Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis.

BACKGROUND & AIMS: We created and validated a clinical decision support tool (CDST) to predict outcomes of vedolizumab therapy for ulcerative colitis (UC). METHODS: We performed logistic regression analyses of data from the GEMINI 1 trial, from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort), to identify factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1). We used these factors to develop a model to predict outcomes of treatment, which we called the vedolizumab CDST. We evaluated the correlation between exposure and efficacy. We validated the CDST in using data from 199 patients treated with vedolizumab in routine practice in the United States from May 2014 through December 2017. RESULTS: Absence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L) were independently associated with corticosteroid-free remission during vedolizumab therapy. Patients in the derivation and validation cohorts were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27-32 points), or high (CDST score, 33 points or more) probability of vedolizumab response. We observed a statistically significant linear relationship between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure (P \u3c .001) in the derivation cohort. In the validation cohort, a cutoff value of 26 points identified patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response (P = .02). The vedolizumab CDST did not identify patients with corticosteroid-free remission during TNF antagonist therapy. CONCLUSIONS: We used data from a trial of patients with UC to develop a scoring system, called the CDST, which identified patients most likely to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. We validated the vedolizumab CDST in a separate cohort of patients in clinical practice. The CDST identified patients most likely to benefited from reducing intervals of vedolizumab administration due to lack of initial response. ClinicalTrials.gov no: NCT00783718

Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn's Disease But Not Ulcerative Colitis.

Background & aimsPatients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration.MethodsWe analyzed data from a retrospective, multicenter, consortium of patients with CD (n = 650) or UC (n = 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (≤2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes.ResultsWithin 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02-2.49), CSFR (aHR, 3.39; 95% CI, 1.66-6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06-3.39). In contrast, disease duration was not a significant predictor of response among patients with UC.ConclusionsPatients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC

Diagnosis and Management of Rectal Neuroendocrine Tumors.

The incidence of rectal neuroendocrine tumors (NETs) has increased by almost ten-fold over the past 30 years. There has been a heightened awareness of the malignant potential of rectal NETs. Fortunately, many rectal NETs are discovered at earlier stages due to colon cancer screening programs. Endoscopic ultrasound is useful in assessing both residual tumor burden after retrospective diagnosis and tumor characteristics to help guide subsequent management. Current guidelines suggest endoscopic resection of rectal NETs ≤10 mm as a safe therapeutic option given their low risk of metastasis. Although a number of endoscopic interventions exist, the best technique for resection has not been identified. Endoscopic submucosal dissection (ESD) has high complete an

Diagnosis and Management of Rectal Neuroendocrine Tumors

The incidence of rectal neuroendocrine tumors (NETs) has increased by almost ten-fold over the past 30 years. There has been a heightened awareness of the malignant potential of rectal NETs. Fortunately, many rectal NETs are discovered at earlier stages due to colon cancer screening programs. Endoscopic ultrasound is useful in assessing both residual tumor burden after retrospective diagnosis and tumor characteristics to help guide subsequent management. Current guidelines suggest endoscopic resection of rectal NETs ≤10 mm as a safe therapeutic option given their low risk of metastasis. Although a number of endoscopic interventions exist, the best technique for resection has not been identified. Endoscopic submucosal dissection (ESD) has high complete and en-bloc resection rates, but also an increased risk of complications including perforation. In addition, ESD is only performed at tertiary centers by experienced advanced endoscopists. Endoscopic mucosal resection has been shown to have variable complete resection rates, but modifications to the technique such as the addition of band ligation have improved outcomes. Prospective studies are needed to further compare the available endoscopic interventions, and to elucidate the most appropriate course of management of rectal NETs

