Developing a Standard Set of Patient-Centred Outcomes for inflammatory Bowel Disease-an international, cross-disciplinary consensus

Background and Aims: Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. Methods: An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. Results: A minimum Standard Set of outcomes was developed for patients [aged =16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaem

Exploring the role of monitoring anti-TNFα drug and antibody levels in the management of inflammatory bowel disease

Crohn’s disease and ulcerative colitis are chronic inflammatory gastrointestinal disorders which often result in significant morbidity or surgery. Current treatment options are not curative and may cause significant adverse effects. The introduction of anti-tumour necrosis factor alpha (anti-TNFα) therapy over a decade ago was a welcome addition to the therapeutic armamentarium and revolutionized the treatment of inflammatory bowel disease (IBD). Despite their relative success, a significant proportion of patients with IBD fail to respond or subsequently lose response anti-TNFα therapy. This review identifies and explores the role of drug levels and immunogenicity (antibody formation) on the efficacy of anti-TNFα therapy and details how monitoring these parameters may help to optimize the management of patients with IBD

Efficacy and Safety of Adalimumab in Crohn's Disease

Adalimumab (ADA) is a subcutaneously (SC) self-administered fully human Ig G1 monoclonal antibody directed against tumor necrosis factor alpha (TNFce). In the CLASSIC dose-ranging trial, ADA was superior to placebo for inducing remission in patients with moderate-to-severe Crohn's disease (CD) naive to TNFa inhibitor therapy. In CLASSIC II, patients in remission following CLASSIC I maintained remission for up to 56 weeks while on ADA. In CHARM, approximately 40% of the 499 patients with moderate-to-severe CD who responded to ADA, maintained remission at 26 and 52 weeks, thus confirming long-term efficacy. ADA demonstrated steroid-sparing properties, beneficial effects in patients with perianal fistulas, and decreases in rates of hospitalization and surgery. Sub-group analyses demonstrated similar remission rates irrespective of concomitant immunosuppressive use or previous exposure to other TNFa inhibitor therapy. In the GAIN trial, 325 patients who had either lost response or become intolerant to infliximab (IFX) were randomized to recieve ADA induction therapy or placebo. In this difficult-to-treat patient population, 21% achieved remission and half demonstrated clinical benefit from ADA induction therapy. Injection site reactions may occur with SC ADA (2-5% of patients), which are generally less dramatic in nature than infusion reactions experienced with intravenous IFX. Immunogenicity occurs with all monoclonal antibodies; however, in the CD development program anti-ADA antibodies were detected at low rates (0.7 and 2.6% of patients in the CLASSIC I and CLASSIC II studies, respectively). Based on robust short- and long-term efficacy data from large randomized controlled trials and a favorable safety signal, ADA has become a key addition to the therapeutic armamentarium in the treatment of moderate-to-severe CD

Immunomodulators for all patients with inflammatory bowel disease?

Recent insight into the pathogenesis of Crohn’s disease (CD) and ulcerative colitis (UC) have led to the development of new treatment options, with a progressive shift to more evidence-based strategies based on sound pathophysiological rationales. A better understanding of inflammatory bowel disease (IBD) pathophysiology has progressively resulted in a more frequent use of immunomodulators. We review the recommended or suggested use of conventional immunomodulators such as azathioprine, 6-mercaptopurine, methotrexate in the treatment of IBD. Moreover, an effort is made to explore some critical areas in which early and more diffuse use of these agents may be advocated

Optimal use of biologics in the management of Crohn’s disease

Crohn’s disease (CD) is a chronic relapsing and remitting disorder of the gastrointestinal tract with no known cure. The inflammation that drives the disease can lead to debilitating symptoms and a number of complications that may lead to surgery. The introduction of biologic therapy a decade ago has offered a new option for patients failing conventional therapy. Over time, biologic therapy has also led to the desire to achieve treatment goals beyond the control of symptoms. In order to achieve short-term and long-term goals with these new agents, it is important to review how these therapies may be optimized for the best results