Author Interviews, Cost of Health Care, Rheumatology, University of Pittsburgh / 01.12.2022

MedicalResearch.com Interview with: Raisa Silva, M.D. Resident physician in Internal medicine University of Pittsburgh Medical Center MedicalResearch.com: What is the background for this study? Response: Systemic lupus erythematosus (lupus for short) is a complex disease that significantly affects patients’ lives. Adherence to medications for lupus is known to be suboptimal (it can be as low as 15% in some studies). Multiple social factors may affect treatment adherence. For example, costs of medications (including copayments, deductibles, co-sharing), polypharmacy (patients with lupus often have comorbid diseases that also need medications), and potential side effects are some of the reasons why patients may have difficulty in taking medications for lupus every day. The costs of insurance copayment may represent a major obstacle to adherence. The lack of adherence to lupus medications is associated with poor control of disease, more symptoms, and worse disease outcomes, such as more hospitalizations and more severe disease. In our study, we examined the association between lupus medications copayment and adherence to these medications (some of the most commonly used medications for lupus). (more…)
Author Interviews, COVID -19 Coronavirus, PLoS, Rheumatology / 04.11.2022

MedicalResearch.com Interview with: Professor Tim Vyse Professor of Molecular Medicine and Dr David Morris Non Clinical Lecturer in Molecular Genetics Guy’s Hospital, London MedicalResearch.com: What is the background for this study? What are the main findings? Response: We observed a correlation between the genetic associations with severe COVID-19 and those with systemic lupus erythematosus (SLE, Lupus), and aimed to discover which genetic loci were shared by these diseases and what biological processes were involved. This resulted in the discovery of several genetic loci, some of which had alleles that were risk for both diseases and some of which were risk for severe COVID-19 yet protective for SLE. The locus with most evidence of shared association (TYK2) is involved in interferon production, a process that is important in response to viral infection and known to be dysregulated in SLE patients.  Other shared associated loci contained genes also involved in the defense response and the immune system signaling. These results add to the growing evidence that there are alleles in the human genome that provide protection against viral infection yet are risk for autoimmune disease. (more…)
Author Interviews, Biogen, NEJM, Rheumatology / 15.09.2022

MedicalResearch.com Interview with: Nathalie Franchimont, M.D., Ph.D. Senior Vice President, Head of Multiple Sclerosis and Immunology Head of the Multiple Sclerosis and Immunology Development Unit Biogen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects multiple organ systems. Rash and arthritis are among the most frequent manifestations of the disease and severe organ damage can also occur especially when organs like the kidney are affected. Litifilimab (known as BIIB059) is a monoclonal antibody being studied for the potential treatment of SLE and cutaneous lupus erythematosus (CLE). The Phase 2 LILAC study evaluated litifilimab versus placebo in two parts: Part A in participants who have SLE with active joint and skin manifestations; and Part B in participants with active CLE, including chronic and subacute subtypes, with or without other organ involvement. Results from the SLE portion of the study (Part A) show litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared to placebo. Total active joint count was defined as the total number of tender or swollen joints. Litifilimab was generally well tolerated, with most reported adverse events (AEs) rated as mild or moderate. Note, this Phase 2 trial was not powered to assess secondary endpoints. Based on these positive Phase 2 results, Biogen is currently enrolling participants into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, which will evaluate the efficacy and safety of litifilimab in participants with active SLE worldwide. Part B results from LILAC were published separately in NEJM on July 28, 2022 and expand the body of evidence supporting litifilimab as a potential first-in-class therapy for cutaneous lupus erythematosus in addition to SLE. (more…)
Author Interviews, COVID -19 Coronavirus, Mental Health Research, Rheumatology / 07.06.2022

