Author Interviews, NYU, Race/Ethnic Diversity, Rheumatology / 21.01.2021

MedicalResearch.com Interview with: Peter Izmirly, M.D. Associate Professor of Medicine, NYU School of Medicine Director of Inpatient Rheumatology, Bellevue Hospital Center co-Director, NYU-Hospital for Joint Diseases Lupus Clinic Research Office Address: NYU School of Medicine New York, NY 10016  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Knowing how many people have systemic lupus erythematosus (SLE) is limited, particularly for racial/ethnic subgroups in the United States. Our work provides accurate estimates of who has  (SLE) among the major racial/ethnic groups in the United States and that our estimates for SLE approach the FDA’s definition or a rare disease. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity, Rheumatology, UCSF / 07.11.2020

MedicalResearch.com Interview with: Milena Gianfrancesco, PhD, MPH Assistant Professor. Education Division of Rheumatology, Department of Medicine University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: This study utilized data from the COVID-19 Global Rheumatology Alliance Provider Survey, which launched on March 25th. To date, it has collected information on over 6,000 patients with rheumatic disease diagnosed with COVID-19 from over 40 countries worldwide. As COVID-19 spread across the world in the spring, and especially within the United States, it became clear that the disease was impacting certain groups more than others. Growing attention and research began to illustrate the disproportionate burden of COVID-19 among racial/ethnic minorities in the United States. We know that racial and ethnic minorities experience a higher burden of rheumatic disease risk and severity; therefore, our group was interested in examining whether the disproportionate burden of COVID-19 also affected this susceptible population. (more…)
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 / 14.06.2020

MedicalResearch.com Interview with: https://www.horizontherapeutics.com/Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics    MedicalResearch.com: What is the background for this study? Response: Pegloticase is an infused biologic approved to treat uncontrolled gout. The drug is highly effective, but patients can develop anti-drug antibodies that may accelerate clearance of pegloticase from the circulation. Randomized clinical trials have shown that 42% of patients treated with bi-weekly pegloticase had a serum uric acid (sUA) below 6.0 mg/dl at 3 and 6 months. Mild-to-moderate immunomodulation has been shown to lower the prevalence of anti-drug antibody formation in patients with other autoimmune diseases (rheumatoid arthritis, Crohn’s disease, juvenile idiopathic arthritis). Case reports and case series in the literature suggest that low to-moderate doses of methotrexate or azathioprine may also decrease anti-drug antibody formation in uncontrolled gout patients treated with pegloticase.   (more…)
AstraZeneca, Author Interviews, Rheumatology / 11.06.2020

MedicalResearch.com Interview with: Richard Alan Furie, MD Professor, Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases Feinstein Institutes for Medical Research Chief, Division of Rheumatology, Northwell Health Professor of Medicine, Donald and Barbara Zucker School of Medicine Hofstra/Northwell MedicalResearch.com: What is the background for this study? Response: It has been known for decades that type I interferons play a role in SLE pathogenesis, and therefore the burning question has been whether inhibitors of these pro-inflammatory cytokines would reduce SLE disease activity and could be used as a therapeutic.  There are several strategies for inhibiting the type I interferon pathway, but a conventional approach is to create an antibody against the target protein. The first few clinical trials in SLE evaluated monoclonal antibodies to alpha interferon.  Results were modest at best.  Since this approach only inhibited one (alpha) of five type I interferon subtypes, there were still four subtypes unaffected that could provoke inflammation.  A rather crucial piece of information is that all five subtypes bind to the same receptor.  Therefore, if the receptor is blocked as opposed to a single cytokine, the entire type I interferon family of proteins would be prevented from binding the receptor. This was accomplished with anifrolumab. The phase 2 study in SLE (known as MUSE), which yielded very robust results, was reported several years ago.  It served as a foundation for the phase 3 program, which consisted of two pivotal studies known as TULIP-1 and TULIP-2. Both studies were reported at the 2019 American College of Rheumatology meeting in November, 2019.  Although TULIP-1 did not achieve the primary endpoint, several secondary endpoints were met.  TULIP-2 was successful.  Between all three studies, approximately 1000 patients were enrolled.  Taking advantage of these large numbers, additional analyses of the combined datasets afforded our ability to answer questions about the effects of anifrolumab that were not previously addressed with greater power. In the narrative that accompanied my presentation, I stated “In lupus, disease activity begets damage, and damage begets more damage.  The long-term sequelae of heightened disease activity, better known as flare, are significant.  Regardless of how flare is defined or measured, a major goal is to prevent flare. It is quite justified to think a drug that reduces lupus disease activity should also prevent flares. Well, the proof is in the pudding. In this analysis, we evaluated the effects of anifrolumab on flares.  Recall that anifrolumab targets the type I interferon receptor, blocking all 5 type I subtypes.  The phase 2 MUSE study yielded robust results as did the phase 3 TULIP-2 study.  While, the phase 3 TULIP-1 study did not achieve its primary endpoint, many secondary endpoints showed benefit. In this study, we focused on flare, and examined TULIP-1 and 2 individually as well as pooled data from both studies.”  (more…)
Author Interviews, COVID -19 Coronavirus, Lancet, Rheumatology / 08.05.2020

