* Dr. Lally of New England Retina Consultants joins to discuss avacincaptad pegol, a promising injection treatment for GA, and its supporting data from the GATHER trial program. Will the complement C5 inhibitor drug receive FDA approval in 2023? Lally discusses this and more on the latest DocTalk.
* One of the most notable topics discussed at the 2022 American Academy of Ophthalmology Meeting in Chicago was new advancements in geographic atrophy (GA) treatment. A form of advanced age-related macular degeneration (AMD), there are no currently available treatments for the debilitating disease. In this episode of , we spoke with Arshad Khanani, MD, Director of Clinical Research, Sierra Eye Associates, on the findings from the GATHER2 trial on avacincaptad pegol for the treatment of GA. Throughout our conversation, Khanani laid out the first-time efficacy results of the phase 3 trial and its patient population, the overall safety of the agent, and what it might mean to alleviate the biggest unmet need in retina today. We hope you enjoy. If you are interested in more content from AAO 2022 or our ophthalmology coverage, visit us at HCPLive https://www.hcplive.com/.
* Martha Gulati, MD, Director of Preventive Cardiology, Associate Director of the Barbara Streisand Women’s Heart Center, Associate Director of Preventive and Cardiac Rehabilitation at Cedars-Sinai Medical Center, joins Heart Team to discuss current challenges in women’s cardiovascular disease research and clinical advancement. Gulati also provides guidance on improving female trial enrollment strategies and patient recruitment, and her thoughts on clinician perception of cardiovascular symptoms in men versus women. Heart Team is a monthly multimedia series hosted by Jorge Plutzky, MD, Director of Preventive Cardiology at Harvard Medical School, and Michael Farkouh, MD, Director of the Peter Munk Clinical Trials Unit and Vice Chair of Medicine at the University of Toronto. Watch the video of this interview, with more insights from Dr. Plutzky and Dr. Farkouh, at HCPLive.com. https://www.hcplive.com
* In the first episode from this new cardiovascular medicine series, hosts Dr. Jorge Plutzky and Dr. Michael Farkouh speak with University of Maryland's Dr. Matthew Weir about the growing involvement of renal care in modern heart disease patients.
* This past week, the American Society of Retina Specialists (ASRS) held its 40th Annual Meeting in New York City to discuss landmark data and the newest advancements in retina care. * The team was on-site at the Javits Center in Manhattan conducting interviews with expert retina specialists on topics including drugs for neovascular age-related macular degeneration and geographic atrophy, as well as landmark trials including the phase 3 TENAYA and LUCERNE. * On this episode of we share the biggest highlights and the biggest news from our conversations at the meeting with 5 expert clinicians.
* On Monday, the US Food and Drug Administration (FDA) approved ruxolitinib cream 1.5% for the treatment of nonsegmental vitiligo in adults and pediatric patients 12 years and older, making it both the first FDA-approved therapy for repigmentation and the only topical formulation of a JAK inhibitor approved in the United States. * The groundbreaking approval was supported by phase 3 data from the TRue-V clinical trial program, which found that roughly 3 in 10 patients who were treated with ruxolitinib cream achieved ≥90% improvement on facial vitiligo regimentation after 52 weeks of treatment. * David Rosmarin, MD, Vice Chair for Research and Education at Tufts Medical Center and leading investigator of the True-V program joined us on DocTalk to share his enthusiasm for the approval and speak on how ruxolitinib cream could offer hope to patients who can’t access or properly respond to standard treatments for vitiligo. * “One of the challenges with treating vitiligo is that our big treatment is phototherapy, and that's really inconvenient and inaccessible for many; to have to come into an office for light treatments 2 to 3 times a week is really inconvenient, and sometimes prohibitive,” Rosmarin said “It can also be very costly if there are co-pays each time a patient needs phototherapy. So, having an option where patients can use, at home, a cream twice a day, and the convenience of that, is really important. The best ability is availability. If a patient can't access a treatment, it's no good.”
