Amgen, Author Interviews, Gastrointestinal Disease, Gluten / 07.06.2018 Interview with: Markku Mäki, MD, PhD Professor (emeritus) at the University of Tampere and Presently research director at the Tampere University Hospital Tampere, Finland What is the background for this study? Response: The only treatment for this life-long gluten-induced autoimmune systemic disease is a strict avoidance of wheat, rye and barley, the food cereals which contain gluten, the environmental trigger and driving force in celiac disease.  Gluten causes intestinal inflammation, usually with (but sometimes without) gastrointestinal or nutritional symptoms or signs, and with frequent extra-intestinal diseases. However, it is impossible for celiac disease patients to avoid gluten entirely and indefinitely and a third of patients report symptoms on a strict gluten-free diet. Gut mucosal healing is not optimal in half of the patients, and inflammation and injury is detected for years after starting the diet, presumably due to contamination with gluten in the diet. This is why patients are requesting, and academia and industry are looking for novel adjunct therapies for celiac disease. Initially, these therapies are tested to prevent the consequences of hidden gluten; the ultimate goal being that also celiacs could one day eat safely wheat, barley and rye products. Some 20 novel experimental therapies are at present actively being investigated (modifying wheat or different drugs, devices and vaccines/immunotherapy). The present study investigated whether blocking interleukin 15, an important mediator of celiac disease, reduces or prevents gluten-driven ill health, both the inflammation and injury at the small intestinal mucosal level and gluten-induced symptoms. The experimental drug used was Amgen’s AMG 714, a human monoclonal antibody, used at a low and high dose, in the presence or absence of a high-dose gluten challenge. (more…)
Author Interviews, Gastrointestinal Disease, JAMA / 15.08.2017 Interview with: Maureen Leonard, MD MMSc Clinical Director, Center for Celiac Research and Treatment Instructor in Pediatrics Associate Investigator, Nutrition Obesity Research Center Harvard Medical School Pediatric Gastroenterology & Nutrition MassGeneral Hospital for Children What is the background for this study? What are the main findings? Response: In this systematic review, we discuss the clinical approach to celiac disease and nonceliac gluten sensitivity, highlighting how to distinguish between these two conditions and their management. These disorders cannot be distinguished based on symptoms. A single elevated serology test is not diagnostic for celiac disease, and patients with abnormal serologic testing must be referred to a gastroenterologist for further testing and remain on a gluten-containing diet until their diagnostic evaluation is completed. While the treatment for both conditions is a gluten-free diet, the possibility of long-term complications differs. (more…)
Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017 Interview with: Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA Director, Founder, President and Chief Executive Officer and Dr Robert P Anderson MBChB BMedSc PhD FRACP Chief Scientific Officer ImmusanT, Cambridge, MA What is the background for this study? Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period. (more…)
Author Interviews, Gastrointestinal Disease, JAMA / 04.04.2017 Interview with: Dr. Ann Kurth, Task Force member Dean of the Yale School of Nursing Adjunct professor New York University College of Nursing and the College of Global Public Health. What is the background for this study? Response: Celiac disease, an immune disorder where people should not eat food with gluten, is fairly prevalent. When people with celiac disease eat foods containing gluten, which is found in wheat, rye and barley, their body responds by inflaming or destroying villi—the tiny, fingerlike projections on the inner lining of the small intestine–which prevents the body from absorbing the necessary nutrients from food. (more…)
Author Interviews, Gastrointestinal Disease / 05.07.2015 Interview with: Louise Emilsson, MD PhD, Postdoc Primary Care Research unit Vårdcentralen Värmlands Nysäter and Institute of Health and Society University of Oslo MedicalResearch: What is the background for this study? Dr. Emilsson: Genetics is considered an important factor in the development of celiac disease and other autoimmune diseases. For e.g. the prevalence of celiac disease is about 10% in first-degree relatives of celiac patients compared to about 1% in the general population. Several earlier genome-wide association study (GWAS) studies have established shared genetic features also in-between different autoimmune diseases, however, very little is known about the risk of developing other autoimmune diseases in relatives of celiac patients. Therefore we assessed the risk of several other non-celiac autoimmune diseases (Crohn’s disease, type 1 diabetes mellitus, hypothyroidism, hyperthyroidism, psoriasis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus or ulcerative colitis) in all first degree relatives and spouses of Swedish celiac patients. MedicalResearch: What are the main findings? Dr. Emilsson: The main finding is that both first-degree relatives (+28%) and spouses (+20%) are at increased risk of other autoimmune diseases. There are several plausible explanations for these findings. One is of course that individuals with celiac disease and their first-degree relatives share a genetic autoimmune predisposition, another potential explanation involves shared environment (relevant for both first-degree relatives and spouses) but finally we cannot rule out that a certain degree of increased awareness of signs and symptoms in both first-degree relatives and spouses might lead to more examinations and thereby diagnoses (so-called ascertainment bias). Probably all these mechanisms contributed to the finding. (more…)
Author Interviews, Gastrointestinal Disease, Genetic Research, NEJM, Pediatrics / 03.07.2014

Dr. Daniel Interview with: Dr. Daniel Agardh M.D., Ph.D Department of Pediatrics Diabetes and Celiac Disease Unit Skåne University Hospital Malmo, Sweden, MedicalResearch: What are the main findings of the study? Dr. Agardh: In this study, we stratify the risk of celiac disease among children according to their HLA genotype and country of residence. We confirm that HLA-DQ2/2 genotype is the major risk factor for early celiac disease, but also show how the risk differs between the participating countries despite of sharing similar HLA risk. This points to the direction of an interaction between HLA and the environment that eventually lead to an autoimmune response in genetic susceptible children. (more…)
Author Interviews, Gastrointestinal Disease, OBGYNE / 29.10.2013 Interview with Dr. Ketil Stordal Researcher/consultant paediatrician National Institute of Public Health Norway What are the main findings of the study? Dr. Stordal: Mothers who used iron supplementation during pregnancy had an increased risk for having children with a diagnosis of celiac disease. This association was not caused by maternal anemia during pregnancy, anemia was not a predictor of celiac disease in the offspring. The risk for celiac disease when the mother had used the highest doses and for the longest period. (more…)