MedicalResearch.com Interview with: Dr. Giulio Cavalli MD PhD & Prof. Lorenzo Dagna MD FACP Ospedale San Raffaele and Vita-Salute San Raffaele University Milan, Italy     MedicalResearch.com: What is the background for this study? Response: Upon encountering pathogens, our immune system produces pro-inflammatory mediators, called cytokines. Cytokines activate cells from the immune system. In most people, production of cytokines is an appropriate and protective response to infection. However, some individuals develop excessive and detrimental inflammatory responses, which are even more harmful than the pathogen itself to the host organism. We hypothesized that some patients with COVID-19 might develop excessive and detrimental inflammation, and that treatment with anti-inflammatory agents might be beneficial in this population. Anakinra is an inhibitor of the pro-inflammatory molecule interleukin 1 (IL-1). It was originally marketed for the treatment of rheumatoid arthritis, but is now mostly used to treat a variety of pediatric inflammatory diseases. (more…)
Author Interviews, COVID -19 Coronavirus, Rheumatology / 16.04.2020

MedicalResearch.com Interview with: Ellen M. Gravallese M.D. President, American College of Rheumatology Dr. Gravallese discusses the recent guidance document issued by ACR for the treatment of rheumatic disease patients during the COVID-19 pandemic. MedicalResearch.com: What is the background for this announcement? Are patients with rheumatic disease at greater risk of severe illness or death from the SARS-CoV-2 virus?  Response: This week the ACR issued a guidance document that is the product of the ACR’s Clinical Guidance Task Force, a newly appointed task force that includes experts in infectious disease, as well as experts in biologic and non-biologic rheumatic disease therapies. This clinical guidance document was prepared to assist rheumatology professionals in the care of their patients during this novel pandemic, and to advise as to how to handle rheumatic disease therapies. There is no data to suggest that patients with rheumatic disease are at greater risk of severe illness or death simply because they have a rheumatic disease. Rheumatic disease patients appear to be at risk for poor outcomes if they become infected primarily because of general risk factors such as older age or comorbid medical conditions, such as significant heart or lung disease. A global alliance has been created by the rheumatology community that has developed an international case-reporting registry to collect information pertinent to COVID-19 infection in patients with rheumatic disease. The ACR has played an active role in helping the Alliance get their message out to the rheumatology community, and we continue to support the Alliance with its data dissemination and communication efforts. We hope this registry will provide valuable data to address additional questions about the best way to manage rheumatology patients affected by COVID-19 and we encourage providers to submit their COVID-19-related cases to the Alliance website at www.rheum-covid.org. (more…)
Author Interviews, Rheumatology / 14.11.2019

MedicalResearch.com Interview with: Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, Principal Investigator of ArthritisPower  MedicalResearch.com: What is the background for this study? Response: Patient-reported outcomes (PROs) are important indicators of treatment effectiveness, but little is known about which PRO measures that patients find the most important to track for their disease management and to evaluate treatment effectiveness and health outcomes. In this study, we used the ArthritisPower Research Registry to evaluate which PROs patients with rheumatological conditions voluntarily selected to understand their experience of disease.  (more…)
Author Interviews, Opiods, Rheumatology / 12.11.2019