Primary Care Providers Are Vital to Carrying out Hepatitis C Screening

Background: Chronic Hepatitis C Virus (HCV) infection affects approximately 3 million Americans. The 1945-1965 birth cohort has the highest prevalence, estimated at 2%. In 2013, the United States Preventive Services Task Force (USPSTF) endorsed screening for HCV in this cohort with the goal of identifying cases and initiating treatment. However, a variety of obstacles to screening are suspected to contribute to low screening rates. This study evaluated the role of the primary care physician in completing recommended screening in an historically underserved community with a high prevalence of HCV. Methods: Individuals attending an August 2015 health exposition sponsored by the Rodham Institute completed an anonymous survey. The exposition was hosted in an urban setting where the population has historically been predominantly African American; currently 92% of residents identify as such. The survey included questions on demographic information, access to a PCP, insurance status, as well as knowledge of various topics related to Hepatitis C. Responses were excluded if they did not provide information on their history of screening. The university institutional review board approved the study. Statistical analysis was performed using Fisher’s exact test, with significance set at p\u3c0.05. Results: Ninety five responses were analyzed. Among them were 29 born in the 1945-1965 timeframe. All of members of this cohort reported having a primary physician and 27 (96.4%) had health insurance. Sixteen discussed HCV with their doctor and 12 of them (75.0%) were screened. Thirteen respondents had not discussed HCV; among them, three (23.1%) were tested for the virus. Having a discussion with the primary physician resulted in a significantly higher rate of HCV screening (p=0.0092). Conclusions: The primary care provider is vital to implementing preventive health recommendations including those related to HCV screening. Our study showed that in a high-prevalence, insured cohort, patients who had discussed HCV with their primary physician were three times more likely to have been screened for the infection. The population studied all had health insurance and a primary care provider, so health care was broadly accessible. The study also suggests that some recent USPSTF guidelines may not have penetrated into community primary care practices as the screening rates were suboptimal

Patients with High Educational Attainment Are More Likely to Have Screening for Hepatitis C Virus

Introduction Approximately 3 million people in the United States are afflicted with chronic Hepatitis C virus (HCV) infection. Infection is most prevalent in patients born between 1945-1965, and the African American community is disproportionately affected. A screening test is available and recommended, but many patients with HCV infection are unaware that they are infected. There are many obstacles to obtaining preventative care, and a lower level of education has been associated with decreased access. This study evaluated the impact of education level on access to HCV screening in a historically underserved community. Methods Individuals attending a health exposition in August 2015 sponsored by the Rodham Institute completed an anonymous survey. The exposition was hosted in an urban setting with a predominantly African-American population. The survey included questions regarding demographics, access to care, insurance status, and HCV screening and awareness. Responses were excluded if education level was not specified or any questions went unanswered. Statistical analysis was performed using Fisher’s exact test, with significance set at p \u3c 0.05. Results There were 102 respondents. Ninety-two (90.2%) completed the HCV screening and education questions and were included in the study. Thirty (32.6%) had a college degree; 19 (63.3%) of them had discussed HCV screening with their primary care providers. Sixty-two (68.8%) had high school education or less and 24 (38.7%) discussed HCV screening with their doctor (p\u3c0.0440). There were 27 respondents born between 1945 and 1965. Twelve (44.4%) had a college education and 15 (55.6%) had less. Within this cohort, 10 (83.3%) college-educated respondents and five (33.3%) of the others had discussed HCV screening with the primary doctor (p\u3c0.0185). Discussion The African-American population is disproportionately affected by HCV, and many of these patients are unaware of their infection status. Our study found that in this underserved community, those with higher education were more likely to discuss HCV screening with their primary care provider than those without. Interestingly, this trend was more pronounced among the 1945-1965 birth cohort, in whom universal screening is recommended. Although our study may be limited by a small sample size, it highlights that access to higher education may be associated with increased knowledge of HCV and availability of screening. It is imperative that physicians continue to discuss HCV screening with all at-risk patients in order to spread awareness and reduce morbidity. The study demonstrates that education is an important social determinant of health

Youth Has its Disadvantages -- Younger Consumers are Less Likely to Understand Their Health Insurance

