Feature

Boston Scientific said it is voluntarily recalling all unused inventory of the Lotus Edge transcatheter aortic valve replacement system effective immediately.

In making the announcement today, Boston Scientific chair and CEO Mike Mahoney said the company has been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve – key features of the system.

“The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform,” Mr. Mahoney said.

Instead, the company will focus on the ACURATE neo2 aortic valve system, the Sentinel cerebral embolic protection device, and other high-growth areas, he noted.

The decision is expected to result in a $225 million to $300 million pretax charge, with $100 million to $150 million of these charges to impact the company’s adjusted results.

The Lotus device was approved in the United States in April 2019 for use in patients with severe aortic stenosis at high surgical risk based on the REPRISE 3 trial.

The Lotus Edge valve was approved in Europe in 2016, but final testing and rollout of the valve in the United States were delayed following a 2017 global recall of all Lotus valves because of reports of premature release of a pin connecting the valve to the delivery system.

Issues with the delivery system led to other Lotus valve recalls in both 2016 and 2014.

“Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire Lotus product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease,” the statement said.

There is no safety issue for patients who currently have an implanted Lotus Edge valve, the company said.

This article first appeared on Medscape.com.

Boston Scientific said it is voluntarily recalling all unused inventory of the Lotus Edge transcatheter aortic valve replacement system effective immediately.

In making the announcement today, Boston Scientific chair and CEO Mike Mahoney said the company has been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve – key features of the system.

“The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform,” Mr. Mahoney said.

Instead, the company will focus on the ACURATE neo2 aortic valve system, the Sentinel cerebral embolic protection device, and other high-growth areas, he noted.

The decision is expected to result in a $225 million to $300 million pretax charge, with $100 million to $150 million of these charges to impact the company’s adjusted results.

The Lotus device was approved in the United States in April 2019 for use in patients with severe aortic stenosis at high surgical risk based on the REPRISE 3 trial.

The Lotus Edge valve was approved in Europe in 2016, but final testing and rollout of the valve in the United States were delayed following a 2017 global recall of all Lotus valves because of reports of premature release of a pin connecting the valve to the delivery system.

Issues with the delivery system led to other Lotus valve recalls in both 2016 and 2014.

“Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire Lotus product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease,” the statement said.

There is no safety issue for patients who currently have an implanted Lotus Edge valve, the company said.

This article first appeared on Medscape.com.

Boston Scientific said it is voluntarily recalling all unused inventory of the Lotus Edge transcatheter aortic valve replacement system effective immediately.

In making the announcement today, Boston Scientific chair and CEO Mike Mahoney said the company has been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve – key features of the system.

“The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform,” Mr. Mahoney said.

Instead, the company will focus on the ACURATE neo2 aortic valve system, the Sentinel cerebral embolic protection device, and other high-growth areas, he noted.

The decision is expected to result in a $225 million to $300 million pretax charge, with $100 million to $150 million of these charges to impact the company’s adjusted results.

The Lotus device was approved in the United States in April 2019 for use in patients with severe aortic stenosis at high surgical risk based on the REPRISE 3 trial.

The Lotus Edge valve was approved in Europe in 2016, but final testing and rollout of the valve in the United States were delayed following a 2017 global recall of all Lotus valves because of reports of premature release of a pin connecting the valve to the delivery system.

Issues with the delivery system led to other Lotus valve recalls in both 2016 and 2014.

“Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire Lotus product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease,” the statement said.

There is no safety issue for patients who currently have an implanted Lotus Edge valve, the company said.

This article first appeared on Medscape.com.

As part of the 50th anniversary of Dermatology News, it is intriguing to think about where a time machine journey 5 decades back would find the field of pediatric dermatology, and to assess the changes in the specialty during the time that Dermatology News (operating then as “Skin & Allergy News”) has been reporting on innovations and changes in the practice of dermatology.

Society for Pediatric Dermatology

So, starting in 1970, we would find that pediatric dermatology did not exist as an organized specialty. It was not until 3 years later, in October 1973 in Mexico City, that the first international symposium on Pediatric Dermatology was held, and the International Society for Pediatric Dermatology was founded. I reached out to Andrew Margileth, MD, 100 years old this past July, and still active voluntary faculty in pediatric dermatology at the University of Miami, to help me “reach back” to those days. Dr. Margileth commented on how the first symposium was “brilliantly orchestrated by Ramon Ruiz-Maldonado,” from the National Institute of Paediatrics in Mexico, and that it was his “Aha moment for future practice!” That meeting spurred discussions on the development of the Society for Pediatric Dermatology the next year, with Alvin Jacobs, MD; Samuel Weinberg, MD; Nancy Esterly, MD; Sidney Hurwitz, MD; William Weston, MD; and Coleman Jacobson, MD, as some of the initial “founding mothers and fathers,” and the society was officially established in 1975.

The field of pediatric dermatology was fairly “infantile” 50 years ago, with few practitioners. But the early leaders in the field recognized that up to 30% of pediatric primary care visits included skin problems, and that there was limited training for dermatologists, as well as pediatricians, about skin diseases in children. There were clearly clinical and educational needs to establish a subspecialty of pediatric dermatology, and over the next 1-2 decades, the field expanded. The journal Pediatric Dermatology was established (in 1982), the Section on Dermatology was established by the American Academy of Pediatrics (in 1986), and fellowship programs were launched at select academic centers. And it was 30 years into our timeline before the formal subspecialty of pediatric dermatology was established through the American Board of Dermatology (2000).

The field of pediatric dermatology has evolved and matured rapidly. Standard reference textbooks have been developed in the United States and around the world (and of course, online). Pediatric dermatology is an essential part of the core curriculum for dermatologist trainees. Organizations promoting pediatric research have developed to influence basic, translational, and clinical research in conditions in neonates through adolescents, such as the Pediatric Dermatology Research Alliance (PeDRA). And meetings throughout the world now feature pediatric dermatology sessions and help to spread the advances in the diagnosis and management of pediatric skin disorders.

The practice of pediatric dermatology: How has it changed?

