Endoscopic assessment of the J pouch in ulcerative colitis: A narrative review.

Patients with ulcerative colitis sometimes need a total colectomy with ileal pouch-anal anastomosis due to medically refractory disease or colitis-associated neoplasia. Up to 50% of patients with ulcerative colitis postoperatively develop pouchitis and the rate of chronic inflammatory pouch conditions requiring pouch excision or diverting ileostomy is reported to be 10%. In order to diagnose and monitor pouchitis, pouchoscopy is essential to assess endoscopic inflammatory findings of the J pouch and to survey neoplasia development, particularly in the remnant distal rectum. However, endoscopic protocols for the evaluation of the pouch may not be standardized worldwide and the reliability of existing disease activity indices for pouchitis has been questioned due to the lack of validation. Recently, reliable endoscopic scoring systems based on an observation of the anatomical location of the J pouch were reported and a significant association between the distribution pattern of endoscopic inflammation (i.e., endoscopic phenotype) and pouch outcomes was also uncovered. In this review, we discuss how to survey the J pouch using pouchoscopy, endoscopic indices for pouchitis disease activity, endoscopic phenotypes and classification, and the pathological mechanisms of pouchitis phenotype in patients with ulcerative colitis.

The Communicating Needs and Features of IBD Experiences (CONFIDE) Study: US and European Patient and Health Care Professional Perceptions of the Experience and Impact of Symptoms of Moderate-to-Severe Ulcerative Colitis.

BACKGROUND: The Communicating Needs and Features of IBD Experiences (CONFIDE) study aimed to evaluate the experience and impact of ulcerative colitis (UC) symptoms on patients' lives and elucidate gaps in communication between patients and health care professionals (HCPs). METHODS: Online, quantitative, cross-sectional surveys of patients with moderate-to-severe UC and HCPs responsible for making prescribing decisions were conducted in the United States (US) and Europe. UC disease severity was defined by treatment, steroid use, and/or hospitalization history. RESULTS: Surveys were completed by 200 US and 556 European patients and 200 US and 503 European HCPs. The most common UC symptoms experienced in the preceding month were diarrhea, bowel urgency, and increased stool frequency. Many patients (45.0% of US patients, 37.0% of European patients) reported wearing diapers/pads/protection at least once a week in the past 3 months due to fear/anticipation of fecal urge incontinence. The top reasons for declining participation in social events, work/school, and sports/exercise were due to bowel urgency and fear of fecal urge incontinence. HCPs ranked diarrhea, blood in stool, and increased stool frequency as the most common symptoms. While over half HCPs ranked bowel urgency as a top symptom affecting patients' lives, less than a quarter ranked it in the top 3 most impactful on treatment decisions. CONCLUSIONS: Similar disparities exist between patient and HCP perceptions in the United States and Europe on the experience and impact of UC symptoms. Bowel urgency has a substantial and similar impact on US and European patients, is underappreciated by HCPs, and should be addressed during routine appointments.

Delays in Therapy Associated With Current Prior Authorization Process for the Treatment of Inflammatory Bowel Disease.

Despite a high approval rate, there were unnecessary delays in therapy due to prior authorizations. This study identified the impact of type of IBD, FDA-labeled indication, and dose escalations on approvals.

Assessment of the Degree of Variation of Histologic Inflammation in Ulcerative Colitis.

