Perched on a meditation cushion with the day’s first light creeping up the Himalayan foothills around me, I felt more at ease within myself than I could ever recall over my previous 19 years.

Alec Terrana

My immersion in daily conversations within the Tibetan monastic community on achieving a more harmonious relationship to our thoughts and feelings awoke a consideration of myself and my inner life in a way that I’d never truly contemplated before. These reflections gave me a vocabulary and a toolkit for navigating my own internal landscape that I have used ever since.

However, upon returning home, I was forced to acknowledge how fortunate I had been, and that these tools and the underlying spirit of inquiry are not commonplace in our society. Despite great strides in shifting views toward mental illness over the past few decades, our public discourse rarely captures the nuances of the mental health crisis that our culture has faced well before COVID-19 catalyzed even greater distress. We all pay the price of this cultural deficit to varying degrees, and I became captivated by the notion that things could be different.

I followed that thread of inquiry through the practices of Buddhist studies, massage therapy, yoga instruction, and refugee aid before coming to psychiatry as the unlikely yet ideal crucible for integrating my experiences in these spaces. Since arriving at medical school, however, my vision of myself as a psychiatrist has changed dramatically as my aspirations have collided with the realities of clinical experience and been tempered by the wisdom of mentors, colleagues, and patients, opening up a space for a deeper appreciation of what psychiatry might offer.
 

Clinical experience changes perspective

Short on clinical experience, I had previously imagined my future practice primarily as one of mindful listening and finding presence with each patient as a kind ear, supplemented by the ability to prescribe medication. Since then, working with patients has offered me insight into the ways in which my personality, perception, and potential access to a range of affective stances can serve as tools for skillfully developing the therapeutic encounter.

Moreover, “challenging” patients have taught me that my role is not always to offer unbounded empathetic support, but to potentially initiate compassionately tactful confrontation, shifting my sense of my role in the therapeutic relationship.

My responsibility is neither to passively support my patients by unambiguously endorsing the validity of experiences, nor to win them over to a particular way of viewing and approaching the world, but to help them get better. This is a lofty goal, which might entail modeling the successful navigation of potential ruptures and the subsequent repair of relationships so that they can live more adaptably in the world.

However, while I can support their envisioning of a realistic future for themselves and facilitate their acquisition of the tools needed to get there, my role is significant yet limited. This has been a hard truth to reckon with, but one that’s opened up pathways to greater empathy and a deeper understanding of each patient’s struggles. As a result, my view of pathology as a state has shifted to one of a dynamic process that emerges through the interaction of their genes, environment, life history, pharmacological supplements, psychodynamic tendencies, diet, and more.

Yet, while holding this reality of the complexities of mental illness, clinical decision-making often hinges on making binary choices regarding diagnoses, medications, and criteria for legal determinations. Developing this capacity to simultaneously practice different ways of knowing and sit with uncertainty excites me tremendously, not only equipping me to balance clinical practice with the demands of the modern health care system, but also nourishing the roots of a rich and ethical life.

Psychiatry calls to me for this expectation of sustaining an appropriate tension between uncertainty and decisiveness. It also inspires a deeper dive into the history of the field in order to learn the roots of its theories and perspectives so I can better understand how those inform contemporary practice in ways that are both helpful and harmful.
 

From individual to community

In tandem with this outer work of learning to appropriately position myself within individual patient relationships, the broader health care system, and the legacy of the field, I’ve also sought to develop a better understanding of how my own history, beliefs, and motivations shape my collaborative efforts.

Through my mindfulness practice and participation in exploratory psychoanalysis, I’ve caught glimpses of my own countertransference investments and opened up space for seeing how patients might experience me as a clinician. This has allowed for tuning in to my own response to them, identifying where in the typology of personality structures our reciprocal experiences might exist, and learning to manage those feelings to ultimately foster empathy through the interaction.

This has shifted my sense of the work from solely mindfully listening and thoughtfully responding to honing deliberate ways of both listening and responding in a way that is directly informed by the person sitting in front of me so I can best support them in creating change.

Given the responsibility inherent to this work, I have treated my medical education as an opportunity to build a foundation for stepping into this role. This has involved going beyond exploring these dynamics within individual clinician-patient relationships and carried over into my experiences with community-based research and program development. It has asked me to recognize the perceptual frames and prioritization of values that I bring to any given project.

This process has sharpened my aim of discovering each community’s understanding of their mental health needs so that I’m not implicitly imposing my own notions of psychological wholeness and “wellness” on others.

Working with San Diego’s Somali and Spanish-speaking populations has helped me to better understand each community’s own conceptualization of their strengths and needs, teaching me how to engage in reciprocal partnerships that honor each of our areas of expertise. Investing myself in medical school curricular reform represents the flip side of this coin, serving as an attempt to better understand my own medical community, how we think about health, and how we can best care for ourselves.

These experiences have offered opportunities to refine my skills in appreciative inquiry, coalition building, navigating institutional dynamics, and initiating and sustaining change within complex systems to carry the lessons of psychiatry beyond explicitly clinical spaces.
 

Toward integrative care

Ultimately, I view my community-based research and academic program development as outgrowths of my commitment to clinical psychiatry and my desire to learn how to provide people with the tools for changing their relationship to themselves, others, and their communities.

Equipped with formal medical training as the bedrock of this skill set, I have actively sought out opportunities to draw from practices that are outside the scope of the formal curriculum. These range from psychoanalysis and narrative medicine to cultural psychiatry and psychological anthropology, as well as my background in bodywork and mindfulness education. I’m eager to dive more fully into psychiatric practice as I work to integrate these disparate knowledge bases with the biomedical and psychodynamic views of the mind to develop a strengths-based practice that tends to patients’ bodies, minds, and spirits by bringing forth their own knowledge of themselves and their lives as they imagine what could be.

These realizations bring me back to that Himalayan sunrise more than a decade ago. They affirm that my heart lies with traversing disciplines to provide integrative psychiatric care in the community and developing infrastructure that supports these efforts. I’m filled with enthusiasm by the breadth of what psychiatry training offers as I continue expanding my capacity to support patients in this lifelong healing journey.

Alec Terrana is a rising fourth-year medical student at the University of California, San Diego, who intends to apply into psychiatry residency programs. He’s invested in exploring how we can more effectively conceptualize and measure mental health outcomes within San Diego’s Somali and Spanish-speaking communities, as well as advancing mindfulness and compassion training in undergraduate medical education. His professional interests also include implementation science, cultural psychiatry, psychodynamics, and strengthening public mental health infrastructure.

Perched on a meditation cushion with the day’s first light creeping up the Himalayan foothills around me, I felt more at ease within myself than I could ever recall over my previous 19 years.

Alec Terrana

My immersion in daily conversations within the Tibetan monastic community on achieving a more harmonious relationship to our thoughts and feelings awoke a consideration of myself and my inner life in a way that I’d never truly contemplated before. These reflections gave me a vocabulary and a toolkit for navigating my own internal landscape that I have used ever since.

However, upon returning home, I was forced to acknowledge how fortunate I had been, and that these tools and the underlying spirit of inquiry are not commonplace in our society. Despite great strides in shifting views toward mental illness over the past few decades, our public discourse rarely captures the nuances of the mental health crisis that our culture has faced well before COVID-19 catalyzed even greater distress. We all pay the price of this cultural deficit to varying degrees, and I became captivated by the notion that things could be different.

I followed that thread of inquiry through the practices of Buddhist studies, massage therapy, yoga instruction, and refugee aid before coming to psychiatry as the unlikely yet ideal crucible for integrating my experiences in these spaces. Since arriving at medical school, however, my vision of myself as a psychiatrist has changed dramatically as my aspirations have collided with the realities of clinical experience and been tempered by the wisdom of mentors, colleagues, and patients, opening up a space for a deeper appreciation of what psychiatry might offer.
 

Clinical experience changes perspective

Short on clinical experience, I had previously imagined my future practice primarily as one of mindful listening and finding presence with each patient as a kind ear, supplemented by the ability to prescribe medication. Since then, working with patients has offered me insight into the ways in which my personality, perception, and potential access to a range of affective stances can serve as tools for skillfully developing the therapeutic encounter.

Moreover, “challenging” patients have taught me that my role is not always to offer unbounded empathetic support, but to potentially initiate compassionately tactful confrontation, shifting my sense of my role in the therapeutic relationship.

My responsibility is neither to passively support my patients by unambiguously endorsing the validity of experiences, nor to win them over to a particular way of viewing and approaching the world, but to help them get better. This is a lofty goal, which might entail modeling the successful navigation of potential ruptures and the subsequent repair of relationships so that they can live more adaptably in the world.

However, while I can support their envisioning of a realistic future for themselves and facilitate their acquisition of the tools needed to get there, my role is significant yet limited. This has been a hard truth to reckon with, but one that’s opened up pathways to greater empathy and a deeper understanding of each patient’s struggles. As a result, my view of pathology as a state has shifted to one of a dynamic process that emerges through the interaction of their genes, environment, life history, pharmacological supplements, psychodynamic tendencies, diet, and more.

Yet, while holding this reality of the complexities of mental illness, clinical decision-making often hinges on making binary choices regarding diagnoses, medications, and criteria for legal determinations. Developing this capacity to simultaneously practice different ways of knowing and sit with uncertainty excites me tremendously, not only equipping me to balance clinical practice with the demands of the modern health care system, but also nourishing the roots of a rich and ethical life.

Psychiatry calls to me for this expectation of sustaining an appropriate tension between uncertainty and decisiveness. It also inspires a deeper dive into the history of the field in order to learn the roots of its theories and perspectives so I can better understand how those inform contemporary practice in ways that are both helpful and harmful.
 

From individual to community

In tandem with this outer work of learning to appropriately position myself within individual patient relationships, the broader health care system, and the legacy of the field, I’ve also sought to develop a better understanding of how my own history, beliefs, and motivations shape my collaborative efforts.

Through my mindfulness practice and participation in exploratory psychoanalysis, I’ve caught glimpses of my own countertransference investments and opened up space for seeing how patients might experience me as a clinician. This has allowed for tuning in to my own response to them, identifying where in the typology of personality structures our reciprocal experiences might exist, and learning to manage those feelings to ultimately foster empathy through the interaction.

This has shifted my sense of the work from solely mindfully listening and thoughtfully responding to honing deliberate ways of both listening and responding in a way that is directly informed by the person sitting in front of me so I can best support them in creating change.