It is beyond the scope of this article to try to comprehensively review all of the changes in pediatric dermatology practice. But review of the evolution of a few disease states (choices influenced by my discussions with my 100-year old history guide, Dr. Margileth) displays examples of where we have been, and where we are going in our next 5, 10, or 50 years.

Hemangiomas and vascular malformations

Some of the first natural history studies on hemangiomas were done in the early 1960s, establishing that standard cutaneous hemangiomas had a typical clinical course of fairly rapid growth, plateau, and involution over time. Of interest, the hallmark article’s first author was Dr. Margileth, published in 1965 in JAMA!.This was still at a time when the identification of hemangiomas of infancy (or “HOI” as we say in the trade) was confused with vascular malformations, and no one had recognized the distinct variant tumors such as rapidly involuting and noninvoluting congenital hemangiomas (RICHs or NICHs), tufted angiomas, or hemangioendotheliomas. PHACE syndrome was not yet described (that was done in 1996 by Ilona Frieden, MD, and colleagues). And for a time, hemangiomas were treated with x-rays, before the negative impact of such radiation was acknowledged. It seems that, as a consequence of the use of x-ray therapy and as a backlash from the radiation therapy side effects and potential toxicities, even deforming and functionally significant lesions were “followed clinically” for natural involution, with a sensibility that doing nothing might be better than doing the wrong thing.

Over the next 15 years, the recognition of functionally significant hemangiomas, deformation associated with their proliferation, and the recognition of PHACE syndrome made hemangiomas of infancy an area of concern, with systemic steroids and occasionally chemotherapeutic agents (such as vincristine) being used for problematic lesions.

It has now been 12 years since the work of Christine Léauté-Labrèze, MD, et al., from the University of Bordeaux (France), led to the breakthrough of propranolol for hemangioma treatment, profoundly changing hemangioma management to an incredibly effective medical therapy extensively studied, tested in formal clinical trials, and approved by regulatory authorities. And how intriguing that this was pursued after the chance (but skilled) observation that a child who developed hypertension as a side effect of systemic steroids for nasal hemangioma treatment was prescribed propranolol for the hypertension and had his nasal hemangioma rapidly shrink, with a response superior and much quicker than that to corticosteroids.

Courtesy of Rady Children's Hospital

Inflammatory skin disorders: Acne, psoriasis, and atopic dermatitis

The care of pediatric inflammatory skin disorders has evolved, but more slowly for some diseases than others. Acne vulgaris is now recognized as much more common under age 12 than previously, presumably reflecting earlier pubertal changes in our preteens. Over the past 30 years, therapy has evolved with the use of topical retinoids (still underused by pediatricians, considered a “practice gap”), hormonal therapy with combined oral contraceptives, and oral isotretinoin, a powerful but highly effective systemic agent for severe and refractory acne. Specific pediatric guidelines came much later, with expert recommendations formulated by the American Acne and Rosacea Society and endorsed by the American Academy of Pediatrics in 2013. Over the past few years, there has been a push by experts for more judicious use of antibiotics for acne (oral and topical) to minimize the emergence of bacterial resistance. There are unanswered questions as we evolve our care: How will the new topical antiandrogens be used? Will spironolactone become part of hormonal therapy under age 18? Will the insights on certain strains of Cutibacterium acnes being associated with worse acne translate to microbiome or vaccine-based strategies?

Pediatric psoriasis has suffered, being “behind in the revolution” of biologic agents because of delayed approval of any biologic agent for treatment of pediatric psoriasis in the United States until just a few years ago, and lags behind Europe and elsewhere in the world by almost a decade. Only this year have we expanded beyond one biologic agent approved for under age 12 and two for ages 12 and older, with other approvals expected including interleukin (IL)-17 and IL-23 agents. Adult psoriasis has been recognized to be associated with a broad set of comorbidities, including obesity and early heart disease, and there is now research on how children are at risk as well, with new recommendations on how to screen children with psoriasis, supplied first by PeDRA and then in the new American Academy of Dermatology-National Psoriasis Foundation pediatric psoriasis guidelines .

Pediatric atopic dermatitis (AD) is in its early years of revolution. In the 50-year period of our thought experiment, AD has increased in prevalence from 5% or less of the pediatric population to 10%-15%. Treatment of most individuals has remained the same over the decades: Good skin care, frequent moisturizers, topical corticosteroids for flares, and management of infection if noted. The topical calcineurin inhibitors (TCIs) broadened the therapeutic approach when introduced in 2000 and 2001, but the boxed warning resulted in some practitioners minimizing their use of these useful agents. But newer studies are markedly reassuring about their safe use in children.

Steroid phobia, as well as concerns about potential side effects of the TCIs, has resulted in undertreatment of childhood AD. It is quite common to see multiple children during pediatric dermatology office hours with poorly controlled eczema, high body-surface areas of eczema, compromised sleep, secondary infections, and anxiety and depression, especially in our moderate to severe adolescents. The field is “hot” with new topical and systemic agents, including our few years’ experience with topical crisaborole, a phosphodiesterase (PDE)-4 inhibitor; and dupilumab, an IL-4-alpha blocker – the first biologic agent approved for AD and the first systemic agent (other than oral corticosteroids), just extended from 12 years to 6 years of age! As dupilumab gets studied for younger children, other biologics (including IL-13 and IL-31 blockers) are undertaking pediatric and/or adolescent trials, oral and topical JAK inhibitors are including adolescents in core clinical trials, and other novel topical agents are under study, including an aryl-hydrocarbon receptor–modulating agent and other PDE-4 inhibitors.

Procedural pediatric dermatology: From liquid nitrogen to laser, surgery, and multimodal skin care

The first generation of pediatric dermatologists were considered medical dermatologist specialists. The care of the conditions discussed above, as well as genodermatoses, diagnostic dilemmas, and management of dermatologic manifestations of systemic disease and other conditions, was the “bread and butter” of pediatric dermatology care. When I was in training, my mentor Paul Honig, MD, at the Children’s Hospital of Philadelphia had a procedure half-day each week, where he would care for a few patients who needed liquid nitrogen therapy for warts, or who needed biopsies. It was uncommon to have a large procedural/surgical part of pediatric dermatology practice. But this is now a routine part of many specialists in the field. How did this change occur?

