Katharine A. Germansky

Efficacy and safety of natalizumab in Crohn's disease patients treated at 6 Boston academic hospitals.

Background:Despite trials demonstrating its efficacy, many physicians harbor concerns regarding the use of natalizumab in the treatment of patients with refractory Crohn’s disease (CD). The purpose of this study was to perform a descriptive analysis of a series of CD patients not currently enrolled in a clinical trial. Methods:A retrospective case review of patients treated with natalizumab at 6 sites in Massachusetts: Boston Medical Center, Beth Israel Deaconess Medical Center, Brigham & Women’s Hospital, Lahey Clinic, Massachusetts General Hospital, and UMass Medical Center. Results:Data on 69 CD patients on natalizumab were collected. At the start of treatment, patients’ disease duration was 12 years. A high proportion of patients were women (68%), presented with perianal disease (65%) and upper gastrointestinal tract involvement (14%). Prior nonbiologic therapies were steroids (96%), thiopurines (94%), antibiotics (74%), methotrexate (58%), and at least two anti-tumor necrosis factor agent failures (81%). Sixty-nine percent (44 of 64 patients) with available medical evaluation had a partial or complete clinical response. Loss of response was 13% after an average of 1 year of treatment. Adverse events were infusion reactions, headaches, fever, and infections. No case of progressive multifocal leukoencephalopathy was observed. Conclusions:In our clinical experience outside the context of a clinical trial, natalizumab is largely reserved for CD patients with extensive ileocolonic disease who have failed conventional immunosuppressants and of at least 2 anti-tumor necrosis factor agents. This drug is, however, well tolerated and offers significant clinical improvement for more than a year in one-third of these difficult-to-treat CD patients.

Advances in Hereditary Colorectal and Pancreatic Cancers

PURPOSE Innovations in genetic medicine have led to improvements in the early detection, prevention, and treatment of cancer for patients with inherited risks of gastrointestinal cancer, particularly hereditary colorectal cancer and hereditary pancreatic cancer. METHODS This review provides an update on recent data and key advances that have improved the identification, understanding, and management of patients with hereditary colorectal cancer and hereditary pancreatic cancer. FINDINGS This review details recent and emerging data that highlight the developing landscape of genetics in hereditary colorectal and pancreatic cancer risk. A summary is provided of the current state-of-the-art practices for identifying, evaluating, and managing patients with suspected hereditary colorectal cancer and pancreatic cancer risk. The impact of next-generation sequencing technologies in the clinical diagnosis of hereditary gastrointestinal cancer and also in discovery efforts of new genes linked to familial cancer risk are discussed. Emerging targeted therapies that may play a particularly important role in the treatment of patients with hereditary forms of colorectal cancer and pancreatic cancer are also reviewed. Current approaches for pancreatic cancer screening and the psychosocial impact of such procedures are also detailed. IMPLICATIONS Given the availability of new diagnostic, risk-reducing, and therapeutic strategies that exist for patients with hereditary risk of colorectal or pancreatic cancer, it is imperative that clinicians be vigilant about evaluating patients for hereditary cancer syndromes. Continuing to advance genetics research in hereditary gastrointestinal cancers will allow for more progress to be made in personalized medicine and prevention.

Development of quality measures for monitoring and improving care in gastroenterology

Over the past decade, most quality assurance (QA) efforts in gastroenterology have been aimed at endoscopy. Endoscopic quality improvement was the rational area to begin QA work in gastroenterology due to the relatively acute nature of complications and the high volume of procedures performed. While endoscopy is currently the focus of most quality assurance (QA) measures in gastroenterology, more recent efforts have begun to address clinical gastroenterology practices both in the outpatient and inpatient settings. Clinical outpatient and inpatient gastroenterology is laden with areas where standardization could benefit patient care. While data and experience in clinical gastroenterology QA is relatively limited, it is clear that inconsistent use of guidelines and practice variations in gastroenterology can lead to lower quality care. In this review, we review a variety of areas in clinical gastroenterology where existing guidelines and published data suggest both the need and practicality of active QA measures.