Given the responsibility inherent to this work, I have treated my medical education as an opportunity to build a foundation for stepping into this role. This has involved going beyond exploring these dynamics within individual clinician-patient relationships and carried over into my experiences with community-based research and program development. It has asked me to recognize the perceptual frames and prioritization of values that I bring to any given project.

This process has sharpened my aim of discovering each community’s understanding of their mental health needs so that I’m not implicitly imposing my own notions of psychological wholeness and “wellness” on others.

Working with San Diego’s Somali and Spanish-speaking populations has helped me to better understand each community’s own conceptualization of their strengths and needs, teaching me how to engage in reciprocal partnerships that honor each of our areas of expertise. Investing myself in medical school curricular reform represents the flip side of this coin, serving as an attempt to better understand my own medical community, how we think about health, and how we can best care for ourselves.

These experiences have offered opportunities to refine my skills in appreciative inquiry, coalition building, navigating institutional dynamics, and initiating and sustaining change within complex systems to carry the lessons of psychiatry beyond explicitly clinical spaces.
 

Toward integrative care

Ultimately, I view my community-based research and academic program development as outgrowths of my commitment to clinical psychiatry and my desire to learn how to provide people with the tools for changing their relationship to themselves, others, and their communities.

Equipped with formal medical training as the bedrock of this skill set, I have actively sought out opportunities to draw from practices that are outside the scope of the formal curriculum. These range from psychoanalysis and narrative medicine to cultural psychiatry and psychological anthropology, as well as my background in bodywork and mindfulness education. I’m eager to dive more fully into psychiatric practice as I work to integrate these disparate knowledge bases with the biomedical and psychodynamic views of the mind to develop a strengths-based practice that tends to patients’ bodies, minds, and spirits by bringing forth their own knowledge of themselves and their lives as they imagine what could be.

These realizations bring me back to that Himalayan sunrise more than a decade ago. They affirm that my heart lies with traversing disciplines to provide integrative psychiatric care in the community and developing infrastructure that supports these efforts. I’m filled with enthusiasm by the breadth of what psychiatry training offers as I continue expanding my capacity to support patients in this lifelong healing journey.

Alec Terrana is a rising fourth-year medical student at the University of California, San Diego, who intends to apply into psychiatry residency programs. He’s invested in exploring how we can more effectively conceptualize and measure mental health outcomes within San Diego’s Somali and Spanish-speaking communities, as well as advancing mindfulness and compassion training in undergraduate medical education. His professional interests also include implementation science, cultural psychiatry, psychodynamics, and strengthening public mental health infrastructure.

Perched on a meditation cushion with the day’s first light creeping up the Himalayan foothills around me, I felt more at ease within myself than I could ever recall over my previous 19 years.

Alec Terrana

My immersion in daily conversations within the Tibetan monastic community on achieving a more harmonious relationship to our thoughts and feelings awoke a consideration of myself and my inner life in a way that I’d never truly contemplated before. These reflections gave me a vocabulary and a toolkit for navigating my own internal landscape that I have used ever since.

However, upon returning home, I was forced to acknowledge how fortunate I had been, and that these tools and the underlying spirit of inquiry are not commonplace in our society. Despite great strides in shifting views toward mental illness over the past few decades, our public discourse rarely captures the nuances of the mental health crisis that our culture has faced well before COVID-19 catalyzed even greater distress. We all pay the price of this cultural deficit to varying degrees, and I became captivated by the notion that things could be different.

I followed that thread of inquiry through the practices of Buddhist studies, massage therapy, yoga instruction, and refugee aid before coming to psychiatry as the unlikely yet ideal crucible for integrating my experiences in these spaces. Since arriving at medical school, however, my vision of myself as a psychiatrist has changed dramatically as my aspirations have collided with the realities of clinical experience and been tempered by the wisdom of mentors, colleagues, and patients, opening up a space for a deeper appreciation of what psychiatry might offer.
 

Clinical experience changes perspective

Short on clinical experience, I had previously imagined my future practice primarily as one of mindful listening and finding presence with each patient as a kind ear, supplemented by the ability to prescribe medication. Since then, working with patients has offered me insight into the ways in which my personality, perception, and potential access to a range of affective stances can serve as tools for skillfully developing the therapeutic encounter.

Moreover, “challenging” patients have taught me that my role is not always to offer unbounded empathetic support, but to potentially initiate compassionately tactful confrontation, shifting my sense of my role in the therapeutic relationship.

My responsibility is neither to passively support my patients by unambiguously endorsing the validity of experiences, nor to win them over to a particular way of viewing and approaching the world, but to help them get better. This is a lofty goal, which might entail modeling the successful navigation of potential ruptures and the subsequent repair of relationships so that they can live more adaptably in the world.

However, while I can support their envisioning of a realistic future for themselves and facilitate their acquisition of the tools needed to get there, my role is significant yet limited. This has been a hard truth to reckon with, but one that’s opened up pathways to greater empathy and a deeper understanding of each patient’s struggles. As a result, my view of pathology as a state has shifted to one of a dynamic process that emerges through the interaction of their genes, environment, life history, pharmacological supplements, psychodynamic tendencies, diet, and more.

Yet, while holding this reality of the complexities of mental illness, clinical decision-making often hinges on making binary choices regarding diagnoses, medications, and criteria for legal determinations. Developing this capacity to simultaneously practice different ways of knowing and sit with uncertainty excites me tremendously, not only equipping me to balance clinical practice with the demands of the modern health care system, but also nourishing the roots of a rich and ethical life.

Psychiatry calls to me for this expectation of sustaining an appropriate tension between uncertainty and decisiveness. It also inspires a deeper dive into the history of the field in order to learn the roots of its theories and perspectives so I can better understand how those inform contemporary practice in ways that are both helpful and harmful.
 

From individual to community

In tandem with this outer work of learning to appropriately position myself within individual patient relationships, the broader health care system, and the legacy of the field, I’ve also sought to develop a better understanding of how my own history, beliefs, and motivations shape my collaborative efforts.

Through my mindfulness practice and participation in exploratory psychoanalysis, I’ve caught glimpses of my own countertransference investments and opened up space for seeing how patients might experience me as a clinician. This has allowed for tuning in to my own response to them, identifying where in the typology of personality structures our reciprocal experiences might exist, and learning to manage those feelings to ultimately foster empathy through the interaction.

This has shifted my sense of the work from solely mindfully listening and thoughtfully responding to honing deliberate ways of both listening and responding in a way that is directly informed by the person sitting in front of me so I can best support them in creating change.

Given the responsibility inherent to this work, I have treated my medical education as an opportunity to build a foundation for stepping into this role. This has involved going beyond exploring these dynamics within individual clinician-patient relationships and carried over into my experiences with community-based research and program development. It has asked me to recognize the perceptual frames and prioritization of values that I bring to any given project.

This process has sharpened my aim of discovering each community’s understanding of their mental health needs so that I’m not implicitly imposing my own notions of psychological wholeness and “wellness” on others.

Working with San Diego’s Somali and Spanish-speaking populations has helped me to better understand each community’s own conceptualization of their strengths and needs, teaching me how to engage in reciprocal partnerships that honor each of our areas of expertise. Investing myself in medical school curricular reform represents the flip side of this coin, serving as an attempt to better understand my own medical community, how we think about health, and how we can best care for ourselves.

These experiences have offered opportunities to refine my skills in appreciative inquiry, coalition building, navigating institutional dynamics, and initiating and sustaining change within complex systems to carry the lessons of psychiatry beyond explicitly clinical spaces.
 

Toward integrative care

Ultimately, I view my community-based research and academic program development as outgrowths of my commitment to clinical psychiatry and my desire to learn how to provide people with the tools for changing their relationship to themselves, others, and their communities.

Equipped with formal medical training as the bedrock of this skill set, I have actively sought out opportunities to draw from practices that are outside the scope of the formal curriculum. These range from psychoanalysis and narrative medicine to cultural psychiatry and psychological anthropology, as well as my background in bodywork and mindfulness education. I’m eager to dive more fully into psychiatric practice as I work to integrate these disparate knowledge bases with the biomedical and psychodynamic views of the mind to develop a strengths-based practice that tends to patients’ bodies, minds, and spirits by bringing forth their own knowledge of themselves and their lives as they imagine what could be.

These realizations bring me back to that Himalayan sunrise more than a decade ago. They affirm that my heart lies with traversing disciplines to provide integrative psychiatric care in the community and developing infrastructure that supports these efforts. I’m filled with enthusiasm by the breadth of what psychiatry training offers as I continue expanding my capacity to support patients in this lifelong healing journey.

Alec Terrana is a rising fourth-year medical student at the University of California, San Diego, who intends to apply into psychiatry residency programs. He’s invested in exploring how we can more effectively conceptualize and measure mental health outcomes within San Diego’s Somali and Spanish-speaking communities, as well as advancing mindfulness and compassion training in undergraduate medical education. His professional interests also include implementation science, cultural psychiatry, psychodynamics, and strengthening public mental health infrastructure.

My use of drug names is a mixed bag of terms.

In medical school we learn drugs by their generic names, but it doesn’t take long before we realize that each has both a generic name and one (or more) brand names. I suppose there’s also the chemical names, but no one outside the lab uses those. They’re waaaaay too long.

There is, for better or worse, a lot of variability in this. The purists (almost always academics, or cardiologists, or academic cardiologists) insist on generic names only. In their notes, conversations, presentations, whatever. If you’re a medical student or resident under them, you learn fast not to use the brand name.

After 30 years of doing this ... I don’t care. My notes are a mishmash of both.

Let’s face it, brand names are generally shorter and easier to type, spell, and pronounce than the generic names. I still need to know both, but when I’m writing up a note Keppra is far easier than levetiracetam. And most patients find the brand names a lot easier to say and remember.

An even weirder point, which is my own, is that one of my teaching attendings insisted that we capitalize both generic and brand names while on his rotation. Why? He never explained that, but he was pretty insistent. Now, for whatever reason, the habit has stuck with me. I’m sure the cardiologist down the hall would love to send my notes back, heavily marked up with red ink.

There’s even a weird subdivisions in this: Aspirin is a brand name by Bayer. Shouldn’t it be capitalized in our notes? But it isn’t, and to make things more confusing that varies by country. Why? (if you’re curious, it’s a strange combination of 100-year-old patent claims, generic trademark rulings, and also what country you’re in, whether it was involved in World War I, and, if so, which side. Really).