The fundamental shift began to occur with the introduction of the pulsed dye laser for treatment of port-wine birthmarks in children with minimal scarring, and a seminal article published in the New England Journal of Medicine in 1989. Vascular lesions including port-wine stains were common, and pediatric dermatologists managed these patients for both diagnosis and medical management. Also, dermatology residencies at this time offered training in cutaneous surgery, excisions (including Mohs surgery) and repairs, and trainees in pediatric dermatology were “trained up” to high levels of expertise. As lasers were incorporated into dermatology residency work and practices, pediatric dermatologists developed the exposure and skill to do this work. An added advantage was having the knowledge of how to handle children and adolescents in an age-appropriate manner, with consideration of methods to minimize the pain and anxiety of procedures. Within a few years, pediatric dermatologists were at the forefront of the use of topical anesthetics (EMLA and liposomal lidocaine) and had general anesthesia privileges for laser and excisional surgery.

So while pediatric dermatologists still do “small procedures” every hour in most practices (cryotherapy for warts, cantharidin for molluscum, shave and punch biopsies), a subset now have extensive procedural practices, which in recent years has extended to pigment lesion lasers (to treat nevus of Ota, for example), hair laser, and combinations of lasers, including fractionated CO₂ technology, to treat hypertrophic, constrictive and/or deforming scars.
 

The future

What will pediatric dermatology be like in 10, 20, or 50 years?

I have not yet discussed some of the most challenging diseases in our field, including epidermolysis bullosa, ichthyosis, and neurocutaneous disorders and other genetic skin disorders that have an incredible impact on the lives of affected children and their families, with incredible morbidity and with many conditions that shorten lifespans. But these are the conditions where “the future is happening now,” and we are looking forward to our new gene therapy techniques helping to transform our care.

And other aspects of practice? Will we be doing a large percentage of practice over the phone (or whatever devices we have then – remember, the first iPhone was only released 13 years ago)?

Will our patients be using their own imaging systems to evaluate their nevi and skin growths, and perhaps to diagnose and manage their rashes?

Will we have prevented our inflammatory skin disorders, or “turned them off” in early life with aggressive therapy in infantile life?

I project only that all of us in dermatology will still be a resource to our pediatric patients, from neonate through young adult, through our work of preventing, caring, healing and minimizing disease impact, and hopefully enjoying the pleasures of seeing our patients healthfully develop and evolve! As will our field.
 

Dr. Eichenfield is professor of dermatology and pediatrics and vice-chair of the department of dermatology at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. Dr. Eichenfield reports financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including products for the diseases discussed here.

As part of the 50th anniversary of Dermatology News, it is intriguing to think about where a time machine journey 5 decades back would find the field of pediatric dermatology, and to assess the changes in the specialty during the time that Dermatology News (operating then as “Skin & Allergy News”) has been reporting on innovations and changes in the practice of dermatology.

Society for Pediatric Dermatology

So, starting in 1970, we would find that pediatric dermatology did not exist as an organized specialty. It was not until 3 years later, in October 1973 in Mexico City, that the first international symposium on Pediatric Dermatology was held, and the International Society for Pediatric Dermatology was founded. I reached out to Andrew Margileth, MD, 100 years old this past July, and still active voluntary faculty in pediatric dermatology at the University of Miami, to help me “reach back” to those days. Dr. Margileth commented on how the first symposium was “brilliantly orchestrated by Ramon Ruiz-Maldonado,” from the National Institute of Paediatrics in Mexico, and that it was his “Aha moment for future practice!” That meeting spurred discussions on the development of the Society for Pediatric Dermatology the next year, with Alvin Jacobs, MD; Samuel Weinberg, MD; Nancy Esterly, MD; Sidney Hurwitz, MD; William Weston, MD; and Coleman Jacobson, MD, as some of the initial “founding mothers and fathers,” and the society was officially established in 1975.

The field of pediatric dermatology was fairly “infantile” 50 years ago, with few practitioners. But the early leaders in the field recognized that up to 30% of pediatric primary care visits included skin problems, and that there was limited training for dermatologists, as well as pediatricians, about skin diseases in children. There were clearly clinical and educational needs to establish a subspecialty of pediatric dermatology, and over the next 1-2 decades, the field expanded. The journal Pediatric Dermatology was established (in 1982), the Section on Dermatology was established by the American Academy of Pediatrics (in 1986), and fellowship programs were launched at select academic centers. And it was 30 years into our timeline before the formal subspecialty of pediatric dermatology was established through the American Board of Dermatology (2000).

The field of pediatric dermatology has evolved and matured rapidly. Standard reference textbooks have been developed in the United States and around the world (and of course, online). Pediatric dermatology is an essential part of the core curriculum for dermatologist trainees. Organizations promoting pediatric research have developed to influence basic, translational, and clinical research in conditions in neonates through adolescents, such as the Pediatric Dermatology Research Alliance (PeDRA). And meetings throughout the world now feature pediatric dermatology sessions and help to spread the advances in the diagnosis and management of pediatric skin disorders.

The practice of pediatric dermatology: How has it changed?

It is beyond the scope of this article to try to comprehensively review all of the changes in pediatric dermatology practice. But review of the evolution of a few disease states (choices influenced by my discussions with my 100-year old history guide, Dr. Margileth) displays examples of where we have been, and where we are going in our next 5, 10, or 50 years.

Hemangiomas and vascular malformations

Some of the first natural history studies on hemangiomas were done in the early 1960s, establishing that standard cutaneous hemangiomas had a typical clinical course of fairly rapid growth, plateau, and involution over time. Of interest, the hallmark article’s first author was Dr. Margileth, published in 1965 in JAMA!.This was still at a time when the identification of hemangiomas of infancy (or “HOI” as we say in the trade) was confused with vascular malformations, and no one had recognized the distinct variant tumors such as rapidly involuting and noninvoluting congenital hemangiomas (RICHs or NICHs), tufted angiomas, or hemangioendotheliomas. PHACE syndrome was not yet described (that was done in 1996 by Ilona Frieden, MD, and colleagues). And for a time, hemangiomas were treated with x-rays, before the negative impact of such radiation was acknowledged. It seems that, as a consequence of the use of x-ray therapy and as a backlash from the radiation therapy side effects and potential toxicities, even deforming and functionally significant lesions were “followed clinically” for natural involution, with a sensibility that doing nothing might be better than doing the wrong thing.