INTRODUCTION: Treatment of ulcerative colitis (UC) now includes mucosal healing. Adoption of histologic end points is hindered by a lack of evidence guiding optimal sampling, interpretation, and reproducibility of results. METHODS: We analyzed biopsy fragments from colonoscopies in 92 patients with UC. Fragments were scored using 6-point histologic inflammatory activity (HIA) scale. Variability was determined using ordinal representations of HIA scores. The most frequently observed score and percentage of biopsy fragments with that score were determined for each biopsy, each segment, and across all 3 segments for each colonoscopy. Mean percentages and 95% confidence intervals (CIs) were calculated. RESULTS: We reviewed 1802 biopsy fragments. The mean percentages of intrasegment biopsy fragments with the same HIA score were 85.5% (95% CI, 80.9% to 92.9%), 79.6% (95% CI, 76.0% to 87.3%), and 82.7% (95% CI, 79.1% to 90.0%) for the rectum, left colon, and right colon, respectively. The mean percentage of intersegment biopsy fragments with the same HIA score was 70.2% (95% CI, 65.7% to 82.5%). The mean percentages of intrabiopsy fragments with the same HIA score were 83.3% (95% CI, 77.6% to 93.5%), 83.6% (95% CI, 80.1% to 89.7%), and 90.2% (95% CI, 87.6% to 94.7%) for the rectum, left colon, and right colon, respectively. All 3 analyses revealed increased variation when a greater degree of histologic inflammation was present in the biopsies (mean HIA score ≥2). CONCLUSIONS: We found minimal variability between degree of inflammation among biopsy fragments within and among different colorectal segments in UC, suggesting that even a single biopsy would adequately reflect the inflammation of the entire colorectum. These findings have significant implications for the use of histology as a clinical target and trial end point in UC.

Objective disease activity assessment and therapeutic drug monitoring prior to biologic therapy changes in routine inflammatory bowel disease clinical practice: TARGET-IBD.

BACKGROUND: Inflammatory bowel disease (IBD) treatment paradigms recommend objective disease activity assessment and reactive therapeutic drug monitoring (TDM) prior to changes in biologic therapy. We aimed to describe objective marker and TDM assessment in routine clinical practice prior to biologic therapeutic changes in adult IBD patients. METHODS: TARGET-IBD is a prospective longitudinal cohort of over 2100 IBD patients receiving usual care at 34 US academic or community centers enrolled between June 2017 and October 2019 who received biologic therapy and had a dose change or biologic discontinuation for lack of efficacy. Objective markers of disease activity within 12 weeks prior included fecal calprotectin, C-reactive protein (CRP), endoscopy, computed tomography (CT) and magnetic resonance imaging (MRI). TDM data for infliximab or adalimumab was obtained. RESULTS: 525 patients (71.4% Crohn's disease [CD], 28.6% ulcerative colitis [UC]) receiving biologic therapy underwent dose change (55.6%) or discontinuation (44.4%) for lack of efficacy. The majority were Caucasian (85.7%), 18-39 years old (52.2%), privately insured (81.5%), and at academic centers (73.7%). For dose changes, 67.5% had at least one objective disease activity assessment or TDM in the 12 weeks prior (CD 67.9%, UC 66.2%; P = 0.79). The most common objective marker was CRP in both CD (39.1%) and UC (54.5%). CRP and calprotectin were used significantly more in UC (P = 0.02 and P = 0.03). TDM was obtained in 30.7% (28.8% UC, 31.4% CD; P = 0.72) prior to dose change. For biologic discontinuation, 79.4% patients underwent objective assessment or TDM prior. In CD, CRP (46.3%) was most common, and CT (P = 0.03) and MRI (P < 0.001) were significantly more frequent than in UC. TDM was performed in 40.1% of patients (43.5% UC, 38.0% CD, P = 0.49) prior to discontinuation. Among all participants with dose change or discontinuation, endoscopy was performed in 29.3% with CD and 31.3% with UC. Academic care setting was associated with objective assessment before therapy change (OR 1.59, 95% CI 1.01-2.50). CONCLUSION: Nearly one-third of patients undergoing a biologic dose change or discontinuation do not undergo objective disease activity assessment or TDM. Assessment choice differs by disease. Future studies assessing the impact of such practices on long-term outcomes are needed.

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

BACKGROUND: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity. METHODS: An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds. RESULTS: Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain. CONCLUSIONS: A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.

Assessment of Comorbid Depression and Anxiety in Inflammatory Bowel Disease Using Adaptive Testing Technology.

