutaneous, other) | X | - |
| Intra-intestinal complications (yes or no) | X | - |
| Extraintestinal complications (dermatological, osseous, optical, hepatic) | X | - |
| Harvey-Bradshaw index | X | X |
| Crohn’s disease activity index | X | X |
| Partial Mayo Score | X | X |
| Truelove-Witts severity index | X | X |
| Laboratory analysis | ||
| C-reactive protein | X | X |
| Erythrocyte sedimentation rate | X | X |
| Hemoglobin | X | X |
| Calprotectin | X | X |
| CT-P13 trough levels and antibodiesx | - | X |
| Imaging tests | ||
| Disease severity and lesion location according to endoscopy result (mild, moderate, severe) | X | X |
| Disease severity and lesion location according to magnetic resonance enterography result (mild, moderate, severe, fibrotic stenosis) | X | X |
| Treatment data | ||
| Current treatments (mesalazine, cortisone, AZA/6-MP, MTX) | X | X |
| Previous treatments (mesalazine, corticosteroids, AZA/6-MP, MTX, infliximab, adalimumab) | X | - |
| Reasons to start treatment with CT-P13 (corticosteroid dependence, corticosteroid resistance, failure of AZA/6-MP, perianal disease/fistula, start of severe illness) | X | - |
| Clinical situation | ||
| Active clinical disease | X | X |
| Clinical remission | X | X |
| Clinical response | - | X |
Table 2 Clinical characteristics of study patients at baseline, n (%)
| Overall (n = 220) | CD (n = 133) | UC (n = 87) | |
| Endoscopic findings (presence and size of ulcers) | |||
| Unaffected | 9 (4) | 7 (5) | 2 (2) |
| Mild (1-5 mm) | 7 (3) | 1 (1) | 6 (7) |
| Moderate (5-20 mm) | 54 (25) | 21 (16) | 33 (38) |
| Severe (> 20 mm) | 41 (19) | 25 (19) | 16 (18) |
| Fibrotic stenosis | 7 (3) | 7 (5) | 0 (0) |
| Not performed | 102 (46) | 72 (54) | 30 (34) |
| Ultrasound findings (hyperemia of the bowel wall assessed by color Doppler ultrasound) | |||
| Unaffected | 5 (2) | 5 (4) | - |
| Mild (2 signal dots/cm2) | 7 (3) | 7 (5) | - |
| Moderate | 34 (26) | - | |
| (3-5 signal dots/cm2) | 34 (15) | ||
| Severe (> 5 signal dots/cm2) | 22 (10) | 22 (17) | - |
| Not performed | 152 (69) | 65 (49) | 87 (100) |
| Previous treatments | |||
| Mesalazine | 97 (44) | 37 (28) | 60 (69) |
| Corticosteroids | 131 (60) | 73(55) | 58 (67) |
| AZA/6-MP | 135 (61) | 82 (62) | 53 (61) |
| MTX | 12 (5) | 10 (8) | 2 (2) |
| Remicade® | 35 (16) | 21 (16) | 14 (16) |
| Humira® | 22 (10) | 15 (11) | 7 (8) |
| Concomitant treatments | |||
| Mesalazine | 77 (35) | 28 (21) | 49 (56) |
| Corticosteroids | 74 (35) | 37 (28) | 37 (43) |
| AZA/6-MP | 115 (52) | 67 (50) | 48 (55) |
| MTX | 15 (7) | 15 (11) | 0 (0) |
Table 3 Montreal classification of Crohn’s disease and ulcerative colitis at baseline, n (%)
| Montreal classification of CD | CD (n = 133) |
| Age of diagnosis | |
| A1 (below 16 yr) | 15 (11) |
| A2 (between 17 and 40 yr) | 90 (68) |
| A3 (above 40 yr) | 18 (14) |
| - | 10 (8) |
| Location | |
| L1 (ileal) | 62 (47) |
| L2 (colonic) | 16 (12) |
| L3 (ileocolonic) | 47 (35) |
| - | 8 (6) |
| Location L41 (concomitant UGI disease) | |
| Yes | 4 (3) |
| No | 87 (65) |
| - | 42 (32) |
| Behavior | |
| B1 (non-stricturing, non-penetrating) | 60 (45) |
| B2 (stricturing) | 24 (18) |
| B3 (penetrating) | 38 (29) |
| - | 11 (8) |
| P2 (concomitant perianal disease) | |
| Yes | 38 (29) |
| No | 84 (63) |
| - | 11 (8) |
| Montreal classification of UC | UC (n = 87) |
| Extent | |
| E1 (Ulcerative proctitis) | 10 (11) |
| E2 (Left-sided UC - distal UC) | 18 (21) |
| E3 (Extensive UC - pancolitis) | 48 (55) |
| - | 11 (13) |
| Severity | |
| S1 (Mild UC) | 8 (9) |
| S2 (Moderate UC) | 54 (62) |
| S3 (Severe UC) | 15 (17) |
| - | 10 (11) |
Table 4 Clinical course of all patients (Crohn’s disease + ulcerative colitis) (those who switched from infliximab originator are excluded), n (%)
| Active disease | Clinical remission | Clinical response | |
| Baseline (n = 201) | 138 (68.6) | - | - |
| 3 mo (n = 152) | 37 (24.4) | 81 (53.2) | 34 (22.3) |
| 6 mo (n = 122) | 21 (17.2) | 74 (60.7) | 27 (22.1) |
| 9 mo (n = 84) | 8 (9.5) | 61 (72.6) | 15 (17.9) |
| 12 mo (n = 81) | 12 (14.8) | 52 (64.2) | 17 (21) |
Table 5 Type of adverse events reported, n (%)
| Number of AEs1 | 34 (15.45) |
| Hypersensitivity | 9 (26.5) |
| Malignant neoplasm | 1 (2.9) |
| Infections (any type) | 8 (23.5) |
| Respiratory infections | 2 (5.9) |
| Other infections | 6 (17.6) |
| Other AEs | 8 (23.5) |
| Non-specified | 8 (23.5) |
- Citation: Huguet JM, Cortés X, Bosca-Watts MM, Aguas M, Maroto N, Martí L, Amorós C, Paredes JM. Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease. World J Clin Cases 2021; 9(36): 11285-11299
- URL: https://www.wjgnet.com/2307-8960/full/v9/i36/11285.htm
- DOI: https://dx.doi.org/10.12998/wjcc.v9.i36.11285