Over the next 15 years, the recognition of functionally significant hemangiomas, deformation associated with their proliferation, and the recognition of PHACE syndrome made hemangiomas of infancy an area of concern, with systemic steroids and occasionally chemotherapeutic agents (such as vincristine) being used for problematic lesions.

It has now been 12 years since the work of Christine Léauté-Labrèze, MD, et al., from the University of Bordeaux (France), led to the breakthrough of propranolol for hemangioma treatment, profoundly changing hemangioma management to an incredibly effective medical therapy extensively studied, tested in formal clinical trials, and approved by regulatory authorities. And how intriguing that this was pursued after the chance (but skilled) observation that a child who developed hypertension as a side effect of systemic steroids for nasal hemangioma treatment was prescribed propranolol for the hypertension and had his nasal hemangioma rapidly shrink, with a response superior and much quicker than that to corticosteroids.

Courtesy of Rady Children's Hospital

Inflammatory skin disorders: Acne, psoriasis, and atopic dermatitis

The care of pediatric inflammatory skin disorders has evolved, but more slowly for some diseases than others. Acne vulgaris is now recognized as much more common under age 12 than previously, presumably reflecting earlier pubertal changes in our preteens. Over the past 30 years, therapy has evolved with the use of topical retinoids (still underused by pediatricians, considered a “practice gap”), hormonal therapy with combined oral contraceptives, and oral isotretinoin, a powerful but highly effective systemic agent for severe and refractory acne. Specific pediatric guidelines came much later, with expert recommendations formulated by the American Acne and Rosacea Society and endorsed by the American Academy of Pediatrics in 2013. Over the past few years, there has been a push by experts for more judicious use of antibiotics for acne (oral and topical) to minimize the emergence of bacterial resistance. There are unanswered questions as we evolve our care: How will the new topical antiandrogens be used? Will spironolactone become part of hormonal therapy under age 18? Will the insights on certain strains of Cutibacterium acnes being associated with worse acne translate to microbiome or vaccine-based strategies?

Pediatric psoriasis has suffered, being “behind in the revolution” of biologic agents because of delayed approval of any biologic agent for treatment of pediatric psoriasis in the United States until just a few years ago, and lags behind Europe and elsewhere in the world by almost a decade. Only this year have we expanded beyond one biologic agent approved for under age 12 and two for ages 12 and older, with other approvals expected including interleukin (IL)-17 and IL-23 agents. Adult psoriasis has been recognized to be associated with a broad set of comorbidities, including obesity and early heart disease, and there is now research on how children are at risk as well, with new recommendations on how to screen children with psoriasis, supplied first by PeDRA and then in the new American Academy of Dermatology-National Psoriasis Foundation pediatric psoriasis guidelines .

Pediatric atopic dermatitis (AD) is in its early years of revolution. In the 50-year period of our thought experiment, AD has increased in prevalence from 5% or less of the pediatric population to 10%-15%. Treatment of most individuals has remained the same over the decades: Good skin care, frequent moisturizers, topical corticosteroids for flares, and management of infection if noted. The topical calcineurin inhibitors (TCIs) broadened the therapeutic approach when introduced in 2000 and 2001, but the boxed warning resulted in some practitioners minimizing their use of these useful agents. But newer studies are markedly reassuring about their safe use in children.

Steroid phobia, as well as concerns about potential side effects of the TCIs, has resulted in undertreatment of childhood AD. It is quite common to see multiple children during pediatric dermatology office hours with poorly controlled eczema, high body-surface areas of eczema, compromised sleep, secondary infections, and anxiety and depression, especially in our moderate to severe adolescents. The field is “hot” with new topical and systemic agents, including our few years’ experience with topical crisaborole, a phosphodiesterase (PDE)-4 inhibitor; and dupilumab, an IL-4-alpha blocker – the first biologic agent approved for AD and the first systemic agent (other than oral corticosteroids), just extended from 12 years to 6 years of age! As dupilumab gets studied for younger children, other biologics (including IL-13 and IL-31 blockers) are undertaking pediatric and/or adolescent trials, oral and topical JAK inhibitors are including adolescents in core clinical trials, and other novel topical agents are under study, including an aryl-hydrocarbon receptor–modulating agent and other PDE-4 inhibitors.

Procedural pediatric dermatology: From liquid nitrogen to laser, surgery, and multimodal skin care

The first generation of pediatric dermatologists were considered medical dermatologist specialists. The care of the conditions discussed above, as well as genodermatoses, diagnostic dilemmas, and management of dermatologic manifestations of systemic disease and other conditions, was the “bread and butter” of pediatric dermatology care. When I was in training, my mentor Paul Honig, MD, at the Children’s Hospital of Philadelphia had a procedure half-day each week, where he would care for a few patients who needed liquid nitrogen therapy for warts, or who needed biopsies. It was uncommon to have a large procedural/surgical part of pediatric dermatology practice. But this is now a routine part of many specialists in the field. How did this change occur?

The fundamental shift began to occur with the introduction of the pulsed dye laser for treatment of port-wine birthmarks in children with minimal scarring, and a seminal article published in the New England Journal of Medicine in 1989. Vascular lesions including port-wine stains were common, and pediatric dermatologists managed these patients for both diagnosis and medical management. Also, dermatology residencies at this time offered training in cutaneous surgery, excisions (including Mohs surgery) and repairs, and trainees in pediatric dermatology were “trained up” to high levels of expertise. As lasers were incorporated into dermatology residency work and practices, pediatric dermatologists developed the exposure and skill to do this work. An added advantage was having the knowledge of how to handle children and adolescents in an age-appropriate manner, with consideration of methods to minimize the pain and anxiety of procedures. Within a few years, pediatric dermatologists were at the forefront of the use of topical anesthetics (EMLA and liposomal lidocaine) and had general anesthesia privileges for laser and excisional surgery.

