BACKGROUND: Serum tumour necrosis factor-alpha (TNF-α) levels correlate negatively with hepatitis C virus (HCV) antiviral response. OBJECTIVES: To test the hypothesis that a single infliximab induction dose would positively influence on-treatment virological response and sustained virological response (SVR). METHODS: The present study was a phase IIIB, randomized, prospective, open-label pilot trial conducted at eight Canadian sites. Treatment-naive HCV genotype 1-infected patients 18 to 65 years of age with high serum TNF-α values (>300 pg/mL) were randomly assigned to receive a single pretreatment induction infliximab infusion (5 mg/kg) seven days before antiviral therapy (arm A) or no pretreatment (arm B). All patients received pegylated interferon α2b (1.5 μg/kg/week) plus weight-based ribavirin (800 mg/day to 1400 mg/day) for up to 48 weeks. RESULTS: Eighty-five patients (arm A [n=41], arm B [n=44]; 70% male) received pegylated interferon α2b. The mean age (48.1 years), race (81% white) and METAVIR fibrosis stage (F0–2 = 79%, F3–4 = 21%) were similar between groups. Infliximab was well tolerated without attributable severe adverse events; 56.5% completed the study (arm A [n=21], arm B [n=27]). Most discontinuations were due to virological failure at weeks 12 (n=20 [23.5%]) and 24 (n=7 [8.2%]) and did not differ according to group. Numerically lower proportions of infliximab recipients achieved rapid virological response (19.5% versus 36.4%), complete early virological response (43.9% versus 59.1%) and SVR (34.1% versus 52.3%). However, between-group differences did not reach statistical significance. No differences in adverse event profile or laboratory measures were noted. CONCLUSION: A single infliximab dose before pegylated-interferon α2b and ribavirin therapy did not result in greater viral decline during the first 12 weeks of HCV therapy or improved SVR.
Purpose: Crohn's disease is associated with impaired HRQOL. This analysis investigated HRQOL outcomes during maintenance therapy with natalizumab (a humanized monoclonal IgG4 antibody to α4 integrin) in the ENACT-2 trial where higher rates of sustained response and remission were observed compared with placebo. Methods: Patients who responded to natalizumab induction therapy (n = 339) were randomized to natalizumab 300 mg (n = 168) or placebo infusions (n = 171) given monthly for up to 12 months. HRQOL was measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36) at months 0, 3, 6, 9, and 12. Higher scores indicate better HRQOL. A minimally important difference (MID) is defined as 16 pts for Total IBDQ and 5 pts for SF-36 summary scores. Results: The change for all IBDQ scales from ENACT-1 baseline was significantly greater (p < 0.05) in natalizumab-treated patients at all timepoints. Changes in 7 of 10 SF-36 scales were significant by month 3 and all were significant in months 9 and 12. A significantly greater proportion of natalizumab patients achieved MID on the Total IBDQ at months 6–12 and the SF-36 PCS at months 3–12. Mean scores for physical function, social function, role-emotional, and mental health approximated US norms at month 12. Conclusions: Maintenance therapy with natalizumab resulted in significantly improved HRQOL, as evidenced by both disease specific (IBDQ) and general (SF-36) measures.Table: Change From Baseline [Mean (SD)]
An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.
Endoscopic mucosal resection (EMR) is commonly performed for dysplasia/early adenocarcinoma within the setting of Barrett’s esophagus. Cancers that invade the submucosa (T1b) can be further subdivided into SM1, SM2, and SM3, depending on the depth of invasion into the submucosa. Invasive adenocarcinoma significantly increases the risk of lymph node metastasis, which is of critical importance if endoscopic treatment is the only therapy planned. Accurate prediction of lymph node status is therefore crucial in order to determine the appropriate method of treatment (surgery or endoscopic) for early lesions. This study aims to assess the long-term outcomes of patients who have had treatment for a T1b esophageal adenocarcinoma and to determine the extent of lymph node involvement as assessed through surgical specimens or long term clinical/radiological follow up. Additionally, factors associated with lymph node metastasis will be evaluated. A retrospective chart review of patients with T1b esophageal cancer between 01/05-05/17 was performed at St. Paul’s Hospital. Data collected includes demographics, endoscopy dates, indication, findings, imaging, characteristics of the cancer (depth and extent of penetration, size of lesion, differentiation, lymphovascular invasion), method of resection, and follow-up. The study is being performed at 4 sites which deal with most of the esophageal cancers in British Columbia. The data collected presently is just from one site, the other three sites are pending. Out of 313 patients that had a specimen removed from the esophagus, 3.5% (11/313) were found to have a T1b esophageal cancer. 9% (1/11) of patients with T1b cancer were found to have positive lymph nodes. 18% (2/11) of patients had a recurrence with an average of 2.5 years from the initial cancer (range 1 to 4 years). Recurrent disease was managed palliatively in 1 patient and by EMR in another. 36% (4/11) patients underwent transhiatal esophagectomy, with no recurrence. Only 9% of patients have had evidence of lymph node involvement in this small group with T1b esophageal adenocarcinoma. Additional data is being collected to evaluate the results in a Provincial manner and will be presented. None
Intestinal webs are a rare cause of bowel obstruction. A case of a 32‐year‐old man with multiple intestinal webs causing intermittent, partial bowel obstruction is described. The webs were initially detected with capsule endoscopy. The patient was treated with intraoperative endoscopy and balloon dilation. At early follow‐up, no recurrence of his symptoms was evident.
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