BACKGROUND: Depression and anxiety are comorbidities of inflammatory bowel disease (IBD), and it is now recommended to screen IBD patients for these conditions. We screened patients using a novel computerized adaptive testing technology and compared the screening results to measures of disease activity. METHODS: Consecutive patients at our tertiary IBD clinic were asked to complete the validated CAT-MH™ survey (Adaptive Testing Technologies, Chicago, IL); we then reviewed disease and patient characteristics. Clinical remission status was determined based on clinical, laboratory, endoscopy and imaging results. Statistical methods included Fisher's exact test and Pearson Chi-square tests to assess association. Univariable and multivariable analyses were performed. RESULTS: We included 134 patients, of which 34 (25.3%) screened positive for depression and 18 (13.4%) screened positive for anxiety. We identified 19 (55.9 %) and 10 (55.5%) patients who were previously undiagnosed for depression and anxiety, respectively. Patients in clinical remission were less likely to screen positive for depression (OR 0.19; 95%CI 0.07-0.50) and for anxiety (OR 0.30; 95%CI 0.10-0.91). Compared to patients with negative CRP values, patients with positive CRP were more likely to also screen positive for depression (p=0.025) and anxiety (p=0.15). CONCLUSIONS: We demonstrate the utility of a novel testing technology for screening patients with IBD for depression and anxiety. We found a large number of patients with previously undiagnosed anxiety or depression and a significant positive association between clinically active IBD and these mental health conditions. This work supports and informs recommendations for mental health screening in the IBD population.

Sustained long-term benefits of patient support program participation in immune-mediated diseases: improved medication-taking behavior and lower risk of a hospital visit.

