Author Interviews, Gout, Rheumatology / 15.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54552" align="alignleft" width="200"]Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics Dr. LaMoreaux[/caption] 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.
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    [caption id="attachment_54552" align="alignleft" width="200"]Brian LaMoreaux, M.D., M.S. Medical Director, Medical Affairs Horizon Therapeutics Dr. LaMoreaux[/caption] 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.  
AstraZeneca, Author Interviews, Rheumatology / 11.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54497" align="alignleft" width="142"]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 Dr. Furie[/caption] 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.” 
Author Interviews, COVID -19 Coronavirus, Lancet, Rheumatology / 08.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54122" align="alignleft" width="150"]Dr. Giulio Cavalli Dr. Cavalli[/caption] Dr. Giulio Cavalli MD PhD & [caption id="attachment_54123" align="alignleft" width="150"]Prof. Lorenzo Dagna Prof. Dagna[/caption] 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.
Author Interviews, COVID -19 Coronavirus, Rheumatology / 16.04.2020

MedicalResearch.com Interview with: [caption id="attachment_53923" align="alignleft" width="138"]Ellen M. Gravallese M.D. President, American College of Rheumatology Dr. Gravallese[/caption] 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.
Author Interviews, JAMA, Ophthalmology, Rheumatology / 15.12.2019

MedicalResearch.com Interview with: [caption id="attachment_52467" align="alignleft" width="130"]Robert Ritch, MD, FACS, FARVO Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology Surgeon Director Emeritus Chief, Glaucoma Services Emeritus The New York Eye and Ear Infirmary of Mount Sinai New York, NY 10003 Founder, Medical Director and Chairman, Scientific Advisory Board The Glaucoma Foundation Dr. Ritch[/caption] Robert Ritch, MD, FACS, FARVO Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology, Surgeon Director Emeritus Chief, Glaucoma Services Emeritus The New York Eye and Ear Infirmary of Mount Sinai New York, NY 10003 Founder, Medical Director and Chairman, Scientific Advisory Board The Glaucoma Foundation  MedicalResearch.com: What is the background for this study? Response: Nailfold capillaroscopy (NFC), long used in rheumatology is a new approach to investigation of glaucoma. Posterior to the nailbed and just anterior to the proximal nailfold is the cuticle, which has no structural elements visible to the naked eye. NFC is a non-invasive imaging modality that provides a highly magnified view of the capillaries at the nailfold of digits. It has also been used in ophthalmology to show morphological changes at the nailfold capillaries of POAG and XFG/XFS patients, helping to confirm the systemic nature of these diseases. [caption id="attachment_52469" align="alignleft" width="400"]Nailfold Capillaroscopy Dr. Ritch Nailfold Capillaroscopy / Dr. Ritch[/caption] With nailfold capillaroscopy, an extensive array of capillaries can be seen greatly enlarged on a monitor screen. Capillary loops can be imaged, stored, recorded with videoscopy, and blood flow actively imaged and measured.. The first series of papers on glaucoma were written by Prof Josef Flammer’s group at the turn of the 21st century, looking at vasospasm, blood flow in normal-tension and high-tension glaucoma, and relating ocular blood flow alterations to systemic vascular regulation and relating laser Doppler flowmetry to NFC. Studies from Korea later associated nailbed hemorrhages and loss of nailbed capillaries to the presence of optic disc hemorrhages and investigated correlation of of heart rate variability with visual field defects and nailfold capillaroscopy. Studies by our group began with the publication in 2015 of a paper by Pasquale et al (Nailfold Capillary Abnormalities in Primary Open-Angle Glaucoma: A Multisite Study. IOVS;56:7021) using NFC video microscopy, associating dilated capillaries, avascular zones, and hemorrhages with primary open-angle glaucoma. Successive manuscripts and presentations at conferences have indicated differences between capillary loop patterns in high-tension and normal-tension POAG and exfoliation syndrome/exfoliation glaucoma. Our goal in this paper was to compare nailfold peripheral blood flow in XFG, which had not previously been compared to control subjects using NFC. We explored the peripheral blood flow at the nailfold of patients with high-tension glaucoma, normal-tension glaucoma, exfoliation glaucoma (XFG) and compared it to control subjects further evaluate the possible differences between these glaucoma entities. We examined the morphology and extent of nailfold capillary loops, vascular tortuosity, blood flow, and nailfold hemorrhages.
Abbvie, Author Interviews, Rheumatology / 27.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52304" align="alignleft" width="200"]Aileen Lorenzo Pangan MD Executive Medical Director AbbVie Dr. Pangan[/caption] Aileen Lorenzo Pangan MD Executive Medical Director AbbVie MedicalResearch.com: What is the background for this study? Response: Our ongoing commitment to advancing the standard of care for patients with rheumatic diseases is illustrated by our growing portfolio and the thirty-eight abstracts we presented at this year's ACR/ARP Annual Meeting, including results from five studies of RINVOQ in rheumatoid arthritis (RA) and primary results from our study in ankylosing spondylitis (AS).
Author Interviews, Rheumatology / 22.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52279" align="alignleft" width="150"]Professor Jianmin Fang, Ph.D. Founder, CEO & CSO RemeGen Dr. Fang[/caption] Professor Jianmin Fang, Ph.D. Founder, CEO & CSO RemeGen MedicalResearch.com: What is the background for this study? Response: Systemic lupus erythematosus (SLE), known more commonly as lupus, is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue. SLE can affect tissues like the skin, joints, kidneys, brain and other organs, resulting in a wide variety of signs and symptoms. With limited treatment options for lupus and the significant unmet medical needs in the treatment of autoimmune diseases, the Phase 2b study evaluated the efficacy and safety of subcutaneous RC18 (telitacicept), a potential new medicine for the treatment of systemic lupus erythematosus (SLE) versus a placebo in combination with standard therapy in patients with SLE at 48 weeks.
Author Interviews, Rheumatology / 14.11.2019

