ASSESSMENT OF THE PERFORMANCE OF THE PILLCAM COLON CAPSULE IN CROHN‘S DISEASE BEFORE AND AFTER TREATMENT WITH ANTI-TNF

The goals of treatment in Crohn’s disease have evolved in recent years from symptom control to healing of mucosal lesions, usually visualized by endoscopy. Potent therapeutic agents, such as anti-TNF agents, have made restoration of mucosal integrity attainable in a significant proportion of patients. Moreover, anti-TNF therapy was shown to be more effective in patients that had visible ulcers on endoscopy than in patients without such lesions. This means that clinicians are recommended to check for the presence of ulcers before they embark on biological therapy. Finally, endoscopic evaluation of treatment effects in Crohn’s disease has entered routine practice. However, endoscopic procedures are time consuming, invasive and unpleasant for the patient. Surrogate markers for the severity of inflammation such as faecal calprotectine are under investigation. Magnetic resonance enterography was shown to nicely parallel with the severity of inflammation seen at endoscopy, but also this diagnostic tool is expensive and time consuming.
The development of a simple alternative to optical colonoscopy to assess mucosal inflammation in patients with Crohn’s disease would therefore be of extreme importance. A reliable Pillcam examination is high on the priority list of potential options.
Recently, a multicenter study was performed that assessed safety and feasibility of PCCE-2 in evaluating the severity of mucosal inflammation in patients with ileocolonic Crohn's disease (1). Substantial agreement was found between PCCE-2 and conventional colonoscopy for the assessment of mucosal disease activity. Moreover, PCCE-2 was better tolerated than colonoscopy in these patients.
20 pts with active ileocolonic Crohn’s disease undergoing capsule endoscopy using the second generation Pillcam capsule (PCCE 2) instead of a colonoscopy before and 8-12 weeks after treatment initiation with Infliximab or Adalimumab

The goals of treatment in Crohn’s disease have evolved in recent years from symptom control to healing of mucosal lesions, usually visualized by endoscopy. Potent therapeutic agents, such as anti-TNF agents, have made restoration of mucosal integrity attainable in a significant proportion of patients. Moreover, anti-TNF therapy was shown to be more effective in patients that had visible ulcers on endoscopy than in patients without such lesions. This means that clinicians are recommended to check for the presence of ulcers before they embark on biological therapy. Finally, endoscopic evaluation of treatment effects in Crohn’s disease has entered routine practice.



However, endoscopic procedures are time consuming, invasive and unpleasant for the patient. Surrogate markers for the severity of inflammation such as faecal calprotectine are under investigation. Magnetic resonance enterography was shown to nicely parallel with the severity of inflammation seen at endoscopy, but also this diagnostic tool is expensive and time consuming.

The development of a simple alternative to optical colonoscopy to assess mucosal inflammation in patients with Crohn’s disease would therefore be of extreme importance. A reliable Pillcam examination is high on the priority list of potential options.

Recently, a multicenter study was performed that assessed safety and feasibility of PCCE-2 in evaluating the severity of mucosal inflammation in patients with ileocolonic Crohn's disease (1). Substantial agreement was found between PCCE-2 and conventional colonoscopy for the assessment of mucosal disease activity. Moreover, PCCE-2 was better tolerated than colonoscopy in these patients.

Before and 8-12 weeks after the start of treatment with anti-TNF agents

20 patients with symptoms of active (ileo)colonic Crohn’s disease and biochemical evidence of active inflammation (reflected by elevated faecal calprotectin (> 250 ug/g) and/or increased CRP serum levels (i.e. > 5 mg/l)) that need an endoscopic evaluation before starting anti-TNF treatment (Infliximab or Adalimumab) will be invited to take part in this study. Patients will undergo capsule endoscopy using PCCE 2 instead of colonoscopy before starting anti-TNF. After 8-12 weeks of treatment the PCCE-2 procedure will be repeated.