Category Archives: Immunology

argenx Receives Positive CHMP Opinion for Efgartigimod for the Treatment of Adult Patients with Generalized Myasthenia Gravis in Europe – BioSpace

June 25, 2022 medical

Breda, the NetherlandsJune 24, 2022argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission (EC) approval of efgartigimod as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the ECs final decision on argenxs application for efgartigimod. The EC is expected to make a decision within approximately 60 days following CHMP recommendation, which will be applicable to all 27 European Union Member States, in addition to Iceland, Norway and Liechtenstein.

The current treatment of generalized MG in Europe leaves many patients with insufficiently controlled symptoms that markedly decrease quality of life. Caregivers and medical teams are well aware of the need for new treatment options that are safe, effective and targeted to the disease biology said Anthony Bhin, MD neuromuscular physician at Institut de Myologie, La Piti Salptrire, Paris. As a practicing neurologist regularly seeing people who live with this debilitating chronic disease, the CHMPs positive opinion of efgartigimod represents an exciting advancement toward bringing a new treatment option to these patients in Europe.

The MAA included results from the pivotal Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-acetylcholine receptor (AChR) antibody positive gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale following treatment with efgartigimod compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle.

There were additionally significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.

Efgartigimod had a demonstrated safety profile in the ADAPT clinical trial. The most frequently reported adverse reactions were upper respiratory tract infections (10.7% following treatment with efgartigimod vs. 4.8% of placebo) and urinary tract infections (9.5% vs. 4.8%).

We are thrilled by the CHMPs recommendation in favor of efgartigimod, which brings us one step closer to delivering this therapy to people living with gMG in Europe and around the world, said Anant Murthy, Ph.D., General Manager, EU, argenx. We are confident in the European team we have built, and pending marketing authorization, look forward to close collaboration with regulatory bodies and government authorities across the region to ensure this treatment option will be available for as many patients as possible.

Efgartigimod is the first-and-only approved FcRn blocker in the U.S. as VYVGART (efgartigimod alfa-fcab) for the treatment of adult gMG patients who are anti-AChR antibody positive and in Japan for those who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). argenx also plans to launch efgartigimod in Canada, China through its collaboration with Zai Lab, and select additional regions.

About Phase 3 ADAPT Trial

The Phase 3 ADAPT trial was a 26-week randomized, double-blind, placebo-controlled, multi-center, global trial evaluating the safety and efficacy of efgartigimod in adult patients with gMG. A total of 167 adult patients with gMG in North America, Europe and Japan enrolled in the trial. Patients were randomized in a 1:1 ratio to receive efgartigimod or placebo, in addition to stable doses of their current gMG treatment. ADAPT was designed to enable an individualized treatment approach with an initial treatment cycle followed by subsequent treatment cycles based on clinical evaluation. The primary endpoint was the comparison of percentage of MG-ADL responders in the first treatment cycle between efgartigimod and placebo treatment groups in the anti-AChR antibody positive population.

About Efgartigimod

Efgartigimod is an antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor and blocking the IgG recycling process. Efgartigimod is being investigated in several autoimmune diseases known to be mediated by disease-causing IgG antibodies, including neuromuscular disorders, blood disorders, and skin blistering diseases. It is currently approved in the United States for the treatment of adult patients with gMG who are anti-acetylcholine receptor antibody positive, and Japan for adult patients with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies.

About Generalized Myasthenia Gravis

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months1, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population1.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S. and Japan.

For further information, please contact:

Media:Kelsey Kirkkkirk@argenx.com

Investors:Beth DelGiaccobdelgiacco@argenx.com

Michelle Greenblattmgreenblatt@argenx.com

Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, hope, estimates, anticipates, expects, intends, may, will, or should and include statements argenx makes concerning the timing of any approval or marketing authorization by the ECof efgartigimod as an add-on to standard therapy for the treatment of adult patients with gMG who are AChR antibody positive. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenxs actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors. A further list and description of these risks, uncertainties and other risks can be found in argenxs U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenxs most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277

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argenx Receives Positive CHMP Opinion for Efgartigimod for the Treatment of Adult Patients with Generalized Myasthenia Gravis in Europe - BioSpace

Immunology

Deletion of Wt1 gene produces alterations in the reproductive organs of mice – EurekAlert

June 25, 2022 medical

image:The study states that the Wt1 gene is necessary for activating the pathways that determine the development of the male and female sex. view more

Credit: UNIVERSITY OF BARCELONA

The deletion of the Wt1 gene during the early stages of the embryonic reproductive organ formation leads to differences in sex development in adult mice, according to an article published in the journal PLOS Genetics and led by the lecturer Ofelia Martnez-Estrada, from the Faculty of Biology and the Biomedicine Research Institute (IRBio) of the University of Barcelona.

Among the participants in the article are the experts Francesc X. Soriano, from the Department of Cell Biology, Physiology and Immunology, and the Institute of Neurosciences of the UB (UBNeuro), and Manuel Reina, from the same Department and the Research Group Celltec UB.

A decisive gene in the biology of sex

The Wt1 gene or Wilms tumour gene is expressed during the embryonic development of mammals in many organs and tissues (urogenital system, spleen, heart, diaphragm, etc.). In scientific literature, the mutations of the Wt1 gene are related to some pathologies syndromes such as Denys-Drash, Frasier and Meachams which include genitourinary defects and differences in the sex development (such as ambiguous genitalia or abnormal development of the gonads).

These differences in the sexual development are congenital disorders in which the development of the chromosomal, gonadal or anatomic sex is atypical. Despite the efforts to understand the genetic factors that cause these alterations, the origin is unknown in many cases and it is hard to offer a precise diagnosis to the affected people.

Murine models with modifications in the expression of key genes in the sex development are shaped as decisive elements for studying this complex process in mammals. Therefore, in recent years, new genetic tools have been generated in mutant mice models to study different aspects of the biology of the WT1 gene.