BACKGROUND: Patient support programs (PSPs) improve medication-taking behavior in the first 12 months of treatment for patients with immune-mediated diseases, but it is unknown if these benefits are sustained. As immune-mediated diseases continue to increase in prevalence and economic burden, understanding the potential value of PSPs in helping patients adhere to their long-term treatment plan and avoid costly hospital visits is crucial. Launched nationally in 2015, HUMIRA Complete (a PSP for adalimumab patients) provides an opportunity to study long-term effects of PSP participation, including the impact on medication-taking behavior and hospital visits. OBJECTIVE: To evaluate the sustained relationship between PSP participation, long-term medication-taking behavior, and hospital visits. METHODS: A longitudinal, retrospective matched-cohort study was conducted of patients initiating adalimumab between January 2015 and February 2016 with or without enrolling in the PSP, using patient-level data from the HUMIRA Complete PSP linked with Symphony Health claims. The sample included adult, commercially insured patients diagnosed with an indicated disease who were biologic-naive and had data available for ≥ 6 months before and ≥ 12 months after initiating adalimumab. Adherence (proportion of days covered) and hospital visits were assessed at 12, 24, and 36 months for patients with sufficient follow-up data. Multivariable generalized models estimated differences between cohorts, controlling for baseline characteristics and hospital visits. Duration of persistence and time to a hospital visit were compared using Kaplan-Meier analyses. Hazard ratios were estimated using multivariable Cox proportional hazards models. RESULTS: The matched cohort included 2,268 patients (1,134 per cohort), and patient attrition was similar across cohorts. The PSP cohort consistently demonstrated higher adalimumab adherence than the non-PSP cohort at 12 (64.8% vs. 50.1%, P < 0.0001; 29% greater), 24 (49.4% vs. 38.4%; P < 0.0001; 29% greater), and 36 (39.4% vs. 35.1%; P = 0.02; 12% greater) months. PSP participation was associated with a 30% lower hazard of discontinuation (P < 0.0001), and median duration of persistence was 4.8 months longer for the PSP cohort (13.2 vs. 8.4 months; P < 0.0001). The PSP cohort had lower rates of hospital visits at 12 (30% vs. 37%; P < 0.001; 19% lower), 24 (44% vs. 53%; P = 0.01; 17% lower), and 36 (55% vs. 65%; P < 0.01; 16% lower) months, and PSP participation was associated with a 25% lower hazard of a hospital visit (P < 0.0001). Median time to a hospital visit was 10.8 months longer for the PSP cohort (32.7 vs. 21.9 months; P < 0.0001). Findings were consistent across therapeutic areas: hazard of a hospital visit was 28%, 27%, and 37% lower for rheumatology, gastroenterology, and dermatology patients participating in the PSP (all P < 0.05). CONCLUSIONS: Patients with immune-mediated diseases receiving adalimumab and utilizing this PSP had improved long-term medication-taking behavior and lower risk of hospital visits, demonstrating the potential of PSPs to improve patient outcomes and lower the burden to the health care system. DISCLOSURES: Design, study conduct, and financial support for the study were provided by AbbVie Inc., which participated in the interpretation of data, review, and approval of the manuscript. Fendrick has received personal fees from Merck, AstraZeneca, Trizetto, Amgen, Lilly, AbbVie, Johnson & Johnson, and Sanofi; grants from the National Pharmaceutical Council, PhRMA, the Gary and Mary West Health Foundation, the states of New York and Michigan, the Laura and John Arnold Foundation, the Robert Wood Johnson Foundation, and the Agency for Healthcare Research and Quality; and equity in Zansors, Sempre Health, Wellth, and V-BID Health. Brixner has received consulting fees from AbbVie, Novartis, Xcenda, Elevar Therapeutics, Sanofi, UCB Pharma, and the Millcreek Outcomes Group. Rubin has received consulting fees from AbbVie, Abgenomics, Allergan Inc., Amgen, Celgene Corporation, Forward Pharma, Genentech/Roche, Janssen Pharmaceuticals, Merck & Co., Miraca Life Sciences, Mitsubishi Tanabe Pharma Development America, Napo Pharmaceuticals, Pfizer, Salix Pharmaceuticals Inc., Samsung Bioepis, Sandoz Pharmaceuticals, Shire, Takeda, and Target Pharmaceuticals; and research support from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, Takeda, and UCB Pharma. Mease has received grant/research support from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, and UCB; and has served on the speakers bureau for AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB. Liu has no financial conflict of interest. Davis is an employee of Medicus Economics, which received payment from AbbVie to participate in this research. Mittal is an employee and stockholder of AbbVie. This study used a cohort of patients previously described in Brixner D, Rubin DT, Mease P, et al. Patient support program increased medication adherence with lower total health care costs despite increased drug spending. J Manag Care Spec Pharm. 2019 Jul;25(7):770-79 (doi: 10.18553/jmcp.2019.18443). As such, the sample selection and select baseline characteristics and 12-month outcomes have been published previously; however, the hospital visit outcomes and the longer-term medication-taking behavior outcomes have not been previously published or presented.

Black Race and Public Insurance Are Predictive of Inappropriate Evaluation of Iron Deficiency Anemia and Diarrhea.

BACKGROUND AND AIMS: Socioeconomic status, race, and insurance can impact healthcare delivery and utilization in several chronic disease states. The primary aim of our study was to determine whether race and insurance status are predictors of having an appropriate workup for celiac disease and inflammatory bowel disease (IBD) when presenting with iron deficiency anemia (IDA) and chronic diarrhea. METHODS: Medical records of patients seen at the University of Chicago Medical Center between January 1, 2006, and September 20, 2017, were reviewed. Patients with two separate encounters within 6 months associated with the diagnosis codes for both IDA and chronic diarrhea were identified. Patients without a diagnosis code for IBD and celiac disease were further grouped as those that had an "appropriate" workup and those that did not. Factors associated with the appropriate evaluation were analyzed by univariate and multivariate logistic regression. RESULTS: In total, 899,701 records were searched. A total of 83 patients fit inclusion into the study (8 IBD, 3 CD, 72 neither IBD or CD). Black race was associated with a 91% decreased odds of having the appropriate workup on univariate (OR 0.090, 95%CI 0.017-0.475, p = 0.005) and age-adjusted multivariate analysis (OR 0.095, 95% CI 0.017-0.527, p = 0.007). Public insurance status was significantly associated with a 90% decreased odds of appropriate workup on univariate (OR 0.102, 95% CI 0.024-0.438, p = 0.002) and age-adjusted multivariate analysis (OR 0.104, 95% CI 0.021-0.513, p = 0.005). CONCLUSIONS: Black race and public insurance were significantly associated with not having an appropriate workup for IBD and celiac disease when presenting with iron deficiency and chronic diarrhea.