So the medical lists in my notes are certainly understandable, though aren’t going to score me any points for academic correctness. Not that I care. As a medical Shakespeare might have written, Imitrex, Onzetra, Zembrace, Tosymra, Sumavel, Alsuma, Imigran, Migraitan, and Zecuity ... are still sumatriptan by any other name.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

My use of drug names is a mixed bag of terms.

In medical school we learn drugs by their generic names, but it doesn’t take long before we realize that each has both a generic name and one (or more) brand names. I suppose there’s also the chemical names, but no one outside the lab uses those. They’re waaaaay too long.

There is, for better or worse, a lot of variability in this. The purists (almost always academics, or cardiologists, or academic cardiologists) insist on generic names only. In their notes, conversations, presentations, whatever. If you’re a medical student or resident under them, you learn fast not to use the brand name.

After 30 years of doing this ... I don’t care. My notes are a mishmash of both.

Let’s face it, brand names are generally shorter and easier to type, spell, and pronounce than the generic names. I still need to know both, but when I’m writing up a note Keppra is far easier than levetiracetam. And most patients find the brand names a lot easier to say and remember.

An even weirder point, which is my own, is that one of my teaching attendings insisted that we capitalize both generic and brand names while on his rotation. Why? He never explained that, but he was pretty insistent. Now, for whatever reason, the habit has stuck with me. I’m sure the cardiologist down the hall would love to send my notes back, heavily marked up with red ink.

There’s even a weird subdivisions in this: Aspirin is a brand name by Bayer. Shouldn’t it be capitalized in our notes? But it isn’t, and to make things more confusing that varies by country. Why? (if you’re curious, it’s a strange combination of 100-year-old patent claims, generic trademark rulings, and also what country you’re in, whether it was involved in World War I, and, if so, which side. Really).

So the medical lists in my notes are certainly understandable, though aren’t going to score me any points for academic correctness. Not that I care. As a medical Shakespeare might have written, Imitrex, Onzetra, Zembrace, Tosymra, Sumavel, Alsuma, Imigran, Migraitan, and Zecuity ... are still sumatriptan by any other name.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

My use of drug names is a mixed bag of terms.

In medical school we learn drugs by their generic names, but it doesn’t take long before we realize that each has both a generic name and one (or more) brand names. I suppose there’s also the chemical names, but no one outside the lab uses those. They’re waaaaay too long.

There is, for better or worse, a lot of variability in this. The purists (almost always academics, or cardiologists, or academic cardiologists) insist on generic names only. In their notes, conversations, presentations, whatever. If you’re a medical student or resident under them, you learn fast not to use the brand name.

After 30 years of doing this ... I don’t care. My notes are a mishmash of both.

Let’s face it, brand names are generally shorter and easier to type, spell, and pronounce than the generic names. I still need to know both, but when I’m writing up a note Keppra is far easier than levetiracetam. And most patients find the brand names a lot easier to say and remember.

An even weirder point, which is my own, is that one of my teaching attendings insisted that we capitalize both generic and brand names while on his rotation. Why? He never explained that, but he was pretty insistent. Now, for whatever reason, the habit has stuck with me. I’m sure the cardiologist down the hall would love to send my notes back, heavily marked up with red ink.

There’s even a weird subdivisions in this: Aspirin is a brand name by Bayer. Shouldn’t it be capitalized in our notes? But it isn’t, and to make things more confusing that varies by country. Why? (if you’re curious, it’s a strange combination of 100-year-old patent claims, generic trademark rulings, and also what country you’re in, whether it was involved in World War I, and, if so, which side. Really).

So the medical lists in my notes are certainly understandable, though aren’t going to score me any points for academic correctness. Not that I care. As a medical Shakespeare might have written, Imitrex, Onzetra, Zembrace, Tosymra, Sumavel, Alsuma, Imigran, Migraitan, and Zecuity ... are still sumatriptan by any other name.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

While cutting-edge treatments such as CAR T-cell therapies, clinical trials, and costly transplants for chronic lymphocytic leukemia (CLL) are not accessible to all 200,000+ people living with the disease nationwide, newly published data indicate that widely available medications for this most common of adult leukemias have steadily improved overall survival rates over most of the past 3 decades.

“The clinical take-away from our study is that population-based statistics show a decline in mortality and an increase in survival that is concurrent with the introduction of new therapies for treating CLL,” said lead study author Nadia Howlader, PhD, of the Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Md. This research was published in Cancer Epidemiology, Biomarkers & Prevention.

National Cancer Institute, Bethesda, Md.

From 1992 to 2011, CLL mortality decreased 1.1% annually, then the pace of the decline hastened to 3.6% per year from 2011 to 2021 among adults aged ≥ 20 years. Furthermore, 5-year survival rates among patients with CLL increased 0.7% per year on average from 1992 to 2016. To account for yearly random fluctuations in the number of cases detected, incidence data was fit to a model to determine the trend.

Although the study was not designed to specify which treatments were disseminated among patients or to estimate the impact of a specific drug, there were only six new drugs approved for CLL from 1991 to 2010. In contrast, between 2011 and 2018, 11 new CLL drugs (in particular the approval of new tyrosine kinase inhibitors (TKIs)) ushered in a period of more rapid annual decreases in mortality.

“The approval of ibrutinib [2014] was a sea change in decreasing CLL mortality. Earlier therapies like chemoimmunotherapies were not as effective in patients with TP53 mutation and/or 17P deletions,” said Binsah George, MD, of McGovern Medical School at UTHealth, Houston, who was not associated with the study.

New TKIs not only decrease mortality, but also have fewer side effects than earlier cytotoxic therapies, do not require inpatient treatment, and are available to all patients on Medicare and Medicaid.

Although patients with relapsed CLL may benefit from bone marrow transplants or CAR T-cell therapy, these treatments are not available at many community oncology practices. Furthermore, some patients are too sick to receive them or don’t have the economic and social resources to get them.

Even though TKIs increase overall survival in patients with CLL, they are not curative and require lifelong treatment. 

“The estimated cost for CLL treatment is around $600,000 in a lifetime per patient, possibly placing significant burden on patients and the health care system,” said Dr. George.

“Certain trials are looking at stopping TKI treatment after a fixed period of time. This will let us learn more about the disease and could possibly lead to a decrease in cost and side effects of therapy,” concluded Dr. George.

Due to the study’s retrospective nature and data being sourced from state cancer registries and federal statistics, authors posited that rates of CLL could be underestimated, due to miscoding and missing information, particularly from those who get treatment outside of hospital settings. Additionally, some of the improvement in mortality could be attributed to better supportive care and less toxicity in medications, rather than then efficacy of novel agents.

Dr. Howlader and Dr. Binsah reported no conflicts of interest.

While cutting-edge treatments such as CAR T-cell therapies, clinical trials, and costly transplants for chronic lymphocytic leukemia (CLL) are not accessible to all 200,000+ people living with the disease nationwide, newly published data indicate that widely available medications for this most common of adult leukemias have steadily improved overall survival rates over most of the past 3 decades.

“The clinical take-away from our study is that population-based statistics show a decline in mortality and an increase in survival that is concurrent with the introduction of new therapies for treating CLL,” said lead study author Nadia Howlader, PhD, of the Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Md. This research was published in Cancer Epidemiology, Biomarkers & Prevention.

National Cancer Institute, Bethesda, Md.

From 1992 to 2011, CLL mortality decreased 1.1% annually, then the pace of the decline hastened to 3.6% per year from 2011 to 2021 among adults aged ≥ 20 years. Furthermore, 5-year survival rates among patients with CLL increased 0.7% per year on average from 1992 to 2016. To account for yearly random fluctuations in the number of cases detected, incidence data was fit to a model to determine the trend.

Although the study was not designed to specify which treatments were disseminated among patients or to estimate the impact of a specific drug, there were only six new drugs approved for CLL from 1991 to 2010. In contrast, between 2011 and 2018, 11 new CLL drugs (in particular the approval of new tyrosine kinase inhibitors (TKIs)) ushered in a period of more rapid annual decreases in mortality.

“The approval of ibrutinib [2014] was a sea change in decreasing CLL mortality. Earlier therapies like chemoimmunotherapies were not as effective in patients with TP53 mutation and/or 17P deletions,” said Binsah George, MD, of McGovern Medical School at UTHealth, Houston, who was not associated with the study.

New TKIs not only decrease mortality, but also have fewer side effects than earlier cytotoxic therapies, do not require inpatient treatment, and are available to all patients on Medicare and Medicaid.

Although patients with relapsed CLL may benefit from bone marrow transplants or CAR T-cell therapy, these treatments are not available at many community oncology practices. Furthermore, some patients are too sick to receive them or don’t have the economic and social resources to get them.

Even though TKIs increase overall survival in patients with CLL, they are not curative and require lifelong treatment. 

“The estimated cost for CLL treatment is around $600,000 in a lifetime per patient, possibly placing significant burden on patients and the health care system,” said Dr. George.

“Certain trials are looking at stopping TKI treatment after a fixed period of time. This will let us learn more about the disease and could possibly lead to a decrease in cost and side effects of therapy,” concluded Dr. George.

Due to the study’s retrospective nature and data being sourced from state cancer registries and federal statistics, authors posited that rates of CLL could be underestimated, due to miscoding and missing information, particularly from those who get treatment outside of hospital settings. Additionally, some of the improvement in mortality could be attributed to better supportive care and less toxicity in medications, rather than then efficacy of novel agents.

Dr. Howlader and Dr. Binsah reported no conflicts of interest.

While cutting-edge treatments such as CAR T-cell therapies, clinical trials, and costly transplants for chronic lymphocytic leukemia (CLL) are not accessible to all 200,000+ people living with the disease nationwide, newly published data indicate that widely available medications for this most common of adult leukemias have steadily improved overall survival rates over most of the past 3 decades.

“The clinical take-away from our study is that population-based statistics show a decline in mortality and an increase in survival that is concurrent with the introduction of new therapies for treating CLL,” said lead study author Nadia Howlader, PhD, of the Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Md. This research was published in Cancer Epidemiology, Biomarkers & Prevention.

National Cancer Institute, Bethesda, Md.

From 1992 to 2011, CLL mortality decreased 1.1% annually, then the pace of the decline hastened to 3.6% per year from 2011 to 2021 among adults aged ≥ 20 years. Furthermore, 5-year survival rates among patients with CLL increased 0.7% per year on average from 1992 to 2016. To account for yearly random fluctuations in the number of cases detected, incidence data was fit to a model to determine the trend.

