Rifaximin therapy was associated with clinical improvement in patients with Crohn's disease and may be a useful treatment option to consider for inducing and maintaining remission.
These results suggest that SBI improves clinical management of IBD patients who are not fully managed on traditional therapies. SBI should be considered for the nutritional support of IBD regardless of disease activity, location, phenotype, duration, or complexity.
BACKGROUND: The role of wireless capsule endoscopy (WCE) in small bowel Crohn's disease (SBCD) has been studied in many clinical trials and has been shown to be superior to other modalities (eg, barium radiography, colonoscopy with ileoscopy, computed tomography enterography, push enteroscopy) for diagnosing and evaluating non-stricturing SBCD. There has been debate, however, over the utility of SBCE findings for surveillance of mucosal healing and utilizing this data to adjust, individualize, and monitor a variety of treatment plans. Our primary objective was to evaluate whether or not mucosal healing, assessed by WCE, was helpful in decision making to continue or adjust the treatment plan for SBCD patients. METHODS: We performed a retrospective chart review of patients with confirmed SBCD who had undergone serial WCE between 2001 and 2013. Mucosal healing was determined by a single physician reader and expert in inflammatory bowel disease and, when available, the Lewis Score was utilized to objectively define mucosal healing. Crohn's Disease Activity Index (CDAI) was also used to determine clinical disease status. Retrospective review revealed whether the findings of a second WCE study resulted in continuation or adjustment of the initial treatment strategy. RESULTS: Twenty-three patients with confirmed SBCD and at least 2 WCE studies were analyzed. Of the 23 patients, 17 exhibited mucosal healing while 6 exhibited nonhealing at the time of the second WCE study. Of the 17 cases with mucosal healing, continuing the initial treatment resulted in clinical remission in 15 patients. The remaining 2 patients, despite evidence of mucosal healing, had other complications resulting in the need for treatment changes. Of the 6 patients with evidence of nonhealing at the time of the second WCE study, adjusting the treatment strategy by changing to a different drug (n ¼ 3) or different dosage (n ¼ 1) resulted in clinical remission in 4 cases. Two patients with non-healing did not achieve eventual remission, resulting in need for surgery in one, with the other patient entering into a clinical trial. Overall, decision making based on mucosal healing as determined by a second WCE study resulted in eventual remission in 19 out of the 23 patients (83%). Change in treatment based on non-healing as evidenced by WCE findings occurred in 6 out of the 23 patients (26%) and resulting in eventual remission 66% of the time (4 out of 6) while requiring surgery in one patient. CONCLUSIONS: This study demonstrates that evidence of mucosal healing based on serial WCE changed the treatment strategy in 26% of patients studied and achieved improved outcomes in 66% of patients requiring treatment change. Larger, prospective trials evaluating the utility of serial WCE for the surveillance and management of SBCE is warranted.BACKGROUND: The role of wireless capsule endoscopy (WCE) in small bowel Crohn's disease (SBCD) has been studied in many clinical trials and has been shown to be superior to other modalities (eg, barium radiography, colonoscop...
Background: Certolizumab Pegol, a pegylated anti-TNF agent, is currently approved to reduce the signs and symptoms of Crohn's Disease (CD) and maintain clinical response in adult patients with moderately to severely active CD who have had inadequate response to conventional therapy. Biologic agents have demonstrated efficacy in the healing of gut mucosa leading to better long-term outcomes by sustaining steroid free remission, decreasing the need for major surgery and hospitalizations, and by improving patients overall quality of life. Prior studies have revealed certolizumab pegol induced endoscopically measured clinical response and remission at 10 and 54 weeks. Our primary objective was to evaluate mucosal healing assessed by wireless capsule endoscopy (WCE) using the Lewis scoring system (LS) in patients with moderate-to-severe small bowel Crohn's Disease (SBCD) treated with certolizumab pegol. Methods:We performed a prospective, single center, open-label trial in 15 patients with documented moderate-to-severe SBCD for a period of six months. All patients were randomized to receive standard induction therapy (400 mg) with certolizumab pegol at 0, 2, and 4 weeks, then standard maintenance dose therapy (400 mg) every 4 weeks through the end of the 28 week study period. Wireless capsule endoscopy with LS was performed at baseline, 12 weeks, and 24 weeks. Blood work, including complete metabolic panel (CMP), hemogram (HEMGPD), and C-reactive protein (CRP) were obtained as well as Crohn's Disease Activity Index (CDAI) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at baseline and at every visit throughout the study period.Results: Eighteen patients underwent screening assessment with 15 patients qualifying to participate and 13 patients completing the trial. Of the 15 intent to treat patients, 6 were male and 9 were female with an average age of 33 (range 21-50) and a mean disease duration of 11.2 (range 1-26) years. Twelve patients had no prior CD surgery and 3 had previous small bowel resection. Ten of the 15 enrolling patients were secondary non-responders (SNR) to biologics; 4 lost response to both infliximab and adalimumab, 6 lost response to either infliximab or adalimumab, 3 were biologically naïve, and 2 had an allergic reaction to infliximab. None of the 10 biologically exposed patients were primary non-responders to other agents.Ten of the 13 patients (77%) who completed this trial demonstrated an overall improvement in mucosal healing, CDAI, and SIBDQ. Of those who responded to certolizumab pegol, the mean LS fell from 1663 at baseline to 226 at 24 weeks and the mean CDAI decreased from 256 at baseline to 140 at 28 weeks. The mean SIBDQ increased in responders from 40 at baseline to 51 by the end of study. Conclusions:This study demonstrates evidence of mucosal healing using certolizumab pegol in patients with moderate-to-severe SBCD. This study establishes a proof of concept that WCE used in conjunction with the LS is a valuable diagnostic test to assess mucosal healing in patients with SBC...
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