So while pediatric dermatologists still do “small procedures” every hour in most practices (cryotherapy for warts, cantharidin for molluscum, shave and punch biopsies), a subset now have extensive procedural practices, which in recent years has extended to pigment lesion lasers (to treat nevus of Ota, for example), hair laser, and combinations of lasers, including fractionated CO₂ technology, to treat hypertrophic, constrictive and/or deforming scars.
 

The future

What will pediatric dermatology be like in 10, 20, or 50 years?

I have not yet discussed some of the most challenging diseases in our field, including epidermolysis bullosa, ichthyosis, and neurocutaneous disorders and other genetic skin disorders that have an incredible impact on the lives of affected children and their families, with incredible morbidity and with many conditions that shorten lifespans. But these are the conditions where “the future is happening now,” and we are looking forward to our new gene therapy techniques helping to transform our care.

And other aspects of practice? Will we be doing a large percentage of practice over the phone (or whatever devices we have then – remember, the first iPhone was only released 13 years ago)?

Will our patients be using their own imaging systems to evaluate their nevi and skin growths, and perhaps to diagnose and manage their rashes?

Will we have prevented our inflammatory skin disorders, or “turned them off” in early life with aggressive therapy in infantile life?

I project only that all of us in dermatology will still be a resource to our pediatric patients, from neonate through young adult, through our work of preventing, caring, healing and minimizing disease impact, and hopefully enjoying the pleasures of seeing our patients healthfully develop and evolve! As will our field.
 

Dr. Eichenfield is professor of dermatology and pediatrics and vice-chair of the department of dermatology at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. Dr. Eichenfield reports financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including products for the diseases discussed here.

As part of the 50th anniversary of Dermatology News, it is intriguing to think about where a time machine journey 5 decades back would find the field of pediatric dermatology, and to assess the changes in the specialty during the time that Dermatology News (operating then as “Skin & Allergy News”) has been reporting on innovations and changes in the practice of dermatology.

Society for Pediatric Dermatology

So, starting in 1970, we would find that pediatric dermatology did not exist as an organized specialty. It was not until 3 years later, in October 1973 in Mexico City, that the first international symposium on Pediatric Dermatology was held, and the International Society for Pediatric Dermatology was founded. I reached out to Andrew Margileth, MD, 100 years old this past July, and still active voluntary faculty in pediatric dermatology at the University of Miami, to help me “reach back” to those days. Dr. Margileth commented on how the first symposium was “brilliantly orchestrated by Ramon Ruiz-Maldonado,” from the National Institute of Paediatrics in Mexico, and that it was his “Aha moment for future practice!” That meeting spurred discussions on the development of the Society for Pediatric Dermatology the next year, with Alvin Jacobs, MD; Samuel Weinberg, MD; Nancy Esterly, MD; Sidney Hurwitz, MD; William Weston, MD; and Coleman Jacobson, MD, as some of the initial “founding mothers and fathers,” and the society was officially established in 1975.

The field of pediatric dermatology was fairly “infantile” 50 years ago, with few practitioners. But the early leaders in the field recognized that up to 30% of pediatric primary care visits included skin problems, and that there was limited training for dermatologists, as well as pediatricians, about skin diseases in children. There were clearly clinical and educational needs to establish a subspecialty of pediatric dermatology, and over the next 1-2 decades, the field expanded. The journal Pediatric Dermatology was established (in 1982), the Section on Dermatology was established by the American Academy of Pediatrics (in 1986), and fellowship programs were launched at select academic centers. And it was 30 years into our timeline before the formal subspecialty of pediatric dermatology was established through the American Board of Dermatology (2000).

The field of pediatric dermatology has evolved and matured rapidly. Standard reference textbooks have been developed in the United States and around the world (and of course, online). Pediatric dermatology is an essential part of the core curriculum for dermatologist trainees. Organizations promoting pediatric research have developed to influence basic, translational, and clinical research in conditions in neonates through adolescents, such as the Pediatric Dermatology Research Alliance (PeDRA). And meetings throughout the world now feature pediatric dermatology sessions and help to spread the advances in the diagnosis and management of pediatric skin disorders.

The practice of pediatric dermatology: How has it changed?

It is beyond the scope of this article to try to comprehensively review all of the changes in pediatric dermatology practice. But review of the evolution of a few disease states (choices influenced by my discussions with my 100-year old history guide, Dr. Margileth) displays examples of where we have been, and where we are going in our next 5, 10, or 50 years.

Hemangiomas and vascular malformations

Some of the first natural history studies on hemangiomas were done in the early 1960s, establishing that standard cutaneous hemangiomas had a typical clinical course of fairly rapid growth, plateau, and involution over time. Of interest, the hallmark article’s first author was Dr. Margileth, published in 1965 in JAMA!.This was still at a time when the identification of hemangiomas of infancy (or “HOI” as we say in the trade) was confused with vascular malformations, and no one had recognized the distinct variant tumors such as rapidly involuting and noninvoluting congenital hemangiomas (RICHs or NICHs), tufted angiomas, or hemangioendotheliomas. PHACE syndrome was not yet described (that was done in 1996 by Ilona Frieden, MD, and colleagues). And for a time, hemangiomas were treated with x-rays, before the negative impact of such radiation was acknowledged. It seems that, as a consequence of the use of x-ray therapy and as a backlash from the radiation therapy side effects and potential toxicities, even deforming and functionally significant lesions were “followed clinically” for natural involution, with a sensibility that doing nothing might be better than doing the wrong thing.

Over the next 15 years, the recognition of functionally significant hemangiomas, deformation associated with their proliferation, and the recognition of PHACE syndrome made hemangiomas of infancy an area of concern, with systemic steroids and occasionally chemotherapeutic agents (such as vincristine) being used for problematic lesions.

It has now been 12 years since the work of Christine Léauté-Labrèze, MD, et al., from the University of Bordeaux (France), led to the breakthrough of propranolol for hemangioma treatment, profoundly changing hemangioma management to an incredibly effective medical therapy extensively studied, tested in formal clinical trials, and approved by regulatory authorities. And how intriguing that this was pursued after the chance (but skilled) observation that a child who developed hypertension as a side effect of systemic steroids for nasal hemangioma treatment was prescribed propranolol for the hypertension and had his nasal hemangioma rapidly shrink, with a response superior and much quicker than that to corticosteroids.

