Malav P. Parikh

Vedolizumab for Ulcerative Colitis: Treatment Outcomes from the VICTORY Consortium

OBJECTIVES: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. METHODS: Retrospective review (May 2014‐December 2016) of VICTORY Consortium data. Adults with follow‐up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC‐related symptoms) and endoscopic remission (Mayo endoscopic sub‐score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid‐free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non‐response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. RESULTS: We included 321 UC patients (71% prior TNF&agr; antagonist exposure, median follow‐up 10 months). The 12‐month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid‐free remission and deep remission were 37% and 30%, respectively. Using NRI, 12‐month rates were 20% (n = 64/321) for clinical remission, 17% (n=35/203) for endoscopic remission, 15% (n=30/195) for corticosteroid‐free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow‐up at 12 months who were deemed non‐responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n=36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n =56), need for surgery (n=29), or adverse event (n=6). On multivariable analyses, prior exposure to a TNF&agr; antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNF&agr; antagonist therapy (2%) than those who had been exposed to TNF&agr; antagonists (19%). CONCLUSION: In this large real‐world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.

Changing Trends in Age, Gender, Racial Distribution and Inpatient Burden of Achalasia

Background Achalasia is an idiopathic esophageal motility disorder characterized by dysphagia, regurgitation, chest discomfort and weight loss. The aim of this study was to evaluate the temporal trends in demographic variables, interventions, and inpatient burden in achalasia-related hospitalizations. Methods We evaluated the National Inpatient Sample Database (NIS) for all patients in whom achalasia (ICD-9 code: 530.0) was the principal discharge diagnosis from 1997 to 2013. Data regarding the patient demographics, number of hospitalizations, length of stay, associated hospital costs and temporal trends over the study period were obtained. Results In 1997, there were 2,493 admissions with a principal discharge diagnosis of achalasia as compared to 5,195 in 2013 with an average increase of 4% per year (P < 0.001). In 1997, the proportion of patients under 65 years of age was 53.8% versus 60.1% in 2013. Increasing prevalence in African Americans was noted (11.1% to 17.1%). Inflation-adjusted hospital charges related to achalasia showed a mean increase of

Peroral Endoscopic Myotomy Is Effective for Patients With Achalasia and Normal Lower-Esophageal Sphincter Relaxation Pressures

2,521 per year (P < 0.001). There was an increase in Heller myotomy procedures over the study period (P < 0.001). Conclusions The number of hospitalizations for achalasia and associated costs has significantly increased significantly over the last 16 years in the United States with disproportionate increase in patients under 65 years of age and racial minorities. Further research on cost-effective evaluation and management of achalasia is required.

Erratum: Use of a Novel Submucosal Tunneling and Endoscopic Resection (STER) Technique for the Removal of an Esophageal Leiomyoma

Increased lower esophageal sphincter integrated relaxation pressure (LES-IRP) is a cardinal feature of achalasia. However, some patients with characteristic features of achalasia have normal LES-IRP.1,2 The efficacy of peroral endoscopic myotomy (POEM) in achalasia patients with normal LES-IRP is not well known. Hence, we aimed to compare POEM outcomes in achalasia patients with normal (<15 mm Hg) and increased (≥15 mm Hg) LES-IRP.

Proximal Sessile Serrated Adenomas Are More Prevalent in Caucasians, and Gastroenterologists Are Better Than Nongastroenterologists at Their Detection

Use of a Novel Submucosal Tunneling and Endoscopic Resection (STER) Technique for the Removal of an Esophageal Leiomyoma

A Congenital Gastric Anomaly That Appears as a Tumor of the Gastrointestinal Stroma

Background and Aim Proximal sessile serrated adenomas (PSSA) leading to colorectal cancer (CRC) represent an alternate pathway for CRC development. In this study, we aim to determine the prevalence of PSSAs and the impact of patient, colonoscopy, and endoscopist-related factors on PSSA detection. Methods Patients ≥ 50 years of age undergoing a screening colonoscopy between 2012 and 2014 were included. Detection rates based on patient gender, race, colonoscopy timing, fellow participation, bowel preparation quality, and specialty of the endoscopist were calculated. t-tests were used to compare detection rates and a multivariate-adjusted analysis was performed. Results 140 PSSAs were detected from 4151 colonoscopies, with a prevalence of 3.4%. Detection rate was higher in Caucasians compared to African-Americans (AA) (3.7 ± 4.1 versus 0.96 ± 3.5; p < 0.001). Gastroenterologists detected more PSSAs compared to nongastroenterologists (3.9 ± 3.5 versus 2.2 ± 3.0; p = 0.028). These findings were still significant after adjusted multivariate analysis. The rest of the factors did not make significant difference in PSSA detection rate. Conclusions PSSAs are more prevalent in Caucasians compared to AAs. Racial difference in prevalence of PSSAs is intriguing and warrants further investigation. Gastroenterologists have a significantly higher PSSADR compared to nongastroenterologists. Educational measures should be implemented in nongastroenterologists to improve their PSSA detection rates.

A Case of Gastrointestinal Opportunistic Infection

Question: A 25-year-old man was admitted to the hospital with complaints of nausea, vomiting and abdominal pain of 2-3 months’ duration. He reported early satiety, poor appetite and weight loss of 20 lbs over 3 months. On examination, he was noted to be hypotensive (blood pressure, 96/60 mm Hg) and tachycardic (heart rate, 116/min). Complete blood count, serum electrolytes, liver function tests, and lipase levels were within normal limits. A computed tomography (CT) scan of the abdomen revealed a 9.8 7.4-cm heterogeneous mass in the fundus of the stomach (Figure A), which was also noted on a subsequent esophagogastroduodenoscopy (Figure B). Magnetic resonance imaging (MRI) of the abdomen (Figure C) further defined a well-circumscribed, heterogeneous mass with contrast enhancement, raising the suspicion for a gastrointestinal stromal tumor (GIST). A surgical exploration was planned for definitive resection of the gastric mass. Intraoperatively, the suspected gastric lesion was noted to have poorly defined surgical planes with significant surrounding fibrosis and eventually a total gastrectomywith Roux-en-Y-esophagojejunostomywas performed. Histologic examination of the gross (Figure D) and microscopic specimens (Figure E) revealed the correct diagnosis. What is the correct diagnosis? See the Gastroenterology web site (www.gastrojournal.org) for more information on submitting your favorite image to Clinical Challenges and Images in GI.

Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn’s Disease

Division of Hospital Medicine, and Division of Gastroenterology and Hepatology, Cleveland clinic Foundation, Cleveland, Ohio 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 Question: A 34-year-old man with past medical history of human immunodeficiency virus (HIV) infection, presented to the hospital with complaints of dysphagia, epigastric abdominal pain, and watery diarrhea for last 2 months. This was accompanied by low-grade fever and weight loss of 20 pounds in the same time period. Patient reported noncompliance with highly active antiretroviral treatment. Routine blood work showed pancytopenia, low serum albumin level, CD4 count of 45 cells/mm, and HIV viral load of 1,380,000 copies/mL. Esophagogastroduodenoscopy showed diffuse esophageal candidiasis (Figure A) and stomach was normal in appearance. The mucosa of the second part of the duodenum was denuded and studded with white lesions of 1 to 2 mm in diameter each that were biopsied (Figure B). Histologic examination of the biopsy specimen revealed numerous macrophages with intracellular organisms (Figure C-E). What is the diagnosis? See the Gastroenterology web site (www.gastrojournal.org) for more information on submitting your favorite image to Clinical Challenges and Images in GI. 107 108 109 110 111 112 113 Conflicts of interest The authors disclose no conflicts.