As part of the study, the team presents a new genetically modified mouse model (Wt1KO) which revealed the importance of the Wt1 gene in the initial differentiation of the embryonic gonad at early stages and its impact in the formation of the reproductive system of adult mice. According to the conclusions, female and male Wt1KO mutant mice unable to express the Wt1 gene in reproductive organs from the early formation stages showed ambiguous genital tracts and their gonads remained at an undifferenced stage.

In this study, we state that the Wt1 gene is necessary for activating the pathways that determine the development of the male and female sex, since embryonic mutant gonads do not express the specific genes for each genetic program, notes lecturer Ofelia Martnez-Estrada, from the Department of Cell Biology, Physiology and Immunology of the UB.

To date, it has been hard to assess the functions of the WT1 transcription factor coded by the mentioned gene during the early differentiation of the gonad and its impact on adult sex development. The lack of development in gonads or in the genital tract (gonadal agenesis) and the embryonic lethality shown in Wt1KO mutant mice hindered the progress of research to elucidate the role of this gene in these development processes.

Based on the obtained results, we propose that this murine model could contribute to improve the knowledge on the functions of the WT1 gene in some progenitor cell populations in different organs and tissues, as well as the importance of these cell populations in the formation of organs in adults, concludes lecturer Ofelia Martnez-Estrada.

Experimental study

Animals

Deletion of Wt1 during early gonadogenesis leads to differences of sex development in male and female adult mice

15-Jun-2022

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Immunology

Rethinking Malaria Why Now – Speaking of Medicine and Health – PLOS

June 25, 2022 medical

By guest contributors Dyann Wirth, Rose Leke and Michelle A. Williams

Malaria elimination is possible. Ten countries have been certified malaria-free in the past five years, including China, which eliminated the disease from 30 million cases to zero cases. However, progress toward elimination has been uneven. Today, Africa bears 90% of the malaria burden and progress has stalled. In 2020, there were 240 million cases of malaria and 637,000 deaths worldwide. This is the same level of human suffering as was the case in 2015. Now is the time, we must act.

COVID-19 mobilized the world, proving that it is possible tomeet public health challenges quickly and effectively through international cooperation on health research and innovation, multisectoral coalitions, and collective action. This level of global action is exactly what is needed to end malaria.

Malaria, a threat to the most vulnerable in populations with long-term societal impact, must be approached as asocietal problem of health and economic development, not just as a medical problem. Malaria elimination efforts must beled by endemic countriesin partnership with multiple stakeholders within each country. Leadership must come from all levels of government, from community advocates to national leaders. In countries recently certified malaria free, the common feature is effective governmental leadership coupled with technical expertise and a strong community health workforce.

TheCOVID-19 pandemic has laid bare the limitations and inequities of our global health systems, most particularly in challenges related to the global health workforce. Investing in the health workforce is essential. Empowering health workers througheducation, training, and creating sustainable career paths that include fair wages for community health workers, are fundamental to progress. To end malaria, we need a workforce that takes a problem-solving approach and includes players from multiple sectors. Experts in diverse disciplinesbehavioral and social science, communications, finance, data sciencemust come together with community leaders to focus on resolving the barriers to malaria elimination. Universities and educational institutions can enable the training of this workforce at all levels.

Malaria data should be valued, visible, timely and employed by the public and policymakers in the same way COVID-19 data has been used for decision-making. Real-time data has been critical in other disease elimination programs such as smallpox and polio. Why not create Malaria Dashboards at the community level and national level to track progress and inform policy? Malaria has a toolbox of interventions, including the newly recommended vaccine, and the best mix of these tools will be defined by the locally derived data.

Malaria elimination policy and practices must be integrated into the broader health system without losing the focus on reduction of disease burden. Accelerating innovation for new tools and new ways of using existing tools is critical. Endemic countries have a great potential for entrepreneurship, research, and development. The malaria community should harness that potential.

Now is the time to imagine and keep working towards a malaria-free worldwe know it can be achieved.

Read more from the Rethinking Malaria collection on PLOS Global Public Health:

About the authors:

Professor Dyann F. Wirth (Richard Pearson Strong Professor of Infectious Diseases, Harvard T.H. Chan School of Public Health, Chair, WHO Malaria Advisory Group, co-Chair, Rethinking Malaria in the Context of COVID19) has been a major leader in malaria research for more than 30 years. Recognizing the importance of bringing cutting-edge genomic science to the study of infectious diseases, she joined the Broad Institute of MIT and Harvard shortly after its establishment to lead its infectious diseases initiative. two-term Using a multidisciplinary approach, her group explores challenges related to mosquito biology and the malaria parasite.

Leveraging the genomic tools of the human genomic project, the group has applied state-of-the-art technologies and novel approaches to better understand the fundamental biology of the malaria parasite, evolution, and mechanisms of drug and insecticide resistance. This work has provided completely new insight into how the malaria parasite has evolved, specifically in the areas of population biology, drug resistance, and antigenicity. The groups current efforts seek to determine both the number and identity of genes expressed by the parasite in response to drug treatment and to evaluate the role of these genes for parasite survival. This work aims to understand basic molecular mechanisms in protozoan parasites. Current findings have made significant contributions to advancing our understanding of malaria vaccine efficacy with long-term R&D goals to discover and apply preventive and therapeutic interventions against malaria infection. The groups research activities are made possible through collaborative research partnerships with investigators, universities, and clinical centers in Africa, Asia, and the Americas.

