Superior Efficacy of Infliximab Versus Adalimumab for First-Line Treatment of Crohn's Perianal Fistulae.

BACKGROUND: Crohn's disease perianal fistulae (CD-PAF) occur in 25% of patients and are notoriously challenging to manage. Tumor necrosis factor inhibitors are first line agents. AIMS: The aim of this study was to compare infliximab (IFX) versus adalimumab (ADA) efficacy in CD-PAF healing over time. METHODS: A retrospective study at two large-tertiary medical centers was performed. Inclusion criteria were actively draining CD-PAF and initial treatment with IFX or ADA following CD-PAF diagnosis. The primary endpoints were perianal fistula response and remission at 6 and 12 months. Secondary endpoints included biologic persistence over time and dose escalation at 6 and 12 months. RESULTS: Among 151 patients included in the study, 92 received IFX and 59 received ADA as first line agents after CD-PAF diagnosis. At 6 months, the 64.9% of the IFX group and 34.8% of the ADA group demonstrated CD-PAF clinical improvement (p < 0.01). Univariate and multivariate analyses demonstrated significant differences among the IFX and ADA groups for clinical response at 6-months and 12-months (p = 0.002 and p = 0.042, respectively). There were no factors that predicted response, with the exception of concomitant immunomodulator affecting the 6-month clinical response (p = 0.021). Biologic persistence, characterized by Kaplan Meier methods, was significantly longer in the IFX group compared to the ADA group (Log-rank p = 0.01). CONCLUSION: IFX induction and maintenance is associated with higher rates of response and remission in CD-PAF healing as well as higher treatment persistence compared to ADA. Additionally, our study supports the use of concomitant immunomodulator therapy for CD-PAF healing and remission.

Pneumococcal Vaccination Recommendation and Completion Rates Among Patients With Inflammatory Bowel Disease and Barriers to Vaccination.

BACKGROUND: Guidelines for inflammatory bowel disease (IBD) patients receiving immunosuppression encouraged both the pneumococcal polysaccharide vaccine (PPSV23) and the pneumococcal conjugate vaccine (PCV13). We aimed to evaluate which pneumococcal vaccines are recommended and administered, and to understand provider and IBD patient knowledge regarding pneumococcal vaccinations. METHODS: We performed a retrospective, cross-sectional analysis of 357 adult IBD patients on immunosuppression in our health care system. Patient demographics and clinical characteristics were collected. The primary outcome was rate of documented vaccinations recommended by providers; the secondary outcome was rate of receipt of the vaccines. We identified factors associated with receipt of any pneumococcal vaccine through multivariable logistic regression. We also performed provider and IBD patient surveys to understand provider and patient knowledge regarding pneumococcal vaccines. We used χ 2 and Fisher exact tests to assess survey responses. RESULTS: Fifty seven percent of IBD patients had any pneumococcal vaccination recommended and 35% had recommendations for both PPSV23 and PCV13. Forty percent received any pneumococcal vaccine and 18% received both vaccines. In multivariable analyses, increasing age (adjusted odds ratio: 1.03, 95% CI: 1.01-1.05) was associated with receipt of any pneumococcal vaccine, after adjusting for gender, race, insurance, disease activity, and time seen in our gastroenterology clinics. In the survey study, on average, 59% of providers correctly answered questions regarding pneumococcal vaccination indications. CONCLUSION: In our health care system, while recommendation for any pneumococcal vaccination was >50%, receipt of both PPSV23 and PCV13 was low. Simplified vaccine regimens (ie, PCV20) will likely improve vaccination rates.

Early-Onset Colorectal Cancer Is Associated with a Lower Risk of Metachronous Advanced Neoplasia than Traditional-Onset Colorectal Cancer.