* Last week, the US Food and Drug Administration (FDA) approved https://www.hcplive.com/view/fda-approves-pegloticase-plus-methotrexate-for-uncontrolled-gout the co-treatment of pegloticase (Krystexxa) injection plus methotrexate (MTX) for uncontrolled gout, a decision bolstered by data from phase 4 of the MIRROR study. * In that study, 71% of patients who were treated with this combination therapy achieved a complete response over the course of 6 months. Comparatively, only 38.5% of patients who received pelgoticase plus placebo achieved a complete response. * In a then-recent statement, John Botson, MD, RPh, Rhuematology Director at Orthopedic Physicians Alaska stated that the medical community had been “actively engaged” in findings therapeutic options for uncontrolled gout via pelgoticase therapy. * As one of the primary investigators of the MIRROR study, Botson was keenly aware of the implications of this new FDA decision, noting that this new co-treatment option could allow clinicians to “change outcomes for many uncontrolled gout patients, most of whom have no other treatment option." * For this episode of DocTalk, Botson sat down with Associate Editor Giuliana Grossi and spoke of how combination therapy for gout has led to less infusion reactions and increased efficacy, as well as how clinicians have safely incorporated low dose methotrexate, and what he feels will be the future of gout research. * “In the previous studies, about a quarter of the patients would have infusion reactions and lead to some of the side effects that came from getting the medication, and in this case we had 30.6% of the patients on the placebo who didn't take the methotrexate, and only 4.2% of the ones that got the combination,” Botson said. “So basically, there was a 90% or so improvement in safety and a doubling of the efficacy by using the combination. Those were huge, huge takeaways.”
* Despite a bevy of biologics available for people struggling with Crohn’s disease and ulcerative colitis (UC), not all patients are able to respond to or tolerate a vast majority of approved therapies. * Fortunately, new data presented at Digestive Disease Week (DDW) 2022 suggests that ustekinumab (STELARA) could function as an alternative option to bio-failure and bio-naïve patients living with these inflammatory bowel diseases (IBD). * Pooled data from four long-term phase 2 and 3 studies of bio-naïve IBD patients found that event rate per 100 patient-years for adverse events (AE), serious AEs, infection, malignancies, and more were similar and/or numerically lower for patients who received ustekinumab compared to those on placebo. * Similar event rates were observed in five phase 2/3 IBD studies of bio-failure patients over a 5-year period. * Additionally, new phase 2 data showed that participants treated with guselkumab who had inadequate responses to conventional therapies achieved high levels of clinical-biomarker response, endoscopic response, and clinical remission compared to those on placebo. * For this episode of DocTalk, Assistant Managing Editor Kenny Walter spoke with Remo Panaccione, MD, Director of the IBD Clinic and Director of Gastroenterology Research at the University of Calgary, of the implications of the new ustekinumab and guselkumab data on long-term IBD care.
* If you’ve been keeping an eye on recent developments in ophthalmic care, then you’ll know that several new therapeutic agents that had been approved by the US Food and Drug Administration (FDA) in recent months, including ranibizumab delivered via Port Delivery System (PDS) and faricimab https://www.hcplive.com/view/fda-approves-faricimab-patients-wet-amd-or-dme, the latter of which became the first-of-its-kind intravitreal bispecific biologic therapy for both age-related macular degeneration (AMD) and diabetic macular edema. * But the recent advancements in ophthalmology don’t stop there. As Veeral Sheth, MD, Director of Clinical Trials at University Retina would explain, there is so much going on in the world of eye care that it’s been “hard to keep track of all the work”. * In this episode of DocTalk, Dr. Sheth sits down with Associate Editor Connor Iapoce to discuss the potential of gene therapy, developments in the wet- and dry-AMD spaces, new approaches in the management of pigment dispersion syndrome, and the benefits of home-based optical coherence tomography.
* Earlier this month, dupilumab became the first and only biologic medicine approved by the US Food and Drug Administration for the treatment of atopic dermatitis in patients of all ages, from infancy through adulthood. * The approval of dupilumab as an add-on maintenance therapy for children 6 months to 5 years with moderate to severe atopic dermatitis was described as “a tremendous advancement” by Mercades E. Gonzalez, MD, FAAD, pediatric dermatologist at Pediatric Dermatology of Miami. * Gonzalez joined the DocTalk program to speak on the unmet need for therapies such as dupilumab for young children affected by AD, and the various psychological and mental burdens of the skin disease.