MedicalResearch.com Interview with: [caption id="attachment_45610" align="alignleft" width="154"]Dr. W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, study co-author Co-principal investigator of ArthritisPower Dr. Nowell[/caption] 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. 
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Rheumatology / 13.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52139" align="alignleft" width="200"]Natalie McCormick, Ph.D. Post-Doctoral Research Fellow Clinical Epidemiology Program Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital Department of Medicine, Harvard Medical School Arthritis Research Canada Dr. McCormick[/caption] Natalie McCormick, Ph.D. Post-Doctoral Research Fellow Clinical Epidemiology Program Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital Department of Medicine, Harvard Medical School Arthritis Research Canada  MedicalResearch.com: What is the background for this study? Response: Biologic disease-modifying anti-rheumatic drugs (bDMARDs) have improved the health and productivity of many people living with moderate-to-severe inflammatory rheumatic diseases. They are also among the highest-spend drugs in the USA, with substantial out-of-pocket costs that pose barriers to treatment initiation and adherence. To understand the drivers of ongoing bDMARD spending growth, and effective ways of containing costs, we analysed drug spending data for all bDMARD claims in Medicare Part D, Part B fee-for-service, and Medicaid over 2012 to 2016, isolating the impact of changes in drug prices from changes in utilisation. 
Author Interviews, Opiods, Rheumatology / 12.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52079" align="alignleft" width="142"] Dr. Bannuru[/caption] 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.
Author Interviews, Rheumatology / 11.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52102" align="alignleft" width="200"]Kelly Gavigan, MPH Manager, Research and Data Science CreakyJoints  Kelly Gavigan[/caption] 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. 
Author Interviews, Pain Research, Rheumatology / 11.11.2019

MedicalResearch.com Interview with: [caption id="attachment_51988" align="alignleft" width="200"]Féline PB Kroon MD Department of Rheumatology Leiden University Medical Centre LUMC ·  Dr. Kroon[/caption] Féline PB Kroon MD Department of Rheumatology Leiden University Medical Centre LUMC · MedicalResearch.com: What is the background for this study? Response: Hand osteoarthritis (OA) is a prevalent joint condition that causes pain, functional disability, and decreased quality of life, for which patients frequently consult health-care providers. Symptoms usually fluctuate over time, with episodes of joint swelling and erythema. Evidence from previous studies has shown that inflammation plays an important role in the disease, being an important predictor for pain and radiographic damage progression. Therefore, we hypothesized that inflammation could be a treatment target in OA, and we investigated this using prednisolone, a potent anti-inflammatory drug. The aim of the HOPE study was to investigate the clinical efficacy and safety of a six-week course of prednisolone 10 mg daily in patients with painful hand OA who had evidence of synovial inflammation.
Author Interviews, Gout, Kidney Disease, Rheumatology, Transplantation / 10.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52115" align="alignleft" width="126"]Megan Francis-Sedlak, PhD Associate Director of Medical Affairs Horizon Therapeutics Lake Forest, Illinois Dr. Francis-Sedlak[/caption] Megan Francis-Sedlak, PhD Director of Medical Affairs Horizon Therapeutics Lake Forest, Illinois MedicalResearch.com: What is the background for this study? Response: The prevalence of gout is more than ten-fold greater among patients who have undergone a kidney transplant than the general population as post-transplant medications to prevent organ rejection can contribute to increased uric acid levels. Overall studies have shown this can lead to higher rates of uncontrolled gout among this vulnerable population with organ transplants. While we have seen higher mortality rates for patients who have received a kidney transplant with uncontrolled gout compared to kidney transplant patients without uncontrolled gout, we wanted to evaluate the impact of gout on transplant-related complications to better inform patient care and treatment approaches. 
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Dermatology, JAMA, Rheumatology / 09.11.2019