In addition to her research and teaching efforts, Professor Wirth directs Harvards Defeating Malaria: From the Genes to the Globe Initiative, a university-wide effort to produce, transmit, and translate knowledge to support the control and eradication of malaria. Wirth is past chair of the Department of Immunology and Infectious Diseases at the Harvard Chan (20062018). She is a member and current Chair of the World Health Organizations Malaria Policy Advisory Group (MPAG), fellow and past president of the American Society of Tropical Medicine & Hygiene (ASTMH), a fellow of the American Academy of Microbiology and American Association for the Advancement of Science, and member of the National Academy of Medicine of the National Academy of Sciences. Professor Wirth is the first female recipient of the ASTMHs Walter Reed Medal, a recipient of ASTMHs Joseph Augustine LePrince Medal, was honored with BioMalPars Lifetime Achievement Award, and earned the USF Presidents Global Leadership Award. She is a past board member of the Burroughs Wellcome Fund and the Marine Biological Laboratory.

Rose Gana Fomban Leke (Emeritus Professor of Immunology and Parasitology, University of Yaound I, co-Chair, Rethinking Malaria in the Context of COVID-19)is Emeritus Professor of Immunology and Parasitology at the University of Yaound I. Her primary research interests center on the immunology of parasitic infections, in particular, malaria. Professor Leke has a keen interest in global health issues and has been involved in the worldwide Polio Eradication Initiative, global malaria elimination activities, and health systems strengthening efforts. She has been very effective in the training of the next generation of scientists, namely the empowerment of the young female scientists and women overall. Higher Women Cameroon, a high-impact mentoring program, is one of her primary initiatives.

In March 2013, she stepped down as Head of the Department of Immunology and Parasitology at the Faculty of Medicine and Biomedical Sciences and Director of the Biotechnology Centre at the University of Yaound I. Professor Leke is Executive Director of the Cameroon Coalition against malaria, Chair of the Multilateral Initiative on Malaria (MIM) Secretariat, member of the Canada Gairdner Foundation Global Health Award Advisory Committee, President of the Federation of African Immunological Societies, a fellow of the Cameroon Academy of Sciences CAS, a fellow of the African Academy of Science AAS, a fellow of the World Academy of Science, and two-term Council member of the International Union of Immunological Societies.

Professor Leke is co-Chair of Harvards Defeating Malaria: From the Genes to the Globe Initiative Executive Board (alongside Michelle Williams, Dean of the Faculty at the Harvard Chan) and Chair of the Board of Directors of the National Medical Research Institute. She serves as Vice President of the Scientific Committee of Cameroon First Ladys Research Centre. She is a member and Chair of the African Advisory Committee for Health Research (ACHR) and Global ACHR; a Board member of the Global Forum for Health Research; and served as Vice-Chair of the Technical Evaluation Reference Group (TERG) of the Global Fund to Fight HIV, TB, and Malaria. She was awarded a Plaque of Honor in recognition of her outstanding Services and dedication in leading the TERG in 2009.

She has served as a consultant on several past/current committees of the WHO, including the Malaria Policy Advisory Group, Malaria Elimination Oversight Committee, Global Certification Commission, Emergency Committee for Polio Eradication, and the Chair of the African Regional Commission for the Certification of the Eradication of Poliomyelitis. She also served as Chair of the Data Management Committee for a trial on Azithromycin-chloroquine, and was a member of the Scientific Advisory Group for Ebola vaccine trials in Guinea. In 2011, she was one of six women who received the African Union Kwame Nkrumah Scientific Award for Women and received the 2012 award for Excellence in Science from the Cameroon Professional Society. In 2014, she served as the Aggrey-Fraser-Guggisberg Memorial Lecturer at the University of Ghana and was awarded a Doctor Honoris Causa (DSc). In 2015, she was elected International Honorary Fellow of the American Society of Tropical Medicine and Hygiene.

In 2018, she was elected one of nine women as Heroine of Health and was celebrated at a special event in Geneva in the presence of the Director-General World Health Organization (WHO), the Regional Director of the WHO/African Regional Office, and the Cameroon Minister of Health. On November 23, 2018, she was crowned by the Cameroon Medical Council as Queen Mother of the Cameroonian Medical Community.

Dean Michelle A. Williams is Dean of the Faculty, Harvard T.H. Chan School of Public Health, and Angelopoulos Professor in Public Health and International Development, a joint faculty appointment at the Harvard Chan School and Harvard Kennedy School. She is an internationally renowned epidemiologist and public health scientist, an award-winning educator, and a widely recognized academic leader. Prior to becoming Dean of the Faculty at Harvard T.H. Chan School of Public Health in July 2016, she was professor and chair of the Department of Epidemiology and program leader of Harvards Clinical and Translational Sciences Center (Harvard Catalyst) Population Health and Health Disparities Research Program.

Dean Williams joined the Harvard Chan faculty after a distinguished career at the University of Washington (UW) School of Public Health. While at UW, she served as co-director of the Center for Perinatal Studies at the Swedish Medical Center in Seattle, WA. She developed and directed the Reproductive Pediatric and Perinatal Training Program at the UW, held a joint appointment in Global Health from 20082011, and was an affiliate investigator at the Fred Hutchinson Cancer Research Center 19922010.

As an acclaimed researcher, Dean Williamss scientific workplaces special emphasis on the areas of reproductive, perinatal, pediatric, and molecular epidemiology. She has extensive experience in carrying out large-scale, multidisciplinary research involving the collection and analysis of epidemiological data (e.g., sleep characteristics, physical activity, dietary intake, and environmental exposures) and biological specimens (e.g., blood-based biochemistry/biomarkers, flow cytometry, genetic variants, whole-genome expression of mRNA and miRNA), both domestically and internationally.

Dean Williams has published more than 425 peer-reviewed research papers ranging from studies of modifiable behavioral and environmental determinants of adverse health outcomes to genetic and genomic studies of common complications of pregnancy and chronic disorders among children and adults. She has successfully administered large-scale, clinical epidemiology studies that seek to understand genetic and environmental causes of adverse pregnancy outcomes and other non-communicable disorders along the life course. Dean Williams also developed and directed (for more than seven years) the Reproductive Pediatric and Perinatal Training Program at the UW. In 1994, Dean Williams developed and is currently directing, the NIH-funded multidisciplinary international research training (MIRT) program that allows for the development and operations of undergraduate and graduate student training in global health, biostatistics, and epidemiology in over 14 foreign research sites in South America, South East Asia, Africa, and Europe. She was appointed Board Co-Chair of Defeating Malaria: From the Genes to the Globe Initiative at Harvard University in 2016.

