Lupus: Phase 2 Trial of Baricitinib Improved Signs and Symptoms

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

Dr. Wallace

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.

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Number of Joint Replacements Drop in Rheumatoid Arthritis Patients 

MedicalResearch.com Interview with:

Hip Replacement NIH Image

Hip Replacement
NIH Image

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. Continue reading

RNA-based Blood Test Can Detect Fibromyalgia

MedicalResearch.com interview with:

Dr. Chase Spurlock, PhD CEO, IQuity, Specialty Diagnostic Technologies Faculty, Vanderbilt University Medical Center

Dr. Chase Spurlock

Dr. Chase Spurlock, PhD
CEO, 
IQuitySpecialty 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.

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Global Initiative Highlights Inspirational Stories of People Living With Scleroderma

MedicalResearch.com Interview with:

Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Zoz

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.

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.  Continue reading

Stem Cell Transplantation Offers Hope For Severe Scleroderma

MedicalResearch.com Interview with:

“Breastfeeding welcome here” by Newtown grafitti is licensed under CC BY 2.0

Picture of a female patient’s left arm, showing skin lesions caused by Scleroderma
Wikipedia image

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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No Mortality Benefit From Weight Gain in Rheumatoid Arthritis

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

Dr. Sparks

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.

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SIMPONI ARIA (golimumab) Improved Sleep and Pain in Ankylosing Spondylitis Trial

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 

Dr. Deodhar

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.

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Musculoskeletal Symptoms May Mark Onset of Arthritis in Psoriasis Patients

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

Dr. Lihi Eder

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.
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Gum Disease Linked to Autoimmunity in Rheumatoid Arthritis

MedicalResearch.com Interview with:

Maximilian F. Konig, MD Department of Medicine Massachusetts General Hospital Harvard Medical School

Dr. Maximilian F. Konig

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.

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Checkpoint Inhibitor Biologics Linked To Inflammatory Arthritis and Sicca Syndrome

MedicalResearch.com Interview with:

Laura C. Cappelli, M.D Johns Hopkins University School of Medicine

Dr. Laura Cappelli

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.

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Chewing Gum Test Unmasks Jaw Claudication of Giant Cell Arteritis

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.

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Study Finds Lupus Doubles Risk of Dementia

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.

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Screening for Hearing Impairment: A critical issue in patients with Rheumatoid Arthritis

MedicalResearch.com Interview with:

Dr-Amir-Emamifar

Dr. Emamifar

Dr. Amir Emamifar, MD
Department of Rheumatology
Odense university Hospital
Svendborg Hospital, Denmark

Associate Professor Inger Marie Jensen Hansen, PhD, DMsci Department of Rheumatology, Odense university Hospital, Svendborg Hospital, Denmark. University of Southern Denmark.

Dr. Hansen

 

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.

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Immunotherapy with IL-17 Blocker Secukinumab Improves Ankylosing Spondylitis

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.

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microRNAs in Joint Fluid As Biomarker For Antibiotic Refractory Lyme Arthritis

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.

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Biologics in Rheumatic Disease Reduce Missed Workdays

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.

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Hospital-Based Exercise Program Reduced Pain, Improved Quality of Life

Sandra Goldsmith, MA, MS, RD Director of Public and Patient Education at Hospital for Special Surgery New York City.MedicalResearch.com Interview with:
Sandra Goldsmith, MA, MS, RD
Director of Public and Patient Education at Hospital for Special Surgery
New York City.

Medical Research: What is the background for this study? What are the main findings?

Response: Almost 50 million adults in the United States suffer from some form of musculoskeletal disorder, which can affect their mobility and quality of life. Osteoarthritis (OA) is the leading cause of disability in the U.S. and affects more than 70 percent of adults between the ages of 55 and 78. Research has shown that there is a connection between being physically active and maintaining joint health, pain relief and improved quality of life. This study attempts to support the efficacy of Hospital for Special Surgery’s hospital-based exercise programs in increasing physical activity and improving quality of life through pain relief and improved stiffness, fatigue and balance in the older adult community.

This study found that after taking the exercise classes, fewer participants reported experiencing a high level of muscle/joint pain from their condition (56 percent before the program started vs. 47 percent after completing the program). The study also reported improved quality of life, as evidenced by statistically significant reductions in how much their pain interfered with their general activities, ability to walk, mood, sleep and enjoyment of life. In addition, 83 percent of participants indicated a reduction in stiffness; 82 percent said they felt their balance improved; and 67 percent said they experienced less fatigue as a result of taking part in the program. Health outcomes were also related to the type of exercise class participants chose, with the greatest reduction in muscle/joint pain reported by those who took t’ai chi.

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Herbal Cannabis Not Proven Effective For Rheumatic Diseases

Mary-Ann Fitzcharles, MB, ChB, MRCP(UK), FRCP(C) McGill University Health Centre Division of Rheumatology and Alan Edwards Pain Management UnitMedicalResearch.com Interview with:
Mary-Ann Fitzcharles, MB, ChB, MRCP(UK), FRCP(C)
McGill University Health Centre
Division of Rheumatology and Alan Edwards Pain Management Unit


MedicalResearch.com: What are the highlights of your review?

Dr. Fitzcharles: Thank you for your interest in the review article which will shortly be published in Arthritis Care & Research. This was not a research study but rather a review focused towards the use of herbal cannabis for patients with rheumatic diseases.

The essence of our message after a thorough review of the literature is that there is not a single study published regarding efficacy or side effects of herbal cannabis in the rheumatic diseases. It is notable that almost 2 thirds of persons using herbal cannabis for therapeutic reasons report use for musculoskeletal complaints. In the 21st century, we cannot rely upon heresay or anecdote to justify use of a treatment intervention. It is unacceptable to recommend use of a substance without knowledge of concentration of molecules in the product, any knowledge of blood concentrations that might have a positive or negative effect, and formal study in defined patient populations with acceptable endpoint criteria and evidence for short and long term risks.
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