Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn's Disease: Real-World Data from a German IBD Cohort.

: Background and Aims: The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn's disease (CD). Due to the recent approval, real-world German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods: Patients with CD receiving UST treatment in three hospitals and two outpatient centers were included and retrospectively analyzed. Rates for short- and long-term remission and response were analyzed with the help of clinical (Harvey-Bradshaw Index (HBI)) and biochemical (C-reactive protein (CRP), Fecal calprotectin (fCal)) parameters for disease activity. Results: Data from 180 patients were evaluated. One-hundred-and-six patients had a follow-up of at least eight weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin antibodies. The median follow-up was 49.1 weeks (95% CI 42.03-56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 48 (51.6%) responded to UST, and 25 patients (26.9%) were in remission. Steroid-free response and remission at week eight was achieved by 30.1% and 19.3% of patients, respectively. At week 48, 37.6% showed steroid-free response to UST, and 20.4% of the initial patient population was in steroid-free remission. Conclusion: Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment-exposed patients.

Long-term results of endoscopic balloon dilatation of lower gastrointestinal tract strictures in Crohn's disease: a prospective study.

AIM: To examine the long-term results of endoscopic treatment in a prospective study conducted over a period of 10 years, 1997 to January 2007. METHODS: A total of 25 patients (20 female and five male: aged 18-75 years), with at least one symptom of stricture not passable with the standard colonoscope and with a confirmed scarred Crohn's stricture of the lower gastrointestinal tract, were included in the study. The main symptom was abdominal pain. The endoscopic balloon dilatation was performed with an 18 mm balloon under endoscopic and radiological control. RESULTS: Eleven strictures were located in the colon, 13 at the anastomosis after ileocecal resection, three at the Bauhin valve and four in the ileum. Four patients had two strictures and one patient had three strictures. Of the 31 strictures, in 30 was balloon dilatation successful in a single endoscopic session, so that eventually the strictures could be passed easily with the standard colonoscope. In one patient with a long stricture of the ileum involving the Bauhin valve and an additional stricture of the ileum which were 15 cm apart, sufficient dilatation was not possible. This patient therefore required surgery. Improvement of abdominal symptoms was achieved in all cases which had technically successful balloon dilatation, although in one case perforation occurred after dilatation of a recurrent stricture. Available follow-up was in the range of 54-118 mo (mean of 81 mo). The relapse rate over this period was 46%, but 64% of relapsing strictures could be successfully dilated again. Only in four patients was surgery required during this follow-up period. CONCLUSION: We conclude from these initial results that endoscopic balloon dilatation, especially for short strictures in Crohn's disease, can be performed with reliable success. Perforation is a rare complication. It is our opinion that in the long-term, the relapse rate is probably higher than after surgery, but usually a second endoscopic treatment can be performed successfully, leading to a considerable success rate of the endoscopic procedure.

[Endoscopic clipping of a gastric perforation after GIST resection]. / Endoskopische Clip-Therapie einer Magenperforation nach GIST-Abtragung.

BACKGROUND: The application of endoscopic clips in the therapy of bowel or stomach perforations has been reported in few cases only. CASE REPORT: In a 43-year-old woman, endoscopic resection of a submucosal gastric tumor sized 1.2 cm, histologically proven to be a gastrointestinal stromal tumor (GIST), was complicated by bleeding and a small perforation. In the emergency endoscopy not only the bleeding but also the perforation could be treated successfully using hemoclips. The clinical course remained free from further complications. CONCLUSION: This case, as well as previously reported cases, demonstrates that the endoscopic hemoclip technique seems to be suitable for the treatment of some small gastric perforations.