MedicalResearch.com Interview with: Emily S. Ruiz, MD, MPH Director, High-Risk Skin Cancer Clinic, Dana Farber/Brigham and Women’s Cancer Center Assistant Professor, Harvard Medical School, Dermatology Brigham And Women's Faulkner Hospital  MedicalResearch.com: What is the background for this study? Response: Innovation in oncology has led to increased development and market entry of anticancer drugs. For example, from 2009 to 2013, the US FDA approved 51 oral and systemic anticancer drugs for 63 indications. Prices for anticancer drugs have risen faster than inflation over time, especially for older drugs, and prices in the US have largely been set by market forces rather than novelty or efficacy. Understanding the evolving cancer economic landscape requires consideration of annual and cumulative rates of change for key metrics, such as total spending, drug cost per beneficiary, out-of-pocket cost, and utilization. This study sought to weigh the proportional impacts of rising drug costs and utilization on increased Medicare Part D spending for a cohort of oral anticancer drug utilized from 2013-2017. 
Author Interviews, Pain Research, Rheumatology / 12.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51257" align="alignleft" width="154"]Dr. Ben Nowell PhD Director of Patient-Centered Research Global Healthy Living Foundation Co-Principal Investigator of CreakyJoints ArthritisPower  Dr. Ben Nowell[/caption] W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, Principal Investigator of ArthritisPower MedicalResearch.com: What is the background for this study? Response: Over the past fifteen years, the treatment options for people diagnosed and living with rheumatoid arthritis (RA) have grown. There are now many medications (particularly biologic disease-modifying antirheumatic drugs, or bDMARDs) proven to improve disease symptoms and immune system over activity, thereby reducing inflammation and joint damage. The American College of Rheumatology recommends a treat-to-target approach, which has the patient and rheumatologist setting goals for treatment effectiveness and making adjustments over time to meet those goals. This study aimed to determine if rheumatoid arthritis patients are satisfied with their treatment. The goal of this study was to identify the following: patients’ satisfaction with current RA treatment, the current unmet needs perceived by patients with rheumatoid arthritis in the United States, the symptoms of rheumatoid arthritis that are most bothersome to patients, and the impact of symptoms on function and quality of life that may lead patients to need alternative treatments. 
Annals Internal Medicine, Author Interviews, OBGYNE, Rheumatology / 17.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50282" align="alignleft" width="155"]Bella Mehta, MBBS, MS  Assistant Attending Physician, Hospital for Special Surgery Instructor, Weill Cornell Medical College     Dr. Mehta[/caption] 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. 
Author Interviews, Opiods, Orthopedics, Rheumatology / 09.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50189" align="alignleft" width="200"]Professor Martin Englund MD PhD Department of Orthopaedics Lund University Prof. Englund[/caption] Professor Martin Englund MD PhD Department of Orthopaedics Lund University  MedicalResearch.com: What is the background for this study? Response: Currently, there is lack of knowledge of opioid usage in osteoarthritis patients. Opioids are typically not recommended for the treatment of osteoarthritis pain. 
Author Interviews, Bristol Myers Squibb, Rheumatology / 26.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49997" align="alignleft" width="200"]Sean Connolly, Ph.D. Director of Non-Registrational Data Generation Study Director for ASCORE Bristol-Myers Squibb Dr. Connolly[/caption] Sean Connolly, Ph.D. Director of Non-Registrational Data Generation Study Director for ASCORE Bristol-Myers Squibb MedicalResearch.com: What is the background for this study? Response: ASCORE is a two-year, prospective multicenter study to observe retention and response rates of moderate-to-severe rheumatoid arthritis (RA) patients receiving ORENCIA® (abatacept), administered subcutaneously via a pre-filled syringe, in routine clinical practice. Findings shared at the Annual European Congress of Rheumatology (EULAR 2019) are the results from the first 12 months. An important objective of our development program is to understand how well we can replicate findings from our clinical trials among a real-world patient population. In the case of ASCORE, which looked at approximately 3,000 patients, both bio-naïve and patients receiving later-line therapies, these data add to the body of research that may help inform physicians treating patients with RA. Patients participating in ASCORE were divided into two distinct cohorts at the outset of the study: bio-naïve and patients previously administered one or more biologic agents. The primary endpoint is to estimate the rentention rate of patients in each cohort over a 24-month period. Furthermore, ASCORE examines the patient populations across ten countries to understand factors including: how ORENCIA is prescribed, characteristics of patients from each country (socio-demographic data, medical history, co-morbidities, etc.), and population health statistics within each country. This sub-analysis is factored into patient response to treatment across both cohorts, which may help physicians better understand how and why certain populations demonstrate a specific retention rate.
Author Interviews, Orthopedics, Pharmacology, Rheumatology / 28.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47695" align="alignleft" width="143"]Dr. Andrew Spitzer MDCo-director Joint Replacement ProgramCedars-Sinai Orthopedic CenterLos Angeles, CA Dr. Spitzer[/caption] 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.
Author Interviews, JAMA, MRI, Rheumatology / 07.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47400" align="alignleft" width="133"]Signe Møller-Bisgaard MD, PhD Rigshospitalet Center for Rheumatology and Spine Diseases Copenhagen Center for Arthritis Research  Dr. Møller-Bisgaard[/caption] Signe Møller-Bisgaard MD, PhD Rigshospitalet Center for Rheumatology and Spine Diseases Copenhagen Center for Arthritis Research  MedicalResearch.com: What is the background for this study?  Response: The background was that to avoid long-term consequences of rheumatoid arthritis (RA) such as progressive joint damage progression leading to functional impairment and loss of quality of life, it is essential for patients with RA to achieve clinical remission, which is a disease state with no clinical signs and symptoms of disease activity. But despite treating our patients according to current clinical recommendations using targeted treatment strategies, so that the patients reach a state of remission, joint damage progression still occurs in one out of four patients. We knew, that MRI inflammatory findings such as synovitis and bone marrow edema are present in patients in clinical remission and are of prognostic value. In particular bone marrow edema has shown to be a strong predictor of erosive joint damage progression. In the IMAGINE-RA randomized clinical trial we therefore wanted to investigate if an MRI treat-to-target strategy targeting absence of bone marrow edema versus a conventional disease activity-guided treat-to-target strategy would improve clinical and radiographic outcome in rheumatoid arthritis patients in clinical remission. 
Author Interviews, Occupational Health, Rheumatology / 01.11.2018