MedicalResearch.com Interview with: Kelly Gavigan, MPH Director, Data Management and Analytics Global Healthy Living Foundation MedicalResearch.com:  What is the background for this study?  Response: COVID-19 is of particular concern for people living with autoimmune and rheumatic disease, not only because they have an increased risk of infection but also because of the heightened sense of isolation due to strict social distancing protocols that many patients continue to follow through today. As a result, we wanted to better understand if symptoms among the autoimmune and rheumatic disease patients in our ArthritisPower research registry were impacted throughout the COVID-19 pandemic. We previously conducted and reported on an analysis of patient reported outcome data from the ArthritisPower registry between the months of January 2020 to April 2021 at the American College of Rheumatology Convergence in 2021. We conducted a follow-up analysis between May and December 2021, which is our area of focus in this particular abstract. (more…)
Author Interviews, Kidney Disease, Rheumatology / 24.01.2022

Stephen Connelly, PhD Co-founder & Chief Scientific Officer Equillium, Inc. San Diego, California MedicalResearch.com:  What is the background for this study?    Response: Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease that predominantly affects women in the reproductive age range. Approximately 50% of SLE patients experience lupus nephritis (LN), a serious complication that is accompanied by significant morbidity and mortality. Progression of LN to chronic kidney disease is common, with 10% of patients with LN developing end-stage kidney disease. T cells, play a central role in the pathogenesis of both SLE and LN by mediating tissue damage and enhancing the production of autoantibodies by promoting B cell differentiation, proliferation, and maturation. These T cells express CD6, a costimulatory receptor that through its binding to activated leukocyte cell adhesion molecule (ALCAM), expressed on immune cells and tissues, modulates both the activity and trafficking of effector T cells (Teff). The expression of both CD6 and ALCAM (CD6-ALCAM pathway) have been associated with pathogenic effector T cell activity and trafficking in multiple autoimmune and inflammatory diseases. Based on a comprehensive screen of more than 1100 urine proteins, soluble urinary ALCAM (uALCAM) was identified as one of only a few molecules that were elevated in the urine of patients with SLE with active renal involvement compared with patients with quiescent or no prior nephritis. However, no studies had been conducted to characterize the cellular sources of the soluble ALCAM and questions remained about the relevance of this protein and whether it was associated with the pathology of the disease. (more…)
Author Interviews, Rheumatology / 10.11.2021

MedicalResearch.com Interview with: Kelly Gavigan, MPH Manager, Research and Data Science CreakyJoints and Global Healthy Living Foundation MedicalResearch.com: What is the background for this study? Response: We understood that COVID-19 is of particular concern for people living with autoimmune and rheumatic disease because they are at increased risk of infection, and this created a heightened sense of isolation due to the strict social distancing protocols that so many patients have followed. As a result, we wanted to better understand if symptoms among the autoimmune and rheumatic disease patients in our ArthritisPower research registry were impacted throughout the COVID-19 pandemic. We analyzed patient reported outcome scores for mental, social, and physical health measures between the months of January 2020 and April 2021. We tested the null hypothesis that there was no change in monthly average assessment scores across the 15-month observation period. (more…)
Author Interviews, COVID -19 Coronavirus, Rheumatology / 10.11.2021

MedicalResearch.com Interview with: Courtney K. Wells, PhD, MSW, MPH, LGSW Assistant Professor & Field Coordinator Department of Social Work University of Wisconsin-River Falls and member of CreakyJoints MedicalResearch.com: What is the background for this study? Response: This study was initiated because early in the pandemic there was little information available regarding quality of life and the day-to-day activities of patients with rheumatic conditions. We were particularly interested in patients’ psychosocial experiences and how they made decisions about their health. We found that participants’ understanding of their risk for COVID-19 played a key role in their decision making processes. At the beginning of the pandemic, many participants viewed themselves as being high risk because of their condition and/or medications and took extreme precautions. These precautions isolated them from their family, friends, and healthcare, all of which negatively affected their physical and mental health. As the pandemic went on, participants described an exhausting balancing act between their risk for COVID-19, their rheumatic condition, and their mental health. Because we did interviews over 6 months, we saw participants shifting their priorities towards their mental health as more information became available and the vaccine emerged. We also learned that rheumatology patients from BIPOC ( Black, Indigenous, People of Color) and immigrant communities experienced unique stressors during the pandemic such as barriers to accessible and trusted healthcare providers and increased experiences of racism. (more…)
Author Interviews, Gout, Orthopedics, Rheumatology / 09.06.2021