BACKGROUND: Colorectal cancer (CRC) incidence in the USA has increased in adults under age 50. Current CRC surveillance guidelines do not consider age at diagnosis, and there are limited data available on outcomes from surveillance colonoscopies in early-onset CRC (EO-CRC) to guide recommendations on surveillance intervals. AIMS: To compare surveillance outcomes between EO-CRC and traditional-onset colorectal cancer (TO-CRC). METHODS: In a retrospective cohort study in a large tertiary care academic medical center, we collected data on patients with a diagnosis of CRC between 2000 and 2014 who received surgery with curative intent. We used log-rank test and inverse probability of treatment weighted Cox regression analysis to compare the development of metachronous advanced neoplasia (MAN) in patients with EO-CRC (diagnosed ages 18-49) and TO-CRC (diagnosed ages 50-75). RESULTS: Patients with EO-CRC (n = 107) were more likely to present with advanced-stage disease (62% versus 35%, p < 0.0001), rectal tumors (45% versus 27%, p < 0.01), and a family history of CRC (30% versus 16%, p = 0.02) compared to those with TO-CRC (n = 139). Patients with EO-CRC had lower risk of MAN (adjusted HR 0.44, 95% CI 0.22-0.88) than TO-CRC patients. The 5-year event rate for MAN was lower for patients with EO-CRC compared to patients with TO-CRC (5.8% vs. 16.1%, p = 0.07). The presence of synchronous neoplasia or history of diabetes was also predictive of MAN. CONCLUSIONS: EO-CRC was independently associated with a lower risk of developing MAN compared to TO-CRC. Shorter surveillance intervals may not be warranted in EO-CRC; however, large prospective studies are needed.

Patient Navigation After Positive Fecal Immunochemical Test Results Increases Diagnostic Colonoscopy and Highlights Multilevel Barriers to Follow-Up.

BACKGROUND: The fecal immunochemical test (FIT) is a common colorectal cancer screening modality in the USA but often is not followed by diagnostic colonoscopy. AIMS: We investigated the efficacy of patient navigation to increase diagnostic colonoscopy after positive FIT results and determined persistent barriers to follow-up despite navigation in a large, academic healthcare system. METHODS: The study cohort included all health system outpatients with an assigned primary care provider, a positive FIT result between 12/01/2016 and 06/01/2019, and no documentation of colonoscopy after positive FIT. Two non-clinical patient navigators engaged patients and providers to encourage follow-up, offer solutions to barriers, and assist with colonoscopy scheduling. The primary intervention endpoint was completion of colonoscopy within 6 months of navigation. We documented reasons for persistent barriers to colonoscopy despite navigation and determined predictors of successful follow-up after navigation. RESULTS: There were 119 patients who received intervention. Of these, 37 (31.1%) patients completed colonoscopy at 6 months. In 41/119 (34.5%) cases, the PCP did not recommend colonoscopy, most commonly due to a normal colonoscopy prior to the positive FIT (19, 46.3%). There were 41/119 patients (34.5%) that declined colonoscopy despite the patient navigator and the PCP order. Male sex and younger age were significant predictors of follow-up (aOR = 2.91, 95%CI, 1.18-7.13; aOR = 0.92, 95%CI, 0.87-0.99). CONCLUSIONS: After implementation of patient navigation, diagnostic colonoscopy was completed for 31.1% of patients with a positive FIT result. However, navigation also highlighted persistent multilevel barriers to follow-up. Future work will develop targeted solutions for these barriers to further increase FIT follow-up rates in our health system.

Identifying Quality Gaps in Preventive Care for Outpatients With Cirrhosis Within a Large, Academic Health Care System.