Courtesy of Rady Children's Hospital

Inflammatory skin disorders: Acne, psoriasis, and atopic dermatitis

The care of pediatric inflammatory skin disorders has evolved, but more slowly for some diseases than others. Acne vulgaris is now recognized as much more common under age 12 than previously, presumably reflecting earlier pubertal changes in our preteens. Over the past 30 years, therapy has evolved with the use of topical retinoids (still underused by pediatricians, considered a “practice gap”), hormonal therapy with combined oral contraceptives, and oral isotretinoin, a powerful but highly effective systemic agent for severe and refractory acne. Specific pediatric guidelines came much later, with expert recommendations formulated by the American Acne and Rosacea Society and endorsed by the American Academy of Pediatrics in 2013. Over the past few years, there has been a push by experts for more judicious use of antibiotics for acne (oral and topical) to minimize the emergence of bacterial resistance. There are unanswered questions as we evolve our care: How will the new topical antiandrogens be used? Will spironolactone become part of hormonal therapy under age 18? Will the insights on certain strains of Cutibacterium acnes being associated with worse acne translate to microbiome or vaccine-based strategies?

Pediatric psoriasis has suffered, being “behind in the revolution” of biologic agents because of delayed approval of any biologic agent for treatment of pediatric psoriasis in the United States until just a few years ago, and lags behind Europe and elsewhere in the world by almost a decade. Only this year have we expanded beyond one biologic agent approved for under age 12 and two for ages 12 and older, with other approvals expected including interleukin (IL)-17 and IL-23 agents. Adult psoriasis has been recognized to be associated with a broad set of comorbidities, including obesity and early heart disease, and there is now research on how children are at risk as well, with new recommendations on how to screen children with psoriasis, supplied first by PeDRA and then in the new American Academy of Dermatology-National Psoriasis Foundation pediatric psoriasis guidelines .

Pediatric atopic dermatitis (AD) is in its early years of revolution. In the 50-year period of our thought experiment, AD has increased in prevalence from 5% or less of the pediatric population to 10%-15%. Treatment of most individuals has remained the same over the decades: Good skin care, frequent moisturizers, topical corticosteroids for flares, and management of infection if noted. The topical calcineurin inhibitors (TCIs) broadened the therapeutic approach when introduced in 2000 and 2001, but the boxed warning resulted in some practitioners minimizing their use of these useful agents. But newer studies are markedly reassuring about their safe use in children.

Steroid phobia, as well as concerns about potential side effects of the TCIs, has resulted in undertreatment of childhood AD. It is quite common to see multiple children during pediatric dermatology office hours with poorly controlled eczema, high body-surface areas of eczema, compromised sleep, secondary infections, and anxiety and depression, especially in our moderate to severe adolescents. The field is “hot” with new topical and systemic agents, including our few years’ experience with topical crisaborole, a phosphodiesterase (PDE)-4 inhibitor; and dupilumab, an IL-4-alpha blocker – the first biologic agent approved for AD and the first systemic agent (other than oral corticosteroids), just extended from 12 years to 6 years of age! As dupilumab gets studied for younger children, other biologics (including IL-13 and IL-31 blockers) are undertaking pediatric and/or adolescent trials, oral and topical JAK inhibitors are including adolescents in core clinical trials, and other novel topical agents are under study, including an aryl-hydrocarbon receptor–modulating agent and other PDE-4 inhibitors.

Procedural pediatric dermatology: From liquid nitrogen to laser, surgery, and multimodal skin care

The first generation of pediatric dermatologists were considered medical dermatologist specialists. The care of the conditions discussed above, as well as genodermatoses, diagnostic dilemmas, and management of dermatologic manifestations of systemic disease and other conditions, was the “bread and butter” of pediatric dermatology care. When I was in training, my mentor Paul Honig, MD, at the Children’s Hospital of Philadelphia had a procedure half-day each week, where he would care for a few patients who needed liquid nitrogen therapy for warts, or who needed biopsies. It was uncommon to have a large procedural/surgical part of pediatric dermatology practice. But this is now a routine part of many specialists in the field. How did this change occur?

The fundamental shift began to occur with the introduction of the pulsed dye laser for treatment of port-wine birthmarks in children with minimal scarring, and a seminal article published in the New England Journal of Medicine in 1989. Vascular lesions including port-wine stains were common, and pediatric dermatologists managed these patients for both diagnosis and medical management. Also, dermatology residencies at this time offered training in cutaneous surgery, excisions (including Mohs surgery) and repairs, and trainees in pediatric dermatology were “trained up” to high levels of expertise. As lasers were incorporated into dermatology residency work and practices, pediatric dermatologists developed the exposure and skill to do this work. An added advantage was having the knowledge of how to handle children and adolescents in an age-appropriate manner, with consideration of methods to minimize the pain and anxiety of procedures. Within a few years, pediatric dermatologists were at the forefront of the use of topical anesthetics (EMLA and liposomal lidocaine) and had general anesthesia privileges for laser and excisional surgery.

So while pediatric dermatologists still do “small procedures” every hour in most practices (cryotherapy for warts, cantharidin for molluscum, shave and punch biopsies), a subset now have extensive procedural practices, which in recent years has extended to pigment lesion lasers (to treat nevus of Ota, for example), hair laser, and combinations of lasers, including fractionated CO₂ technology, to treat hypertrophic, constrictive and/or deforming scars.
 

The future

What will pediatric dermatology be like in 10, 20, or 50 years?

I have not yet discussed some of the most challenging diseases in our field, including epidermolysis bullosa, ichthyosis, and neurocutaneous disorders and other genetic skin disorders that have an incredible impact on the lives of affected children and their families, with incredible morbidity and with many conditions that shorten lifespans. But these are the conditions where “the future is happening now,” and we are looking forward to our new gene therapy techniques helping to transform our care.

And other aspects of practice? Will we be doing a large percentage of practice over the phone (or whatever devices we have then – remember, the first iPhone was only released 13 years ago)?

Will our patients be using their own imaging systems to evaluate their nevi and skin growths, and perhaps to diagnose and manage their rashes?

