Discuss, Share, and Engage
American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases.
Therapeutic drug monitoring (TDM), which involves measurement of drug or active metabolite levels and anti-drug antibodies, is a promising strategy that can be used to optimize inflammatory bowel disease therapeutics. It is based on the premise that there is a relationship between drug exposure and outcomes, and that considerable inter-individual variability exists in how patients metabolize the drug (pharmacokinetics) and the magnitude and duration of response to therapy (pharmacodynamics). Therefore, the American Gastroenterological Association has prioritized clinical guidelines on the role of TDM in the management of inflammatory bowel disease. To inform these clinical guidelines, this technical review was developed in accordance with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework for interventional and prognostic studies, and focused on the application of TDM for biologic therapy, specifically anti-tumor necrosis factor-α agents, and for thiopurines. Focused questions address the benefits and risks of a strategy of reactive TDM (in patients with active inflammatory bowel disease) to guide treatment changes compared with empiric treatment changes, and the benefits and risks of a strategy of routine proactive TDM (during routine clinical care in patients with quiescent disease) compared with no routine TDM. Additionally, the review addresses the benefits and risks of routine measurement of thiopurine methyltransferase enzyme activity or genotype before starting thiopurine therapy compared with empiric weight-based dosing and explores the performance of different trough drug concentrations for anti-tumor necrosis factor agents and thiopurines to inform clinical decision making when applying TDM in a reactive setting. Due to a paucity of data, this review does not address the role of TDM for more recently approved biologic agents, such as vedolizumab or ustekinumab.
Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American
Gastroenterological Association Institute Technical Review on the Role of
Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases.
Gastroenterology. 2017 Sep;153(3):835-857.e6. doi: 10.1053/j.gastro.2017.07.031.
Epub 2017 Jul 31. Review. PubMed PMID: 28774547.
Patients Before Paperwork is an ACP initiative to reinvigorate the patient-physician relationship by challenging unnecessary practice burdens.
In March 2017, ACP published a foundational set of policy recommendations on reducing excessive administrative tasks. "Putting Patients First by Reducing Administrative Tasks in Health Care: A Position Paper of the American College of Physicians" provides a cohesive framework for identifying and evaluating administrative tasks and outlines detailed recommendations to reduce excessive administrative tasks across the health care system.
ACP is developing an Administrative Tasks and Best Practices Library. This resource will eventually will serve as a means for physicians to communicate administrative pain points with ACP staff, share best practices and innovative ideas with each other, and help inform the creation of additional tools and services.
Using data from the Danish National Patient Registry, researchers found a greater percentage of primary sclerosing cholangitis (PSC), celiac disease, type 1 diabetes (T1D), sarcoidosis, asthma, iridocyclitis, psoriasis, pyoderma gangrenosum, rheumatoid arthritis, and ankylosing spondylitis in patients with IBD (UC and Crohn's disease).
Patients with UC have a higher risk of autoimmune hepatitis, primary biliary cholangitis, Grave’s disease, polymyalgia rheumatica, temporal arteritis , and atrophic gastritis.
Patients with Crohn's disease have a higher risk of psoriatic arthritis and episcleritis.
Halling ML, Kjeldsen J, Knudsen T, Nielsen J, Hansen LK. Patients with inflammatory bowel disease have increased risk of autoimmune and inflammatory diseases. World J Gastroenterol 2017; 23(33): 6137-6146
The Crohn's & Colitis Foundation (the Foundation) and the American Gastroenterological Association Institute, in collaboration with Pfizer, Inc., are issuing a request for proposals (RFP) around interventions that aim to improve shared decision-making and effective health communication between patients with inflammatory bowel disease (IBD) and their clinicians. The goal is to identify and/or establish best practices around shared decision-making that can be easily replicated, broadly disseminated, and widely adopted within the IBD community.
Using an expert panel, the AGA Institute, the Foundation, and Pfizer will select two projects for funding by December 2017. Two projects will be fully funded from 2018–2019 in the amount of $500,000 each, over two years.