Dean Williams has been recognized for her excellence in teaching, as the recipient of the Harvard Chan Schools Outstanding Mentor Award (2015), the White Houses Presidential Award for Excellence in Science, Mathematics, and Engineering Mentoring (2012), the UWs Brotman Award for excellence in teaching (2007), and the American Public Health Associations Abraham Lilienfeld Award for education in epidemiology (2007). She earned undergraduate degrees in Biology and Genetics from Princeton University in 1984. She earned a masters degree in Civil Engineering from Tufts University, and a masters and doctoral degree in Epidemiology from the Harvard T.H. Chan School of Public Health and Harvard University

Disclaimer: Views expressed by contributors are solely those of individual contributors, and not necessarily those of PLOS.

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Immunology

Researchers Continue Study of COVID-19 Vaccinations, Pregnancy and Postpartum – University of California San Diego

June 25, 2022 medical

Christina Chambers, PhD, MPH, is the principal investigator on the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) coordinated by AAAAI, professor in the Department of Pediatrics at UC San Diego School of Medicine and director of the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Studies.

With the SARS-CoV-2 pandemic ongoing, researchers at University of California San Diego School of Medicine, in collaboration with the American Academy of Allergy Asthma and Immunology (AAAAI), will continue a national study to evaluate the safety of COVID-19 vaccinations during pregnancy, and monitor immune response for mother and baby following vaccinations.

Published research has found that pregnant people are particularly vulnerable to SARS-CoV-2 infection and at higher risk of developing a more serious or complicated disease course, including approximately a 70 percent increased risk of death. Infection in pregnancy also increases the risk for preterm delivery and other adverse pregnancy outcomes, including stillbirth.

Pregnant people are considered a priority population for COVID-19 vaccination. However, only about a third of pregnant persons have chosen vaccination, said Christina Chambers, PhD, MPH, principal investigator on the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) coordinated by AAAAI, professor in the Department of Pediatrics at UC San Diego School of Medicine and director of the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Studies.

As pregnant persons were not included in the original clinical trials for COVID-19 vaccinations, there is a critical need to do this work to help provide concrete information about the safety and benefits of these vaccines for both mother and baby.

The continuation of study efforts is made possible by a $10 million, four-year grant and involves evaluating the safety of COVID-19 vaccinations among 1,800 participants.

Alessandra Franco, MD, PhD, is co-investigator of the study, immunologist and associate professor in the Department of Pediatrics at UC San Diego School of Medicine.

Using the established U.S. MotherToBaby pregnancy cohort study at UC San Diego, researchers will follow-up with 900 individuals who received one or more doses of any COVID-19 vaccination during pregnancy and 900 who did not. They will evaluate pregnancy outcomes, including major birth defects, miscarriage, stillbirth, preterm delivery and postpartum growth of infants through one year of age.

In a subset of 180 women in the study, researchers will also collect blood samples after vaccination in different trimesters of pregnancy to measure the cellular immune response to SARS-CoV-2.

The investigators will study the expansion of T lymphocytes that recognize spike and non-spike regions of the virus. The development of T cell memory, critical to determine long-lasting protection from infection, will be also defined together with the measurement of anti-SARS-CoV-2 antibodies in both mother and baby after delivery.

The results of this sub-study will provide essential efficacy information that can support COVID-19 vaccine-related public health recommendations in this special population, said Alessandra Franco, MD, PhD, co-investigator on the study, immunologist and associate professor in Department of Pediatrics at UC San Diego School of Medicine.

Michael Schatz, MD, is lead study coordinator for the American Academy of Allergy Asthma and Immunology.

We feel confident that this study will provide important information in support of best clinical practice for obstetric providers and their patients, said Michael Schatz, MD, lead AAAAI study coordinator.

The study will continue enrolling pregnant persons through 2024, with final results expected in 2026.

The study is supported, in part, by the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) MPRINT Hub and the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA). Grant Number 3P50 HD106463-01S1.

Individuals interested in participating can contact MotherToBaby Pregnancy Studies at mothertobaby.org/pregnancy-studiesor by calling 877-311-8972.

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Researchers Continue Study of COVID-19 Vaccinations, Pregnancy and Postpartum - University of California San Diego

Immunology

Managing asthma in the summer heat – Parkview Health

June 25, 2022 medical

This post was written by Heather Willison, MSN, FNP-C, PPG Allergy, Asthma and Immunology.

I enjoy a beautiful sunny day just like anyone else, but the recent high temperatures have felt downright uncomfortable. Unfortunately, these heat waves can be even more troublesome for those with asthma, as heat can trigger breathing difficulties.

Heat and humidity tend to go hand-in-hand, making the air heavier and more difficult to breathe. Also, the heat causes body temperature to rise, and before long, youre sweating. When you sweat, you are at risk of becoming dehydrated, which in turn causes you to breathe faster, triggering asthma symptoms. Again, the airways narrow, resulting in coughing, wheezing or shortness of breath.

Considering we are at the start of summer, Im certain that we have many more hot days ahead of us this season. Here are some tips to help asthma patients beat the heat:

Work with your provider and make a plan so that you can enjoy the fleeting months of summer as much as possible.

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Managing asthma in the summer heat - Parkview Health

Immunology

Awards and Honors: Summer 2022 | Department of Medicine News – Stanford Medicine

June 25, 2022 medical

Stanford Awards for 2021-22 Academic Year Include Many DOM Faculty and Residents

Congratulations to the more than 40 recipients of awards for excellence in teaching, patient care, and more that were given out recently by Stanford Medicine in recognition of outstanding contributions during the 2021-2022 academic year. See the partial list (including many of our DOM colleagues) below.

