Faculty Bibliography

INTRODUCTION: As our medical armamentarium for IBD continues to expand, it is essential that clinicians understand both optimizing and sequencing of individual and combination therapeutic approaches with available medications. Areas covered: This review summarizes dosing strategies and therapeutic drug monitoring for pharmacologic optimization in IBD. Aminosalicylates remain first-line therapies for mild-to-moderate UC but have limited evidence of efficacy in CD. Budesonide provides an alternative to aminosalicylates when targeted to appropriate sites in the distal small bowel and colon, as do conventional corticosteroids when applied rectally. Systemic steroids are highly efficacious but burdened by toxicity. Thiopurines or methotrexate can be utilized as steroid-sparing agents. Biologic agents targeting TNF remain important for steroid-sparing therapy in moderate-to-severe UC and CD. Newer biologics targeting lymphocyte trafficking and lymphocyte activation are also efficacious for moderate-to-severe IBD. Near future conventional drug options include oral agents such as tofacitinib and mongersen. Expert commentary: Positioning therapies according to the location, phenotypes, and severity, as well as the use of therapeutic and clinical targets, will improve outcomes and minimize toxicities and therapeutic futilities. Future IBD treatment should focus on personalized therapy plans based on genetic determinants, targeted mechanisms of action, and pharmacologic optimization.

OPINION STATEMENT: Infliximab and adalimumab biosimilars have been approved by the FDA and European Medicines Agency and have already been introduced to the international market. Availability into the US market is imminent. Biosimilars are highly similar to the reference biologic product but should not be referred to as, nor equated with, generic medications as no two biosimilars can ever be identical. Regulatory pathways for biosimilar approval consider the totality of evidence for biosimilar approvals, but the preponderance of development relies on analytic and functional testing and allows extrapolation between indications to reduce the financial burden of completing comparative clinical trials for each indication. Neither CT-P13 (infliximab biosimilar) nor ABP 501 (adalimumab biosimilar) was clinically tested in patients with inflammatory bowel disease prior to being submitted for approval by regulatory agencies. The body of available evidence suggests that these drugs will perform similarly to their originators. The pathway for interchangeability of biosimilars has yet to be clarified by federal regulators and currently remains determined by states within the USA. However, preliminary data suggests that switching from originator to biosimilar is safe with minimal differences in clinical efficacy.

OPINION STATEMENT: As new and effective novel therapies in inflammatory bowel disease (IBD) become available, patients are living longer with advancing age and are at increased risk for malignancy. The management of IBD and malignancy involves multiple combinations of chemotherapy agents and IBD drugs, with the potential for interactions between these therapies. Interactions may either potentiate the effectiveness of drug class or exacerbate their common side effects. In this review article, we present a guide on studied interactions between IBD therapies and chemotherapy agents, specifically those of colorectal cancer, breast cancer, non-Hodgkin's lymphoma, and melanoma. The pharmacology and pharmocokinetics of each IBD drug will be discussed. Then, the IBD drug and chemotherapy interactions are summarized in table format. This guide will provide a quick reference to guide clinicians with this challenging management of two disease processes.

GOAL: The purpose of this study was to assess the effect of decreased colonoscopy reimbursement on gastroenterologist practice behavior, including time to retirement and procedure volume. BACKGROUND: In 2015, the Centers for Medicare and Medicaid Services proposed reductions in colonoscopy reimbursements. With new initiatives for increased colorectal cancer screening, it is crucial to understand how reimbursement changes could affect these efforts. STUDY: Randomly selected respondents from the American College of Gastroenterology membership database were surveyed on incremental changes in practice behavior if colonoscopy reimbursement were to decrease by 10, 20, 30, or 40 %. Data were analyzed using both Pearson's Chi-square and analysis of variance. RESULTS: Two thousand and nine gastroenterologists received the survey with a 16.3 % response rate. Procedure volume significantly decreased with degree of reimbursement reductions (p < 0.001). With a 10 % decrease, 72 % of respondents reported no change in the number of colonoscopies performed. With a 20 % decrease, 39 % would decrease their procedure volume, while 21 % of respondents would increase their procedure volume. With a 30 and 40 % decrease, procedure volume decreased by 48 and 50 %, respectively. In terms of retirement, current plans predict a cumulative retirement rate of 29.4 % at 10 years. More than 42 % of respondents plan to retire after 2030. In the 2014-2023 retirement subgroup (N = 74 responses), there was a significant hastening of retirement year at 20 % (p = 0.016), 30 % (p < 0.001), and 40 % (p < 0.001) reimbursement reductions as compared to baseline responses. CONCLUSION: Decreasing colonoscopy reimbursements may have a significant effect on the effective gastroenterology work force.

The optimal method for monitoring quiescent disease in patients with Crohn's disease (CD) and ulcerative colitis is yet to be determined. Endoscopic evaluation with ileocolonoscopy is the gold standard but is invasive, costly, and time-consuming. There are many commercially available biomarkers that may be used in clinical practice to evaluate disease status in patients with inflammatory bowel disease (IBD), but the most widely adopted biomarkers are C-reactive protein (CRP) and fecal calprotectin (FC). This review summarizes the evidence for utilizing CRP and FC for monitoring IBD during clinical remission and after surgical resection. Endoscopic correlation with CRP and FC is evaluated in each disease state. Advantages and drawbacks of each biomarker are discussed with special consideration of isolated ileal CD. Fecal immunochemical testing, traditionally used for colorectal cancer screening, is mentioned as a potential new alternative assay in the evaluation of IBD. Based on a mixture of information gleaned from biomarkers, clinical status, and endoscopic evaluation, the best treatment decisions can be made for the patient with IBD.