P447 Combined fibrin glue with infliximab therapy of postoperative anastomotic fistula in patients with Crohn’s disease: A Pilot study

Abstract Background Postoperative anastomotic fistula is one of the most frequent and potentially life-threatening complications following gastrointestinal resections in patients with Crohn’s disease. The purpose of this study was to report the results of infliximab promoting healing of postoperative anastomotic fistula in patients with Crohn’s disease. Methods In this randomized controlled trial, 37 patients with postoperative fistula were assigned to combined(n=18) or control(n=19) groups and followed up for 6 months. The combined group received usual management protocol for fistula plus an intravenous infliximab therapy for 6 months. The control group received usual fistula protocol. The primary outcome was fistula closure time. The secondary outcome was any infectious complication such as recurrence of ECF, abdominal abscess, pneumonia, infectious diarrhea and other signs of infection. Results Thirty-seven patients with postoperative anastomotic fistula were evaluated. There were18 patients randomized to the combined group who received fibrin glue combined with infliximab therapy. There were 19 patients randomized to the control group who received fibrin glue sealant therapy alone. No significant differences in demographic or clinical characteristics were found between the two groups( P>0.05). The combined group had a shorter closure time than the control group(50.5±11.1 vs 76.2±26.2 days, P=0.011). The combined group did not show higher infectious complications than the control group(P=0.167). Conclusion Infliximab strategy with combining fibrin glue is a safe and effective treatment alternative in the management of postoperative anastomotic fistula in Crohn’s disease, offering the advantage of reduced heal time of fistula.

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Prospective randomised controlled trial of adults with perianal fistulising Crohn’s disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol

BMJ Open ◽

10.1136/bmjopen-2020-043921 ◽

2021 ◽

Vol 11 (7) ◽

pp. e043921

Author(s):

Bonita Gu ◽

Michael De Gregorio ◽

Joseph Louis Pipicella ◽

Niels Vande Casteele ◽

Jane M Andrews ◽

...

Keyword(s):

Crohn’S Disease ◽

Randomised Controlled Trial ◽

Crohn's Disease ◽

Controlled Trial ◽

Dropout Rate ◽

Infliximab Therapy ◽

Infliximab Treatment ◽

Patient Reported ◽

Fistula Healing ◽

Randomised Controlled

IntroductionPerianal fistulising Crohn’s disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy.Methods and analysisPatients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18–80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate.Ethics and disseminationResults will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.

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P392 Initial experience with fibrin glue combined with infliximab treatment of postoperative anastomotic fistula in patients with Crohn’s disease

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.521 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S366-S366

Author(s):

D YAO

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Fibrin Glue ◽

Clinical Characteristics ◽

Infliximab Treatment ◽

Initial Experience ◽

Parallel Study ◽

Treatment Alternative ◽

Life Threatening ◽

Anastomotic Fistula

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Improvement of Lumbar Bone Mass after Infliximab Therapy in Crohn’s Disease Patients

Canadian Journal of Gastroenterology ◽

10.1155/2007/216162 ◽

2007 ◽

Vol 21 (10) ◽

pp. 637-642 ◽

Cited By ~ 32

Author(s):

Marina Mauro ◽

Vladimir Radovic ◽

David Armstrong

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Bone Mass ◽

Disease Activity ◽

Bone Mineral ◽

Infliximab Therapy ◽

Control Group ◽

Infliximab Treatment ◽

Mineral Density ◽

Bone Mass Loss

BACKGROUND: Patients with Crohn’s disease (CD) have a high risk of developing osteoporosis, but the mechanisms underlying bone mass loss are unclear. Elevated proinflammatory cytokines, such as tumour necrosis factor-alpha (TNFα), have been implicated in the pathogenesis of bone resorption.AIM: To assess whether suppression of TNFα with infliximab treatment has a beneficial effect on lumbar bone mass.METHODS: Adult CD patients who had received infliximab treatment, and who underwent lumbar densitometric evaluation before and during treatment, were selected. Adult CD patients who had never received infliximab treatment were selected as controls. Information regarding age, sex, weight, duration of CD, use of glucocorticoids and bisphosphonates, and signs of disease activity between both densitometric measurements were collected.RESULTS: Data from 45 patients were analyzed. The control group (n=30, mean [± SD] 26.7±9 years of age) had a significantly higher increase in body weight between both evaluations (6.26%±8%) than the infliximab group (n=15, 30.6±13 years), which had an increase of 0.3%±7.4%. There was a strong correlation between the final weight and lumbar bone mineral content (BMC) in both groups. The infliximab group had a significant increase in lumbar bone area (4.15%±6.6%), BMC (12.8%±13.6%) and bone mineral density (8.13%±7.7%) between both evaluations (interval 22.6±11 months) compared with the control group. The increase in BMC in patients who had received infliximab treatment was significant when compared with control patients who had received glucocorticoids (n=8) or had evidence of disease activity (n=13).CONCLUSION: Infliximab therapy improved lumbar bone mass independent of nutritional status. This finding suggests that TNFα plays a role in bone loss in CD.

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