Tracy Rydel, MD, clinical associate professor of primary care and population health, received the Henry J. Kaiser Family Foundation Teaching Award for Outstanding and Innovative Contributions to Medical Education.

Daniel Bernstein, MD, the Alfred Woodley Salter and Mabel G. Salter Endowed Professor in Pediatrics;Lars Osterberg, MD, professor of primary care and population health, andHolly Tabor, PhD, associate professor of primary care and population health, received the Henry J. Kaiser Family Foundation Award for Excellence in Preclinical Teaching.

Gordon Gao, MD, clinical assistant professor of medicine,Andre Kumar, MD, clinical assistant professor of medicine, andMo Mertaban, MD, clinical assistant professor of pediatric hospital medicine, received the Henry J. Kaiser Foundation Award for Excellence in Clinical Teaching.

Ara Ko, MD, assistant professor of surgery,An Diem La, MD, clinical assistant professor, andBenjamin Laniakea, MD, clinical assistant professor of primary care and population health, received the Arthur L. Bloomfield Award in Recognition of Excellence in the Teaching of Clinical Medicine.

Mina Charon, MD, clinical assistant professor of primary care and population health, received the Outstanding Community Clinic Preceptor, Clinical Instruction Award.

Pedram Fatehi, MD, clinical associate professor of nephrology, received the Award for Excellence in Promotion of Humanism.

Lisa Chamberlain, MD, professor of pediatrics, andErika Schillinger, MD, clinical professor of primary care and population health, received the Award for Exceptional Community Service.

Medical residents Jonji Barber, MD, Andrew Brennan, MD, Dylan Lukato, MD, Ria Pal, MD, Derek Smith, MD, and Celeste Witting, MD, received the Arnold P. Gold Foundation Award for Humanism and Excellence in Teaching. The award is given to residents based on their commitment to teaching and the compassionate treatment of students, colleagues and patients and their families.

Preetha Basaviah, MD, clinical professor of primary care and population health,Jon Bernstein, MD, PhD, professor of pediatrics,Cynthia DeTata, MD, clinical assistant professor of obstetrics and gynecology,Kimberly Harney, MD, clinical associate professor,Wilma Lee, MD, clinical assistant professor of obstetrics and gynecology,Fernando Mendoza, MD, associate dean of minority advising and programs, andCharles Prober, MD, professor of pediatrics, microbiology and immunology, received the Oscar Salvatierra Award for Exceptional Service to Stanford Medical Students and the School of Medicine.

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Immunology

What to Know About the Latest Advances in Managing Severe Asthma – TIME

June 25, 2022 medical

Graphs and charts dont always tell the whole story. Numbers can be deceiving. But anyone who looks at U.S. trends in asthma mortality can see, without squinting, that things are moving in the right direction.

A 2019 analysis in the American Journal of Respiratory and Critical Care Medicine found that from 1999 to 2015, asthma mortality fell by 43%. The decrease in asthma-related mortality was consistent in both sexes and in all race groups, with the largest decrease in patients older than 65 years, the authors concluded. Figures from the U.S. Centers for Disease Control and Prevention indicate that these positive trends have continued through 2019, and data coming from the U.K. and Europe tell a similarly happy tale.

What I see in the clinic today is completely different than it was 10 years ago, says Dr. Christopher Brightling, a clinical professor in respiratory medicine at the University of Leicester and a senior investigator at the National Institute for Health and Care Research in the U.K. The treatment space is looking really positive, and with the newest drugs I would anticipate responses to be even better.

Biologics, he and others say, are leading the way in the fight against severe asthma. These drugs work by manipulating the activity of genes or cells, and they have been life-changing for many patients. New advancements in inhaler-based medicines and connected technologies are other bright spots, and some health systems are moving their care teams out of the clinic and into community settings in an effort to reach underserved populations.

Together, these and other new advancements are producing real and measurable improvements in patient access and outcomes. It is really a very exciting time in asthma research right now, says Dr. Derek Chu, an assistant professor of medicine and a researcher in allergy and clinical immunology at McMaster University in Canada. Theres a lot in development for both mild and moderate-severe asthma.

Here, Chu and other experts detail the latest on these groundbreaking treatments and strategies.

Read More: How Alternative Medicine Can Help People With Asthma

In 2003, the U.S. Food and Drug Administration (FDA) approved the first biologic for the treatment of severe asthma. That drug, omalizumab, is a monoclonal antibody therapy that works primarily by reducing blood levels of IgE, an immune system antibody that contributes to airway inflammation among people with severe asthma.

Although omalizumab was revolutionary, experts say the past few years have witnessed the arrival of newer and better biologics that have all but eradicated the burden of severe asthma for most patients. These have been totally transformational, says David Jackson, a respiratory medicine specialist at Kings College London. Since 2017, a new biologic has been added to our armory on almost an annual basis, and the number of patients with uncontrolled asthma has gotten smaller and smaller.

Whereas the first biologics blocked IgE, the latest drugs in this category targetwith greater and greater precisionthe specific immune pathways and cells that drive asthma-related inflammation and symptoms. Cells called eosinophils are a hallmark of severe asthma, and these newer biologic therapies can dampen down their production and related pathways in a much more targeted way, Jackson says. He uses a military analogy to highlight the effectiveness of the newest biologics. These are like precision-guided laser bombs, as opposed to the old B52s dropping bombs from 50,000 ft. and just hoping for best.

Some of the newest biologics take aim at two specific immune system proteins: thymic stromal lymphopoietin (TSLP) and interleukin 33. These two activate cells in the airways, which leads to a release of all these [inflammation] players, Brightling explains. Because these two are farther upstream than some of the pathways targeted by older biologics, mellowing their activity may produce broader benefits, he says.