Will we have prevented our inflammatory skin disorders, or “turned them off” in early life with aggressive therapy in infantile life?

I project only that all of us in dermatology will still be a resource to our pediatric patients, from neonate through young adult, through our work of preventing, caring, healing and minimizing disease impact, and hopefully enjoying the pleasures of seeing our patients healthfully develop and evolve! As will our field.
 

Dr. Eichenfield is professor of dermatology and pediatrics and vice-chair of the department of dermatology at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego. Dr. Eichenfield reports financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including products for the diseases discussed here.

Pediatric News welcomes Herschel Lessin, MD, to the editorial advisory board.

Dr. Lessin has been a practicing pediatric clinician for the past 39 years at The Children’s Medical Group. In 1997, he was a founding partner of one of the first private practice “supergroups” by merging two competing pediatric practices into one and expanding it to 25 clinicians, with eight offices in three counties in New York state’s Mid-Hudson Valley. The group provides pediatric care to more than 30,000 children and has a nearly 90-year history, across its various incarnations, providing such care.

Dr. Lessin received his medical degree from Stanford (Calif.) University and trained in pediatrics at Yale-New Haven (Conn.) Medical Center. He has been active in national policy and leadership in the American Academy of Pediatrics, having served on the executive committee of the Section of Administration and Practice Management, the national Committee on Practice and Ambulatory Medicine, and his current appointment to the national Private Payer Advocacy Advisory Committee. In those roles he has authored several national policy statements and clinical guidelines, including “Increasing Immunization Coverage,” “Immunizing Parents and Other Close Family Contacts in the Pediatric Office Setting,” “Instrument-Based Pediatric Vision Screening Policy Statement,” and most recently, “Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents.” He is also the coeditor of the AAP’s ADHD toolkit for clinicians published in 2019. Dr. Lessin served as the director of clinical research for his group for 5 years and the medical director for the practice for 10 years.

He has served as a faculty member at numerous local and regional pediatric meetings. He has been a faculty member at the AAP’s annual national conference and exposition for the past decade, speaking on a variety of topics. Dr. Lessin also has been an invited speaker internationally at pediatric conferences in India and Egypt. He has participated in more than a dozen medical missions to developing countries in Latin America, the Caribbean, Africa, and Vietnam. His expertise includes practice management, the business of medicine, immunizations, ADHD, and liability topics. He has been a testifying expert witness for both defense and plaintiff in medical malpractice litigation for more than 30 years. He founded and served as president of a medical independent practice association that began with 12 physicians and grew to over 3,000 doctors. He is also a certified managed care executive. His most recent interest has been becoming a professional voice-over actor!

While performing all of the above, Dr. Lessin is a dedicated community pediatrician whose first love and primary goal has remained providing the highest quality medical care to children while helping his colleagues manage their businesses in order to be able to survive and continue to provide such care.

Pediatric News welcomes Herschel Lessin, MD, to the editorial advisory board.

Dr. Lessin has been a practicing pediatric clinician for the past 39 years at The Children’s Medical Group. In 1997, he was a founding partner of one of the first private practice “supergroups” by merging two competing pediatric practices into one and expanding it to 25 clinicians, with eight offices in three counties in New York state’s Mid-Hudson Valley. The group provides pediatric care to more than 30,000 children and has a nearly 90-year history, across its various incarnations, providing such care.

Dr. Lessin received his medical degree from Stanford (Calif.) University and trained in pediatrics at Yale-New Haven (Conn.) Medical Center. He has been active in national policy and leadership in the American Academy of Pediatrics, having served on the executive committee of the Section of Administration and Practice Management, the national Committee on Practice and Ambulatory Medicine, and his current appointment to the national Private Payer Advocacy Advisory Committee. In those roles he has authored several national policy statements and clinical guidelines, including “Increasing Immunization Coverage,” “Immunizing Parents and Other Close Family Contacts in the Pediatric Office Setting,” “Instrument-Based Pediatric Vision Screening Policy Statement,” and most recently, “Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents.” He is also the coeditor of the AAP’s ADHD toolkit for clinicians published in 2019. Dr. Lessin served as the director of clinical research for his group for 5 years and the medical director for the practice for 10 years.

He has served as a faculty member at numerous local and regional pediatric meetings. He has been a faculty member at the AAP’s annual national conference and exposition for the past decade, speaking on a variety of topics. Dr. Lessin also has been an invited speaker internationally at pediatric conferences in India and Egypt. He has participated in more than a dozen medical missions to developing countries in Latin America, the Caribbean, Africa, and Vietnam. His expertise includes practice management, the business of medicine, immunizations, ADHD, and liability topics. He has been a testifying expert witness for both defense and plaintiff in medical malpractice litigation for more than 30 years. He founded and served as president of a medical independent practice association that began with 12 physicians and grew to over 3,000 doctors. He is also a certified managed care executive. His most recent interest has been becoming a professional voice-over actor!

While performing all of the above, Dr. Lessin is a dedicated community pediatrician whose first love and primary goal has remained providing the highest quality medical care to children while helping his colleagues manage their businesses in order to be able to survive and continue to provide such care.

Pediatric News welcomes Herschel Lessin, MD, to the editorial advisory board.

Dr. Lessin has been a practicing pediatric clinician for the past 39 years at The Children’s Medical Group. In 1997, he was a founding partner of one of the first private practice “supergroups” by merging two competing pediatric practices into one and expanding it to 25 clinicians, with eight offices in three counties in New York state’s Mid-Hudson Valley. The group provides pediatric care to more than 30,000 children and has a nearly 90-year history, across its various incarnations, providing such care.

Dr. Lessin received his medical degree from Stanford (Calif.) University and trained in pediatrics at Yale-New Haven (Conn.) Medical Center. He has been active in national policy and leadership in the American Academy of Pediatrics, having served on the executive committee of the Section of Administration and Practice Management, the national Committee on Practice and Ambulatory Medicine, and his current appointment to the national Private Payer Advocacy Advisory Committee. In those roles he has authored several national policy statements and clinical guidelines, including “Increasing Immunization Coverage,” “Immunizing Parents and Other Close Family Contacts in the Pediatric Office Setting,” “Instrument-Based Pediatric Vision Screening Policy Statement,” and most recently, “Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents.” He is also the coeditor of the AAP’s ADHD toolkit for clinicians published in 2019. Dr. Lessin served as the director of clinical research for his group for 5 years and the medical director for the practice for 10 years.