The Impact of Intestinal Complications on Health Care Costs Among Patients With Inflammatory Bowel Disease Treated With Anti-Tumor Necrosis Factor Therapies.

BACKGROUND: Although there is evidence that anti-tumor necrosis factor (TNF) utilization earlier in the inflammatory bowel disease (IBD) course and before the onset of disease-related complications leads to improved patient outcomes, the health care costs and utilization impact have not been well defined. This study assessed differences in health care utilization and costs among patients with IBD treated with anti-TNFs. METHODS: Patients with a diagnosis of ulcerative colitis (UC) or Crohn disease (CD) between January 1, 2001, and December 31, 2014, were identified from a claims database. Patients were required to have ≥1 claim for a 5-aminosalicylic acid, corticosteroid, or immunomodulator after the IBD diagnosis and ≥1 anti-TNF drug claim after the first IBD treatment. Complication and noncomplication cohorts were identified based on disease-related complications and IBD-related hospitalizations or emergency department visits for 6 months before anti-TNF initiation. Generalized linear models were used to compare health care costs and utilization for the 12 months after anti-TNF initiation (follow-up). RESULTS: The study included 6329 patients with CD and 4451 patients with UC. In patients with CD with complications, >33.7% had intestinal strictures and 6% had enteroenteric fistula before anti-TNF treatment. Patients with CD with complications incurred significantly higher IBD-related and all-cause health care costs during follow-up, and patients with UC experienced the same trends. CONCLUSIONS: These results suggest that anti-TNF treatment after, rather than before, a patient develops complications leads to a higher economic burden. However, these findings could also result from patients with more severe disease having early complications that are more difficult to treat.

Cost-Effectiveness of 5-Aminosalicylate Therapy in Combination With Biologics or Tofacitinib in the Treatment of Ulcerative Colitis.

INTRODUCTION: Medications are major cost drivers in the treatment of patients with inflammatory bowel disease. Recent analyses suggest that there is no added efficacy in continuing nor harm in stopping 5-aminosalicylate (ASA) therapy in patients with inflammatory bowel disease escalated to biological therapies or tofacitinib. We assessed the cost-effectiveness of discontinuing 5-ASA therapy in patients with ulcerative colitis on biological therapies or tofacitinib, compared with continuing 5-ASA therapy. METHODS: We performed a cost-effectiveness analysis of 5-ASA with biologic therapy and tofacitinib compared with the same treatment without 5-ASA. Our primary outcome was to determine whether biologic/tofacitinib monotherapy was cost-effective compared with biologic/tofacitinib and 5-ASA combination therapy using the incremental cost-effectiveness ratio at a willingness to pay of $50,000/quality-adjusted life year. Owing to the uncertainty surrounding outcome probabilities, probabilistic sensitivity analyses with 10,000 simulations were also performed. We conducted a sensitivity analysis comparing biologic/tofacitinib and 5-ASA therapy compared with biologic/tofacitinib monotherapy, whereby vedolizumab was the first biologic used, followed by infliximab and finally tofacitinib. RESULTS: Our model shows that biologic/tofacitinib monotherapy dominates (cheaper and more effective) combination therapy of biologics/tofacitinib with 5-ASA. Probabilistic sensitivity analyses simulations resulted in biologic/tofacitinib monotherapy dominating 100% of the scenarios, with mean cost savings of $24,483.01 over 2 years. When vedolizumab was the first-line therapy in the sensitivity analysis, biologic/tofacitinib monotherapy continued to dominate the combination of 5-ASA and biologic/tofacitinib therapy. DISCUSSION: This analysis in patients with ulcerative colitis who require treatment with biologics or tofacitinib demonstrates that continuing 5-ASA therapy is not a cost-effective strategy. Discontinuation of 5-ASA therapy in these patients is safe and less expensive and should be recommended.