MedicalResearch.com Interview with: Raveendhara R. Bannuru MD, PhD, FAGE Director, Center for Treatment Comparison and Integrative Analysis (CTCIA) Deputy Director, Center for Complementary and Integrative Medicine (CCIM) Asst Professor of Medicine, Tufts University School of Medicine Asst Professor of Clinical & Translational Science, Sackler School of Graduate Biomedical Sciences Division of Rheumatology, Tufts Medical Center Boston, MA MedicalResearch.com: What is the background for this study? Response: Given the current controversy regarding the use of opioids in chronic pain, we wanted to delve deeper into the efficacy and safety profiles of oral opioid drugs in osteoarthritis patients. Temporal assessments like ours can reveal peak periods of efficacy, and can provide clinicians with a blueprint for optimal durations of treatment regimens. With respect to subgroup analyses based on strength of opioid binding affinity, we sought to explore currently held paradigms that strong opioids may be useful for the treatment of severe pain, and to specifically assess their relevance in OA populations. Knowledge of the relative efficacy and safety profiles of strong versus weak opioids can give clinicians the information they need to weigh benefits and harms of specific subgroups of opioids. (more…)
Author Interviews, Rheumatology / 11.11.2019

MedicalResearch.com Interview with: Kelly Gavigan, MPH Manager, Research and Data Science CreakyJoints  MedicalResearch.com: What is the background for this study? Response: Over the past fifteen years, there have been significant improvements in quality of life among people living with rheumatic and musculoskeletal disease with the introduction of biologics and targeted therapies. However, despite a variety of treatments to try, patients often seek non-pharmacological alternative and complementary treatments, such as marijuana for medical use (MMU), to help manage their condition and symptoms. MMU is becoming increasingly available in the United States as different states legalize it under specific circumstances. Legal or not, according to a survey conducted by CreakyJoints using the ArthritisPower Research Registry (n=1,059 participants), people with arthritis are trying marijuana for medical use.  (more…)
Annals Internal Medicine, Author Interviews, OBGYNE, Rheumatology / 17.07.2019

MedicalResearch.com Interview with: Bella Mehta, MBBS, MS Assistant Attending Physician, Hospital for Special Surgery Instructor, Weill Cornell Medical College MedicalResearch.com: What is the background for this study? What are the main findings? Response: For women with lupus, pregnancy has long been considered high-risk and associated with both medical and obstetric complications. In the 1960s and 1970s, pregnancy was thought to be contraindicated in lupus patients. Beginning in the 1980s, and especially in the 1990s, many studies identified specific risk factors for pregnancy complications and proposed best-practice management guidelines. We wished to see whether these advances improved pregnancy outcomes for lupus patients. Our study showed a decline in maternal mortality and other outcomes in lupus patients. The improvement in pregnancy outcomes was observed more so in lupus patients than those without lupus.  (more…)
Author Interviews, Orthopedics, Pharmacology, Rheumatology / 28.02.2019

MedicalResearch.com Interview with: Dr. Andrew Spitzer MD Co-director Joint Replacement Program Cedars-Sinai Orthopedic Center Los Angeles, CA MedicalResearch.com: What is the background for this study? How does this product differ from other steroid injections for inflammatory arthritis? Dr. Spitzer: Many patients receive repeat injections of intra-articular corticosteroids to manage recurrent osteoarthritis pain and other symptoms. However, in most clinical trials to date, patients only received a single corticosteroid injection, and patients were only followed for 12 to 24 weeks after treatment. For trials that have evaluated repeated injections of corticosteroids over a longer period of time—2 years, for example—injections were administered every 3 months, regardless of the timing of the return of OA symptoms. This is not reflective of what is done in clinical practice, where corticosteroids are administered again in response to the return of pain or a flare of inflammation in the knee. In this study, we used a flexible dosing schedule based on the patients’ symptoms, meaning that patients received the second injection of a recently approved extended-release corticosteroid only when their pain and/or symptoms returned, not before. Safety was monitored for 52 weeks—this length of time should be sufficient to identify any associated side effects, including any potential impact on the knee tissue. Triamcinolone acetonide extended-release (TA-ER; Zilretta®) was approved in late 2017 as an intra-articular injection for the management of osteoarthritis pain of the knee. The formulation utilizes microspheres which enable a slow release of the active agent (triamcinolone acetonide) into the synovial fluid for 12 weeks following injection. Previously, a Phase 3 study demonstrated safety and efficacy of a single injection of TA-ER (Conaghan PG, et al. J Bone Joint Surg Am. 2018;100:666-77). This is the first study evaluating the safety and patient response to repeat administration of TA-ER. This study also included patients that were more typical of who we see in the clinic—those who have higher body mass index, more severe disease, and received prior treatments for their osteoarthritis pain. (more…)
Author Interviews, MRI, Pain Research, Rheumatology / 11.10.2018

