IBD Watch^®

^{Timely Information for Practicing Physicians}

  OCTOBER 2005

CROHN'S DISEASE (CD)

Trial of certolizumab. Schreiber and colleagues conducted a placebo-controlled phase II trial in which 292 patients with moderate to severe CD were randomized to receive certolizumab pegol (a polyethylene-glycolated Fab' fragment of anti–tumor necrosis factor) 100, 200, or 400 mg or placebo at weeks 0, 4, and 8. The primary end point was the percentage of patients with a clinical response at week 12. A clinical response was defined as a decrease of ≥100 points on the CD Activity Index (CDAI) or remission (CDAI score £150 points). Clinical outcomes were improved by all dose levels of certolizumab compared with placebo. Patients with baseline C-reactive protein levels of ≥10 mg/L (n = 119) showed clearer separation between active treatment and placebo. At week 10, clinical response rate was highest in the certolizumab 400 mg group (52.8% vs 30.1% with placebo; P = 0.006). Adverse events were similar among the treatment groups. Phase III trials are under way to establish the clinical efficacy of certolizumab. (Schreiber S, et al. Gastroenterology 2005;129:807–818.)

Trial of Lactobacillus GG (LGG) in addition to standard maintenance therapy in children with CD. Probiotics are widely used by patients with CD to improve their health, but few controlled studies have been performed to evaluate the efficacy of these therapies. Bousvaros and associates conducted a double-blind study in which 75 children with CD in remission were randomized to receive either the probiotic LGG or placebo for up to 2 years to determine if the addition of LGG to standard therapy prolonged remission. Concomitant medications allowed in the study included aminosalicylates, 6-mercaptopurine, azathioprine, and low-dose alternate-day corticosteroids. The median time to relapse was similar between the two treatment groups. Thus, the results of this study did not provide evidence that LGG prolongs time to relapse in children with CD. (Bousvaros A, et al. Inflamm Bowel Dis 2005;11:833–839.)

Oral manifestations. Previous data have suggested that the mouth may be involved frequently in CD. Harty and coworkers report the results of a prospective 3-year study in which dental examinations were performed on all children with suspected inflammatory bowel disease (IBD). The authors observed that oral CD was present in 41.7% of the patients. Noncaseating granulomas were found at biopsy and oral disease was associated with perianal involvement with CD. In a second study performed by Sanderson and others, 19 (54%) of 35 patients who presented with orofacial granulomatosis without abdominal/intestinal symptoms were found to have ileal or colonic abnormalities on endoscopy. Patients with severe oral inflammation were more likely to have intestinal inflammation. These studies provide further evidence that CD is frequently associated with oral disease. (Harty S, et al. Clin Gastroenterol Hepatol 2005;3:886–891 and Sanderson J, et al. Inflamm Bowel Dis 2005;11:840–846.)

IBD

Increased risk for demyelinating and other inflammatory diseases. Reports of multiple sclerosis, demyelination, and optic neuritis in patients treated with infliximab, etanercept, and adalimumab led Gupta and others to perform a retrospective cohort study of 7,988 patients with CD and 12,185 patients with ulcerative colitis (UC). Data had been collected from 1988 to 1997 and entered into a general practice research database. Patients were matched for age, gender, and primary care practice to 80,666 controls. The incidence and prevalence of demyelinating diseases were found to be higher among patients with CD or UC than in controls. In addition, Bernstein and colleagues analyzed data from a population-based University of Manitoba IBD database and observed that patients with CD and UC had a significantly greater likelihood of arthritis, asthma, bronchitis, psoriasis, and pericarditis than did controls. These findings suggest the need for further research to understand the relationship between IBD and these other inflammatory, autoimmune, and demyelinating diseases. (Gupta G, et al. Gastroenterology 2005;129:819–826 and Bernstein CN, et al. Gastroenterology 2005;129:827–836.)

Antibodies as predictors of IBD. Several antibodies have been reported in the sera of patients with CD and UC. Israeli and coworkers assayed serum samples obtained from Israeli Defense Force recruits (drawing and storing serum samples from recruits has been a standard procedure since 1980). Anti-Saccharomyces cerevisiae antibodies (ASCAs) were present in serum samples of 10 (31%) of 32 patients who eventually developed CD. The mean interval between ASCA detection and CD diagnosis was 38 months. None of eight serum samples of UC patients was ASCA positive. However, two were positive for antineutrophil cytoplasmic antibodies (pANCAs). These data suggest that ASCA and pANCA may predict the development of IBD years before the disease is clinically diagnosed. (Israeli E, et al. Gut 2005;54:1232–1236.)

This web site is supported through educational grants from     

Note: By clicking on the above logos you are leaving this educational site

Comments or requests to unsubscribe can be e-mailed to info@ibdwatch.com