* On June 13, the US Food and Drug Administration (FDA) approved oral baricitinib https://www.hcplive.com/view/fda-approves-baricitinib-for-alopecia-areata (Olumiant) tablets for the treatment of severe alopecia areata in adults, which marked the first approval of a systemic treatment for the disorder. * The approval has excited patients and providers alike who struggled for decades to treat severe cases of this autoimmune disorder. * For this episode of , several key opinion leaders in the dermatology field sound off on the implications of this decision, as well as the versatility of Janus kinase (JAK) inhibitors, and how this approval will aid providers in redefining alopecia areata as an autoimmune disorder rather than simply a cosmetic condition, which will help more patients receive proper care. * Joining us on the podcast and in written form are the following dermatologists: __ BRETT KING, MD, PHD, Yale School of Medicine, New Haven LISA ARKIN, MD, member of the Society for Pediatric Dermatology, https://protect-us.mimecast.com/s/HbMqCwplAlU076w0cVV-ai?domain=pedsderm.net/University of Wisconsin School of Medicine & Public Health / American Family Children's Hospital. KARAN LAL, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology https://protect-us.mimecast.com/s/VRrQC9rmymiznvRQTo5exi?domain=pedsderm.net/ BRITTANY CRAIGLOW, MD, Yale School of Medicine, New Haven __
* On June 13, the US Food and Drug Administration (FDA) approved oral baricitinib https://www.hcplive.com/view/fda-approves-baricitinib-for-alopecia-areata (Olumiant) tablets for the treatment of severe alopecia areata in adults, which marked the first approval of a systemic treatment for the disorder. * The approval has excited patients and providers alike who struggled for decades to treat severe cases of this autoimmune disorder. * For this episode of DocTalk, several key opinion leaders in the dermatology field sound off on the implications of this decision, as well as the versatility of Janus kinase (JAK) inhibitors, and how this approval will aid providers in redefining alopecia areata as an autoimmune disorder rather than simply a cosmetic condition, which will help more patients receive proper care. * Joining us on the podcast, and in written form, are the following dermatologists: * · BRETT KING, MD, PHD, Yale School of Medicine, New Haven * · LISA ARKIN, MD, member of the Society for Pediatric Dermatology, https://protect-us.mimecast.com/s/HbMqCwplAlU076w0cVV-ai?domain=pedsderm.net/University of Wisconsin School of Medicine & Public Health / American Family Children's Hospital. * · KARAN LAL, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology https://protect-us.mimecast.com/s/VRrQC9rmymiznvRQTo5exi?domain=pedsderm.net/ * · BRITTANY CRAIGLOW, MD, Yale School of Medicine, New Haven
* After presenting at the SLEEP 2022 annual meeting, Dr. Aric Prather explains the findings of his previous research demonstrated lack of sleep (6 hours or less) was associated with a 4 times higher risk of becoming sick after exposure to rhinovirus in an interview with . Currently, Prather and his team at UCSF are working with a large naive population for a study that began in March 2021. They've been able to evaluate various aspects of health by following individuals through the COVID-19 vaccination and booster process. According to Prather, the aim is to identify psychological, behavioral, sleep, and biological predictors of who mounts and maintains protection.
* In recognition of National Scleroderma Awareness Month, HCPLive spoke with several prominent dermatologists today who addressed some of the concerns and advancements related to the rare, multi-system disease. * Scleroderma is often referred to as “morphea” by dermatologists, and the condition typically presents with the tightening and hardening of the skin. Depending on the region of the body, it can result in everything from swollen joints to lesions on the face, arms, and midsection. * For this episode of DocTalk, Karan Lal, DO, MS, FAAD, Schweiger Dermatology Group and member of The Society for Pediatric Dermatology https://protect-us.mimecast.com/s/VRrQC9rmymiznvRQTo5exi?domain=pedsderm.net/ , returned to the program to speak on the different variations of morphea in pediatric patients, and the communal approach that is required to treat the disease among dermatologists and other branches of medicine.