MedicalResearch.com Interview with: Daniel S. Albrecht, Ph.D. Research Fellow, Department of Radiology Harvard Medical School MedicalResearch.com: What is the background for this study? Can you briefly describe what is meant by fibromyalgia? Response: Fibromyalgia (FM) is a poorly understood chronic condition characterized by widespread musculoskeletal pain, fatigue, unrefreshing sleep, memory deficits and attention difficulties, among other symptoms. FM affects an estimated 4 million adults in the U.S., but despite this prevalence, effective therapies for treating FM are lacking. Part of the reason for the paucity of effective therapeutics is insufficient knowledge of the underlying mechanisms contributing to FM. Previous work from co-senior author of the current manuscript, Eva Kosek, MD, PhD, and collaborators at the Karolinska Institute in Sweden found elevated inflammatory molecules in the cerebrospinal fluid of FM patients, which could be reflective of brain neuroinflammation in these patients. However, no study had directly assessed the presence of neuroinflammation in the brain of FM patients. Co-senior author of the study, Marco Loggia, PhD, and collaborators showed in a 2015 Brain publication that individuals with chronic low back pain (cLBP) exhibit evidence of brain neuroinflammation, specifically activation of glial cells. Our team utilized simultaneous MR/PET imaging to image brain levels of the 18 kDa translocator protein (TSPO), which is widely used as a marker of glial activation due to vast upregulation of TSPO in glial cells, e.g. microglia and astrocytes, in preclinical models of inflammation and neurological disease. Dr. Loggia sought to extend these finding in cLBP to FM, hypothesizing that activation of glial cells may also be associated with FM pathology. To this end, we used the same TSPO PET tracer to image 20 FM patients and 16 healthy controls. During a conference where I was presenting preliminary results of the fibromyalgia study, Dr. Loggia met with Dr. Kosek and discovered that, across the Atlantic, her group was performing a very similar study, imaging 11 FM patients and 11 controls with the same TSPO PET compound. They decided to form a collaboration, and logistic talks began to determine the best strategy to combine and analyze the separate datasets. In addition to PET imaging with the TSPO tracer, which is suggested to reflect activated microglia and astrocytes, Dr. Kosek’s group also collected PET scans using a tracer thought to bind specifically to astrocytes rather than microglia. This tracer was used in order to discern the relative contributions of microglia and astrocytes to any observed differences in TSPO PET signal. (more…)
Author Interviews, Eli Lilly, Lancet, Pharmacology, Rheumatology, UCLA / 26.07.2018

MedicalResearch.com Interview with: Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health Beverly Hills, Ca 90211 MedicalResearch.com: What is the background for this study? What are the main findings?   Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system. The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE. (more…)
Author Interviews, Orthopedics, Rheumatology / 18.06.2018

MedicalResearch.com Interview with: Samuel Hawley | Research Assistant (NIHR PhD Project) | Pharmaco- and Device Epidemiology Group | Centre for Statistics in Medicine | NDORMS | University of Oxford  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The aim was to disentangle some of the potential reasons for the recent decline in joint replacement rates among rheumatoid arthritis (RA) patients in the developed world. The main findings from our UK patient-level analysis indicated that joint replacement rates were not significantly different for users of TNF inhibitors versus the patients who remained only on conventional synthetic DMARDS, however we did find that TNF inhibitor use amongst older RA patients was associated with a 40% reduction in hip replacement rates. (more…)
Author Interviews, Biomarkers, Rheumatology, Vanderbilt / 13.03.2018