Biologics do come with downsides. For one thing, theyre expensive. They often cost around $30,000 a year in the U.S., Jackson says. They are not always covered by insurance. Also, in the past their administration required regular office or clinic visits. Biologics are traditionally delivered via injection anywhere from once every two months to once every two weeks. However, the coronavirus pandemic has helped shift the use of these drugs away from the clinic and into the home. Theres been a big push to self-administration, Jackson says. What we normally do now is to start in the clinicso give the first one to three administrations herethen go to home administration when its clear the patient is doing well.

Despite any lingering financial and logistical hurdles, the benefits provided by biologics are often profound. The latest and greatest biologics work so well that many patients are effectively relieved of the burden of severe asthma attacks or symptomssomething that would have seemed unbelievable just a decade ago.

Unfortunately, not everyone who would benefit from these drugs is getting them. Awareness of this medicine is not what it should be, Jackson says. A lot of patients continue to have asthma attacks and their doctor hasnt picked up on the fact that there are newer therapies. If every clinician who treats severe asthma was up to speed on these drugsand if everyone who truly needs them had access to these medicinesits possible that virtually every person with severe asthma could avoid the worst symptoms, he says.

Read More: The Breathing Technique a Navy SEAL Uses to Stay Calm and Focused

Asthma used to be thought of as a single disease that could range from mild to severe. But thats changed. The model of asthma as a single entity is now obsolete due to an increased understanding of its underlying heterogeneity, wrote the authors of a 2019 study in Clinical Reviews in Allergy & Immunology.

At this point, asthma is an umbrella term for a number of related but distinct diseases that are differentiated in part by the activation of various immune pathways. Those pathways are now better mapped than ever before. By identifying the ones driving pathology in an individual patienta process often called phenotypingclinicians can better predict how that person will fare on a drug. The phenotyping piece has been one of the big shifts, Brightling says. It can help us understand which patients will respond best to a treatment.

Phenotyping often starts with an assessment of a patients demographic or symptom characteristics. Is the person old or young? Do they have early-onset or late-onset asthma? Are they obese? Do they have atopic involvement? In the near futureand this is where some of the latest advancements have occurredphenotyping may involve blood and breath tests. Brightling says blood tests can provide helpful information on eosinophils and other immune system players that give rise to a persons asthma symptoms. Breath tests of exhaled nitric oxide can reveal the involvement of specific immune system proteins, as well as the presence of airway hyperactivity, he adds.

To be effective, the newest treatments have to find their way to the patients who will benefit from them most. Phenotyping plays a crucial matchmaking role.

Every asthma specialist knows that getting patients to reliably take their medicine can be a struggle. Particularly among young people with severe asthma, adherence is often poor. A 2018 study in the European Respiratory Journal found that even after special educational courses in inhaler use and disease management, only 63% of people with severe asthma adhered to their treatment plan.

I think one of the biggest challenges, especially with severe asthma, is that patients feel fine a lot of the time, and its difficult to remember to take a medication every single day if youre feeling good, says Dr. Ruchi Gupta, a professor of pediatrics, preventive medicine, and medicine (allergy and immunology) at Northwestern Universitys Feinberg School of Medicine and Lurie Childrens Hospital. Other experts say that pricey biologics might be needed far less if more patients with severe asthma reliably took their inhaled corticosteroids.

Theres a new solution to this problem: smart inhalers that can notify patients or their care team when doses are missed. For a 2021 study in Pediatrics, Gupta and her colleagues examined the usefulness of inhalers equipped with Bluetooth connected technologies among children with asthma. The inhalers notified a childs care team if they missed their daily doses several days in a row, or if they took too many rescue doses in a single day. After 12 months of follow-up, treatment adherence had increased by 17% and measures of asthma-symptom burden had likewise improved, the study found. Patients felt like someone was looking out for them and taking care of them, Gupta says.

Some of these smart-inhaler technologies are already available (though usually not covered by insurance). For example, patients can buy inhaler sensors that will remind them when to take their meds. Some health care systems have also set up office notifications similar to the type Gupta and her team studied. But for the most part, these new technologies are not widely deployed. My dream is that every time a patient uses their inhaler, this information would go straight into their electronic medical chart, she says. I know some groups are working on that.

One of the persistent challenges of modern medicine is ensuring the equitable distribution of quality care. Gupta mentions drug costs, Medicare and Medicaid coverage, and access to asthma specialists as some of the barriers between patients and the treatment they need.

In an effort to provide quality care to underserved groups, some asthma specialists are leaving the clinic and meeting patients where they live and work. Doctors here in Chicago are going out into the community and setting up tents where people know theyll be, or going to schools and giving checkups in parking lots, Gupta says.

She also mentions the asthma vans that are now operating in Chicago. These clinics on wheels, staffed by allergy specialists, drive to underserved communities and offer on-site treatment. These have been very effective resources, she says. More solutions like this are needed to improve access to appropriate asthma care.

Read More: How Climate Change and Air Pollution Affect Kids Health

Theres a lot more going on in the field of severe asthma care. For a 2021 study in JAMA, Chu found that triple-drug therapyadding a third medication to the common two-drug combination of corticosteroids and bronchodilatorsled to a lower incidence of severe attacks among patients who use inhalers.

Although the future looks bright, he says that more work lies ahead. The main issues are the critical need for head-to-head studies of active drugs or management approaches, rather than purely placebo-controlled studies, he says. This work could further clarify best treatment approaches.

However, life for many people with severe asthma has never been better. Many patients almost feel like they dont have the disease anymore, says Jackson. They stop having attacks, stop showing up in hospitals, and can function without asthma interfering in their life. Thats worth celebrating.

A mother’s blood may carry the secret to one type of autism – EurekAlert

June 25, 2022 medical

Autism is a neurodevelopment condition affecting 1 in 44 children in the U.S. It has a wide range of characteristics with different intensities and causes. One type of autism is maternal autoantibodyrelated autism spectrum disorder (MAR ASD).