Cost-effectiveness analysis of a fecal microbiota transplant center for treating recurrent C.difficile infection.

OBJECTIVE: We assessed the cost-effectiveness of establishing a fecal microbial transplant (FMT) unit in Canada for the treatment of recurrent CDI. DESIGN: We performed a cost-effectiveness analysis to determine the number of patients with recurrent CDI needed to treat (NNT) annually to make establishing a FMT unit cost-effective. We compared treating patients for their second recurrence of CDI with FMT in a jurisdiction with a FMT unit, compared to being treated with antibiotics; then sent to a medical center with FMT available for the third recurrence. We used a willingness to pay threshold of $50,000 per quality-adjusted-life-year gained. RESULTS: The minimum annual NNT was 15 for FMT via colonoscopy, 17 for FMT via capsule, and 44 for FMT via enema compared with vancomycin, and 16, 18, and 47 compared with fidaxomicin, respectively. A medical center's minimum catchment area when establishing a FMT unit would have to be 56,849 if using FMT via colonoscopy, or 64,429 if using capsules. CONCLUSION: We report the minimum number of patients requiring treatment annually with FMT to achieve cost-effectiveness, when including start-up and ongoing costs. FMT is cost-effective in Canada in populations with a sufficient number of eligible patients, ranging from 15 to 47 depending on the FMT modality used. This is crucial for medical jurisdictions making decisions about establishing a FMT unit for the treatment of recurrent CDI. The cost-effectiveness can be generalized in other countries.

Stopping Clinical Trials in Inflammatory Bowel Disease During the COVID-19 Pandemic Is Not a Responsible Act.

The intense competition for resources to combat COVID-19 has greatly reduced access to health care for patients with other diseases. After the disastrous overrun of hospitals through COVID-19 patients in some jurisdictions, availability of resources for 'elective' medical procedures, including care for the chronically ill, has been greatly reduced in many places as a pre-emptive measure before or during the blooming of infection clusters. Pharmaceutical companies have either stopped recruitment or even cancelled ongoing clinical trials in chronic diseases. Pre-emptive triage and its impact on medical ethics is discussed in the framework of care for inflammatory bowel disease.

The Cost of Inflammatory Bowel Disease: An Initiative From the Crohn's & Colitis Foundation.

BACKGROUND: The Crohn's & Colitis Foundation's Cost of Inflammatory Bowel Disease (IBD) Care Initiative seeks to quantify the wide-ranging health care costs affecting patients living with IBD. We aimed to (1) describe the annualized direct and indirect costs of care for patients with Crohn's disease (CD) or ulcerative colitis (UC), (2) determine the longitudinal drivers of these costs, and (3) characterize the cost of care for newly diagnosed patients. METHODS: We analyzed the Optum Research Database from the years 2007 to 2016, representing commercially insured and Medicare Advantage-insured patients in the United States. Inclusion for the study was limited to those who had continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before through 12 months after the index date of diagnosis). The value of patient time spent on health care was calculated as number of workplace hours lost due to health care encounters multiplied by the patients' estimated average wage derived from the Bureau of Labor Statistics. Comparisons between IBD patients and non-IBD patients were analyzed based on demographics, health plan type, and length of follow-up. We used generalized linear models to estimate the association between total annual costs and various patient variables. RESULTS: There were 52,782 IBD patients (29,062 UC; 23,720 CD) included in the analysis (54.1% females). On a per-annual basis, patients with IBD incurred a greater than 3-fold higher direct cost of care compared with non-IBD controls ($22,987 vs $6956 per-member per-year paid claims) and more than twice the out-of-pocket costs ($2213 vs $979 per-year reported costs), with all-cause IBD costs rising after 2013. Patients with IBD also experienced significantly higher costs associated with time spent on health care as compared with controls. The burden of costs was most notable in the first year after initial IBD diagnosis (mean = $26,555). The study identified several key drivers of cost for IBD patients: treatment with specific therapeutics (biologics, opioids, or steroids); ED use; and health care services associated with relapsing disease, anemia, or mental health comorbidity. CONCLUSION: The costs of care for IBD have increased in the last 5 years and are driven by specific therapeutics and disease features. In addition, compared with non-IBD controls, IBD patients are increasingly incurring higher costs associated with health care utilization, out-of-pocket expenditures, and workplace productivity losses. There is a pressing need for cost-effective strategies to address these burdens on patients and families affected by IBD.

