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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