MAR ASD is marked by the presence of specific maternal immune proteins known as autoantibodies that react to certain proteins found in the fetal brain. The maternal autoantibodies (IgG) cross the placenta and access the developing brain. Once there, they may cause changes in the way the brain develops in the offspring, leading to behaviors linked to autism.

Two new UC Davis MIND Institute studies are expanding our understanding of this type of autism. They found support for predictive protein patterns in the blood of expecting mothers and links of MAR ASD to higher intensities of autistic traits.

MAR ASD patterns linked to autism before birth

The MIND Institutes Judy Van de Water and a team of researchers showed that autoantibody binding to nine specific combinations of proteins (known as MAR ASD patterns) successfully predicts autism in previously diagnosed children. They tested maternal blood samples collected during pregnancy to see if they could validate the identified patterns. They wanted to see if the patterns accurately predicted autism in the children. Their study findings were published in Molecular Psychiatry.

Previously, we identified nine patterns linked to MAR ASD. In this study, we wanted to check the accuracy of these patterns in predicting MAR ASD. To do that, we tested plasma from pregnant mothers, collected by the Early Markers for Autism (EMA) study, said Van de Water, the studys senior author. Van de Water is a UC Davis professor of immunology and neurodevelopment.

The study screened the plasma of 540 mothers of autistic children, 184 mothers of kids with intellectual disability but no autism, and 420 general population mothers of kids with no known autism or intellectual disability at the time of the study.

It found reactivity to at least one of the nine MAR ASD patterns in 10% of the autistic group. This is compared with 4% of the intellectual disability group for some patterns, and 1% of the general population group. Four patterns were present only in mothers whose children were later diagnosed with autism, making those particular autoantibody patterns highly predictive.

The study also found that a mother with reactivity to any one of the nine MAR ASD patterns has around 8 times the chance of having an autistic child.

Several MAR ASD patterns were strongly associated with autism with intellectual disability. Others were linked to autism without intellectual disability. The protein pattern most strongly linked to autism was (CRMP1+CRMP2). It increased the likelihood of an autism diagnosis by 16 times and was not found in the non-autism groups.

MAR ASD similarly present across states

Previous research found the MAR subtype of autism in 20% of a Northern California sample of autistic kids Yet, until now, this type of autism has not been studied in any state besides California.

A team of researchers led by Kathleen Angkustsiri explored MAR ASD in two new clinical sites: the Childrens Hospital of Philadelphia (CHOP) and Arkansas Childrens Hospital and Research Institute (ACHRI). Their study, published in The Journal of Developmental and Behavioral Pediatrics, recruited 68 mothers of autistic children ages 2-12 years. The mothers provided blood samples and completed behavioral questionnaires about their children.

The study also included data from the children's clinical diagnostic assessments. It used established diagnostic measures known as ADOS (the autism diagnostic observation schedule) and Social Communication Questionnaire (SCQ) to assess the childrens autistic characteristics.

MAR ASD was present in 21% of CHOPs and 26% of ACHRIs samples. Overall, 23.5% of the blood samples were considered MAR positive (+MAR), showing autoantibodies reacting to known MAR ASD protein patterns.

Our study showed similar MAR ASD frequencies in two other states similar to what we observed in Northern California, Angkustsiri said. Angkustsiri is an associate professor of developmental-behavioral pediatrics at UC Davis Children's Hospital and the UC Davis MIND Institute and the studys lead author. This suggests that the prevalence of MAR ASD is consistent across different demographics and geographic settings.

MAR ASD and autism characteristics

The study also examined the link between MAR ASD and autism severity. It showed that children of mothers with +MAR antibodies had higher autism severity scores than those of -MAR mothers. It did not find significant differences in their IQ, adaptive function or unusual behavior.

MAR ASD positivity may be linked to more severe autism behaviors, Angkustsiri said. Both the SCQ reported by parents and the ADOS assessed by clinicians supported these findings.

Further study is needed to understand why mothers develop these antibodies and how long these antibodies may persist. Testing for MAR ASD patterns can be used to assess the probability of a child having autism before characteristics are present. The researchers aim to develop an accurate clinical test to provide clinicians with more tools for an earlier diagnosis of ASD.

We hope our work can help develop better-tailored services based on the type of autism and the child's strengths and specific challenges, Van de Water said.

###

Co-authors on Van de Waters study are Alexandra Ramirez-Celis, Joseph Schauer and Paul Ashwood from UC Davis, Lisa Croen, Cathleen Yoshida and Stacey Alexeeff from Kaiser Permanente, and Robert Yolken from Johns Hopkins University. Funding was provided by the NIEHS Center for Childrens Environmental Health and Environmental Protection Agency (EPA) grants (2P01ES011269-11, 83543201), the NIEHS-funded EMA study (R01ES016669), the NICHD-funded IDDRC (P50HD103526) and Consejo Nacional de Ciencia y Tecnologia (CONACYT- UC MEXUS) Doctoral Fellowships.

Co-authors on Angkustsiris study are Jill Fussell, Amanda Bennett, Joseph Schauer, Alexandra Ramirez-Celis, Robin Hansen and Judy Van de Water. The study was funded by the DBPNet Young Investigator Award UT5MC42432 and the NICHD-funded IDDRC (P50HD103526)

The authors recognize that medical terms such as symptom and severity are pathologizing and are making efforts to move away from this historical terminology. In this paper, the analysis is based on the calibrated severity score generated from the use of the diagnostic test the ADOS, which is why theyre using them in this instance.

Molecular Psychiatry

Maternal autoantibody profiles as biomarkers for ASD and ASD with co-occurring intellectual disability

26-May-2022

Judy Van de Water has patents issued for this technology and has founded a UC Davis startup company to develop this technology. The remaining authors have no conflicts of interest.

Read the rest here:
A mother's blood may carry the secret to one type of autism - EurekAlert

Immunology

Dried samples of saliva and fingertip blood are useful in monitoring responses to coronavirus vaccines – EurekAlert

June 15, 2022 medical

Based on an antibody study, dried samples of easily self-collected saliva and of blood drawn from the fingertip could be useful for monitoring peoples immune responses to vaccination.