Proposal to Update the Curriculum in Inflammatory Bowel Diseases for Categorical Gastroenterology Fellows.

Education in inflammatory bowel disease (IBD) varies widely between categorical gastroenterology (GI) programs and is largely related to the presence of expert clinicians, patient population, and the presence of an IBD center. The treatment of IBD is becoming increasingly complex at a rapid pace, widening this educational divide. This manuscript outlines all the current US educational offerings in IBD for GI fellows, including how to obtain supplemental education during the 3-year training period and beyond. It reviews how to assess trainee knowledge in the field of IBD and proposes 8 clinically anchored, entrustable professional activities that should help prioritize important aspects of IBD management to incorporate during categorical GI training.

Patient Support Program Increased Medication Adherence with Lower Total Health Care Costs Despite Increased Drug Spending.

BACKGROUND: The U.S. health care system is currently evolving from a volume-based care to a value-based care approach, which is in part supported by the introduction of patient support programs (PSP). For patients treated with adalimumab (ADA), the addition of a dedicated, trained nurse to the PSP (HUMIRA Complete, rolled out nationally in 2015) provides further emphasis on value-based care. OBJECTIVE: To determine the effectiveness of the HUMIRA Complete PSP, including the Nurse Ambassador component, in a real-world setting for patients receiving ADA across a broad range of approved indications (rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa). METHODS: A longitudinal retrospective study was conducted using patient-level data from the HUMIRA Complete PSP data linked to the real-world, patient-level Symphony Health Solutions administrative claims database. Commercially insured patients were included who were aged ≥ 18 years with ≥ 2 diagnoses of an indicated disease who were biologically naive before initiating ADA or who had no claims for synthetic-targeted immune modulator therapy before their earliest ADA claim in the database between January 2015 and February 2017. The first claim had to have occurred in 2015 or later, and continuous medical and drug data coverage were required for ≥ 6 months before and ≥ 12 months after the first ADA claim and index date. PSP patients (with at least an initial and follow-up dedicated nurse call) were matched 1:1 to non-PSP patients based on pharmacy type, indication, and propensity score, estimated with covariates for age, sex, year of first ADA use, and baseline comorbidities. Adherence to ADA was compared using proportion of days covered along with discontinuation of ADA, defined as a gap in treatment greater than the previous days supply with no additional ADA claim, total costs, medical costs, and drug costs (2017 U.S. dollars) over 12 months. Baseline demographic and clinical characteristics were summarized descriptively. Differences between cohorts were assessed using t-tests for adherence and costs and log-rank tests for discontinuation. RESULTS: 2,268 patients (1,134 per group) were included. Baseline characteristics were similar between cohorts after matching. Participation in the PSP was associated with 29.3% higher ADA adherence (64.8% vs. 50.1%; P < 0.0001) and 22.0% lower ADA discontinuation rate (51.4% vs. 65.9%; P < 0.0001). Disease-related medical costs and all-cause medical costs were significantly lower by 35% ($10,162 vs. $15,511; P = 0.005) and 29.2% ($25,074 vs. $35,419; P = 0.0004), respectively, for PSP versus non-PSP patients. Total costs were also lower by 9% ($62,421 vs. $68,706; P = 0.056), and drug costs were 12.2% higher ($37,347 vs. $33,287; P = 0.0016). CONCLUSIONS: This retrospective study demonstrates that participation in the PSP augments value-based care by improving outcomes for patients with chronic diseases by helping them not only manage a complex treatment regimen but also lower annual health care costs. DISCLOSURES: Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the manuscript; all authors contributed to the development of the publication and maintained control over the final content. Brixner reports consulting fees from AbbVie, AstraZeneca, Becton Dickinson, Millcreek Outcomes Group, Sanofi, and UCB Pharma. Rubin reports consulting fees from AbbVie, Abgenomics, Allergan, Forward Pharma, Genentech/Roche, Janssen Pharmaceuticals, Merck & Co., Napo Pharmaceuticals, Pfizer, Shire, Takeda, and Target Pharmaceuticals and research support from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda. Mease reports grant/research support from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; and served on the speakers bureaus for AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and UCB. Mittal and Ganguli are employees and stockholders of AbbVie. Liu has no financial conflict of interest. Davis is an employee of Medicus Economics, which reports payment from AbbVie to participate in this research. Fendrick reports personal fees from Merck, AstraZeneca, Trizetto, Amgen, Lilly, AbbVie, Johnson & Johnson, and Sanofi; grants from the National Pharmaceutical Council, PhRMA, the Gary and Mary West Health Foundation, the states of New York and Michigan, the Laura and John Arnold Foundation, the Robert Wood Johnson Foundation, and the Agency for Healthcare Research and Quality; and has equity in Zansors, Sempre Health, Wellth, and V-BID Health. Data from this study were presented in part at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 25, 2018; Boston, MA.

