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©2007 Baishideng Publishing Group Inc.
World J Gastroenterol. Oct 21, 2007; 13(39): 5238-5244
Published online Oct 21, 2007. doi: 10.3748/wjg.v13.i39.5238
Published online Oct 21, 2007. doi: 10.3748/wjg.v13.i39.5238
Table 1 Demographic and clinical characteristics of the study population
Clinical characteristics | IBD (CD + UC) | Crohn’s disease | Ulcerative colitis |
n | 50 | 40 | 10 |
Gender (M/F) | 23/27 | 18/22 | 4/6 |
Age (yr)1 | 47.7 ± 15.6 | 45.4 ± 17.9 | 52.7 ± 8.9 |
Median disease duration (yr) | 10.8 | 9.2 | 9.3 |
(range) | (0.3-22.2) | (0.3-22.2) | (2.1-15.1) |
Disease activity (T0)1 | N/A | 245.0 ± 99.3 (CDAI)2 | 12.9 ± 2.8 (CAI) |
Site of disease n (%): | |||
Small bowel/pouch | 13 (32.5) | ||
Large bowel | 4 (10) | 10 | |
Ileum-colon | 23 (57.5) | ||
Steroid therapy at enrolment (%) (≥ 0.7 mg/kg per day) | 39 (78) | 30 (75) | 9 (90) |
Concomitant medications n (%): | |||
Salicylates | 29 | 21 (52.5) | 8 (80) |
6-MP/azathioprine | 31 | 28 (70) | 3 (30) |
Antibiotics | 25 | 24 (60) | 1 (10) |
Table 2 Efficacy profile of maintenance protocol
IBD (CD + UC) | Crohn's disease | Ulcerative colitis | ||||
IFX infusions total number | 637 | 493 | 144 | |||
Median number (range) | 15 (4-25) | 15 (4-25) | 14.5 (6-22) | |||
Median duration (mo) of IFX therapy (range) | 27 (4-64) | 27 (4-64) | 24.5 (6-46) | |||
No. patients maintaining remission with IFX (%) | 41/50 | 82 | 32/40 | 80 | 9/10 | 90 |
Median duration (mo) of remission during IFX treatment (range) | 25 (4-59) | 25.5 (4-59) | 25 (6-46) | |||
No. patients discontinuing therapy during clinical remission (%) | 13/38 | 34 | 9/29 | 31 | 4/9 | 44 |
Median duration (mo) of remission after treatment discontinuation (range) | 15.5 (4-30) | 16 (5-30) | 6.5 (4-16) | |||
No. patients on corticosteroids1 during maintenance with IFX (%) | 1/50 | 2 | 10/40 | 25 | 1/10 | 10 |
Table 3 Summary of IFX related adverse events
Adverse event | IBD (CD + UC) | Crohn’s disease | Ulcerative colitis |
Acute infusion reaction (%) (Mild, moderate, severe) | 3/50 (6) | 3/40 (7.5) | 0 |
Delayed infusion reaction (%) (Serum sickness-like) | 1/50 (2) | 1/40 (2.5) | 0 |
Opportunistic infection (%) | 9/50 (18) | 8/40 (20) 5 HSV 1 VZV 2 atypical pneumoniae | 1/10 (10) 1 HSV |
Lymphoproliferative diseases | 0 | 0 | 0 |
Malignant disorder (%) | 3/50 (6) | 2/40 (5) | 1/10 (10) |
Table 4 Clinical characteristics of patients developing malignant disorders during IFX treatment
Patients | 1 | 2 | 3 |
Gender | F | F | F |
Disease | Ulcerative colitis | Crohn’s disease | Crohn’s disease |
Disease duration (yr) | 22 | 3 | 3 |
Site of disease | Left colon | Ileum-colon | Ileum-colon |
Type of neoplasia (TNM) | Breast cancer (T2mN3M0) | Gastric cancer (T2aN0M0) | Endometrial cancer (T1cN0M0) |
Concomitant medication | Azathioprine | Azathioprine/cyprofloxacine/metronidazole | Azathioprine/ cyprofloxacine/ metronidazole |
N. IFX infusions | 13 | 6 | 10 |
Months since first IFX infusion | 21 | 24 | 14 |
- Citation: Caviglia R, Ribolsi M, Rizzi M, Emerenziani S, Annunziata ML, Cicala M. Maintenance of remission with infliximab in inflammatory bowel disease: Efficacy and safety long-term follow-up. World J Gastroenterol 2007; 13(39): 5238-5244
- URL: https://www.wjgnet.com/1007-9327/full/v13/i39/5238.htm
- DOI: https://dx.doi.org/10.3748/wjg.v13.i39.5238