The RFP is open from September 11–October 13, 2017. Awardees will be determined by November 22, 2017.
Learn more about this opportunity here: http://www.crohnscolitisfoundation.org/science-and-professionals/research/shareddecisionmaking.html
What do we know about IBD and the cumulative effect of environmental exposures and risk factors?
Abstract: Inflammatory bowel diseases consisting of Crohn's disease and ulcerative colitis are chronic inflammatory diseases of the gastrointestinal tract. In addition to genetic susceptibility and disturbances of the microbiome, environmental exposures forming the exposome play an important role. Starting at birth, the cumulative effect of different environmental exposures combined with a predetermined genetic susceptibility is thought to cause inflammatory bowel disease. All these environmental factors are part of a Western lifestyle, suiting the high incidence rates in Europe and the United States. Whereas receiving breastfeeding, evidence of a Helicobacter pylori infection and vitamin D are important protective factors in Crohn's disease as well as ulcerative colitis, increased hygiene, experiencing a bacterial gastroenteritis in the past, urban living surroundings, air pollution, the use of antibiotics, nonsteroidal anti-inflammatory drugs, and oral contraceptives are likely to be the most important risk factors for both diseases. Current cigarette smoking yields a divergent effect by protecting against ulcerative colitis but increasing risk of Crohn's disease, whereas former smoking increases chances of both diseases. This review gives a clear overview of the current state of knowledge concerning the exposome. Future studies should focus on measuring this exposome yielding the possibility of combining all involved factors to one exposome risk score and our knowledge on genetic susceptibility.
van der Sloot KWJ, Amini M, Peters V, Dijkstra G, Alizadeh BZ. Inflammatory Bowel Diseases: Review of Known Environmental Protective and Risk Factors Involved. Inflamm Bowel Dis. 2017 Sep;23(9):1499-1509. doi: 10.1097/MIB.0000000000001217. PubMed PMID: 28777099.
Infliximab and Cyclosporine and Risk of Colectomy in Hospitalized Patients with UC Complicated by CMV
A study published in Inflammatory Bowel Diseases evaluates:
Impact of Infliximab and Cyclosporine on the Risk of Colectomy in Hospitalized Patients with Ulcerative Colitis Complicated by Cytomegalovirus—A Multicenter Retrospective Study
The aim of this study was to compare the outcome of CMV-positive hospitalized patients with UC treated with antiviral therapy either alone or combined with salvage anti-inflammatory therapy (infliximab [IFX] or cyclosporine A [CsA]).
Interestingly, the authors found that IFX or cyclosporine therapy is not associated with additional risk for colectomy over antiviral therapy alone in hospitalized CMV-positive patients with UC
Inflammatory Bowel Diseases: September 2017 - Volume 23 - Issue 9 - p 1605–1613
ulcerative colitis, cytomegalovirus, infliximab, cyclosporine
The American Medical Association (AMA) has a resource titled, "Tips to help physicians reduce the prior authorization burden in their practice." You can find this resource here:
Electronic Transaction Toolkits for Administrative Simplification
They offer very practical tips and suggestions to improve workflow efficiency and reduce waste. Here are some of those tips:
Tip #1: check prior authorization requirements before providing services or sending prescriptions to the pharmacy
Tip #2: establish a protocol to consistently document data required for a prior authorization in the medical record
Tip #3: select the prior authorization method that will be most efficient, given the particular situation and health plan's prior authorization options
Variations in Health Insurance Policies Regarding Biologic Therapy Use in Inflammatory Bowel Disease
Variations in Health Insurance Policies Regarding Biologic Therapy Use in Inflammatory Bowel Disease
Yadav, Abhijeet MD; Foromera, Joshua MD; Feuerstein, Ilana MD; Falchuk, Kenneth R. MD; Feuerstein, Joseph D. MD
Inflammatory Bowel Diseases: June 2017 - Volume 23 - Issue 6 - p 853–857
Background: The American Gastroenterological Association (AGA) has developed guidelines for the management of ulcerative colitis and Crohn's disease (CD) recommending anti-TNF therapy in moderate-severe disease. However, which drug is used is often dictated by insurance company policies. We sought to determine the insurance policy requirements prior to approval of biologic therapies.