Although the study was not designed to specify which treatments were disseminated among patients or to estimate the impact of a specific drug, there were only six new drugs approved for CLL from 1991 to 2010. In contrast, between 2011 and 2018, 11 new CLL drugs (in particular the approval of new tyrosine kinase inhibitors (TKIs)) ushered in a period of more rapid annual decreases in mortality.

“The approval of ibrutinib [2014] was a sea change in decreasing CLL mortality. Earlier therapies like chemoimmunotherapies were not as effective in patients with TP53 mutation and/or 17P deletions,” said Binsah George, MD, of McGovern Medical School at UTHealth, Houston, who was not associated with the study.

New TKIs not only decrease mortality, but also have fewer side effects than earlier cytotoxic therapies, do not require inpatient treatment, and are available to all patients on Medicare and Medicaid.

Although patients with relapsed CLL may benefit from bone marrow transplants or CAR T-cell therapy, these treatments are not available at many community oncology practices. Furthermore, some patients are too sick to receive them or don’t have the economic and social resources to get them.

Even though TKIs increase overall survival in patients with CLL, they are not curative and require lifelong treatment. 

“The estimated cost for CLL treatment is around $600,000 in a lifetime per patient, possibly placing significant burden on patients and the health care system,” said Dr. George.

“Certain trials are looking at stopping TKI treatment after a fixed period of time. This will let us learn more about the disease and could possibly lead to a decrease in cost and side effects of therapy,” concluded Dr. George.

Due to the study’s retrospective nature and data being sourced from state cancer registries and federal statistics, authors posited that rates of CLL could be underestimated, due to miscoding and missing information, particularly from those who get treatment outside of hospital settings. Additionally, some of the improvement in mortality could be attributed to better supportive care and less toxicity in medications, rather than then efficacy of novel agents.

Dr. Howlader and Dr. Binsah reported no conflicts of interest.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

BALTIMORE – Poor prenatal sleep may increase the risk of postpartum depression, and prenatal depression may reduce the likelihood of mothers coming to their prenatal appointments, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Together, the two studies suggest that commonly overlooked experiences in the prenatal period can have negative effects down the line if clinicians aren’t asking patients about them and addressing the issue.

”I think the national conversation around mental health in general will hopefully carry us forward to better supporting the patients who are coming in with preexisting conditions,” lead author Minnie Jang, a 4th-year medical student at Johns Hopkins University, Baltimore, said in an interview.

Most of the attention on mood disorders of pregnancy focus on the postpartum period, but preexisting or new-onset depression during pregnancy deserves more attention, Ms. Jang told attendees. ACOG recommends that clinicians screen all patients at least once during the perinatal period, but that could be anywhere from early pregnancy to the postpartum period. Ms. Jang would like to see recommendations addressing both early pregnancy and the postpartum period.

“I think there’s this framing that postpartum depression is a distinct entity from other mental health conditions whereas it’s really part of a continuum,” Ms. Jang said in an interview.

She retrospectively analyzed the medical records of all pregnant women who completed the Edinburgh Postnatal Depression Scale (EPDS) during their first or second trimesters between 2002 and 2021 at Johns Hopkins Hospital. Among the 718 women who were screened in early pregnancy, 44.6% were Black or African American, 39.7% were white, and 15.7% were of a different race. Nearly all (94%) were not Hispanic/Latino.

Most (59%) were partnered, employed (68%), and had private insurance (58%). Only 7% used tobacco while 11% used alcohol and 6% used illicit drugs.

Twelve percent of the patients scored positive for depression, with a score of at least 10 or an affirmative answer to question 10 regarding self-harm. These women tended to be younger (P = .034), with an median age of 28 at their first visit versus 31 for those who screened negative, and were more likely to be publicly insured (P = .013) and without a partner (P = .005).

Patients who screened positive were more likely to have a history of substance use or history of a previous psychiatric diagnosis (P < .0001 for both). In addition, more patients who screened positive (49%) than those who screened negative (26%) had fetal complications (P < .001).

”There are some interesting subgroups of patients who are screening positive for depressive symptoms early on in pregnancy,” Ms. Jang said. Some come into pregnancy with preexisting mental health conditions while others have situational depressive symptoms, such as the subgroup referred to social work who had diagnosed fetal complications, she said. “Then there’s a whole other group of patients who are developing new symptoms during pregnancy.”

Patients who screened positive tended to start prenatal care later, at a median 12.3 weeks gestational age, than patients who screened negative, at a median 10.7 weeks gestational age (P = .002), the analysis found.

The number of routine prenatal care visits did not significantly differ between those who screened positive and those who screened negative, but patients with positive depression screens were almost half as likely to complete glucose tolerance testing (odds ratio, 0.6) or group B streptococcus testing (OR, 0.56) after adjusting for insurance status, gravidity, and gestational age at the patient’s first visit.

The researchers also identified a significant positive association between higher EPDS scores and the number of labor and delivery triage visits (P = .006). There were no significant differences in the rates of Tdap vaccination or screening for sexually transmitted infections between the two groups.
 

Poor sleep linked to later depression

The other study was prospective, using data from the PATCH Prenatal Care and Maternal and Child Health Outcomes study, which initially “compared health outcomes and satisfaction with prenatal care between patients receiving Centering Pregnancy group prenatal care and patients receiving traditional prenatal care,” the authors explained. This secondary analysis looked at sleep problems and postpartum depression.

“We don’t routinely ask patients about sleep or screen patients for sleeping issues,” lead author Carolyn Sinow, MD, a 4th-year resident at Kaiser Permanente Santa Clara (Calif.) Medical Center, said in an interview. “I think that we need to take sleep complaints more seriously overall, especially in early pregnancy.” While sleep problems in the third trimester often have more to do with discomforts from pregnancy itself, better sleep “in the first and second trimester is something we can really target with good sleep hygiene,” she added.

The 336 pregnant participants were recruited from Health Connect as long as they had a singleton pregnancy, were receiving prenatal care from Kaiser Permanente Northern California, and completed baseline questionnaires about their sleep and depression and anxiety symptoms during their first trimester between August 2020 and April 2021. Those with clinical depression or a high-risk pregnancy were excluded. The participants then completed the questionnaires again between 4 and 8 weeks post partum.

After adjusting for baseline depression and potential confounders, patients with poor sleep quality, indicated by a score greater than 5 on the Pittsburgh Sleep Quality Index (PSQI), were 12% more likely to develop postpartum depression, indicated by a score on the Patient Health Questionnaire depression scale (PHQ-8) of 10 or greater (relative risk, 1.12; 95% confidence interval, 1.01-1.25).

The two aspects of sleep that specifically correlated with postpartum depression were sleep quality and sleep latency, or taking a long time to fall asleep. Those reporting poor sleep quality were twice as likely to develop postpartum depression (relative risk, 2.18; 95% CI, 1.22-3.91), and those who took a while to fall asleep were 52% more likely to develop postpartum depression (RR, 1.52; 95% CI, 1.06-2.17).

Though the study also found prenatal sleep problems correlated with higher postpartum anxiety scores on the General Anxiety Disorder scale (GAD-7), the results were not statistically significant.

Kathleen Morrell, MD, MPH, an ob.gyn. in New York, was not involved in the study and said she was surprised it wasn’t something that had been studied much before because it makes sense.

“I always like it when studies confirm what we think should make sense, so it’s nice to see it,” Dr. Morrell said in an interview. “I think anytime you put something out, research it, and define it with numbers for doctors, that sometimes allows us to [realize], ‘Oh, that’s probably something we should be paying more attention to, especially if we have available treatments for it,’” she added.

“The clinical takeaway is that we really need to be screening for sleep pattern disruptions early in pregnancy, because even though it makes logical sense, it might not be something on our radar to think about,” Dr. Morrell said. “If people aren’t sleeping, well, their mental health is negatively affected.”

The most promising therapy for sleep issues currently is cognitive-behavioral therapy, which can accessed through various apps, Dr. Sinow said in an interview. “There are also safe interventions, such as melatonin and Unisom, that are totally safe in pregnancy that we can use to target sleep in early pregnancy.”

Dr. Morrell added that vitamin B6, often taken for nausea and vomiting during pregnancy, can also sometimes help people sleep and is safe during pregnancy.

“We know that postpartum depression does not necessarily only have a negative effect on the mother, but also has a negative effect on the infant and the family dynamic as well,” Dr. Morrell said. “So, we should be looking and screening for it so that we can offer people potential treatment because we know it can have long-term effects.”

Ms. Jang and Dr. Sinow did not have any disclosures. Dr. Morrell has done training for Nexplanon. Neither study noted external funding.

At the end of 2022, the European Medicines Agency’s Emergency Task Force warned European regulatory bodies, governments, and doctors that monoclonal antibodies authorized for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. Antiviral drugs remain available but have many limitations. And, of course, there are still vaccines, which can significantly reduce (but not remove) the risk of severe cases and decrease the number of deaths, although they have lost the efficacy that they once had in countering the original virus.

Research therefore continues. Immunologists continue to search for new targets to synthesize broadly neutralizing monoclonal antibodies for treating or preventing the infection. These results could also lead to new vaccines that induce longer-lasting immunity not only against the thousands of subvariants and recombinant versions of SARS-CoV-2 being identified around the world, but also possibly against other coronaviruses that could emerge in the coming years. A study conducted at Stanford (Calif.) University and published in the journal Science Translational Medicine has afforded a glimmer of hope by discovering the broadly neutralizing efficacy of some antibodies produced by macaque monkeys in response to vaccination with AS03 (squalene) adjuvanted monovalent subunit vaccines.

The speed with which the virus continues to evolve has rendered the plan for annual vaccine updates, which initially was envisioned early in the pandemic, unfeasible for the time being. In 2020, scientists were considering updating vaccines annually based on the prevalent variants of the disease, similar to the approach to the flu. Perhaps that day will come, but in the meantime, laboratories are pursuing other routes: finding spike epitopes that are preserved more than others each time the virus evolves or focusing on other virus proteins that still manage to induce a neutralizing antibody response.

Eventually, artificial intelligence might be able to custom design monoclonal antibodies that are even more effective than natural ones. Or researchers could completely change tack and shift their attention to the host, rather than the virus itself.

