Abstract

Clinical remission can be achieved with exclusive enteral nutrition (EEN) in patients with Crohn's Disease with different sites of involvement, varying severity, and complications such as abscess and fistula. In the CHARM study, weekly or every other week administration of adalimumab (ADA) did not provide a significant difference in remission rates. Nevertheless, the subgroup analysis showed that in patients with anti-TNF experience, moderate-to-severely active disease, and high CRP values, rates of remission were significantly higher with weekly doses. Our aim was to determine the efficacy of EEN and weekly adalimumab combination in Crohn's patients with fibroinflammatory stenosis. Seven consecutive patients with newly diagnosed severe disease and fibro-inflammatory stenosis were included in this retrospective study. The PRO-2 score was used to assess clinical remission, the SES-CD score to determine the severity of endoscopic activity, the Nancy score to determine the severity of inflammation in tissue samples, and the MaRIA score to determine changes in magnetic resonance enterography (MRE). Nestle Modulen® (35kcal/kg) was used for twelve weeks as the EEN solution. In addition to the formulation, patients were only allowed to consume water. At the end of the 12th week, the patients gradually switched to a standard diet. Concomitantly initiated ADA was continued at 40 mg weekly after standard loading doses of 160 mg-80 mg-40 mg. The patients were evaluated with clinical and laboratory findings at the 1st, 4th and 8th weeks of the treatment, and also with colonoscopy and MRE at the 12th week. The difference between mean PRO-2 score (24.7 ± 1.97, 20.1 ± 1.63, 15.3 ± 1.81,11.4 ± 2.15, 5 ± 1.1, p = 0.031), CRP (14.3 ± 4.54, 11.2 ± 3.31, 6.92 ± 2.88, 2.16 ± 1.14, 0.25 ± 0.13, p = 0.022), albumin (2.9 ± 0.21, 3.05 ± 0.33, 3.4 ± 0.29, 4.1 ± 0.45, 4.6 ± 0.27, p = 0.044), hemoglobin (11.38 ± 0.97, 12.65 ± 0.87, 13.41 ± 0.91, 13.89 ± 0.76, 14.44 ± 0.65, p = 0.063), SES-CD score (17.14 ± 4.87, 7.66 ± 5.98, p = 0.014), MaRIA score (21.13 ± 7.42, 9.91 ± 4.55, p = 0.003) and Nancy score (3.71±0.48, 1.71±0.36, p=0.028) were all statistically significant. The stenotic segment endoscopically passed at week 12 in every patient but one, which had minimally invasive surgery (ileoascendostomy) because of ileus that developed at the eighth week of therapy. Of note, the patient who underwent surgery had perianal involvement. Despite the extremely limited number of patients and short-term follow-up results, 12-week EEN and concurrent weekly ADA therapy may be effective in inducing remission in this group of patients. There is a need for large-scale, prospective studies on this subject.

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