MedicalResearch.com interview with: Dr. Chase Spurlock, PhD CEO, IQuity, Specialty Diagnostic Technologies Faculty, Vanderbilt University Medical Center Dr. Spurlock discusses IQuity's release of IsolateFibromyalgia, the first RNA-based blood test to detect fibromyalgia. MedicalResearch.com: What is the background for this test? Would you briefly explain what fibromyalgia is, whom it affects and why it has been difficult to definitely diagnosis?  Dr. Spurlock: We developed the IsolateFibromyalgia™ test using our established RNA assay platform, IQIsolate™, to help clinicians receive timely and accurate information. This technology has evolved from over a decade of research at Vanderbilt University and continues at IQuity funded by both the National Institutes of Health (NIH) as well as private investors. We discovered that differences in RNA expression patterns could be detected in patients with a variety of human conditions spanning infection to more complex inflammatory diseases. With our focus on autoimmune disease, we identified and validated RNAs capable of distinguishing multiple sclerosis, IBS, Crohn’s, ulcerative colitis and fibromyalgia syndrome. In the case of fibromyalgia, our research involved almost 600 subjects including healthy individuals, patients with endocrine conditions, dermatologic conditions and rheumatologic diseases — rheumatoid arthritis, Sjogren’s syndrome and systemic lupus erythematosus. Reported sensitivity and specificity of this assay is 92 percent and 96 percent, respectively. Fibromyalgia syndrome is characterized by widespread musculoskeletal pain often initially localized to the neck and shoulders. Patients typically describe pain throughout the muscles but may also report pain in the joints. Furthermore, fibromyalgia is usually accompanied by fatigue as well as cognitive disturbance. Patients most afflicted are women between ages 20 and 55. Fibromyalgia affects approximately as many as 6-10 million people in the U.S. The difficulty in reaching a definitive diagnosis lies in two important issues. First, the cause of the syndrome is unknown, and the way the condition presents and progresses can vary among patients. Secondarily, fibromyalgia syndrome mimics many other conditions due to the multiple nonspecific symptoms associated with fibromyalgia. Patients look well, there are no obvious abnormalities on physical examination other than tenderness, and laboratory and radiologic studies are normal. With no discernable abnormalities in routine clinical laboratory testing or imaging, the diagnosis is based on subjective reporting of symptoms. The difficulties and complex nature of receiving a correct fibromyalgia diagnosis are apparent. Despite improved awareness among primary care clinicians, many continue to be uncomfortable with making this diagnosis. Fibromyalgia patients on average wait almost a year after experiencing symptoms before seeing a physician and end up visiting on average 3.7 different physicians before a diagnosis. The diagnostic journey can take years. IsolateFibromyalgia provides the clinician and patient actionable information with 94 percent accuracy. (more…)
Author Interviews, Boehringer Ingelheim, Dermatology, Pulmonary Disease, Rheumatology / 05.03.2018

MedicalResearch.com Interview with: Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this platform? Would you briefly explain what is meant by scleroderma? How does it affect a person's skin and ability to function? Whom does this disease primarily affect? Response: “More Than Scleroderma™: The Inside Story” is Boehringer Ingelheim’s new global initiative highlighting real-life, inspirational stories of people living with the rare disease scleroderma. The new effort, created with support from the Scleroderma Foundation in the U.S., aims to raise awareness of the disease, dispel misperceptions and provide important resources to support and guide those on their journey with scleroderma. The initiative’s website http://www.morethanscleroderma.com/us/ features a powerful and inspiring collection of diverse photographs and video profiles of 10 people across the U.S. living with scleroderma and sharing their ‘inside story.’ Each tells their unique and moving experience with scleroderma through diagnosis to learning to live with the disease and manage it. Many less fortunate people in developing countries have to deal with this on a daily basis and only have the support of Orphan Drug Distributors and charities and I'm so thankful that people like this are available to support these people! Scleroderma, also known as systemic sclerosis, is a rare disease characterized by thickening and scarring of the skin, lungs and other organs. Scleroderma affects fewer than 200,000 people in the U.S. and typically affects women in the prime of their lives, between the ages of 25 and 55 taking a marked toll just as they are building their careers and bearing the responsibility of caring for their family. Nearly all people with scleroderma (more than 90%) will develop some skin symptoms including skin thickening, tightened skin around the joints, small red spots on the face and hands and hard lumps on pressure points and joints. Most people with the disease will also develop some degree of lung scarring, or interstitial lung disease (ILD). When the disease's signature thickening and scarring develops in vital organs, such as the lungs, there are potentially debilitating and life-threatening consequences. (more…)
Author Interviews, Duke, NEJM, Rheumatology, Stem Cells, Transplantation / 04.01.2018