MedicalResearch.com Interview with: Dr. Prof. Dr.  Gurkirpal Singh, MD Adjunct Clinical Professor of Medicine Stanford University MedicalResearch.com: What is the background for this study? Response: Joint damage from gout has been linked to a possible increase in knee and hip joint replacements. The strong association between gout and osteoarthritis could also lead to an increased risk of joint replacements in patients with gout as the presence of gout may accelerate or worsen osteoarthritis.[i] This study aimed to evaluate total or partial hip and knee joint replacements in patients with gout in the U.S. and to estimate their economic impact. Data was analyzed on hospitalizations in patients with gout with hip and knee joint replacements in 2018, using the Nationwide Inpatient Sample  (NIS) which is the largest publicly available all-payer inpatient healthcare database. (more…)
Author Interviews, BMJ, COVID -19 Coronavirus, Gout, Rheumatology / 03.02.2021

MedicalResearch.com Interview with: Dr Rene Oliveira Department of Internal Medicine Ribeirao Preto Medical School University of Sao Paulo Ribeirao Preto, Brazil  MedicalResearch.com: What is the background for this study? Response: As rheumatologists our background for testing colchicine for COVID-19 was the effect of the drug on gout, Behçet's disease and familial Mediterranean fever. For these diseases, the drug is able to reduce systemic inflammation by acting in some cytokine pathways which the first reports in COVID-19 suggested being the same. We found that colchicine was able to reduce systemic inflammation and diminish the length of need for supplemental oxygen and hospitalisation. (more…)
Author Interviews, CMAJ, Orthopedics, Rheumatology, Surgical Research / 02.02.2021

MedicalResearch.com Interview with: Codie Primeau, MSc Physical Therapy Student & Ph.D. Candidate (Combined MPT/Ph.D.) Wolf Orthopaedic Biomechanics Lab, Fowler Kennedy Sport Medicine Clinic Western University London, ON, Canada MedicalResearch.com: What is the background for this study? Response: High tibial osteotomy (HTO) is a surgery for patients with varus alignment (bowed legs) and earlier-stage knee osteoarthritis. By correcting alignment, HTO shifts load to less diseased parts of the knee. One of the goals of HTO is to delay or even prevent the need for knee replacement surgery later.  (more…)
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, Orthopedics, Radiology, Rheumatology, UCSF, Weight Research / 18.11.2020

MedicalResearch.com Interview with: Silvia Schirò MD Department of Radiology and Biomedical Imaging University of California, San Francisco MedicalResearch.com: What is the background for this study?  Response: Knee osteoarthritis (OA) is worldwide the second most frequent cause of lower extremity disability, and it has a global incidence of 199 cases per 100.000, including over 14 million people with symptomatic knee OA in the US. Overweight and obese individuals have a higher incidence of knee OA due to excessive knee joint load. The association between physical activity and knee OA, has not been systematically addressed in overweight and/or obese subjects and its association seems to be controversial. On the one hand, mild to non-weight-bearing physical activities have been found to be beneficial in the management knee homeostasis, the physiologic knee joint load providing an optimized environment for the joint tissues. On the other hand, excessive fast-paced physical activity with high load-joint torsion such as racquet sports, ball sports and running have been found to have an increased incidence of knee injury compared to mild-moderate exercise such as swimming, bicycling and low-impact aerobics independent of body weight. (more…)
Author Interviews, Gout, Rheumatology / 12.11.2020