Methods: Using the National Association of Insurance Commissioners report of the top 125 insurance companies by market share in 2014, we reviewed the first 50 that had online policies regarding anti-TNF and vedolizumab available. Policies were reviewed for criteria needed for approval of anti-TNF or vedolizumab therapy, and for compliance with the current AGA clinical pathway recommendations.
Results: Ninety-eight percent of policies are inconsistent with the AGA ulcerative colitis pathway and require step-wise drug failure before approval of an anti-TNF. Only 11% of the policies allowed starting vedolizumab without initial failures of an anti-TNF agent, and 21% required the failure of two or more anti-TNF agents. Ninety percent of the policies are inconsistent with AGA CD pathway and require step-wise drug failure before approval of an anti-TNF. Seventy-four percent allowed for initiating infliximab specifically for fistulizing CD. Twenty-eight percent required failing of at least two or more drugs before starting anti-TNF. Only 8% policies allowed starting vedolizumab without initial failures of an anti-TNF agent, and 28% required the failure of two anti-TNF agents.
Conclusions: The majority of the policies reviewed fail to adhere to the current AGA pathway recommendations for ulcerative colitis and CD. Further interventions are needed to better align policies with optimal evidence-based drug therapy.
The AGA quality measures for IBD remind us to always test for latent TB and assess for HBV prior to starting anti-TNF therapy.
While TB testing may be performed using a skin test (using PPD or purified protein derivative), there is also a TB blood test called QuantiFERON.
When documenting for HBV testing, be sure to include the following:
What do we know about colonic phenotypes and response to biologic therapies in patients with IBD?
Although anti-tumor necrosis factor (TNF) agents are effective in patients with inflammatory bowel disease (IBD), many patients either do not respond to anti-TNF treatment or lose response over time. The aim of this study was to determine factors associated with response to anti-TNF therapy in IBD.
Patients with Crohn's disease (CD) or ulcerative colitis who had consented to participate in a genetics registry and been treated with anti-TNF agents were evaluated retrospectively and categorized as primary nonresponders or secondary nonresponders. We evaluated clinical, serological, and genetic characteristics associated with primary nonresponse or time to loss of response to anti-TNF agents.
We included 314 CD (51 [16.2%] primary nonresponders and 179 [57.0%] secondary nonresponders) and 145 subjects with ulcerative colitis (43 [29.7%] primary nonresponders and 74 [51.0%] secondary nonresponders). Colonic involvement (P = 0.017; odds ratio = 8.0) and anti-TNF monotherapy (P = 0.017; odds ratio = 4.9) were associated in a multivariate analysis with primary nonresponse to anti-TNF agents in CD. In addition, higher anti-nuclear cytoplasmic antibody levels (P = 0.019; hazard ratio = 1.01) in CD, anti-nuclear cytoplasmic antibody positivity (P = 0.038; hazard ratio = 1.6) in ulcerative colitis, and a positive family history of IBD (P = 0.044; hazard ratio = 1.3) in all patients with IBD were associated with time to loss of response to anti-TNF agents. Furthermore, various known IBD susceptibility single-nucleotide polymorphisms and additional variants in immune-mediated genes were shown to be associated with primary nonresponse or time to loss of response.
Our results may help to optimize the use of anti-TNF agents in clinical practice and position these therapies appropriately as clinicians strive for a more personalized approach to managing IBD.
Yoon SM, Haritunians T, Chhina S, Liu Z, Yang S, Landers C, Li D, Ye BD, Shih
D, Vasiliauskas EA, Ippoliti A, Rabizadeh S, Targan SR, Melmed GY, McGovern DPB.
Colonic Phenotypes Are Associated with Poorer Response to Anti-TNF Therapies in
Patients with IBD. Inflamm Bowel Dis. 2017 Jun 5. doi:
10.1097/MIB.0000000000001150. [Epub ahead of print] PubMed PMID: 28590340.