* Last week https://www.hcplive.com/view/fda-approves-tapinarof-cream-adults-plaque-psoriasis, the US Food and Drug Administration approved tapinarof cream, 1% (VTAMA) for the treatment of plaque psoriasis of all severities in adult patients, ushering in the first and only FDA-approved steroid-free topical medication in its class. * Remarkably, it had been 25 years since a novel chemical entity had been introduced into psoriasis care from a brand-new mechanism of action, and from the data gathered from the phase 3 PSOARING 1 and 2 trials as well as the long term extension (LTE) study, it couldn’t have come at a better time. * Pivotal phase 3 data showed treatment with tapinarof cream led to statistically significant improvements in Physician Global Assessment (PGA) score of “clear” or “almost clear” with a minimum 2-grade improvement compared with vehicle treatment from baseline to week 12. * Better yet, the median duration of clear or almost clear skin was approximately 4 months after cessation of treatment with tapinarof cream, which was detailed in the phase 3 LTE study for patients who achieved clear skin (PGA 0) during PSOARING 1 or 2. * “I think the patients that participated and had exposure to the product for up to a year, were indicating that to us that (tapinarof cream) was easy to use, it was extremely well tolerated, it had remarkable impact on their disease, and the fact that they can discontinue therapy for an extended period of time is absolutely incredible,” said Philip Brown, MD, JD, Chief Medical Officer at Dermavant Sciences. * For this episode of DocTalk, Brown and Chief Executive Officer Todd Zavodnick joined the program to speak to the implications of the FDA decision, and how tapinarof cream is set to revolutionize psoriasis management.
* In recent years, the acknowledgement of cardiac involvement in patients with sarcoidosis has become increasingly important. Thanks to advanced screening techniques, new research has suggested that approximately 2-5% of patients with sarcoidosis also struggle with cardiac sarcoidosis. * However, the practice of adding echocardiography and ambulatory ECG to standard screening with the intention of identifying cardiac sarcoidosis has been deemed controversial by some researchers. * Additionally, previous analyses of various screening approaches have been limited by small patient numbers, selection bias, and inconsistent use of echocardiographic parameters such as global longitudinal strain. * “Advanced screening techniques suggests that around a quarter of people with sarcoidosis could have evidence of cardiac sarcoidosis, and so you can see right away that there's a discrepancy between what you can find with an advanced imaging technique,” said Dan Culver, DO, Chair of the Department of Pulmonary Medicine at the Cleveland Clinic. “This raises the question of how much should you look, when do you look and in whom should you look to try to find cardiac sarcoidosis? And this gets us to the original question of how you screen for cardiac sarcoidosis.” * In this episode of DocTalk, Culver spoke on how patients develop cardiac sarcoidosis and why periodic screening could prove beneficial for patients with sarcoidosis. * He also touched on preliminary data of a recent interim analysis regarding the addition of baseline echocardiography and ambulatory ECG in routine screening in patients without obvious cardiac sarcoidosis.
* Beyond vaccination, what are some methods for treating COVID-19 in both inpatient and outpatient settings? In the 2 years since the beginning of the pandemic, the strategies for protecting people from this deadly virus have certainly evolved, yet questions remain regarding COVID-19 therapeutics and their availability in certain communities and during times of scarcity. * For this episode of DocTalk, Tara Vijayan, MD, MPH, who is a member of the division of infectious diseases at the David Geffen School of Medicine, offered insights into the mechanisms of several COVID-19 treatments, as well as the primary outcomes of these treatments in clinical trials and how they influence prioritization. * This conversation was based off her session, “Navigating Novel COVID-19 Therapeutics in Times of Scarcity and Beyond,” which was presented at Pri-Med West 2022 in Anaheim, California. * Though she is confident with certain aspects of COVID-19 care, she is also focused on improving upon treatment from “an equity standpoint, an ethical standpoint, and an evidence standpoint”.
