Author Interviews, Gout, Hepatitis - Liver Disease, Rheumatology / 15.06.2020

MedicalResearch.com Interview with: Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics   MedicalResearch.com: What is the background for this study? Response: Hyperuricemia is associated with non-alcoholic fatty liver disease (NAFLD) but the relationship to fibrosis remains uncertain. Moreover, it is not known whether lowering serum urate will affect the course of NAFLD.   (more…)
Author Interviews, Gout, Rheumatology / 15.06.2020

MedicalResearch.com Interview with: Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics  MedicalResearch.com: What is the background for this study? Response: Pegloticase is a PEGylated biologic therapy for patients with uncontrolled gout who have not improved on or could not tolerate conventional urate-lowering therapies. All biologics have the ability to engender anti-drug antibodies (ADAs) and it is known that some patients given pegloticase develop ADAs that cause them to stop treatment prior to receiving a complete course of therapy. In other rheumatic autoimmune diseases, DMARDs such as methotrexate or azathioprine are used as standard of care to prevent the development of ADAs to biologics. These DMARDs often allow patients to remain on biologic therapies longer and receive the full therapeutic benefits while minimizing adverse events. While pegloticase has been used traditionally as monotherapy, recent case series have demonstrated the therapeutic benefit of immunomodulator co-administration, allowing more patients to receive a full course of pegloticase therapy. Little has been published on how widespread this practice is and whether it has changed over time. (more…)
Author Interviews, Gout, Heart Disease / 14.06.2020

MedicalResearch.com Interview with: Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics MedicalResearch.com: What is the background for this study? Response: This is an independent study by Dr. Gurkipal Singh for which Horizon provided support and funding. Heart failure is the eighth leading cause of death in the US, with a 38% increase in the number of deaths due to HF from 2011 to 2017. Dr. Gurkirpal Singh conducted this analysis on heart failure hospitalization rates in patients with gout in the US to estimate their clinical and economic impact. Gout and hyperuricemia have previously been recognized as significant risk factors for heart failure, but there is little nationwide data on the clinical and economic consequences of these comorbidities. (more…)
Author Interviews, Diabetes, Gout / 14.06.2020

MedicalResearch.com Interview with: Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics MedicalResearch.com: What is the background for this study? Response: People with diabetes are known to have an increased risk of undergoing amputation procedures, however it was not known if patients with gout have an elevated independent risk for digit or limb amputations, or whether gout potentiates amputation rates in patients with diabetes. This analysis assessed and compared the rate of amputation procedures conducted in patients with gout, diabetes, both gout and diabetes, and neither gout nor diabetes via examining records from a large US claims database. (more…)
Author Interviews, Endocrinology, Thyroid Disease / 11.06.2020

MedicalResearch.com Interview with: https://www.horizontherapeutics.com/ Elizabeth H.Z. Thompson, Ph.D. Group vice president, Clinical Development and External Search Horizon Therapeutics MedicalResearch.com: What is the background for this study? Response: This study provides the first U.S.-based validation of the Graves' Ophthalmopathy Quality of Life (GO-QOL) questionnaire. For your background, Graves’ Ophthalmopathy is another term used to describe Thyroid Eye Disease (TED). The GO-QOL questionnaire includes eight questions, each on visual functioning and appearance-related impacts of TED on patients. Though widely used and validated in Europe, the relevance of the questions for patients in the United States hasn’t previously been explored.For this evaluation, 13 eligible TED patients completed the questionnaire and then underwent a separate cognitive QOL-related interview. (more…)
Author Interviews, Endocrinology, Ophthalmology, Thyroid Disease / 06.04.2020

MedicalResearch.com Interview with: Dr. Raymond Douglas MD PhD Board Certified Oculoplastic Surgeon Beverly Hills, CA  MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by proptosis?  How does teprotumumab work? Response: This study provides pooled efficacy data from the Phase 2 and 3 clinical trials of teprotumumab showing that the recently FDA-approved medicine effectively reduces proptosis, also known as eye bulging, in patients with Thyroid Eye Disease (TED) regardless of age, gender and smoking status. Proptosis is one of the most debilitating symptoms of TED, especially given the accompanying pain, vision impairment and emotional distress. Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the IGF-1 receptor. In patients with Thyroid Eye Disease, the IGF-1 receptor is overexpressed on orbital tissues and when activated, causes inflammation and enlargement of ocular muscles, expansion of orbital tissue and fat and forward displacement of the eye, resulting in eye bulging. The proteins in teprotumumab target and bind to the IGF-1 receptor and inhibit its function, thereby reducing inflammation, preventing tissue expansion behind the eye, and preventing muscle and fat tissue remodeling. Based on this mechanism of action, it is believed that teprotumumab addresses the underlying biology of the disease.  (more…)
Author Interviews, Endocrinology, NEJM, Thyroid Disease / 23.01.2020

MedicalResearch.com Interview with: Raymond S Douglas MD PhD Professor of Surgery, Division of Ophthalmology Director of the Orbital and Thyroid Eye Disease Program Cedars Sinai Medical Center MedicalResearch.com: What is the background for this study? Response: Thyroid eye disease (TED) is a debilitating disease that affects all aspects of a patients life. It is often associated with Graves' disease and thyroid abnormalities. TED causes profound bulging of the eyes impairing vision, causing eye pain and facial disfigurement. (more…)