Results of prospective evaluation of mucosal changes in the small bowel by capsule enteroscopy in patients with Crohn’s disease treated with infliximab and adalimumab


Authors: L. Kužela;  M. Oltman;  J. Šutka;  B. Zacharová;  P. Paulen;  B. Repákova;  V. Syč-Milý;  M. Rajská
Authors‘ workplace: Gastroentero-Hepatologické centrum THALION
Published in: Gastroent Hepatol 2010; 64(2): 22-30
Category: IBD

Overview

Introduction:
Until recently, the focus of treatment of patients with Crohn’s disease (CD) was on improvement of the signs and symptoms of the disease without aiming at mucosal healing (MH). However, in recent years MH has proven to be an important therapeutical goal in patients with CD. Interest was raised recently by findings showing that biological agents not only rapidly improve the symptoms but also induce healing of ileocolonic lesions. As a consequence, current clinical trials regard MH as an important therapeutical goal and it has also been implemented in clinical practice to a greater extent. Aim:The aim of the proposed study is to evaluate mucosal lesions in the small intestine by capsule endoscopy (CE) in patients with CD before the administration of infliximab (IFX) and adalimumab (ADA) and following one-year maintenance treatment with these agents. The secondary endpoint is to evaluate the tolerance of CE by the patient, the possible side effects of this procedure and also the diagnostic efficacy of this procedure in patients with CD. Material and methods: Following approval from the Ethics Committee and after signing the Informed Consent, the group of consequently included 50 patients with CD, not previously treated with IFX (n = 25) or ADA (n = 25), but suitable for biological treatment with respect to the indication criteria, were monitored. After patients with CD were included in the study, CE using the M2A capsule was performed in each patient before the first dose of biological treatment was administered. Results were seen as conclusive if the following signs of CD localized in the small intestine were observed: erythema, edema, villus abrasion, aphtous lesions, ulcerations, scars, openings of fistula, possible strictures, bleeding. Results were seen as inconclusive if the findings were not typical for active CD: isolated aphtous lesions and ulcerations (fewer than 3) and normal. Examination was regarded as complete if the capsule reached cecum. Tolerance of CE from the patient’s side and side effects were also evaluated. The efficacy of the examination was assessed in each patient (conclusive findings, inconclusive findings or normal findings) before and after treatment with IFX and ADA. Results: From the group of prospectively enrolled patients with CD (n = 50) we had to exclude 4 patients due to IFX infusion reactions and 4 patients due to reactivation of CD (2 treated with IFX and 2 with ADA). 42 patients (19 treated with IFX and 23 with ADA) concluded the prospective evaluation by means of 1-year treatment with biological agents and repeated CE examination. In the group of ADA treated patients (n = 23) after one year we observed a change from conclusive to normal in 2 patients. We observed in 1 patient a deterioration of the findings from inconclusive to conclusive and in 1 patient from inconclusive to normal. In all the other patients the findings remained without change (in 9 conclusive, in 9 normal and in 1 inconclusive). In the group of IFX treated patients (n = 19) after one year we observed changes from conclusive to normal in 2 patients. In all the other patients the findings remained without change (in 6 conclusive, in 8 normal and in 3 inconclusive). The CE examination was well tolerated, without serious side effects, in all patients. In 7 patients the capsule did not reach cecum. Conclusion: Despite the fact that we did not observe statistically significant effect of ADA or IFX treatment on small bowel MH, we observed in our group of CD patients improvement by means of a drop in the Crohn’s Disease Activity Index (CDAI) during 1-year maintenance biological treatment. CE could therefore in the future be helpful in selecting the right patient with mucosal lesions in terms of achieving the best clinical results for the biological treatment. The validity of this approach is necessarily to be determined in prospective studies with CD patients, where MH has to be established as the main treatment goal. Further studies are also needed to create a standardized endoscopic scoring system for MH, which has to be proven in prospective clinical studies evaluating long-term development of CD. Until then it is not clear what our approach to MH in clinical practice should be.

Key words:
Crohn’s disease – mucosal healing – capsule endoscopy – infliximab – adalimumab


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Labels
Paediatric gastroenterology Gastroenterology and hepatology Surgery

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