Management Decisions in Crohn's Disease Are Changed by Knowledge of Proactive and Reactive Testing of Antitumor Necrosis Factor Drug Levels.

Background: There is controversy about the proactive clinical application of therapeutic drug monitoring (TDM) of biologic drugs in Crohn's disease (CD). One way to practically assess this is to examine how TDM influences management decisions. We examined how knowledge of proactive and reactive antitumor necrosis factor (anti-TNF) drug levels changes management in a variety of clinical scenarios. Methods: In this retrospective cohort study, all adults with CD having trough level infliximab or adalimumab measurements at Liverpool Hospital between June 2013 and July 2016 were included. Demographics, indications for testing, anti-TNF drug levels, and treatment details were collected along with subsequent management decisions. The decision made by the treating clinician after receiving the drug level was compared to a consensus decision from a panel of 3 gastroenterologists based on the clinical, laboratory, imaging, and/or endoscopic results without the drug level. When these 2 decisions were discrepant, the anti-TNF drug level was deemed to have changed management. Results: One hundred and eighty-seven trough levels of infliximab or adalimumab from 108 patients were analyzed. Overall, assessment of anti-TNF levels affected management in 46.9% of the instances. Knowledge of the drug level was also more likely to result in management change when the test was performed for reactive TDM compared to proactive TDM (63% vs 36%, P = .001). Conclusions: The addition of TDM of anti-TNF agents to routine investigations alters management decisions in adult CD patients on anti-TNF therapy in both proactive and reactive settings.

Improved survival in young women with colorectal cancer.

BACKGROUND: Studies have reported the effect of gender in the context of assessing predictors of survival from colorectal cancer (CRC); however, few have specifically addressed the impact of gender on the clinical and pathological outcomes of CRC. Appreciation of gender disparities may assist in the implementation of measures to address these differences, and improve the overall outcomes of patients with CRC. METHODS: The South Western Sydney Colorectal Tumour Group registry, which encompasses a population in excess of 800,000, prospectively collects data on new patients with CRC. Data from 1997 to 2004 were collected, including demography, site, grade, histopathology, stage, treatment, and survival. RESULTS: In total, 2,050 consecutive patients (44% women) with CRC were analyzed. Compared to men, women were older (median 69 yr, range 27-95 yr vs 67, range 22-92 yr, P= 0.001), had more emergency surgery for CRC-related complications (18.8%vs 15.1%, P= 0.03), had more proximal cancers (42.2%vs 31.5%, P < 0.001), had more poorly differentiated cancers (16.9%vs 12.9%, P= 0.01), and had fewer radiotherapy treatments for Dukes B and C rectal cancers (36.4%vs 48.1%, P= 0.02). Young women (aged 50 yr and below) had significantly better overall survival compared to young men; in this group, female gender predicted improved overall survival independent of age, emergency surgery, site, grade, and stage (hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.25-0.86, P= 0.01). Similarly, young women had significantly better cancer-specific survival (HR 0.46, 95% CI 0.25-0.85, P= 0.01). However, older women (aged over 50 yr) had worse survival independent of age, emergency surgery, site, grade, and stage (HR 1.38, 95% CI 1.14-1.68, P= 0.001). There were no gender differences in screening, histopathology, stage, or utilization of chemotherapy. CONCLUSIONS: This study demonstrated an opposing effect of gender on overall and cancer-specific survival at either side of the age of 50 yr. The protective effect of estrogen on CRC may be an important factor. Women had a greater proportion of emergency surgery, which was related to the predominance of proximal cancers in this gender. Women also had more proximal cancers, thereby limiting flexible sigmoidoscopy as a screening test.

Clinical outcomes after double-balloon enteroscopy in patients with obscure GI bleeding and a positive capsule endoscopy.

BACKGROUND: Obscure GI bleeding (OGIB) accounts for about 5% of all patients with GI bleeding. There are limited data on double-balloon enteroscopy (DBE) after a positive finding on capsule endoscopy (CE) in this setting. OBJECTIVE: To determine the clinical outcomes after DBE therapy. DESIGN: Prospective single-center cohort study. SETTING: Tertiary referral university hospital. MAIN OUTCOME MEASUREMENTS: Recurrent bleeding and blood transfusion requirements. PATIENTS AND METHODS: This prospective study of 60 consecutive patients with OGIB was conducted between July 2004 and March 2006. Patients underwent CE before DBE to target the lesion for either further diagnostic evaluation or therapeutic intervention. The mean (standard deviation [SD]) duration of follow-up was 10.0 +/- 5.2 months. RESULTS: The mean (SD) age was 62 +/- 18 years, with 31 men. A total of 74 DBE procedures were performed. An abnormality was seen by DBE in 45 patients (75%). In 12 patients (20%), a diagnosis was clarified or a new diagnosis was made. Therapy at DBE was performed in 34 patients (57%): 30 diathermies and 4 polypectomies. Endoscopic tattooing for targeted surgical removal was made in 3 additional patients. Multiple logistic regression analysis identified previous blood transfusion (odds ratio 10.5, 95% confidence interval 3.1-35; P < .001) to be the only independent predictor that required endoscopic therapy at DBE. Forty-eight patients (80%) had no further bleeding, and 46 patients (77%) had a normal Hb. Blood transfusion requirements fell from 34 patients to 10, P < .001. One patient had a perforation after therapeutic diathermy. LIMITATIONS: Nonrandomized study. CONCLUSIONS: In patients with OGIB and a positive finding on CE, DBE provided a safe and ambulatory method to achieve an excellent clinical outcome with significant reductions in recurrent bleeding and blood-transfusion requirements.

Double-balloon enteroscopy in the diagnosis and the management of small-bowel diseases: an initial experience in 40 patients.

BACKGROUND: Double-balloon enteroscopy (DBE) is a new technique, recently described by its innovator, and it is seen to be beneficial in the diagnosis and management of small-bowel disease. OBJECTIVE: To evaluate this new technique in consecutive patients with suspected small-bowel disease. DESIGN: Single-center prospective study. SETTING: Tertiary referral hospital, conducted from July to December 2004. PATIENTS: Forty consecutive patients with suspected small-bowel disease referred for DBE, mean age of 58 years (range, 14-89 years), 17 men. INTERVENTIONS: Endoscopic biopsies or therapy was performed as clinically indicated. MAIN OUTCOME MEASUREMENTS: Significant diagnostic input and therapeutic intervention based on clinical outcomes. RESULTS: Indications included obscure GI bleeding (18), iron deficiency anemia (6), anemia of chronic disease (4), acute obscure GI bleeding (4), abdominal pain with other symptoms (4), Crohn's disease (3), and abdominal pain alone (1). Nineteen patients (47.5%) had a small-bowel finding, with 30 of 40 (75%) of the patients having a significant diagnostic input. Intervention was performed in 13 (32.5%) patients with success in 10 (77%). The only variable significantly associated with therapeutic success was a previous history of blood transfusions (p < 0.01). This was the only independent predictor identified by multiple logistic regression analysis (Odds ratio 13.5: 95% confidence interval [1.5, 120]). One perforation from contact diathermy occurred. In 10 attempts at total enteroscopy, none were successful. LIMITATIONS: Nonblinded nonrandomized study. CONCLUSIONS: These early data suggest DBE to be effective in the diagnosis and the therapy of small-bowel disease, particularly those patients with a history of blood transfusion.