MedicalResearch.com Interview with: Keith M. Sullivan, M.D. James B. Wyngaarden Professor Of Medicine Division of Cellular Therapy Duke University Medical Center Durham, North Carolina 27710, USA  MedicalResearch.com: What is the background for this study? What are the main findings?
  • Scleroderma with internal organ involvement is a devastating  autoimmune disorder with considerable morbidity and high mortality which have not changed in 40 years of reporting. Effective new therapies are needed.
  • Despite 2 prior randomized trials showing benefit for reduced-intensity stem cell transplant vs. conventional cyclophosphamide immune suppression, clinical practice in the US did not change due in part due to concern about patient safety and durability of response (attached).
  • The current randomized trial compares 12 monthly infusions of cyclophosphamide with high-dose chemotherapy plus whole-body irradiation designed to wipe-out (myeloablate) the defective, self-reactive immune system and replace with the patients own stem cells which had been treated to remove self-reacting lymphocytes. This was the first study to test if myeloablative autologous could re-establish a normal functioning immune system in patients with scleroderma.
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Author Interviews, Brigham & Women's - Harvard, Rheumatology, Weight Research / 04.12.2017

MedicalResearch.com Interview with: Jeffrey A. Sparks, M.D., M.M.Sc. Assistant Professor of Medicine Division of Rheumatology, Immunology and Allergy Department of Medicine Brigham and Women’s Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: We compared women diagnosed with rheumatoid arthritis (RA) during follow-up in the Nurses’ Health Study and matched women without RA during the same index time period. Women with RA had higher mortality than women without RA. In both groups, those that had severe weight loss (>30 pounds), had the highest mortality after the early RA/index period. Weight gain in the early RA period was not associated with mortality for either group. (more…)
Author Interviews, Pain Research, Rheumatology, Sleep Disorders / 20.06.2017

MedicalResearch.com Interview with: Atul A. Deodhar, MD, MRCP, FACP, FACR Professor of Medicine Medical Director, Rheumatology Clinics Medical Director, Immunology Infusion Center Oregon Health & Science University  MedicalResearch.com: What is the background for this study? Response: The GO-ALIVE study (CNTO148AKS3001) is a multicenter, randomized, double-blind, placebo-controlled study of golimumab, an anti-TNFα monoclonal antibody, administered intravenously (IV), in adult patients with active ankylosing spondylitis (AS). The primary objective is to evaluate the efficacy of golimumab 2 mg/kg in patients with active AS by assessing the reduction in signs and symptoms of AS. The secondary objectives include assessing efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes. A total of 208 patients who had a diagnosis of definite  ankylosing spondylitis (per modified New York criteria) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, total back pain visual analogue scale (VAS) ≥4, and CRP ≥0.3 mg/dL were randomized.  Patients were treated with IV golimumab (n=105) at Weeks 0, 4, and every 8 weeks through Week 52 or placebo (n=103) at Weeks 0, 4, and 12, with crossover to IV golimumab at Week 16 and through Week 52. (more…)
Author Interviews, Dermatology, Rheumatology / 01.03.2017