This is the approach taken by one study published in Nature Microbiology, which starts from a simple assumption: SARS-CoV-2 continues to modify its spike protein because of the evolutionary pressure of the antibodies produced by millions of infected people, but all these variants and subvariants, both present and future, enter cells by binding – not solely, but mostly – to the ACE2 receptor. Instead of neutralizing the virus, why not try to block its access to the cells occupying its route in? In this way, we could also be ready for future emerging sarbecoviruses that will have a spike sequence that cannot yet be predicted.

Researchers at Rockefeller University, New York, have generated six human monoclonal antibodies that bind to the ACE2 receptor, rather than to the spike, preventing infection by all sarbecoviruses tested, even at low concentrations, including the virus that originated in Wuhan, China; the aggressive Delta variant; and various forms of Omicron.

The monoclonal antibodies bind to the ACE2 receptor at a part of the protein that is distal to the active enzyme portion that converts angiotensin and does not modify its expression on the cell surface. Therefore, no adverse effects are expected at this level. In animal models, these monoclonal antibodies succeed in stopping the infection. Moving into the clinical phase will be needed to find out if it will be possible to create products adapted to preventing and treating all SARS-CoV-2 variants, and perhaps also the next coronavirus large enough to spill over into a new epidemic that threatens the human race.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

At the end of 2022, the European Medicines Agency’s Emergency Task Force warned European regulatory bodies, governments, and doctors that monoclonal antibodies authorized for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. Antiviral drugs remain available but have many limitations. And, of course, there are still vaccines, which can significantly reduce (but not remove) the risk of severe cases and decrease the number of deaths, although they have lost the efficacy that they once had in countering the original virus.

Research therefore continues. Immunologists continue to search for new targets to synthesize broadly neutralizing monoclonal antibodies for treating or preventing the infection. These results could also lead to new vaccines that induce longer-lasting immunity not only against the thousands of subvariants and recombinant versions of SARS-CoV-2 being identified around the world, but also possibly against other coronaviruses that could emerge in the coming years. A study conducted at Stanford (Calif.) University and published in the journal Science Translational Medicine has afforded a glimmer of hope by discovering the broadly neutralizing efficacy of some antibodies produced by macaque monkeys in response to vaccination with AS03 (squalene) adjuvanted monovalent subunit vaccines.

The speed with which the virus continues to evolve has rendered the plan for annual vaccine updates, which initially was envisioned early in the pandemic, unfeasible for the time being. In 2020, scientists were considering updating vaccines annually based on the prevalent variants of the disease, similar to the approach to the flu. Perhaps that day will come, but in the meantime, laboratories are pursuing other routes: finding spike epitopes that are preserved more than others each time the virus evolves or focusing on other virus proteins that still manage to induce a neutralizing antibody response.

Eventually, artificial intelligence might be able to custom design monoclonal antibodies that are even more effective than natural ones. Or researchers could completely change tack and shift their attention to the host, rather than the virus itself.

This is the approach taken by one study published in Nature Microbiology, which starts from a simple assumption: SARS-CoV-2 continues to modify its spike protein because of the evolutionary pressure of the antibodies produced by millions of infected people, but all these variants and subvariants, both present and future, enter cells by binding – not solely, but mostly – to the ACE2 receptor. Instead of neutralizing the virus, why not try to block its access to the cells occupying its route in? In this way, we could also be ready for future emerging sarbecoviruses that will have a spike sequence that cannot yet be predicted.

Researchers at Rockefeller University, New York, have generated six human monoclonal antibodies that bind to the ACE2 receptor, rather than to the spike, preventing infection by all sarbecoviruses tested, even at low concentrations, including the virus that originated in Wuhan, China; the aggressive Delta variant; and various forms of Omicron.

The monoclonal antibodies bind to the ACE2 receptor at a part of the protein that is distal to the active enzyme portion that converts angiotensin and does not modify its expression on the cell surface. Therefore, no adverse effects are expected at this level. In animal models, these monoclonal antibodies succeed in stopping the infection. Moving into the clinical phase will be needed to find out if it will be possible to create products adapted to preventing and treating all SARS-CoV-2 variants, and perhaps also the next coronavirus large enough to spill over into a new epidemic that threatens the human race.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

At the end of 2022, the European Medicines Agency’s Emergency Task Force warned European regulatory bodies, governments, and doctors that monoclonal antibodies authorized for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. Antiviral drugs remain available but have many limitations. And, of course, there are still vaccines, which can significantly reduce (but not remove) the risk of severe cases and decrease the number of deaths, although they have lost the efficacy that they once had in countering the original virus.

Research therefore continues. Immunologists continue to search for new targets to synthesize broadly neutralizing monoclonal antibodies for treating or preventing the infection. These results could also lead to new vaccines that induce longer-lasting immunity not only against the thousands of subvariants and recombinant versions of SARS-CoV-2 being identified around the world, but also possibly against other coronaviruses that could emerge in the coming years. A study conducted at Stanford (Calif.) University and published in the journal Science Translational Medicine has afforded a glimmer of hope by discovering the broadly neutralizing efficacy of some antibodies produced by macaque monkeys in response to vaccination with AS03 (squalene) adjuvanted monovalent subunit vaccines.

The speed with which the virus continues to evolve has rendered the plan for annual vaccine updates, which initially was envisioned early in the pandemic, unfeasible for the time being. In 2020, scientists were considering updating vaccines annually based on the prevalent variants of the disease, similar to the approach to the flu. Perhaps that day will come, but in the meantime, laboratories are pursuing other routes: finding spike epitopes that are preserved more than others each time the virus evolves or focusing on other virus proteins that still manage to induce a neutralizing antibody response.

Eventually, artificial intelligence might be able to custom design monoclonal antibodies that are even more effective than natural ones. Or researchers could completely change tack and shift their attention to the host, rather than the virus itself.

This is the approach taken by one study published in Nature Microbiology, which starts from a simple assumption: SARS-CoV-2 continues to modify its spike protein because of the evolutionary pressure of the antibodies produced by millions of infected people, but all these variants and subvariants, both present and future, enter cells by binding – not solely, but mostly – to the ACE2 receptor. Instead of neutralizing the virus, why not try to block its access to the cells occupying its route in? In this way, we could also be ready for future emerging sarbecoviruses that will have a spike sequence that cannot yet be predicted.

Researchers at Rockefeller University, New York, have generated six human monoclonal antibodies that bind to the ACE2 receptor, rather than to the spike, preventing infection by all sarbecoviruses tested, even at low concentrations, including the virus that originated in Wuhan, China; the aggressive Delta variant; and various forms of Omicron.

The monoclonal antibodies bind to the ACE2 receptor at a part of the protein that is distal to the active enzyme portion that converts angiotensin and does not modify its expression on the cell surface. Therefore, no adverse effects are expected at this level. In animal models, these monoclonal antibodies succeed in stopping the infection. Moving into the clinical phase will be needed to find out if it will be possible to create products adapted to preventing and treating all SARS-CoV-2 variants, and perhaps also the next coronavirus large enough to spill over into a new epidemic that threatens the human race.

This article was translated from Univadis Italy. A version appeared on Medscape.com.

Lack of vaccination against COVID-19 was associated with a significantly higher risk for hospitalization, compared with vaccinated status and boosted status, new evidence suggests.

A retrospective, population-based cohort study in Alberta, Edmonton, found that between late September 2021 and late January 2022, eligible unvaccinated patients with COVID-19 had a nearly 10-fold higher risk for hospitalization than did patients who were fully vaccinated with two doses. Unvaccinated patients had a nearly 21-fold higher risk than did patients who were boosted with three doses.

“We have shown that eligible nonvaccinated persons, especially in the age strata 50-79 years, accounted for 3,000-4,000 potentially avoidable hospitalizations, 35,000-40,000 avoidable bed-days, and $100–$110 million [Canadian dollars] in avoidable health care costs during a 120-day period coinciding with the fourth (Delta) and fifth (Omicron) COVID-19 waves, respectively,” wrote Sean M. Bagshaw, MD, chair of critical care medicine at the University of Alberta, Edmonton, and colleagues.

The findings were published in the Canadian Journal of Public Health.
 

‘Unsatisfactory’ vaccine uptake

While a previous study by Dr. Bagshaw and colleagues recently showed that higher vaccine uptake could have avoided significant intensive care unit admissions and costs, the researchers sought to expand their analysis to include non-ICU use.

The current study examined data from the government of Alberta and the Discharge Abstract Database to assess vaccination status and hospitalization with confirmed SARS-CoV-2. Secondary outcomes included avoidable hospitalizations, avoidable hospital bed-days, and the potential cost avoidance related to COVID-19. 

During the study period, “societal factors contributed to an unsatisfactory voluntary vaccine uptake, particularly in the province of Alberta,” wrote the authors, adding that “only 63.7% and 2.7% of the eligible population in Alberta [had] received two (full) and three (boosted) COVID-19 vaccine doses as of September 27, 2021.” 

The analysis found the highest number of hospitalizations among unvaccinated patients (n = 3,835), compared with vaccinated (n = 1,907) and boosted patients (n = 481). This finding yielded a risk ratio (RR) of hospitalization of 9.7 for unvaccinated patients, compared with fully vaccinated patients, and an RR of 20.6, compared with patients who were boosted. Unvaccinated patients aged 60-69 years had the highest RR for hospitalization, compared with vaccinated (RR, 16.4) and boosted patients (RR, 151.9).

The estimated number of avoidable hospitalizations for unvaccinated patients was 3,439 (total of 36,331 bed-days), compared with vaccinated patients, and 3,764 (total of 40,185 bed-days), compared with boosted patients. 

The avoidable hospitalization-related costs for unvaccinated patients totaled $101.4 million (Canadian dollars) if they had been vaccinated and $110.24 million if they had been boosted.

“Moreover, strained hospital systems and the widespread adoption of crisis standards of care in response to surges in COVID-19 hospitalizations have contributed to unnecessary excess deaths,” wrote the authors. “These are preventable and missed public health opportunities that provoked massive health system disruptions and resource diversions, including deferral of routine health services (e.g., cancer and chronic disease screening and monitoring and scheduled vaccinations), postponement of scheduled procedures and surgeries, and redeployment of health care professionals.” 

Dr. Bagshaw said in an interview that he was not surprised by the findings. “However, I wonder whether the public and those who direct policy and make decisions about the health system would be interested in better understanding the scope and sheer disruption the health system suffered due to COVID-19,” he said.