In a study by the University of Helsinki and HUS Helsinki University Hospital, the levels of antibodies associated with the SARS-CoV-2 virus were analysed in more than 1,200 employees in the social welfare and healthcare sector to determine whether there were differences in different antibody classes according to viral exposure. Dried saliva and blood samples collected between January and March 2021 were utilised in the study. The exposure and background data were collected using a questionnaire.

Based on the results, immunoglobulin G (IgG) has a 99.5% sensitivity and 75.3% specificity to distinguish people with two vaccinations from non-exposed and exposed individuals, individuals with previous Covid-19 infection, and those with one vaccination. IgG measured from saliva also had an 85.3% sensitivity and 65.7% specificity in distinguishing people with two vaccinations from the other groups.

The results of the study have been published in the Medical Microbiology and Immunology journal.

The study attested to the exposure of social welfare and healthcare employees to coronavirus, visible in the results as elevated antibody levels. A total of 47.5% of nurses and 47.7% of doctors were seropositive due to either a previous infection, vaccination or exposure, whereas only 8.7% of dentists had been exposed to the virus. In addition to dentists, the lowest antibody levels were observed in administrative staff and social workers.

The highest antibody levels in both the blood and saliva were found in those who had both had Covid-19 and had been vaccinated. The lowest antibody levels were seen in individuals who had not been exposed to the virus, who had not had a previous infection and who had not received a vaccination.

Against our expectations, there have been fewer coronavirus infections and instances of exposure among dental care staff compared to, for example, hospital doctors, even though a lot of aerosol-producing procedures are carried out close to the patient in dental care, researcher Laura Lahdentausta says.

At the time of sample collection, the dental care staff had also received the lowest number of coronavirus vaccines, which was reflected in their antibody levels.

Another goal of the study was to develop research methods. In fact, the study provides important information on the use of saliva in the determination of antibody levels.

Based on the results, dried samples reliably reveal antibodies associated with the virus, says Professor Pirkko Pussinen.

The benefit of dried saliva and fingertip blood samples is that they are easy to collect. Samples can be taken at home outside laboratory conditions. Their collection is inexpensive and, in the case of saliva samples, non-invasive.

In the future, this assay technique based on dried spot samples could be effectively utilised to monitor both the immune response produced by vaccination and the need for vaccines in large patient populations, Pussinen adds.

Original article: Lahdentausta L, Kivimki A, Oksanen L, Tallgren M, Oksanen S, Sanmark E, Salminen A, Geneid A, Sairanen M, Paju S, Saksela K, Pussinen P, Pietiinen M. Blood and saliva SARS-Cov-2 antibody levels in self-collected dried spot samples. Medical Microbiology and Immunology. Doi 10.1007/s00430-022-00740-x

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Blood and saliva SARS-Cov-2 antibody levels in self-collected dried spot samples

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Immunology

DE Shaw Research Licenses First-in-Class Therapeutic for Immunological Diseases to Lilly – PR Newswire UK

June 15, 2022 medical

NEW YORK, June 13, 2022 /PRNewswire/ -- D. E.Shaw Research (DESRES) today announced that it has entered into an exclusive global license agreement with Eli Lilly and Company (Lilly) for the clinical development and commercialization of DESRES's program of Kv1.3-targeted therapeutics for the treatment of various immunological and inflammatory diseases.

The lead compound, DES-7114, is an orally administered, highly selective small-molecule inhibitor of the ion channel protein Kv1.3. This first-in-class compound recently completed successful Phase 1 clinical trials in healthy volunteers and has demonstrated efficacy in preclinical models of several chronic inflammatory and autoimmune diseases, including ulcerative colitis, Crohn's disease and atopic dermatitis.

Under the terms of the agreement, Lilly will make an initial payment of $60 million to DESRES, with potential development and commercial milestone payments of up to $475 million, as well as royalties on worldwide sales.

The design of DES-7114 by DESRES was enabled by the use of proprietary special-purpose supercomputers that DESRES developed and constructed to perform ultra-high-speed, atomically detailed simulations of the three-dimensional motion of biologically and pharmaceutically significant molecules. A series of such simulations, in combination with experimental studies, resulted in DESRES's unique understanding of Kv1.3's structural, dynamic, and functional properties, leading to the design of compounds that bind strongly to the target protein while likely avoiding undesirable interactions with other ion channels.

"We're enthusiastic about DES-7114's potential, and are hopeful that it will ultimately have a meaningful impact on the lives of patients throughout the world," said DavidE.Shaw, Ph.D., chief scientist at DESRES. "We're also enthusiastic about teaming up with Lilly, which is one of the global leaders in therapeutics for immunological diseases, and is exceptionally well positioned to carry the compound forward through clinical development and commercialization."

"Kv1.3 inhibition represents a promising new approach in immunology," said AjayNirula, M.D., Ph.D., vice president of immunology at Lilly. "We are particularly excited about DESRES's discovery of DES-7114 because the molecule's properties could translate into significant advantages for addressing unmet patient needs."

About D. E. Shaw Research

D.E.Shaw Research (DESRES) uses advanced computational technologies to understand the behavior of biologically and pharmaceutically significant molecules at an atomic level of detail, and to design precisely targeted, highly selective drugs for the treatment of various diseases. Among its core technologies is a proprietary special-purpose supercomputer that it designed and constructed to perform molecular dynamics simulations more than 100 times faster than the world's fastest general-purpose supercomputers. DESRES uses these machines, together with machine learning methods and other computational techniques, in both internal and collaborative drug discovery programs. For more information, visit http://www.DEShawResearch.com.

ContactMadeleine WeingartenD. E. Shaw ResearchMadeleine.Weingarten@DEShawResearch.com

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DE Shaw Research Licenses First-in-Class Therapeutic for Immunological Diseases to Lilly - PR Newswire UK