The risks of post-operative complications following pre-operative infliximab therapy for Crohn's disease in patients undergoing abdominal surgery: a systematic review and meta-analysis.

BACKGROUND: Infliximab is an anti-TNF alpha blocker frequently utilized in the management of moderate to severe Crohn's Disease. The immunosuppressive effects of infliximab may increase the risk for post-operative complications among Crohn's Disease patients undergoing abdominal surgery. We conducted a systematic review and meta-analysis of studies comparing the rates of post-operative complications among Crohn's disease patients treated with Infliximab therapy versus alternative therapies. METHODS: We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and searched 4 electronic databases along with major conference abstract databases from inception of database until November, 2012. English-language articles and abstracts evaluating post-operative complications among Crohn's disease patients were considered eligible. We applied meta-analysis with random effects model to calculate the overall odds ratio for total major complications as well as several secondary outcomes. RESULTS: Data were extracted from six studies including 1159 patients among whom 413 complications were identified. The most common complications were wound infections, anastomotic leak and sepsis. There was no significant difference in the major complication rate (OR=1.59[95% CI: 0.89-2.86]; p=0.15), minor complication rate (OR=1.80 [CI: 0.87-3.71]; p=0.11), reoperation rate (OR=1.33 [CI: 0.55-3.20]; p=0.52) or 30 day mortality rate (OR=3.74 [CI: 0.56-25.16]; p=0.13) between the Infliximab and control groups. CONCLUSIONS: This meta analysis provides some evidence that infliximab may be safe to continue in the pre-operative period without increasing the risk of post-operative complications for Crohn's disease patients undergoing abdominal surgery.

Clinical characteristics of non-perianal fistulating Crohn's disease in China: a single-center experience of 184 cases.

BACKGROUND: There is little information of non-perianal fistulating Crohn's disease in the consensus published by the European Crohn's and Colitis Organization in 2006 and 2010. This study was designed to demonstrate the clinical characteristics of non-perianal fistulating Crohn's disease among homogenous Chinese population. METHODS: One-hundred-and-eighty-four patients were retrospectively collected. All of these patients were diagnosed of Crohn's disease between February 2001 and April 2011. RESULTS: The male-to-female ratio was 2.7:1. The most common symptoms at onset were abdominal pain (88.0%), diarrhea (34.7%), and fever (28.3%). The most common disease location and behavior at diagnosis were small bowel (56.0%) and penetrating (51.6%). Among 324 non-perianal fistulae, the most common types were ileocolonic anastomotic (30.9%), terminal ileocutaneous (19.7%), and enteroenteric anastomotic (11.4%). One-hundred-and-thirty- eight (75.0%) patients received antibiotics, and ß-lactam (85.5%) and metronidazole (67.4%) are most frequently used. One-hundred-and-seventy-eight (96.7%) patients suffered 514 surgical operations, and the cumulative surgical rates after 1, 3, and 5 years were 38.0%, 52.2%, and 58.7% respectively. Nine patients died during the follow-up period, and the cumulative survival rates after 1, 3, and 5 years were 97.8%, 96.7%, and 96.2% respectively. CONCLUSIONS: This study displayed the clinical characteristics of non-perianal fistulating Crohn's disease in our center. Large population-based studies are required for further investigation in China.

Time trends in therapies and outcomes for adult inflammatory bowel disease, Northern California, 1998-2005.

BACKGROUND & AIMS: The management of inflammatory bowel disease (IBD) has become increasingly complicated, and it is unknown whether poor outcomes (prolonged steroid use, hospitalizations, and surgery) have declined in the general population. METHODS: This multilevel study used computerized clinical data. The study comprised 2892 adults with Crohn's disease (CD) and 5895 with ulcerative colitis (UC) who received care at 16 medical centers within an integrated care organization in Northern California between 1998 and 2005. RESULTS: Time trends included (1) a shift in gastroenterology-related visits from the gastroenterology division to primary care; (2) increased use of IBD-related drugs, except for a 7% decline in use of 5-aminosalicylate in CD and no change in steroid use for CD; (3) for the prevalence of prolonged steroid exposure (120 days of continuous use), a 36% decline for CD with a 27% increase for UC; (4) declines in the hospitalization rates of 33% for CD and 29% for UC; and (5) for the surgery rate, no significant change for CD with a 50% decline for UC. CONCLUSIONS: Declines in prolonged steroid exposure and the hospitalization rate for CD and in the hospitalization and surgery rate for UC are encouraging; however, the increase in prolonged steroid exposure for UC merits concern and further investigation. The variability in care patterns observed in this study suggests lack of standardization of care and the opportunity to identify targets for quality improvement. These findings should stimulate research to quantify the effect of current trends in IBD management.

Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases.

OBJECTIVES: Clinical trials of tumour necrosis factor antagonists have raised questions about the potential risk of certain serious adverse events (SAE). To assess the safety of adalimumab in rheumatoid arthritis (RA) over time and across five other immune-mediated inflammatory diseases and to compare adalimumab malignancy and mortality rates with data on the general population. METHODS: This analysis included 19,041 patients exposed to adalimumab in 36 global clinical trials in RA, psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), psoriasis and juvenile idiopathic arthritis (JIA) to 15 April 2007. Events per 100 patient-years were calculated using SAE reported after the first dose to 70 days after the last dose. Standardised incidence rates were calculated for malignancies using national and state-specific databases. Standardised mortality rates (SMR) were calculated for each disease using data from the World Health Organization. RESULTS: Cumulative rates of SAE of interest in RA have remained stable over time. Rates of SAE of interest for PsA, AS, CD, psoriasis and JIA were similar to or lower than rates for RA. Overall malignancy rates for adalimumab-treated patients were as expected for the general population. SMR across all six diseases indicated that no more deaths occurred with adalimumab than expected in the general population. CONCLUSIONS: Based on 10 years of clinical trial experience across six diseases, this safety report and the established efficacy of adalimumab in these diseases provide the foundation for a better understanding of its benefit-risk profile.