Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study

Background/Aims@#The efficacy and safety of vedolizumab in moderate-to-severely active Crohn’s disease (CD) were demonstrated in the GEMINI 2 study (NCT00783692). This post-hoc exploratory analysis aimed to assess the efficacy and safety of vedolizumab in the subgroup of patients from Asian countries. @*Methods@#During the induction phase (doses at day 1, 15), clinical remission, enhanced clinical response, and change in C-reactive protein at 6 weeks; during the maintenance phase, clinical remission, enhanced clinical response, glucocorticoid-free remission and durable clinical remission at 52 weeks, were the efficacy outcomes of interest. Efficacy and safety of vedolizumab compared to placebo were assessed in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) using descriptive analyses. @*Results@#During the induction phase, in Asian countries (n = 51), 14.7% of the vedolizumab-treated patients achieved clinical remission at week 6 compared to none with placebo (difference, 14.7%; 95% confidence interval, 15.8%–43.5%). In non-Asian countries (n = 317), the remission rate at week 6 with vedolizumab was 14.5%. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks and placebo were 41.7%, 36.4%, and 0%, respectively; while enhanced clinical response rates were 41.7%, 63.6%, and 42.9%, respectively. During induction, 39.7% of patients with vedolizumab experienced an adverse event compared to 58.8% of patients with placebo, and vedolizumab was generally well-tolerated. @*Conclusions@#This post-hoc analysis demonstrates the treatment effect and safety of vedolizumab in moderateto-severely active CD in patients from Asian countries.

Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia

The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn's and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn's disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.

Healing the mucosa in Crohn's disease: does it matter?

Clinical remission has been the therapeutic goal of Crohn's disease treatment for many years. While it has helped to ameliorate the symptoms, this treatment strategy has not brought about significant changes in the need for abdominal surgery in the natural history of Crohn's disease. The advent of biological agents (biologics) has shown that it is possible to induce and maintain mucosal healing in a significant proportion of treated patients. Data is also emerging to show that this has translated to fewer instances of hospitalisation and surgery for these patients. This is a paradigm shift in the therapeutic goal of Crohn's disease treatment.

The use of parenteral nutrition in an acute care hospital

<p><b>INTRODUCTION</b>Parenteral nutrition (PN) is an important supportive therapy. However, it is expensive and associated with significant complications. Our aim is to describe the patients given PN in 2006, to compare with the 2001 cohort and determine if PN had been prescribed for the appropriate indications.</p><p><b>MATERIALS AND METHODS</b>A retrospective cohort study of adult patients receiving PN between January and December 2006 was undertaken in a single institution. Appropriateness of indications for PN was based on the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) guidelines 2002.</p><p><b>RESULTS</b>One hundred and eighty-two patients received 194 courses (102 males, 92 females) of PN. Median age was 62 years (range, 16 to 100). Eighty-two percent were surgical patients and 18% were medical patients. Median PN duration was 9 days (range, 2 to 115). Common indications were surgeons' anticipation of non-functioning gut postoperatively [47 (24.2%) courses], postoperative complications [33 (17.0%) courses] and postoperative ileus [31 (16.1%) courses]. Indications for PN met A.S.P.E.N. guidelines in 93.3% of cases compared to 78.3% in 2001. In 1.5% of cases, we were unable to determine if the indications met the guidelines. Ten courses did not meet the guidelines; 3 had PN for <7 days preoperatively, 6 had PN because the managing team thought the patients were critically ill and 1 was given PN for refusal to eat because of depression.</p><p><b>CONCLUSION</b>Since 2001, there has been an increase in the proportion of PN given for appropriate indications. However, physician education with respect to the benefit of PN for preoperative and critically ill patients with functioning guts needs reinforcing.</p>