James D Lewis

University of Pennsylvania | UP · Perelman School of Medicine

Background While patients with Crohn’s disease commonly report fatigue, an association of Crohn’s disease with mild neurocognitive impairment has also been suggested. This study investigated the relationship between Crohn’s disease activity, fatigue, and neurocognitive functioning. Methods In this cross-sectional study, adults with Crohn’s disease...

Immunosuppression after solid organ transplantation is associated with an increased risk of keratinocyte carcinoma (KC). Despite its established morbidity, KC risk in liver transplant (LT) recipients is understudied, including the contribution of immunosuppression regimen and latitude. A retrospective cohort of 9,966 adult first LT alone recipients...

End-stage renal disease (ESRD) after liver transplantation (LT) is associated with high morbidity and mortality. The consequences of hospitalizations for post-LT acute kidney injury (AKI) are poorly understood. Using linked Medicare claims and transplant registry data, we analyzed adult liver alone recipients not receiving pre-transplant dialysis b...

Background: Fatigue imposes a socioeconomic burden on patients with Crohn's disease (CD) and ulcerative colitis (UC). We assessed the prevalence of fatigue among patients with CD or UC and identified disease activity measures associated with fatigue. Methods: Data from the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Dise...

Bowel urgency is a highly burdensome symptom among patients with inflammatory bowel disease (IBD). To assess changes in severity of bowel urgency and identify predictors of worsening or improvement among patients with Crohn’s disease (CD) and ulcerative colitis (UC) at 6 months from their enrollment visit. Data from patients in the Study of a Prosp...

Background & Aims While avoidance of long-term corticosteroids is a common objective in the management of autoimmune hepatitis (AIH), prolonged immunosuppression is usually required to prevent disease progression. This study investigates the patient and provider factors associated with treatment patterns in U.S. patients with AIH. Approach & Resul...

Background Opportunistic infections (OIs) are a significant cause of morbidity and mortality after organ transplantation, though data in the liver transplant (LT) population are limited. Methods We performed a retrospective cohort study of LT recipients between January 1, 2007 and Deceber 31, 2016 using Medicare claims data linked to the Organ Pro...

Background & Aims Crohn’s disease is associated with alterations in the gut microbiome and metabolome described as dysbiosis. We characterized the microbial and metabolic consequences of ileal resection, the most common Crohn’s disease surgery. Methods Patients with and without intestinal resection were identified from the Diet to Induce Remission...

Purpose To facilitate claims‐based research on populations with juvenile idiopathic arthritis (JIA), we sought to validate an algorithm of new medication use as a proxy for worsening JIA disease activity. Methods Using electronic health record data from three pediatric centers, we defined new JIA medication use as (re)initiation of disease‐modifyi...

Statins reduce the risk of major coronary outcomes and all cause mortality. They are generally well tolerated, but are associated with uncommon but serious adverse events. Pharmacokinetic studies show statins metabolized by the CYP3A4 isoenzyme (statin 3A4 substrates) are susceptible to drug interactions when concomitantly administered with drugs t...

Hospitalized inflammatory bowel disease (IBD) patients are at increased risk of venous thromboembolism (VTE). We aimed to evaluate the effectiveness and safety of prophylactic anticoagulation compared with no anticoagulation in hospitalized IBD patients. We conducted a retrospective cohort study using a hospital-based database. We included IBD pati...

Background and Aims Immunosuppressed individuals are at higher risk for COVID-19 complications, yet data in patients with inflammatory bowel disease (IBD) are limited. We evaluated the risk of COVID-19- severe sequelae by medication utilization in a large cohort of patients with IBD. Methods We conducted a retrospective cohort study utilizing insu...

Though diet quality is widely recognized as linked to risk of chronic disease, health systems have been challenged to find a user-friendly, efficient way to obtain information about diet. The Penn Healthy Diet (PHD) survey was designed to fill this void. The purposes of this pilot project were to assess the patient experience with the PHD, to valid...

Background: Fatigue has a detrimental impact on health-related quality of life and functioning in patients with Crohn's disease (CD). We aimed to confirm the relevance and importance of fatigue, establish the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), qualitatively explore meaningful change in fatig...

Background & aims: We sought to estimate the incidence, prevalence and racial-ethnic distribution of physician-diagnosed inflammatory bowel disease (IBD) in the United States. Methods: The study utilized four administrative claims datasets: a 20% random sample of national fee for service Medicare data (2007 to 2017); Medicaid data from Florida,...

Background: Antitumor necrosis factor (anti-TNF) inhibitors are first-line treatment among patients with ulcerative colitis (UC). With time, patients tend to lose response or become intolerant, necessitating switching to small cell biologics such as tofacitinib or vedolizumab. In this real-world study of a large, geographically diverse US populati...