The current study suggests that “at least some of this could have been avoided,” said Dr. Bagshaw. “I hope we – that is the public, users of the health system, decision-makers and health care professionals – can learn from our experiences.” Studies such as the current analysis “will reinforce the importance of timely and clearly articulated public health promotion, education, and policy,” he added.
 

Economic benefit underestimated

Commenting on the study, David Fisman, MD, MPH, an epidemiologist and professor at the University of Toronto, said: “The approach these investigators have taken is clear and straightforward. It is easy to reproduce. It is also entirely consistent with what other scientific groups have been demonstrating for a couple of years now.” Dr. Fisman was not involved with the study.

A group led by Dr. Fisman as senior author has just completed a study examining the effectiveness of the Canadian pandemic response, compared with responses in four peer countries. In the as-yet unpublished paper, the researchers concluded that “relative to the United States, United Kingdom, and France, the Canadian pandemic response was estimated to have averted 94,492, 64,306, and 13,641 deaths, respectively, with more than 480,000 hospitalizations averted and 1 million QALY [quality-adjusted life-years] saved, relative to the United States. A United States pandemic response applied to Canada would have resulted in more than $40 billion in economic losses due to healthcare expenditures and lost QALY; losses relative to the United Kingdom and France would have been $21 billion and $5 billion, respectively. By contrast, an Australian pandemic response would have averted over 28,000 additional deaths and averted nearly $9 billion in costs in Canada.”

Dr. Fisman added that while the current researchers focused their study on the direct protective effects of vaccines, “we know that, even with initial waves of Omicron, vaccinated individuals continued to be protected against infection as well as disease, and even if they were infected, we know from household contact studies that they were less infectious to others. That means that even though the implicit estimate of cost savings that could have been achieved through better coverage are pretty high in this paper, the economic benefit of vaccination is underestimated in this analysis, because we can’t quantify the infections that never happened because of vaccination.”

The study was supported by the Strategic Clinical Networks, Alberta Health Services. Dr. Bagshaw declared no relevant financial relationships. Dr. Fisman has taken part in advisory boards for Seqirus, Pfizer, AstraZeneca, Sanofi, and Merck vaccines during the past 3 years.

A version of this article first appeared on Medscape.com.

Lack of vaccination against COVID-19 was associated with a significantly higher risk for hospitalization, compared with vaccinated status and boosted status, new evidence suggests.

A retrospective, population-based cohort study in Alberta, Edmonton, found that between late September 2021 and late January 2022, eligible unvaccinated patients with COVID-19 had a nearly 10-fold higher risk for hospitalization than did patients who were fully vaccinated with two doses. Unvaccinated patients had a nearly 21-fold higher risk than did patients who were boosted with three doses.

“We have shown that eligible nonvaccinated persons, especially in the age strata 50-79 years, accounted for 3,000-4,000 potentially avoidable hospitalizations, 35,000-40,000 avoidable bed-days, and $100–$110 million [Canadian dollars] in avoidable health care costs during a 120-day period coinciding with the fourth (Delta) and fifth (Omicron) COVID-19 waves, respectively,” wrote Sean M. Bagshaw, MD, chair of critical care medicine at the University of Alberta, Edmonton, and colleagues.

The findings were published in the Canadian Journal of Public Health.
 

‘Unsatisfactory’ vaccine uptake

While a previous study by Dr. Bagshaw and colleagues recently showed that higher vaccine uptake could have avoided significant intensive care unit admissions and costs, the researchers sought to expand their analysis to include non-ICU use.

The current study examined data from the government of Alberta and the Discharge Abstract Database to assess vaccination status and hospitalization with confirmed SARS-CoV-2. Secondary outcomes included avoidable hospitalizations, avoidable hospital bed-days, and the potential cost avoidance related to COVID-19. 

During the study period, “societal factors contributed to an unsatisfactory voluntary vaccine uptake, particularly in the province of Alberta,” wrote the authors, adding that “only 63.7% and 2.7% of the eligible population in Alberta [had] received two (full) and three (boosted) COVID-19 vaccine doses as of September 27, 2021.” 

The analysis found the highest number of hospitalizations among unvaccinated patients (n = 3,835), compared with vaccinated (n = 1,907) and boosted patients (n = 481). This finding yielded a risk ratio (RR) of hospitalization of 9.7 for unvaccinated patients, compared with fully vaccinated patients, and an RR of 20.6, compared with patients who were boosted. Unvaccinated patients aged 60-69 years had the highest RR for hospitalization, compared with vaccinated (RR, 16.4) and boosted patients (RR, 151.9).

The estimated number of avoidable hospitalizations for unvaccinated patients was 3,439 (total of 36,331 bed-days), compared with vaccinated patients, and 3,764 (total of 40,185 bed-days), compared with boosted patients. 

The avoidable hospitalization-related costs for unvaccinated patients totaled $101.4 million (Canadian dollars) if they had been vaccinated and $110.24 million if they had been boosted.

“Moreover, strained hospital systems and the widespread adoption of crisis standards of care in response to surges in COVID-19 hospitalizations have contributed to unnecessary excess deaths,” wrote the authors. “These are preventable and missed public health opportunities that provoked massive health system disruptions and resource diversions, including deferral of routine health services (e.g., cancer and chronic disease screening and monitoring and scheduled vaccinations), postponement of scheduled procedures and surgeries, and redeployment of health care professionals.” 

Dr. Bagshaw said in an interview that he was not surprised by the findings. “However, I wonder whether the public and those who direct policy and make decisions about the health system would be interested in better understanding the scope and sheer disruption the health system suffered due to COVID-19,” he said.

The current study suggests that “at least some of this could have been avoided,” said Dr. Bagshaw. “I hope we – that is the public, users of the health system, decision-makers and health care professionals – can learn from our experiences.” Studies such as the current analysis “will reinforce the importance of timely and clearly articulated public health promotion, education, and policy,” he added.
 

Economic benefit underestimated

Commenting on the study, David Fisman, MD, MPH, an epidemiologist and professor at the University of Toronto, said: “The approach these investigators have taken is clear and straightforward. It is easy to reproduce. It is also entirely consistent with what other scientific groups have been demonstrating for a couple of years now.” Dr. Fisman was not involved with the study.

A group led by Dr. Fisman as senior author has just completed a study examining the effectiveness of the Canadian pandemic response, compared with responses in four peer countries. In the as-yet unpublished paper, the researchers concluded that “relative to the United States, United Kingdom, and France, the Canadian pandemic response was estimated to have averted 94,492, 64,306, and 13,641 deaths, respectively, with more than 480,000 hospitalizations averted and 1 million QALY [quality-adjusted life-years] saved, relative to the United States. A United States pandemic response applied to Canada would have resulted in more than $40 billion in economic losses due to healthcare expenditures and lost QALY; losses relative to the United Kingdom and France would have been $21 billion and $5 billion, respectively. By contrast, an Australian pandemic response would have averted over 28,000 additional deaths and averted nearly $9 billion in costs in Canada.”

Dr. Fisman added that while the current researchers focused their study on the direct protective effects of vaccines, “we know that, even with initial waves of Omicron, vaccinated individuals continued to be protected against infection as well as disease, and even if they were infected, we know from household contact studies that they were less infectious to others. That means that even though the implicit estimate of cost savings that could have been achieved through better coverage are pretty high in this paper, the economic benefit of vaccination is underestimated in this analysis, because we can’t quantify the infections that never happened because of vaccination.”

The study was supported by the Strategic Clinical Networks, Alberta Health Services. Dr. Bagshaw declared no relevant financial relationships. Dr. Fisman has taken part in advisory boards for Seqirus, Pfizer, AstraZeneca, Sanofi, and Merck vaccines during the past 3 years.

A version of this article first appeared on Medscape.com.

Lack of vaccination against COVID-19 was associated with a significantly higher risk for hospitalization, compared with vaccinated status and boosted status, new evidence suggests.

A retrospective, population-based cohort study in Alberta, Edmonton, found that between late September 2021 and late January 2022, eligible unvaccinated patients with COVID-19 had a nearly 10-fold higher risk for hospitalization than did patients who were fully vaccinated with two doses. Unvaccinated patients had a nearly 21-fold higher risk than did patients who were boosted with three doses.

“We have shown that eligible nonvaccinated persons, especially in the age strata 50-79 years, accounted for 3,000-4,000 potentially avoidable hospitalizations, 35,000-40,000 avoidable bed-days, and $100–$110 million [Canadian dollars] in avoidable health care costs during a 120-day period coinciding with the fourth (Delta) and fifth (Omicron) COVID-19 waves, respectively,” wrote Sean M. Bagshaw, MD, chair of critical care medicine at the University of Alberta, Edmonton, and colleagues.

The findings were published in the Canadian Journal of Public Health.
 

‘Unsatisfactory’ vaccine uptake

While a previous study by Dr. Bagshaw and colleagues recently showed that higher vaccine uptake could have avoided significant intensive care unit admissions and costs, the researchers sought to expand their analysis to include non-ICU use.

The current study examined data from the government of Alberta and the Discharge Abstract Database to assess vaccination status and hospitalization with confirmed SARS-CoV-2. Secondary outcomes included avoidable hospitalizations, avoidable hospital bed-days, and the potential cost avoidance related to COVID-19. 

During the study period, “societal factors contributed to an unsatisfactory voluntary vaccine uptake, particularly in the province of Alberta,” wrote the authors, adding that “only 63.7% and 2.7% of the eligible population in Alberta [had] received two (full) and three (boosted) COVID-19 vaccine doses as of September 27, 2021.” 

The analysis found the highest number of hospitalizations among unvaccinated patients (n = 3,835), compared with vaccinated (n = 1,907) and boosted patients (n = 481). This finding yielded a risk ratio (RR) of hospitalization of 9.7 for unvaccinated patients, compared with fully vaccinated patients, and an RR of 20.6, compared with patients who were boosted. Unvaccinated patients aged 60-69 years had the highest RR for hospitalization, compared with vaccinated (RR, 16.4) and boosted patients (RR, 151.9).

The estimated number of avoidable hospitalizations for unvaccinated patients was 3,439 (total of 36,331 bed-days), compared with vaccinated patients, and 3,764 (total of 40,185 bed-days), compared with boosted patients. 

The avoidable hospitalization-related costs for unvaccinated patients totaled $101.4 million (Canadian dollars) if they had been vaccinated and $110.24 million if they had been boosted.