Faecal Calprotectin Is a Very Reliable Tool to Predict and Monitor the Risk of Relapse After Therapeutic De-escalation in Patients With Inflammatory Bowel Diseases.

AIMS: To assess faecal calprotectin [Fcal] levels before and after therapeutic de-escalation, to predict clinical relapse in patients with inflammatory bowel disease [IBD]. METHODS: From a prospectively maintained database, we enrolled 160 IBD patients [112 Crohn's disease/48 ulcerative colitis] in clinical remission, with Fcal measured within 8 weeks before therapeutic de-escalation. Clinical relapse was defined using the Harvey-Bradshaw index or Simple Clinical Colitis Activity Index. RESULTS: Using a receiver operating characteristic [ROC] curve, Fcal >100 µg/g was the best threshold to predict clinical relapse after therapeutic de-escalation (area under the curve [AUC] = 0.84). In multivariate analysis, clinical remission >6 months before therapeutic de-escalation (hazard ratio [HR] = 0.57 [0.33-0.99]; p = 0.044) was associated with decreased risk of relapse, whereas current steroid medication ( = 1.67[1.00-2.79]; p <0.0001) was a risk factor. Fcal >100 µg/g was predictive of clinical relapse (HR = 3.96 [2.47-6.35]; p < 0.0001) in the whole cohort but also in patients receiving anti-tumour necrosis factor [TNF] agents [n = 85 patients; p <0.0001], anti-integrins [n = 32; p = 0.003], or no biologics [n = 43; p = 0.049], or attempting to discontinue steroids [n = 37; p = 0.001]. One patient [1/98] and seven patients [7/88, 8.0%] with baseline Fcal <100 µg/g relapsed within 3 months and 6 months after therapeutic de-escalation, respectively. A total of 74 Fcal measurements were performed in 52 patients after therapeutic de-escalation. Monitoring Fcal >200 µg/g [ROC curve with AUC = 0.96] was highly predictive of clinical relapse in multivariate analysis ([HR = 31.8 [3.5-289.4], p = 0.002). Only two relapses [2/45, 4.4%] occurred within 6 months while Fcal <200 µg/g. CONCLUSIONS: Fcal level is highly accurate to predict and monitor the risk of relapse after therapeutic de-escalation in IBD patients and could be used in daily practice.