Various medications used to treat inflammatory bowel diseases have been implicated to cause hepatotoxicity. These include sulfasalazine, 5-aminosalicylic acids, fluoroquinolones, metronidazole, thiopurines, methotrexate, anti–tumor necrosis factor agents, and alpha-4 integrin inhibitors. Various types of liver injury have been reported in association with these medications including hypersensitivity reaction, hepatocellular or cholestatic disease, nodular regenerative hyperplasia, liver fibrosis/cirrhosis, portal hypertension and autoimmune liver injury. The revised Roussel Uclaf Causality Assessment Method (RUCAM) provides a scoring system to determine the likelihood of whether a drug caused liver injury. Unfortunately some of the reported liver injuries in association with these treatments have not undergone RUCAM assessment. Therefore, although some of the reports used in this review article show an association between a medication and the reported liver injury, they may not necessarily show causation. In this article, we address methods of monitoring to detect these injuries. We also discuss the prognosis and recommended management plans when liver injury occurs.

01 Nov 2013·Cellular ImmunologyQ3 · MEDICINE

Crohn’s disease: A review of treatment options and current research

Q3 · MEDICINE

Review

Author: Platt, Manu O ; Gupta, Shabnam ; Bandzar, Sean

Crohn's disease is an autoimmune disorder that affects nearly 1.4 million Americans. The etiology of Crohn's disease is not completely understood, however, research has suggested a genetic link. There is currently no known cure for Crohn's disease and, as a result, most government-funded research is being conducted to increase the quality of life of afflicted patients (i.e. reducing chronic inflammation and alleviating growth impairment in pediatric patients). A number of treatment options are available including an alpha-4 integrin inhibitor and several TNF-alpha inhibitors. Furthermore, research is being conducted on several alternative treatment options to help understand exactly which cellular mechanisms (i.e. inducing apoptosis in leukocytes) are required for clinical efficacy. This review seeks to chronicle the current available treatment options for patients affected by Crohn's disease to aid in understanding potential cellular mechanistic requirements for an efficacious drug, and shed light on potential options for future treatment.

01 Mar 2009·Journal of ImmunotoxicologyQ4 · MEDICINE

Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs

Q4 · MEDICINE

Author: Joseph R Piccotti ; Thomas T Kawabata ; Herve N Lebrec ; Ellen Evans ; Daniel Wierda ; Ian S Gourley ; Danuta J Herzyk ; Leigh Ann Burns-Naas ; Kenneth L Hastings

The number of anti-inflammatory and immunomodulatory drugs being developed in the pharmaceutical industry has increased considerably in the past decade. This increase in research and development has been paralleled by questions from both regulatory agencies and industry on how best to assess decreased host resistance to infections or adverse immunostimulation caused by immunomodulatory agents such as anti-cytokine antibodies (e.g., the tumor necrosis factor-alpha inhibitors), anti-adhesion molecule antibodies (e.g., anti-alpha-4 integrin inhibitors) and immunostimulatory molecules (e.g., anti-CD28 antibodies). Although several methods have been developed for nonclinical assessment of immunotoxicity, highly publicized adverse events have brought to light significant gaps in the application of nonclinical immunotoxicity testing in assessing potential risk in humans. Confounding this problem is inconsistent application of immunotoxicology methods for risk assessment within the scientific community, limited understanding of appropriate immunotoxicity testing strategy for immunomodulators and inconsistent testing requests by regulatory agencies. To address these concerns, The Immunotoxicology Technical Committee (ITC) of the International Life Science Institute (ILSI) Health and Environmental Sciences Institute (HESI) organized a workshop on Immunomodulators and Clinical Immunotoxicology in May 2007. The Workshop was convened to identify key gaps in nonclinical and clinical immunotoxicity testing of anti-inflammatory and immunomodulatory agents and to begin to develop consistent approaches for immunotoxicity testing and risk assessment. This paper summarizes the outcome of the HESI ITC Immunomodulators and Clinical Immunotoxicology Workshop. Topics not discussed at the Workshop were outside the scope of this report. Although more work is needed to develop consistent approaches for immunotoxicity assessment of immunomodulators, this Workshop provided the foundation for future discussion.

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Indication	Highest Phase	Country/Location	Organization	Date
Neovascularization, Pathologic	Discovery	US	Northwestern University	-

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