“Moreover, strained hospital systems and the widespread adoption of crisis standards of care in response to surges in COVID-19 hospitalizations have contributed to unnecessary excess deaths,” wrote the authors. “These are preventable and missed public health opportunities that provoked massive health system disruptions and resource diversions, including deferral of routine health services (e.g., cancer and chronic disease screening and monitoring and scheduled vaccinations), postponement of scheduled procedures and surgeries, and redeployment of health care professionals.” 

Dr. Bagshaw said in an interview that he was not surprised by the findings. “However, I wonder whether the public and those who direct policy and make decisions about the health system would be interested in better understanding the scope and sheer disruption the health system suffered due to COVID-19,” he said.

The current study suggests that “at least some of this could have been avoided,” said Dr. Bagshaw. “I hope we – that is the public, users of the health system, decision-makers and health care professionals – can learn from our experiences.” Studies such as the current analysis “will reinforce the importance of timely and clearly articulated public health promotion, education, and policy,” he added.
 

Economic benefit underestimated

Commenting on the study, David Fisman, MD, MPH, an epidemiologist and professor at the University of Toronto, said: “The approach these investigators have taken is clear and straightforward. It is easy to reproduce. It is also entirely consistent with what other scientific groups have been demonstrating for a couple of years now.” Dr. Fisman was not involved with the study.

A group led by Dr. Fisman as senior author has just completed a study examining the effectiveness of the Canadian pandemic response, compared with responses in four peer countries. In the as-yet unpublished paper, the researchers concluded that “relative to the United States, United Kingdom, and France, the Canadian pandemic response was estimated to have averted 94,492, 64,306, and 13,641 deaths, respectively, with more than 480,000 hospitalizations averted and 1 million QALY [quality-adjusted life-years] saved, relative to the United States. A United States pandemic response applied to Canada would have resulted in more than $40 billion in economic losses due to healthcare expenditures and lost QALY; losses relative to the United Kingdom and France would have been $21 billion and $5 billion, respectively. By contrast, an Australian pandemic response would have averted over 28,000 additional deaths and averted nearly $9 billion in costs in Canada.”

Dr. Fisman added that while the current researchers focused their study on the direct protective effects of vaccines, “we know that, even with initial waves of Omicron, vaccinated individuals continued to be protected against infection as well as disease, and even if they were infected, we know from household contact studies that they were less infectious to others. That means that even though the implicit estimate of cost savings that could have been achieved through better coverage are pretty high in this paper, the economic benefit of vaccination is underestimated in this analysis, because we can’t quantify the infections that never happened because of vaccination.”

The study was supported by the Strategic Clinical Networks, Alberta Health Services. Dr. Bagshaw declared no relevant financial relationships. Dr. Fisman has taken part in advisory boards for Seqirus, Pfizer, AstraZeneca, Sanofi, and Merck vaccines during the past 3 years.

A version of this article first appeared on Medscape.com.

DENVER – The use of mindfulness-based interventions for patients with multiple sclerosis (MS), whether delivered in person or through online video conferencing, resulted in improved cognitive function and reduced symptoms of depression, anxiety, and stress, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
 

Putting mindfulness to the test

Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.

The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.

Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.

Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.

“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.

Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).

Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).

Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).

After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.

Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.

Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.

The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
 

Another tool for managing MS

Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.

“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.

She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.

“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.

The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
 

An online-only mindfulness program

One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.

Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.

The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).

The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”

Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.

Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.

DENVER – The use of mindfulness-based interventions for patients with multiple sclerosis (MS), whether delivered in person or through online video conferencing, resulted in improved cognitive function and reduced symptoms of depression, anxiety, and stress, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
 

Putting mindfulness to the test

Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.

The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.

Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.

Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.

“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.

Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).

Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).

Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).

After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.

Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.

Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.

The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
 

Another tool for managing MS

Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.

“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.

She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.

“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.

The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
 

An online-only mindfulness program

One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.

Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.

The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).

The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”

Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.

Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.

DENVER – The use of mindfulness-based interventions for patients with multiple sclerosis (MS), whether delivered in person or through online video conferencing, resulted in improved cognitive function and reduced symptoms of depression, anxiety, and stress, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Two studies assessed the effects of two mindfulness-based stress reduction (MBSR) programs, one primarily in person until the pandemic forced a move to online participation, and the other exclusively online. The in-person course also found, in a subset of the participants, that blood inflammation markers matched the patients’ reported reduction in stress and loneliness.
 

Putting mindfulness to the test

Previous research has found that life stressors are linked to clinical MS flares, Chris Hemond, MD, an assistant professor of neurology at the University of Massachusetts, Worcester, told attendees. He also noted previous research exploring possible explanations for how MBSR programs might improve clinical symptoms of MS. One hypothesis involves an effect on the “forebrain limbic areas responsible for the neurobiological stress response.” Part of this study therefore involved looking for possible MRI changes before and after the MBSR program to test this hypothesis.

The study involved 23 patients, all women with relapsing remitting MS with an median age of 45, and 57% of whom were taking B cell–depleting agents. The patients’ average Expanded Disability Status Scale score was 2, and none experienced any new clinical or MRI disease activity during a 12-week observation period.

Patients volunteered to participate in the free 8-week MBSR program. Half attended MBSR classes in person while the other half had to attend virtual classes due to the pandemic. The program involved eight weekly 2.5-hour classes with daily homework assignments. The program, developed by Jon Kabat-Zinn at the University of Massachusetts, is intended to be “mental training for nonjudgmental awareness of moment-to-moment experience” that aims to “improve accuracy of perception, acceptance of intractable health-related changes, realistic sense of control, and appreciation of available life experiences,” Dr. Hemond said.

Among the 91% of participants who completed the course, 57% underwent both pre- and postcourse structural MRI scans, and 83% completed both the pre- and postcourse questionnaires. A subset of patients (53%) also provided blood samples for analysis of inflammatory gene expression markers.

“The conserved transcriptional response to adversity (CTRA) score was determined using well-established methods from 53 prespecified blood gene expression markers representing a composite of inflammation, interferon response, and immunoglobulin expression,” Dr. Hemond explained.

Participants’ average scores both pre- and post questionnaires revealed statistically significant improvements in stress, anxiety, depression, fatigue, loneliness, well-being, and interoceptive awareness (P < .01 for all).

Although precise values were not provided in the presentation, patients’ scores significantly decreased on the Brief Inventory of Perceived Stress (BIPS) for “lack of control,” “pushed,” and “conflict” (P < .03). Average scores also improved (decreased) on the Modified Fatigue Inventory Scale, the UCLA Loneliness Scale, and all three subscales of the Depression Anxiety Stress Scales assessment (P <.01). Participants’ scores increased on the Mental Health Continuum “hedonic” and “eudaimonic well-being” scales (P < .05).

Improvements on the Multidimensional Assessment of Interoceptive Awareness included self-regulation, attention regulation, “noticing” (P = .02), “not worrying” (P < .01), “emotional awareness” (P < .01), “body listening” (P < .01), and “trusting” (P < .01).

After adjustment for age, race, body mass index, medical therapy and time, the researchers found changes in inflammatory gene expression in the 12 participants who provided blood samples, and these changes correlated inversely with changes in their reported loneliness (P =.002), pain (P <.001), several interoception aspects (P < .01), and stress (P < .0001), particularly regarding feeling a lack of control.

Although no structural MRI changes were observed in the amygdala or prefrontal cortex, the researchers did see a 1% volume increase on the right-side hippocampus. Though the increase was significant (P < .01) and right hippocampal enlargement has been linked with MBSR in past studies, Dr. Hemond acknowledged the study’s small sample size and urged caution in interpreting that finding.

Dr. Hemond also reported that interaction between higher CTRA and the MSBR training attenuated the right hippocampal volume increase that was seen with MBSR, a finding which raises more questions than it answers.

The primary finding, however, was that “mindfulness-based stress reduction was associated with substantial improvement in multiple patient-reported outcomes of the debilitating ‘silent symptoms’ of MS,” Dr. Hemond told attendees. Though the study is limited by its small sample size, observational biases, and missing data, the findings suggest the possibility that MBSR is also associated with structural limbic brain changes, especially in the right hippocampus.
 

Another tool for managing MS

Ellen Mowry, MD, MCR, a professor of neurology and epidemiology at Johns Hopkins University, Baltimore, who attended the presentation, said she was very enthusiastic about this research.

“People with MS often are seeking ways that they can have self-efficacy and managing the symptoms of their disease, and we know that the disease-modifying therapies make a big difference, but we need additional therapies that can help people feel better and live better with MS,” Dr. Mowry commented.

She also acknowledged the challenges, however, in developing a mindfulness program that is accessible by a broad range of MS patients. This particular program involved several hours of work per day.

“People with MS often are either on the younger side, and they’re working and raising their family and doing all the same stuff that everybody else is doing, or they might be quite disabled and have more fatigue and other things that might make it really challenging to persist through that long of an intervention,” Dr. Mowry said.

The ideal program would be one that’s financially accessible, either through insurance, society more broadly, or another source, and which is logistically feasible for a wide range of patients. Finding a “sweet spot” with a program that doesn’t “require such a lengthy amount of time in order to see a success would be really great,” Dr. Mowry said. “You have to start somewhere, though, and you have to start with a program that’s already been tried and true and work from there.”
 

An online-only mindfulness program

One possible way to find that sweet spot is through an all-online program that patients access from home, similar to the 8-week MBSR program offered by Concord (N.H.) Hospital featured in the second study. The program was conducted via Zoom during once weekly synchronous meetings throughout 2021 and 2022 for eight cohorts of 5-15 participants each. The time of day the program was offered alternated between evening and daytime courses each quarter and was free for patients because of a hospital grant, according to Nicole Delcourt, BSN, RN, MSCN, of Concord Hospital Neurology, who facilitated patient sign-ups for the program.

Before and after each 8-week course, participants completed the PHQ-9, the PROMIS Cognitive Function, the PROMIS Fatigue–MS, and the Wasson Health Confidence assessments. Among the total 77 participating adults with MS, the completion rate was 81%, with 73% completing the preprogram assessments and 53% completed the postprogram assessments.

The assessments revealed a statistically significant increase in cognitive function and health confidence and decrease in depressive symptoms and fatigue following the program. Participants’ average PROMIS Cognitive Function scores increased from 16.7 before the program to 22.4 after, and their average Wasson Health Confidence score increased from 13.6 to 15.3 (P < .01 for both). Meanwhile, improvement in depressive symptoms was seen in participants’ decrease in Patient Health Questionnaire–9 scores from an average 6.9 to 4.6 (P = .01), and their average PROMIS Fatigue scores fell slightly but significantly from 59.3 to 55.3 (P < .05).