MedicalResearch.com Interview with: Jeffrey D. Kent, M.D., FACG, FACP Executive Vice President, Medical Affairs and Outcomes Research Horizon MedicalResearch.com: What is the background for this study? What is the marker for reduced immunogenicity with Pegloticase?   Response: Pegloticase is a recombinant, pegylated uricase that is used for treatment of chronic gout in patients who fail oral urate lowering therapy (uncontrolled gout) and has a demonstrated impact on the serum uric acid (sUA) level. As with other biologics, in some people the body’s immune system develops anti-drug antibodies and reduces the effectiveness of the biologic therapy.  Recent case series and open-label trials have suggested that using an immunomodulator with pegloticase has the potential to increase the durability of response so patients can receive a full course of therapy. Researchers in the RECIPE trial sought to examine whether the co-administration of disease-modifying antirheumatic drugs (DMARDs), specifically mycophenolate mofetil, may mitigate this loss of efficacy and increase in response rates for people living with uncontrolled gout (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, COVID -19 Coronavirus, NYU, Rheumatology / 26.08.2020

MedicalResearch.com Interview with: Dr. Fernandez-RuizRuth Fernandez-Ruiz, MD Post-Doctoral Fellow Department of Rheumatology NYU Langone Heath  MedicalResearch.com: What is the background for this study? Response: Patients with systemic lupus erythematosus (SLE) represent a unique population in considering risk for COVID-19 with biologic, genetic, demographic, clinical and treatment issues at play. By the nature of their chronic inflammatory autoimmune condition, the presence of comorbidities, and regular use of immunosuppressants, these individuals would traditionally be considered at high risk of contracting SARS-CoV-2 and possibly having worse outcomes from the viral infection. However, it might be speculated that inherently elevated type I Interferon, characteristic of the majority of patients with SLE, confers a protective effect as a first line anti-viral defense. Additionally, hydroxychloroquine, which was suggested as a potential therapeutic agent for COVID-19 early on, is used in most patients with SLE. Accordingly, we initiated this study to provide critical data needed to address the frequency and severity of COVID-19 in patients with SLE. (more…)
Author Interviews, Biogen, Rheumatology / 06.07.2020

MedicalResearch.com Interview with: Nathalie Franchimont, M.D., Ph.D. Vice President Multiple Sclerosis and Immunology Development Unit Biogen MedicalResearch.com: What is the background for this study? Response: BIIB059 is an investigational fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells (pDCs), a protein present in specific cells within the immune system. An antibody against BDCA2 may potentially interrupt production of interferons, which are inflammatory molecules that are increased in patients with lupus and thought to contribute to disease activity. The LILAC study is two-part, Phase 2, randomized, double-blind trial investigating the efficacy and safety of BIIB059 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). Data from the CLE portion of the study were recently presented at the European E-Congress of Rheumatology (EULAR) 2020, which was held virtually from June 3-6, 2020. Overall, study participants with CLE who received BIIB059 demonstrated statistically significant reduction of disease activity compared to those who received placebo, as assessed by the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score. The results were encouraging and it warrants continued evaluation of BIIB059 in patients with CLE. Cutaneous lupus erythematosus is a chronic autoimmune disease wherein the body’s immune system attacks healthy skin, often causing rashes and skin lesions which can be painful or itchy. There is substantial unmet medical need for people with lupus given the limited number of treatment options available to manage this difficult-to-treat and chronic disease. Ultimately, we are motivated by the possibility of bringing potential new treatment options to lupus patients in need. (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 / 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: 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. (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, JAMA, Ophthalmology, Rheumatology / 15.12.2019

MedicalResearch.com Interview with: 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. 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. (more…)
Abbvie, Author Interviews, Rheumatology / 27.11.2019

MedicalResearch.com Interview with: 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). (more…)
Author Interviews, Rheumatology / 22.11.2019

MedicalResearch.com Interview with: 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. (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, Brigham & Women's - Harvard, Cost of Health Care, Rheumatology / 13.11.2019

MedicalResearch.com Interview with: 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.  (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…)