* Today's episode features Selena S. Li, MD, a Massachusetts General Hospital surgery resident, who recently traveled overseas with a volunteer medical group to provide treatments and care to refugees escaping the Russian invasion. For more clinical news and expert interviews, visit us at HCPLive.com. https://hcplive.com/ To learn more about donating to or volunteering with Medical Volunteers International, click here. https://medical-volunteers.org/
* When it comes to allergies, the number of affected individuals in the United States alone is staggering. Approximately 20 million adults and 6 million children in the US are affected by seasonal allergies, and roughly 32 million Americans struggle with a myriad of food allergies. * Seasonal allergies have been front-of-mind for many Americans, especially with the Spring season in full effect. * The struggles people with seasonal allergies face have no doubt worsened with the introduction of longer and more severe pollen seasons, as well concerning levels of air pollution recorded https://www.hcplive.com/view/western-us-residents-people-of-color-impoverished-increasingly-impacted-poor-air-quality across the country that were detailed in the latest State of the Air Report by the American Lung Association. * In this wide-ranging interview for , Christine Rauscher, MD, member of the Allegheny Health Network and Assistant Professor of Medicine at Drexel University, offered an overview of some of the most common allergies in the US as well as what could be done to prevent severe allergic reactions among adult and pediatric populations.
* The newly approved ophthalmic drug faricimab (Vabysmo) has already made waves by being the first of its drug class to be approved for both diabetic macular edema (DME) and neovascular age-related degeneration (nAMD). * A new phase 4 clinical trial from Genentech seeks to expand on the efficacy of the drug in patients with DME from underrepresented populations. * The efficacy and safety of faricimab will be assessed in patients from African American, Hispanic, Latin American, and Indigenous communities throughout the Elevatum trial, which Matthew Cunningham, MD, of the Florida Retina Institute, believes to be the first industry-sponsored assessment regarding representation in DME trials. * For this episode of DocTalk, Cunningham sits down with managing editor Kevin Kunzmann to speak to the issue of representation in DME and other ophthalmology trials, and how DME disproportionately affects underrepresented populations. * Furthermore, Cunningham details the burdens that patients from underrepresented communities face with trial inclusion standards.
* When addressing psoriatic disease, it is important to consider how it uniquely affects people with skin of color. People from different racial and ethnic groups often struggle with psoriatic disease due to delays in diagnosis, misdiagnosis, and limited access to diagnostic testing and treatment. * Furthermore, the lack of access to care and treatment has resulted in biologic use being 69% lower in patients with skin of color compared to white patients. * All of these factors stem from a lack of understanding from providers as to how conditions such as psoriasis and psoriatic arthritis affect Black, Hispanic, Asian, and Indigenous communities. * Recently, Janssen Pharmaceuticals announced Determi-Nation, a program created to increase the number of dermatology residents from underrepresented minority groups by over 50% by 2027. * Lynn McKinley-Grant, MD, FAAD, Associate Professor of Dermatology at Howard University College of Medicine and former President of the Skin of Color Society and Determi-Nation member will be offering her indispensable knowledge on psoriatic disease in skin of color to bolster this multi-year commitment. * But her passion for accurate clinical assessments of psoriatic disease in people of color is very much rooted in the present and what can be improved upon now to ensure a more inclusive future for patients with skin of color and psoriasis. * In this episode of , McKinley-Grant speaks on psoriatic disease presents itself in skin of color, improving upon diversity in clinical trials, how scientific literature on psoriatic disease continues to evolve, the lack of exposure to skin of color some providers may have based on their location, and much more.
* Last week, a new investigation https://www.hcplive.com/view/vos-md-future-research-pediatric-nafld confirmed a higher prevalence of non-alcoholic fatty liver disease (NAFLD) in pediatric patients than previously thought. * The data was part of the ongoing observational study called TARGET-NASH, which included participants with NAFLD and/or alcoholic steatohepatitis (NASH). * The study, which included 660 pediatric patients, cited an increase in liver disease following evaluation of alanine aminotransferase. * Notably, pediatric patients with greater than 250 U/L ATL had an eight-fold greater risk of developing cirrhosis. * For this episode of , Miriam Vos, MD, MSPH, Department of Pediatrics, School of Medicine, Emory University, sat down with assistant managing editor Kenny Walter to discuss the data from TARGET-NASH as well as the implications of NAFLD in pediatric patients.