MedicalResearch.com Interview with: Lihi Eder MD PhD Rheumatologist, Women’s College Hospital Scientist, Women’s College Research Institute Assistant Professor of Medicine, University of Toronto Toronto, ON, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: There significant delays in the diagnosis of psoriatic arthritis (PsA) among patients with psoriasis. Many patients with psoriasis experience musculoskeletal symptoms. The majority of them do not have PsA, but other non-inflammatory conditions such as fibromyalgia or osteoarthritis. In this study, we aimed to assess whether the presence and the degree of musculoskeletal symptoms in psoriasis patients predict the development of psoriatic arthritis. We analyzed a cohort of 410 psoriasis patients who were followed over a period of 9 years. These patients did not have arthritis at baseline. The patients were assessed annually by a rheumatologist for signs of PsA. A total of 57 patients developed psoriatic arthritis during the follow-up period. (more…)
Author Interviews, Brigham & Women's - Harvard, Dental Research, Infections, Rheumatology, Science / 17.12.2016

MedicalResearch.com Interview with: Maximilian F. Konig, MD Division of Rheumatology, Johns Hopkins University School of Medicine Current affiliation: Department of Medicine Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response:The idea that rheumatoid arthritis (RA), an autoimmune disease that leads to chronic joint inflammation and destruction, may be initiated by a bacterial infection is not novel, but has been posited for more than a century. Based on the clinical observation that patients with RA frequently have severe periodontal disease (gum disease), gum inflammation has long been thought to contribute to disease development in RA. However, limited understanding of the mechanisms that fuel and sustain the autoimmune attack in RA made it difficult to pinpoint a specific bacterial trigger. In recent years, our understanding of the abnormal immune response that attacks the joints in patients with RA has grown exponentially, and we now know that disease-specific autoantibodies (ACPAs) target modified self-proteins (this modification is known as citrullination). It is this abnormal immune response against citrullinated proteins that appears to drive the joint (and sometimes lung) inflammation seen in rheumatoid arthritis. Recent studies from our laboratory at The Johns Hopkins University (led by principle investigator Felipe Andrade, MD, PhD) suggested that an immune cell called the neutrophil, which normally protects us from infection at sites like the oral cavity or anywhere else in the body, also appears to be the source of the proteins attacked in RA. We were therefore interested to understand what drives the association of gum disease, an inflammation commonly triggered by bacteria, with RA. (more…)
Author Interviews, BMJ, Immunotherapy, Johns Hopkins, Rheumatology / 27.06.2016

MedicalResearch.com Interview with: Laura C. Cappelli, M.D Johns Hopkins University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We had been referred several patients with inflammatory arthritis or dry mouth and dry eyes after being treated with immune checkpoint inhibitors. When searching the literature for information on how to evaluate and treat these patients, we realized that there was minimal information available. We wanted to describe our experience and inform the medical community about these events so that recognition could increase. (more…)
Author Interviews, NEJM, Rheumatology / 02.06.2016

MedicalResearch.com Interview with: Chih-Hung Kuo, M.B., B.S. Peter McCluskey, M.D. Clare L. Fraser, M.B., B.S. University of Sydney Sydney, NSW, Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Giant cell arteritis is a life and sight threatening systemic inflammatory condition, which remains difficult to diagnose. Jaw claudication (cramping of muscle from ischemia) is a highly specific symptom with significant diagnostic and prognostic (risk of permanent blindness) values. The reporting of jaw symptoms may be affected by many factors, such as diet. There remains no standardized clinical test available for clinicians. We study the use of chewing gum as a standardized test (like a stress test for angina pain) to better characterize this critical symptom. The pilot study of two cases with abnormal results were published in the New England Journal of Medicine. Chewing gum at a rate of 1 chew/second can reproduce the jaw claudication symptom around 2-3 minutes. In one case, the jaw claudication was unmasked by the test with a subsequent positive biopsy result. The test result became negative after corticosteroid treatment. (more…)
Alzheimer's - Dementia, Author Interviews, Rheumatology / 16.05.2016

MedicalResearch.comcom Interview with: Hui-Wen Lin MD, PHD Department of Mathematics, Soochow University Evidence-Based Medicine Center, Wan Fang Hospital, Taipei Medical University Taipei, Taiwan MedicalResearch.com: What is the background for this study? Dr. Hui-Wen Lin: Systemic lupus erythematosus (SLE) is a systemic autoimmune disorder that affects multiple organ systems and it predominantly affects women aged 20 to 40 years, and clinical symptoms caused by autoantibody deposition that triggers subsequent inflammatory reactions vary between individuals. There were 30~80% of SLE patients present neurological symptoms, and it is referred to as neuropsychiatric SLE (NPSLE). However there is no research about risk of dementia for SLE patients. Therefore we investigated this issue by analyzing the National Health Insurance Research Database in Taiwan. (more…)
Author Interviews, Hearing Loss, Rheumatology / 28.04.2016