Background: Endoscopic healing has been associated with improved long-term clinical outcomes in inflammatory bowel disease (IBD) and is a recommended target for treatment. Evidence is limited regarding real-world uptake and patterns of treat-to-target monitoring to assess endoscopic healing following treatment initiation. We aimed to estimate the...

Background: To facilitate inflammatory bowel disease (IBD) research in the United States, we developed and validated claims-based definitions to identify incident and prevalent IBD diagnoses using administrative healthcare claims data among multiple payers. Methods: We used data from Medicare, Medicaid, and the HealthCore Integrated Research Dat...

Purpose Achieving and maintaining symptom control is a key treatment goal in ulcerative colitis (UC). Bowel urgency is an important symptom of UC, thus measurement of urgency is critical. This research explored the patient experience of UC and “remission” in UC, with a focus on urgency, and cognitively debriefed the Urgency Numeric Rating Scale (NR...

Importance Bariatric surgery procedures, in particular Roux-en-Y gastric bypass (RYGB), have been associated with subsequent alcohol-related complications. However, previous studies lack data to account for changes in body mass index (BMI) or alcohol use over time, which are key potential confounders. Objective To evaluate the association between...

The human gut microbiota is highly heterogenous between individuals and also exhibits considerable day-to-day variation within individuals. We hypothesized that diet contributed to such inter- and/or intra-individual variance. Hence, we investigated the extent to which diet normalization impacted microbiota heterogeneity. We leveraged the control a...

Introduction: Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD. Methods: We conducte...

Background There is a need for a feasible, user-friendly tool that can be employed to assess the overall quality of the diet in U.S. clinical settings. Our objectives were to develop the Penn Healthy Diet (PHD) screener, evaluate screener item correlations with Healthy Eating Index (HEI)-2015 components, and develop a simple scoring algorithm. Met...

Background: The Urgency Numeric Rating Scale (NRS) was developed as a content-valid single-item patient-reported outcome measure to assess severity of bowel urgency. Here, we evaluated the psychometric properties of the Urgency NRS. Methods: Data were from a multicenter, randomized, placebo-controlled phase 3 trial in adults with moderately to s...

Importance: Patients with cirrhosis have increased risk of postoperative mortality. Several models have been developed to estimate this risk; however, current risk estimation scores cannot compare surgical risk with the risk of not operating. Objective: To identify clinical optimal thresholds to favor operative or nonoperative management for a c...

Background: Immunosuppression is a critical aspect of post-transplant management, yet practices at intermediate and late time points after liver transplantation (LT) are poorly characterized. Methods: A retrospective cohort of 11 326 adult first LT alone recipients between 2007 and 2016 was identified by linking United Network for Organ Sharing...

Background Bowel urgency is commonly experienced by patients with ulcerative colitis (UC) and is associated with reduced health-related quality of life (QoL). Mirikizumab, a humanized monoclonal antibody directed against the p19 subunit of IL-23, significantly reduced bowel urgency in a double-blind, randomized, placebo-controlled phase 2 clinical...

Background Patients with recent hematopoietic cell transplantation (HCT) are considered high risk for gastrointestinal endoscopy due to the potential for procedural bacterial translocation. Prior studies investigating these risks do not account for the higher baseline rate of infectious complications among those who are immunocompromised. We perfor...

Background Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease. Methods We conducted a randomised, double-blind, parallel-group, active-comparator...

Background: Malnutrition is associated with poor outcomes in hospitalized adults. We aimed to assess the effectiveness of hospital-initiated interventions for patients with malnutrition. Methods: Data sources included MEDLINE, Embase, Cochrane Library from January 1, 2000 to June 3, 2021. We included randomized controlled trials (RCTs) assessing...

Background Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. Methods In a prospective cohort of adult IBD patients, we captured data on clinical risk factors and IBD medication utilization. The outcome of interest was develop...

BACKGROUND Delays in advancing to biologic therapies are associated with adverse outcomes in inflammatory bowel disease (IBD). Insurer-mandated prior authorizations have been linked to prolonged medication initiation times. We hypothesized that prior authorizations are associated with prolonged biologic initiation time and increased IBD-related hea...

OBJECTIVE To assess the association of sodium–glucose cotransporter 2 (SGLT2) inhibitors with diabetic ketoacidosis compared with dipeptidyl peptidase 4 (DPP-4) inhibitors and sulfonylureas in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a new-user active comparator cohort study to examine two pairwise comparisons: 1) SG...