Introduction: Implementation of the Affordable Care Act provided Approximately 23 million people acquired health insurance as a result of Affordable Care Act. While access to insurance may have increased, applicants have been faced with a wide variety of choices of insurance products, in some cases more than they would have had with employer-based plans. Consumers faced with acronyms such as HMO, PPO, HDHPs, and POS are asked to choose coverage while they may have little understanding of what these terms mean and how they differ. Young people typically have had little exposure to insurance plans in the past and may be at a greater disadvantage in choosing a policy. This study examined understanding of one’s health insurance plan as a function of age. Methods: Individuals attending a Washington, DC health exposition sponsored by the Rodham Institute completed an anonymous survey in August 2015. The exposition was hosted in an urban, medically underserved setting where the population has historically been predominantly African American; currently 92% of residents identify as such. The survey included questions on demographic information, insurance status, as well as questions related to obtaining insurance. Responses were excluded if questions regarding age or insurance knowledge were unanswered. The university institutional review board approved the study. Statistical analysis was performed using Fisher’s exact test, with significance set at p\u3c0.05. Results: There were 96 responses analyzed. Twenty eight (29.2%) individuals were over the age of 50 and 68 (70.8%) were younger. Twenty (29.4%) of the younger respondents reported understanding how their insurance worked. In the older age group, 26 (92.8%) understood their health insurance. Those over the age of 50 were more likely to have a firm understanding of their medical insurance plan compared to those under the age of 50 (p=0.0001). Among 28 college educated respondents, 23 (82.1%) understood their insurance. Fifty one (76.1%) of 67 respondents with less education had such an understanding. There was no difference with respect to education level (p=0.5973). Discussion: Our study revealed that younger customers are three times less likely to endorse an understanding of how their health insurance works. While the Affordable Care Act has expanded access to health insurance, many face a wider variety of options than they may have had prior to the passage of reforms. Because younger people have had less experience (or no experience) with health insurance in the past, they would benefit from educational resources to inform their choices. A disadvantageous selection of plan, deductible, and coinsurance may make financial concerns a greater component of medical decision making

Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn's Disease But Not Ulcerative Colitis.

Background & aimsPatients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration.MethodsWe analyzed data from a retrospective, multicenter, consortium of patients with CD (n = 650) or UC (n = 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (≤2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes.ResultsWithin 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02-2.49), CSFR (aHR, 3.39; 95% CI, 1.66-6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06-3.39). In contrast, disease duration was not a significant predictor of response among patients with UC.ConclusionsPatients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC

Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

Background & aimsWe aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice.MethodsA multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately.ResultsA total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754).ConclusionsTreatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients

Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis.

Background & aimsWe created and validated a clinical decision support tool (CDST) to predict outcomes of vedolizumab therapy for ulcerative colitis (UC).MethodsWe performed logistic regression analyses of data from the GEMINI 1 trial, from 620 patients with UC who received vedolizumab induction and maintenance therapy (derivation cohort), to identify factors associated with corticosteroid-free remission (full Mayo score of 2 or less, no subscore above 1). We used these factors to develop a model to predict outcomes of treatment, which we called the vedolizumab CDST. We evaluated the correlation between exposure and efficacy. We validated the CDST in using data from 199 patients treated with vedolizumab in routine practice in the United States from May 2014 through December 2017.ResultsAbsence of exposure to a tumor necrosis factor (TNF) antagonist (+3 points), disease duration of 2 y or more (+3 points), baseline endoscopic activity (moderate vs severe) (+2 points), and baseline albumin concentration (+0.65 points per 1 g/L) were independently associated with corticosteroid-free remission during vedolizumab therapy. Patients in the derivation and validation cohorts were assigned to groups of low (CDST score, 26 points or less), intermediate (CDST score, 27-32 points), or high (CDST score, 33 points or more) probability of vedolizumab response. We observed a statistically significant linear relationship between probability group and efficacy (area under the receiver operating characteristic curve, 0.65), as well as drug exposure (P < .001) in the derivation cohort. In the validation cohort, a cutoff value of 26 points identified patients who did not respond to vedolizumab with high sensitivity (93%); only the low and intermediate probability groups benefited from reducing intervals of vedolizumab administration due to lack of response (P = .02). The vedolizumab CDST did not identify patients with corticosteroid-free remission during TNF antagonist therapy.ConclusionsWe used data from a trial of patients with UC to develop a scoring system, called the CDST, which identified patients most likely to enter corticosteroid-free remission during vedolizumab therapy, but not anti-TNF therapy. We validated the vedolizumab CDST in a separate cohort of patients in clinical practice. The CDST identified patients most likely to benefited from reducing intervals of vedolizumab administration due to lack of initial response. ClinicalTrials.gov no: NCT00783718