MedicalResearch.com Interview with: [caption id="attachment_45610" align="alignleft" width="154"]Dr. W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, study co-author Co-principal investigator of ArthritisPower Dr. Nowell[/caption] Dr. W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, study co-author Co-principal investigator of ArthritisPower MedicalResearch.com: What is the background for this study? What are the main findings? Response: Rheumatoid Arthritis (RA) can diminish patients’ work productivity and increase the risk of long-term disability, economic insecurity and worsening health, but limited research informs these issues. The purpose of our study was to examine associations between patients’ RA disease activity and their productivity and workplace support, using real-world data from the ArthritisPower research registry. Our study looked at a sample of participants with RA who had a history of or current treatment with non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARD) (n=296). Among the study sample, 74 percent had high disease activity (HDA) as determined by RAPID3 (>12), a common measure of disease activity in RA.
  • High disease activity was associated with lower education (p<0.001) and higher likelihood of disability (9%, p<0.001) compared to those without high disease activity.
    • Patients with HDA missed more days of work than non-HDA patients (mean: 6.1 vs 3.8 days, respectively; p=0.03), but non-HDA participants reported more days off due to medical appointments (2.6 vs 1.2 days, respectively) while HDA patients missed more days due to RA treatment side effects (mean: 0.5 vs 0.1 days, respectively).
  • Based on scores from the Work Productivity and Activity Impairment (WPAI) questionnaire, RA seems to affect work productivity to a greater extent in participants with HDA than without (WPAI scores 5.3 and 3.3, respectively; p<0.001). Participants who were not currently employed reported having more physically demanding tasks (e.g. heavy load lifting) and less workplace flexibility (e.g. working from home) in their most recent paid position than currently employed participants.
  • However, in a multivariate regression analysis, we found that participants who could request changes in work start and stop times on a daily basis were 2.9 (95% CI: 1.53, 5.46) times more likely to be unemployed (adjusting for age, disease activity, and satisfaction with social participation) than those unable to make this request (p<0.0001).
About ArthritisPower: Created by CreakyJoints and supported by a multiyear, multimillion dollar investment by the Patient-Centered Outcomes Research Institute (PCORI), ArthritisPower is the first-ever patient-centered research registry for joint, bone, and inflammatory skin conditions. The free ArthritisPower mobile and desktop application allows patients to track and share their symptoms and treatments while also participating in voluntary research studies in a secure and accessible manner. ArthritisPower Patient Governors serve as gatekeepers for researchers who seek access to registry data or solicit the community to participate in unique, voluntary studies. To learn more and join ArthritisPower, visit www.ArthritisPower.org. 
Author Interviews, Genetic Research, NEJM, Pulmonary Disease, Rheumatology / 24.10.2018