MedicalResearch.com Interview with: Dr. Amir Emamifar, MD Department of Rheumatology Odense university Hospital Svendborg Hospital, Denmark   Associate Professor Dr. Inger Marie Jensen Hansen, PhD, DMsci Department of Rheumatology Odense university Hospital Svendborg Hospital University of Southern Denmark   MedicalResearch.com: What is the background for this study? Response: Rheumatoid arthritis is a systemic, inflammatory disease that affects 1% of the general population. Apart from main articular manifestations, rheumatoid arthritis may involve other organs including heart, lung, skin, and eye. The auditory system can be affected during the course of the disease as well; however the association between rheumatoid arthritis and hearing impairment has not been clearly defined. It seems that hearing impairment in rheumatoid arthritis is a multifactorial disease affecting by environmental factors and disease and patient characteristics. We did a comprehensive review of all published data to reveal the potential link between rheumatoid arthritis and hearing impairment. (more…)
Author Interviews, Immunotherapy, NEJM, Rheumatology / 24.12.2015

MedicalResearch.com Interview with: Prof. dr. D.L.P. Baeten MD Clinical Immunology and Rheumatology Academic Medical Center University of Amsterdam Amsterdam, The Netherlands Medical Research: What is the background for this study? What are the main findings? Prof. Baeten: Ankylosing spondylitis is a debilitating rheumatic condition which affects young adults and with NSAIDS and TNF inhibitors as only therapeutic option. Over the last years, we generated evidence that IL-17 is an important inflammatory mediator in this condition. In the two studies reported here in the NEJM, we demonstrate that IL-17 inhibition with secukinumab has a very profound and long-lasting effect on signs and symptoms as well as inflammation in ankylosing spondylitis patients, even in those patients that failed a TNF blocker before. (more…)
Author Interviews, Biomarkers, Lyme, Rheumatology / 10.11.2015

MedicalResearch.com Interview with: Robert B. Lochhead PhD Clinical Fellow in Medicine  Division of Rheumatology, Allergy & Immunology Massachusetts General Hospital Harvard Medical School, Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Lochhead: Lyme arthritis (LA), caused by the tick-borne spirochete Borrelia burgdorferi, usually resolves appropriately with antibiotic treatment, called antibiotic-responsive Lyme arthritis. However, in some patients, arthritis persists for months or years after spirochetal killing with oral and IV antibiotic therapy, called antibiotic-refractory Lyme arthritis. Synovial lesions in these patients show marked synovial proliferation, inflammation, and vascularization, accompanied by autoimmune T and B cell responses. MicroRNAs (miRNAs) regulate many biological processes including inflammation, immune responses, and cell proliferation, and are effective biomarkers that may reveal molecular mechanisms of disease. Our objective here was to identify extracellular miRNAs (ex-miRNAs) in synovial fluid (SF) that distinguish regulated (responsive) from dysregulated (refractory) immune responses in Lyme arthritis, thereby providing insights into underlying biological processes and potential diagnostic biomarkers to distinguish between  these disease courses. (more…)
Author Interviews, Outcomes & Safety, Rheumatology / 15.06.2015

MedicalResearch.com Interview with: Cécile Gaujoux-Viala, MD, PhD Université Montpellier I Chef de Service de Rhumatologie CHU de Nîmes Carémeau France Medical Research: What is the background for this study? Response: Chronic inflammatory rheumatic diseases – such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)  – confer significant patient and economic burdens : 1/5 of people with rheumatic conditions has been forced to change career, 1/3 will have stopped working within two years of onset and 1/2 will be unable to work within ten years. The addition of biological agents in treatment strategies for rheumatic diseases have improved the possibility of controlling disease activity and slowing the progression of joint damage. But these treatments are very expensive and their effect on work participation remains unclear. (more…)