The participants “really felt like they were more in touch with their own feelings and emotions, and it helped them self-regulate,” Ms. Delcourt sad, “so it was really exciting.”

Patients also expressed satisfaction more subjectively in their feedback surveys. “I feel more aware of my body’s reactions to food and movement, and things that make me feel better physically,” one participant said. Another said that the class’s “lasting value ... will be to remember my own needs and how to become one with them.” Another participant praised the relevance of the printed and course materials, the speed of feedback on homework, and the quality of the video conference.

Dr. Hemond owns stock in VIVIO health. No other authors of either study reported other disclosures. Dr. Mowry has received grant funding from Biogen and Genentech. Ms. Delcourt had no disclosures. The in-person program study was funded by CMSC. Funding information for the Concord online program was unavailable.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

Compared with the complicated and ever-changing recommended vaccine schedule for infants and children, vaccines for adults have been straightforward. Adults without compromised immunity who received all their childhood vaccinations are eligible for a tetanus and diphtheria (Td) or tetanus, diphtheria, and pertussis (Tdap) booster every 10 years, recombinant herpes zoster vaccine at age 50, and pneumococcal vaccines at age 65, along with annual influenza and (likely) COVID-19 vaccines. Last year, due to rising rates of acute hepatitis B, the Centers for Disease Control and Prevention first recommended universal hepatitis B vaccination for adults aged 19-59 years without a record of previous hepatitis B infection or vaccination.

An additional routine vaccine for adults is now on the horizon. The U.S. Food and Drug Administration recently approved Arexvy, a vaccine against respiratory syncytial virus (RSV) for adults aged 60 years or older. Two more RSV vaccines are in the final stages of development. Why should family physicians prioritize vaccinating older adults against RSV, and how can we incorporate this new vaccine into our practices and overcome patient hesitancy to receive yet another vaccine?

Clinicians tend to think of RSV as a serious disease in young children – which it is – but data suggest that in 2019, RSV infection led to more than 100,000 hospitalizations and 7,700 deaths in older adults in the United States. In a randomized controlled trial of 25,000 adults aged 60 years or older with a median of 6.7 months of follow-up, Arexvy reduced severe RSV disease by 94% and RSV-related acute respiratory infections by 71%, with similar effectiveness in adults with underlying health conditions. That’s considerably better protection than current influenza vaccines and comparable to COVID-19 mRNA vaccines before variants became widespread. Pain and fatigue were the most common side effects and usually resolved within 1-2 days.

Although the seasonal pattern of RSV shifted during the COVID-19 pandemic, RSV season historically begins in October, peaks in December, and ends in April. If the vaccine is recommended by the CDC and is widely available by fall, as the manufacturer, GSK, expects, it could be administered around the same time as influenza and COVID-19 vaccines.

The challenges of incorporating this new vaccine into practice will feel familiar: Many of our patients won’t have heard about it, may feel that they don’t need it, or may decline it because of concerns about side effects, real or imagined. (Of note, the FDA is requiring GSK to perform a postmarketing study to rule out associations with rare cases of Guillain-Barré syndrome and acute disseminated encephalomyelitis, and the company also plans to monitor the incidence of atrial fibrillation, which was slightly more common in the vaccine group than the placebo group.)

While a strong recommendation from a family physician is often enough to convince patients to accept vaccination, rampant misinformation during the pandemic may have worsened vaccine hesitancy for some. It may feel like a fruitless exercise to try to convince adults who have refused COVID-19 and influenza vaccines to accept a newer vaccine against a respiratory virus that causes less serious illness overall. But with other RSV vaccines and monoclonal antibodies for older adults and infants likely to be approved soon, it’s important for us to start laying the groundwork now by educating colleagues, staff, and patients about preventing serious illness caused by RSV.

Dr. Lin is an associate professor in the Department of Family Medicine at Georgetown University and a staff physician atMedStar Health Center, both in Washington. He has received income from UpToDate, Wiley-Blackwell, and the American Academy of Family Physicians.

A version of this article first appeared on Medscape.com.

Compared with the complicated and ever-changing recommended vaccine schedule for infants and children, vaccines for adults have been straightforward. Adults without compromised immunity who received all their childhood vaccinations are eligible for a tetanus and diphtheria (Td) or tetanus, diphtheria, and pertussis (Tdap) booster every 10 years, recombinant herpes zoster vaccine at age 50, and pneumococcal vaccines at age 65, along with annual influenza and (likely) COVID-19 vaccines. Last year, due to rising rates of acute hepatitis B, the Centers for Disease Control and Prevention first recommended universal hepatitis B vaccination for adults aged 19-59 years without a record of previous hepatitis B infection or vaccination.

An additional routine vaccine for adults is now on the horizon. The U.S. Food and Drug Administration recently approved Arexvy, a vaccine against respiratory syncytial virus (RSV) for adults aged 60 years or older. Two more RSV vaccines are in the final stages of development. Why should family physicians prioritize vaccinating older adults against RSV, and how can we incorporate this new vaccine into our practices and overcome patient hesitancy to receive yet another vaccine?

Clinicians tend to think of RSV as a serious disease in young children – which it is – but data suggest that in 2019, RSV infection led to more than 100,000 hospitalizations and 7,700 deaths in older adults in the United States. In a randomized controlled trial of 25,000 adults aged 60 years or older with a median of 6.7 months of follow-up, Arexvy reduced severe RSV disease by 94% and RSV-related acute respiratory infections by 71%, with similar effectiveness in adults with underlying health conditions. That’s considerably better protection than current influenza vaccines and comparable to COVID-19 mRNA vaccines before variants became widespread. Pain and fatigue were the most common side effects and usually resolved within 1-2 days.

Although the seasonal pattern of RSV shifted during the COVID-19 pandemic, RSV season historically begins in October, peaks in December, and ends in April. If the vaccine is recommended by the CDC and is widely available by fall, as the manufacturer, GSK, expects, it could be administered around the same time as influenza and COVID-19 vaccines.

The challenges of incorporating this new vaccine into practice will feel familiar: Many of our patients won’t have heard about it, may feel that they don’t need it, or may decline it because of concerns about side effects, real or imagined. (Of note, the FDA is requiring GSK to perform a postmarketing study to rule out associations with rare cases of Guillain-Barré syndrome and acute disseminated encephalomyelitis, and the company also plans to monitor the incidence of atrial fibrillation, which was slightly more common in the vaccine group than the placebo group.)

While a strong recommendation from a family physician is often enough to convince patients to accept vaccination, rampant misinformation during the pandemic may have worsened vaccine hesitancy for some. It may feel like a fruitless exercise to try to convince adults who have refused COVID-19 and influenza vaccines to accept a newer vaccine against a respiratory virus that causes less serious illness overall. But with other RSV vaccines and monoclonal antibodies for older adults and infants likely to be approved soon, it’s important for us to start laying the groundwork now by educating colleagues, staff, and patients about preventing serious illness caused by RSV.

Dr. Lin is an associate professor in the Department of Family Medicine at Georgetown University and a staff physician atMedStar Health Center, both in Washington. He has received income from UpToDate, Wiley-Blackwell, and the American Academy of Family Physicians.

A version of this article first appeared on Medscape.com.

Compared with the complicated and ever-changing recommended vaccine schedule for infants and children, vaccines for adults have been straightforward. Adults without compromised immunity who received all their childhood vaccinations are eligible for a tetanus and diphtheria (Td) or tetanus, diphtheria, and pertussis (Tdap) booster every 10 years, recombinant herpes zoster vaccine at age 50, and pneumococcal vaccines at age 65, along with annual influenza and (likely) COVID-19 vaccines. Last year, due to rising rates of acute hepatitis B, the Centers for Disease Control and Prevention first recommended universal hepatitis B vaccination for adults aged 19-59 years without a record of previous hepatitis B infection or vaccination.

An additional routine vaccine for adults is now on the horizon. The U.S. Food and Drug Administration recently approved Arexvy, a vaccine against respiratory syncytial virus (RSV) for adults aged 60 years or older. Two more RSV vaccines are in the final stages of development. Why should family physicians prioritize vaccinating older adults against RSV, and how can we incorporate this new vaccine into our practices and overcome patient hesitancy to receive yet another vaccine?

Clinicians tend to think of RSV as a serious disease in young children – which it is – but data suggest that in 2019, RSV infection led to more than 100,000 hospitalizations and 7,700 deaths in older adults in the United States. In a randomized controlled trial of 25,000 adults aged 60 years or older with a median of 6.7 months of follow-up, Arexvy reduced severe RSV disease by 94% and RSV-related acute respiratory infections by 71%, with similar effectiveness in adults with underlying health conditions. That’s considerably better protection than current influenza vaccines and comparable to COVID-19 mRNA vaccines before variants became widespread. Pain and fatigue were the most common side effects and usually resolved within 1-2 days.

Although the seasonal pattern of RSV shifted during the COVID-19 pandemic, RSV season historically begins in October, peaks in December, and ends in April. If the vaccine is recommended by the CDC and is widely available by fall, as the manufacturer, GSK, expects, it could be administered around the same time as influenza and COVID-19 vaccines.

The challenges of incorporating this new vaccine into practice will feel familiar: Many of our patients won’t have heard about it, may feel that they don’t need it, or may decline it because of concerns about side effects, real or imagined. (Of note, the FDA is requiring GSK to perform a postmarketing study to rule out associations with rare cases of Guillain-Barré syndrome and acute disseminated encephalomyelitis, and the company also plans to monitor the incidence of atrial fibrillation, which was slightly more common in the vaccine group than the placebo group.)

While a strong recommendation from a family physician is often enough to convince patients to accept vaccination, rampant misinformation during the pandemic may have worsened vaccine hesitancy for some. It may feel like a fruitless exercise to try to convince adults who have refused COVID-19 and influenza vaccines to accept a newer vaccine against a respiratory virus that causes less serious illness overall. But with other RSV vaccines and monoclonal antibodies for older adults and infants likely to be approved soon, it’s important for us to start laying the groundwork now by educating colleagues, staff, and patients about preventing serious illness caused by RSV.

Dr. Lin is an associate professor in the Department of Family Medicine at Georgetown University and a staff physician atMedStar Health Center, both in Washington. He has received income from UpToDate, Wiley-Blackwell, and the American Academy of Family Physicians.

A version of this article first appeared on Medscape.com.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.