MedicalResearch.com Interview with: [caption id="attachment_45454" align="alignleft" width="133"]Joyce S. Lee, MD Associate Professor Director, Interstitial Lung Disease Program Department of Medicine Division of Pulmonary Sciences and Critical Care Medicine University of Colorado School of Medicine Dr. Lee[/caption] Joyce S. Lee, MD Associate Professor Director, Interstitial Lung Disease Program Department of Medicine Division of Pulmonary Sciences and Critical Care Medicine University of Colorado School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Rheumatoid arthritis (RA) is a common inflammatory arthritis that can be complicated by interstitial lung disease (ILD). Patients with RA-ILD share clinical characteristics with another ILD called idiopathic pulmonary fibrosis (IPF). Given the similar clinical phenotype, our goal was to see if these lung diseases (IPF and RA-ILD) shared a common genetic risk factor. The MUC5B promoter variant is the most common risk factor (genetic and otherwise) for the development of IPF. Our findings demonstrate the MUC5B promoter variant is also a strong risk factor for the development of RA-ILD among patients with RA.
Author Interviews, Bristol Myers Squibb, Rheumatology, Smoking / 24.10.2018

MedicalResearch.com Interview with: [caption id="attachment_45370" align="alignleft" width="90"]Pr Gilles Boire, M.D., M. ScService de rhumatologie Département de médecine Faculté de médecine et des sciences de la santé Université de Sherbrooke Prof. Boire[/caption] Pr Gilles Boire, M.D., M. ScService de rhumatologie Département de médecine Faculté de médecine et des sciences de la santé Université de Sherbrooke MedicalResearch.com: What is the background for this study? Response: Rheumatoid arthritis (RA) patients are heterogeneous at initial presentation, in response to treatments and according to their outcomes. No clinical features and very few biomarkers, except autoantibodies such as anti-Cyclic Citrullinated Peptides/Proteins (CCP), identify patients with divergent prognostic trajectories. To help improve early prognostic classification, we initiated 20 years ago the single center longitudinal observational Early Undifferentiated PolyArthritis (EUPA) study of consecutive patients presenting with recent-onset inflammatory polyarthritis, 90% of which fulfill classification criteria for RA at baseline. Our registry includes 739 very early RA patients (median symptom duration 3.6 months), rapidly treated to joint remission (i.e. 0/66 swollen joint) and followed over 5 years. Each patient visit is linked to biosamples and to sequential radiographs scored according to the modified Sharp/van der Heijde method. As we had the clinical impression that clinical features of recruited patients were evolving, we compared patients from 3 periods (1998-2004; 2005-2010; 2011-2017). 
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. [caption id="attachment_45185" align="aligncenter" width="400"]This combined MR/PET image highlights areas of the brain in which patients with fibromyalgia were found to have increased glial activation, compared with unaffected control volunteers. Credit: Marco Loggia, PhD, Martinos Center for Biomedical Imaging, Massachusetts General Hospital This combined MR/PET image highlights areas of the brain in which patients with fibromyalgia were found to have increased glial activation, compared with unaffected control volunteers.
Credit: Marco Loggia, PhD, Martinos Center for Biomedical Imaging, Massachusetts General Hospital[/caption] 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.
Author Interviews, Rheumatology / 03.10.2018