Background and aims Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the PROCTRIAL (Definition and endpoints for ulcerative PROCtitis in clinical TRIALs) initiative was to develop consensus statements for definitions, inclusion criteria, a...

Background Surveillance colonoscopy is recommended to reduce colorectal cancer (CRC)-related morbidity and mortality in patients with inflammatory bowel disease (IBD). The comparative effectiveness of varying colonoscopy intervals on CRC outcomes among IBD patients is unknown. Method We performed a retrospective cohort study of patients with confi...

Background Corticosteroids (CS) are widely used to treat Crohn’s disease (CD) and ulcerative colitis (UC), but are not recommended as maintenance therapy. Biologic drugs are widely used as an alternative to or in conjunction with CS to induce and maintain remission. This meta-analysis tested the hypothesis that CS use is associated with differentia...

Background and aims: Patients discharged with enteral nutrition (EN) through an enteral access device (DCENs) are noted to have increased hospital readmissions, but data on the readmission causes are limited. We assessed the proportion of these readmissions attributed to EN and determined the contributing factors to readmissions. Methods: Using...

Background Hospitals are held accountable for quality metrics, through public reporting programs and by payers. However, little is known about hospital performance in GIB nationally. Methods A retrospective longitudinal analysis utilizing Vizient’s database was performed to identify GIB hospitalizations across 349 hospitals from 2016 to 2018. The...

Background Cases of coronavirus disease 2019 (COVID-19) have emerged in discrete waves. We explored temporal trends in the reporting of COVID-19 in inflammatory bowel disease (IBD) patients. Methods The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry of IBD...

Background: Apixaban and rivaroxaban are replacing vitamin K antagonists for the treatment of venous thromboembolism (VTE) in adults; however, head-to-head comparisons remain limited. Objective: To assess the effectiveness and safety of apixaban compared with rivaroxaban in patients with VTE. Design: Retrospective new-user cohort study. Setti...

Background & Aims Epidemiologic and murine studies suggest that dietary emulsifiers promote development of diseases associated with microbiota dysbiosis. While the detrimental impact of these compounds on the intestinal microbiota and intestinal health have been demonstrated in animal and in vitro models, impact of these food additives in healthy h...

Background and aims: Patient-reported outcomes are recommended endpoints in Crohn's disease (CD) trials. The association between patient-reported general well-being relative to symptoms of diarrhea and abdominal pain (AP) in patients with moderate-to-severe CD was explored. Methods: Patients from 3 randomized, placebo-controlled, double-blind ad...

Introduction Laboratory studies have demonstrated that antibiotic use in conjunction with bowel purgatives causes alterations to the gut microbiota. Because gut microbiota changes may be a trigger for the development of irritable bowel syndrome (IBS), we sought to assess whether individuals who undergo bowel cleansing for colonoscopy and have concu...

Background: Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods:...

Background: Direct oral anticoagulants (DOACs) are replacing warfarin for stroke prevention in patients with atrial fibrillation (AF). Objective: To assess the effectiveness and safety of concomitant treatment with antiplatelet-DOAC compared to antiplatelet-warfarin in patients with ACS and AF. Design: Retrospective propensity score-matched cohort...

Objective In patients with ulcerative colitis (UC) and Crohn’s disease (CD), this research examined: prevalence of fecal urgency (hereafter urgency), association of urgency with inflammatory bowel disease (IBD) symptoms and fecal calprotectin, and association between well-being and urgency. Methods In this cross-sectional study from the Study of a...

Background and Aims Patients with cirrhosis have an increased risk of post-operative mortality for a range of surgeries, however they are also at risk of post-operative complications such as infection and cirrhosis decompensation. To date there are no prediction scores that specifically risk stratify patients for these morbidities. Methods This wa...

The coronavirus disease 2019 (COVID-19) has affected more than 29 million people and led to more than 542,000 deaths in the United States.1 Older age, comorbidities, and racial and ethnic minority status are associated with severe COVID-19.2 Among patients with inflammatory bowel disease (IBD), racial and ethnic minorities have worse outcomes, medi...

Purpose Population‐level studies on the treatment practices and comparative effectiveness of therapies in autoimmune hepatitis (AIH) are lacking due to the absence of validated methods to identify patients with AIH in large databases, such as administrative claims or electronic health records. This study ascertained the performance of International...

Objective Therapeutic diets have been used to treat symptomatic Crohn's disease (CD). The Specific Carbohydrate Diet (SCD) and Mediterranean Diet (MD) have been associated with reduced CD symptoms. This study compared the effectiveness of these two diets for mild to moderate CD symptoms. Methods The Diet to INducE Remission in Crohn's Disease (DIN...