* Today, the American Lung Association released the 23rd annual “State of the Air” report, which detailed the nationwide exposure to ozone and particle pollution in the United States in 2022. * The new report revealed that approximately 9 million more people were affected by particle pollution since last year’s report, with more reported days with “very unhealthy” and “hazardous” air quality than ever published in the 2-decade history of the “State of the Air”. * The “State of the Air” report functions as a “report card” of sorts, one that tracks and grades exposure to levels of short-term spikes in particle pollution across the country. * Additionally, the report is defined by 2 grades for particle pollution including “short-term” and “year-round”. * Regarding short-term pollution, the 2022 report found that roughly 63.2 million people lived in counties with an “F” grade for unhealthy spikes in particle pollution, with 4 of the top 4 most polluted cities located in California. * Additionally, more than 20.3 million people were reported to live in 1 of 21 counties where year-round particle pollution levels were worse than the national air quality limit, with all of the top 5 most polluted cities being located in California. * The report also noted that 122.3 million people reside in counties with failing grades for ozone pollution. Despite being 860,000 fewer people than last year’s report, the numbers remain alarming. * Once again, the “State of the Air” report detailed the staggering affect of climate change on air quality in the US. * For this episode of DocTalk, Managing Editor Kevin Kunzmann spoke with Stephanie Lovinsky-Desir, MD, MS, Volunteer Medical Spokesperson for the American Lung Association, who further elucidated the data found in the report. * As a pediatric pulmonologist, Lovinsky-Desir details the notable burden that air pollution has on children. She also speaks to the associations between air quality and cardiovascular disease, the influence of Clean Air Act on better air quality, informing patients on how to avoid certain pollutants, and what can be done to reduce carbon footprints on both personal and communal levels. * “Ultimately, I think the goal is for clean, healthy air, and I think we all as Americans deserve to breathe clean, healthy air,” Lovinsky-Desir said. “So advocating for that on multiple levels, and making sure that we are partnering with the people who are most likely contributing to the emissions, I think is going to be the key. It's a multi-pronged approach. It's not just one specific group that is responsible for making this change.”
* An estimated 2 million patients in the United States have vitiligo, which is a dermatologic condition defined by depigmentation of the skin. * Though there is currently no cure, recent medical advancements have helped patients and providers alike gain a broader perspective on the skin condition. Likewise, prominent cultural figures with vitiligo have also contributed addressing the stigma surrounding the disease. * Despite this, vitiligo is still considered by many to be solely a cosmetic condition, though it is very much a medical condition as well. * Sarah Asch, MD, FAAP, FAAD, Society of Pediatric Dermatology https://protect-us.mimecast.com/s/AdtSC1wDnDunB4qyULkDQB?domain=pedsderm.net/ , Teledermatology Committee Chair, spoke of how the public perception of vitiligo has evolved in recent years, as well as how vitiligo affects adults and pediatric patients differently and the myriad of promising new therapies that are currently being explored.
* Last week, the Alliance for Sleep committee announced new data from the largest sleep-based survey in the US, which found that 70% of people with trouble sleeping due to insomnia were “desperate to find a solution”. * Insomnia affects approximately 25 million adults in the US, and is partially responsible for the roughly $7 billion spent annually on products or sleep aids such as blackout curtains, eye masks, and white noise machines. * Findings from Wake Up America: The Night & Day Impact of Insomnia survey put in to sharp focus the complications of insomnia, which includ a notable lack of discussions being had among patients and providers regarding sleep health. * According to the survey, only 66% of primary care physicians reported frequently asking about sleep during routine visits, and only 27% of patients with trouble sleeping reported that their doctors asked about their sleep during every visit. * Co-chair of The Alliance for Sleep committee Dr. Ruth Benca spoke of how the survey results could provide Americans with wake up call regarding insomnia prevalence and improve upon the conversations between patients and healthcare providers.