MedicalResearch.com Interview with: [caption id="attachment_44987" align="alignleft" width="178"]Virginia Ladd, CEO   Virginia Ladd, CEO[/caption] Virginia Ladd, CEO   American Autoimmune Related Disease Association (AARDA) MedicalResearch.com: Would you briefly explain what is meant by autoimmune disorders? Response: Autoimmune disease is a broad category of related diseases which share both genetic and mechanistic properties.  They occur when the person’s immune system attacks the body’s own cell, and tissue. The immune system goes awry and mistakenly attacks the tissues and organs it was designed to protect. Normally the immune system protects the It does this by body by responding to invading microorganisms, such as bacteria, and viruses. Producing antibodies which are special proteins that recognize and destroy the invaders. Autoimmune diseases occur when autoantibodies attack the body’s own cells, tissue and organs.
Author Interviews, Depression, JAMA, Rheumatology / 13.09.2018

MedicalResearch.com Interview with: [caption id="attachment_44404" align="alignleft" width="183"]Andrea L. Roberts, MPH, PhD Research Associate, Department of Social and Behavioral Sciences Harvard T.H. Chan School of Public Health Dr. Roberts[/caption] Andrea L. Roberts, MPH, PhD Research Associate, Department of Social and Behavioral Sciences Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: There is some evidence that depression may increase risk of autoimmune diseases. For example, among people with autoimmune diseases, more people have depression than in the general population. Also, people who have autoimmune diseases who also have depression have more severe disease symptoms.
Author Interviews, Gout, Obstructive Sleep Apnea, Rheumatology / 30.08.2018

MedicalResearch.com Interview with: [caption id="attachment_44241" align="alignleft" width="200"]Dr M Blagojevic-Bucknal Senior Lecturer in Statistics Arthritis Research UK Primary Care Centre Research Institute for Primary Care & Health Sciences Keele University Staffordshire UK Dr. Blagojevic-Bucknal[/caption] Dr M Blagojevic-Bucknal Senior Lecturer in Statistics Arthritis Research UK Primary Care Centre Research Institute for Primary Care & Health Sciences Keele University Staffordshire UK  MedicalResearch.com: What is the background for this study? Response: Evidence suggests that elevated serum uric acid levels, the cause of gout, are also frequently identified in patients with sleep apnoea However, despite prevalent hyperuricaemia in patients with sleep apnoea, shared risk factors with gout of obesity and alcohol consumption, and research identifying the associations between gout and other co-morbidities, few studies have considered the possibility of an association between sleep apnoea and gout in short and long term.
Author Interviews, JAMA, Rheumatology, Statins / 31.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43568" align="alignleft" width="180"]Dr Gillian E. Caughey PhD Senior Research Fellow | School of Medicine | Discipline of Pharmacology THE UNIVERSITY OF ADELAIDE Australia Dr. Caughey[/caption] Dr Gillian E. Caughey PhD Senior Research Fellow | School of Medicine Discipline of Pharmacology THE UNIVERSITY OF ADELAIDE Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Statins are one of the most commonly prescribed medications worldwide.  Muscular adverse effects (myalgia and myopathy) are well recognised adverse effects and symptoms resolve with cessation of statins. Idiopathic inflammatory myositis (IIM) is a heterogeneous group of autoimmune myopathies that may also be associated with statin use. IIM does not resolve with cessation of statin therapy, requires treatment with immunosuppressive agents and is a severe, debilitating condition. To date, there have been no epidemiological studies examining exposure to statins and the association of histologically confirmed IIM. In our case control study of 221 cases o fIdiopathic inflammatory myositis, there was an almost 2-fold increased likelihood of statin exposure in patients with IIM compared with controls (adjusted odds ratio, 1.79; 95%CI, 1.23-2.60). After observing a significant association of statin exposure with IIM, we conducted a sensitivity analysis where we excluded those patients with necrotizing myositis as recent studies have reported this type of IIM to be associated with statin use and the presence of autoantibodies against HMG-CoA reductase. Exclusion of these specific cases from the analysis did not change our study findings and an increased risk of Idiopathic inflammatory myositis with statin exposure remained (adjusted OR, 1.92; 95% CI, 1.29-2.86).  This suggest the potential association of all types of Idiopathic inflammatory myositis with statin exposure.