We sought to identify specific gaps in preventive care provided to outpatients with cirrhosis and to determine factors associated with high quality of care (QOC), to guide quality improvement efforts. Outpatients with cirrhosis who received care at a large, academic tertiary health care system in the United States were included. Twelve quality indicators (QIs), including preventive care processes for ascites, esophageal varices, hepatic encephalopathy, hepatocellular carcinoma (HCC), and general cirrhosis care, were measured. QI pass rates were calculated as the proportion of patients eligible for a QI who received that QI during the study period. We performed logistic regression to determine predictors of high QOC (≥ 75% of eligible QIs) and receipt of HCC surveillance. Of the 439 patients, the median age was 63 years, 59% were male, and 19% were Hispanic. The median Model for End-Stage Liver Disease-Sodium score was 11, 64% were compensated, and 32% had hepatitis C virus. QI pass rates varied by individual QIs, but were overall low. For example, 24% received appropriate HCC surveillance, 32% received an index endoscopy for varices screening, and 21% received secondary prophylaxis for spontaneous bacterial peritonitis. In multivariable analyses, Asian race (odds ratio [OR]: 3.7, 95% confidence interval [CI]: 1.3-10.2) was associated with higher QOC, and both Asian race (OR: 3.3, 95% CI: 1.2-9.0) and decompensated status (OR: 2.1, 95% CI: 1.1-4.2) were associated with receipt of HCC surveillance. A greater number of specialty care visits was not associated with higher QOC. Conclusion: Receipt of outpatient preventive cirrhosis QIs was variable and overall low in a diverse cohort of patients with cirrhosis. Variation in care by race/ethnicity and illness trajectory should prompt further inquiry into identifying modifiable factors to standardize care delivery and to improve QOC.

Patients without colonoscopic follow-up after abnormal fecal immunochemical tests are often unaware of the abnormal result and report several barriers to colonoscopy.

BACKGROUND: The fecal immunochemical test (FIT) is the second most commonly used colorectal cancer (CRC) screening modality in the United States; yet, follow-up of abnormal FIT results with diagnostic colonoscopy is underutilized. Our objective was to determine patient-reported barriers to diagnostic colonoscopy following abnormal FIT in an academic healthcare setting. METHODS: We included patients age 50-75 with an abnormal FIT result between 1/1/2015 and 10/31/2017 and no documented follow-up diagnostic colonoscopy. We abstracted demographic data from the electronic health record (EHR). Study personnel conducted telephone surveys with patients to confirm colonoscopy completion and elicit data on notification of FIT results and barriers to colonoscopy. We also provided brief verbal education about diagnostic colonoscopy. We calculated frequencies of demographic data and survey responses and compared survey responses by interest in colonoscopy after education. RESULTS: We surveyed 67 patients. Fifty-one were aware of the abnormal FIT result, and a majority learned of the abnormal FIT result by direct communication with providers (19, 37.3%) or EHR messaging (11, 21.6%). Overall, fifty-three patients (79.1%) confirmed lack of colonoscopy, citing provider-related (19, 35.8%), patient-related (16, 30.2%), system-related (1, 1.9%), or multifactorial (17, 32.1%) reasons. Lack of knowledge of FIT result (14, 26.4%) was most common. After brief education, 20 (37.7%) patients requested colonoscopy. CONCLUSION: Patients with an abnormal FIT reported various multi-level barriers to diagnostic colonoscopy after abnormal FIT, including knowledge of FIT results. When provided with brief education, participants expressed interest in diagnostic colonoscopy. Future efforts will evaluate interventions to improve colonoscopy follow-up.

Making FIT Count: Maximizing Appropriate Use of the Fecal Immunochemical Test for Colorectal Cancer Screening Programs.

Colorectal cancer (CRC) remains one of the most common and deadly malignancies despite advancements in screening, diagnostic capabilities, and treatment. The ability to detect and remove precancerous and cancerous lesions via screening has altered the epidemiology of the disease, decreasing incidence, mortality, and late-stage disease presentation. The fecal immunochemical test (FIT) is a screening test that aims to detect human hemoglobin in the stool. FIT is the most common CRC screening modality worldwide and second most common in the United States. Its use in screening programs has been shown to increase screening uptake and improve CRC outcomes. However, FIT-based screening programs vary widely in quality and effectiveness. In health systems with high-quality FIT screening programs, only superior FIT formats are used, providers order FIT appropriately, annual patient participation is high, and diagnostic follow-up after an abnormal result is achieved in a timely manner. Proper utilization of FIT involves multiple steps beyond provider recommendation of the test. In this commentary, we aim to highlight ongoing challenges in FIT screening and suggest interventions to maximize FIT effectiveness. Through active engagement of patients and providers, health systems can use FIT to help optimize CRC screening rates and improve CRC outcomes.