He has served as a faculty member at numerous local and regional pediatric meetings. He has been a faculty member at the AAP’s annual national conference and exposition for the past decade, speaking on a variety of topics. Dr. Lessin also has been an invited speaker internationally at pediatric conferences in India and Egypt. He has participated in more than a dozen medical missions to developing countries in Latin America, the Caribbean, Africa, and Vietnam. His expertise includes practice management, the business of medicine, immunizations, ADHD, and liability topics. He has been a testifying expert witness for both defense and plaintiff in medical malpractice litigation for more than 30 years. He founded and served as president of a medical independent practice association that began with 12 physicians and grew to over 3,000 doctors. He is also a certified managed care executive. His most recent interest has been becoming a professional voice-over actor!

While performing all of the above, Dr. Lessin is a dedicated community pediatrician whose first love and primary goal has remained providing the highest quality medical care to children while helping his colleagues manage their businesses in order to be able to survive and continue to provide such care.

The number of new cases soared in the past week as the United States exceeded 1 million children infected with the coronavirus, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the first time, the number of cases in children for the week ending Nov. 12 passed 100,000, and it didn’t stop until it reached 111,946, bringing the total for the pandemic to 1,039,464 reported cases in 49 states (New York is not reporting ages), the District of Columbia, New York City, and Guam, the AAP and the CHA said in their weekly COVID-19 update.

“As a pediatrician who has practiced medicine for over 3 decades, I find this number staggering and tragic. We haven’t seen a virus flash through our communities in this way since before we had vaccines for measles and polio,” AAP President Sally Goza, MD, said in a written statement.

The previous 1-week high of almost 74,000 cases came just last week, and that number had surpassed the previous week’s new high of 61,000. The number of cumulative child cases, meanwhile, has doubled since Sept. 3, when it was just over 513,000. Children now represent 11.5% of all COVID-19 cases since the start of the pandemic in the jurisdictions reporting age distribution, the AAP and CHA said.

For the week ending Nov. 12, COVID-19 cases children made up 14% of cases nationally, rising from 13% the week before and reversing a decline that started in mid-October, the AAP/CHA data show.

The two groups continue to note the rarity of severe illness in children, but the number of deaths nationally had its biggest 1-week increase since late July, as the total rose from 123 to 133 in the 42 states reporting such data by age, as well as New York City. The cumulative hospitalization rate for children decreased slightly in the past week and is now down to 1.6% in the 23 states (and NYC) with available data, the AAP and CHA said.

The AAP called on elected leaders to enact a national strategy to combat the spread of the virus and urged health authorities to do more to collect data on longer-term impacts on children.

“Most natural disasters have an end, but this pandemic has gone on for over 8 months, and is likely to continue to disrupt our lives for many more. We’re very concerned about how this will impact all children, including toddlers who are missing key educational opportunities, as well as adolescents who may be at higher risk for anxiety and depression,” Dr. Goza said.

rfranki@mdedge.com

The number of new cases soared in the past week as the United States exceeded 1 million children infected with the coronavirus, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the first time, the number of cases in children for the week ending Nov. 12 passed 100,000, and it didn’t stop until it reached 111,946, bringing the total for the pandemic to 1,039,464 reported cases in 49 states (New York is not reporting ages), the District of Columbia, New York City, and Guam, the AAP and the CHA said in their weekly COVID-19 update.

“As a pediatrician who has practiced medicine for over 3 decades, I find this number staggering and tragic. We haven’t seen a virus flash through our communities in this way since before we had vaccines for measles and polio,” AAP President Sally Goza, MD, said in a written statement.

The previous 1-week high of almost 74,000 cases came just last week, and that number had surpassed the previous week’s new high of 61,000. The number of cumulative child cases, meanwhile, has doubled since Sept. 3, when it was just over 513,000. Children now represent 11.5% of all COVID-19 cases since the start of the pandemic in the jurisdictions reporting age distribution, the AAP and CHA said.

For the week ending Nov. 12, COVID-19 cases children made up 14% of cases nationally, rising from 13% the week before and reversing a decline that started in mid-October, the AAP/CHA data show.

The two groups continue to note the rarity of severe illness in children, but the number of deaths nationally had its biggest 1-week increase since late July, as the total rose from 123 to 133 in the 42 states reporting such data by age, as well as New York City. The cumulative hospitalization rate for children decreased slightly in the past week and is now down to 1.6% in the 23 states (and NYC) with available data, the AAP and CHA said.

The AAP called on elected leaders to enact a national strategy to combat the spread of the virus and urged health authorities to do more to collect data on longer-term impacts on children.

“Most natural disasters have an end, but this pandemic has gone on for over 8 months, and is likely to continue to disrupt our lives for many more. We’re very concerned about how this will impact all children, including toddlers who are missing key educational opportunities, as well as adolescents who may be at higher risk for anxiety and depression,” Dr. Goza said.

rfranki@mdedge.com

The number of new cases soared in the past week as the United States exceeded 1 million children infected with the coronavirus, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

For the first time, the number of cases in children for the week ending Nov. 12 passed 100,000, and it didn’t stop until it reached 111,946, bringing the total for the pandemic to 1,039,464 reported cases in 49 states (New York is not reporting ages), the District of Columbia, New York City, and Guam, the AAP and the CHA said in their weekly COVID-19 update.

“As a pediatrician who has practiced medicine for over 3 decades, I find this number staggering and tragic. We haven’t seen a virus flash through our communities in this way since before we had vaccines for measles and polio,” AAP President Sally Goza, MD, said in a written statement.

The previous 1-week high of almost 74,000 cases came just last week, and that number had surpassed the previous week’s new high of 61,000. The number of cumulative child cases, meanwhile, has doubled since Sept. 3, when it was just over 513,000. Children now represent 11.5% of all COVID-19 cases since the start of the pandemic in the jurisdictions reporting age distribution, the AAP and CHA said.

For the week ending Nov. 12, COVID-19 cases children made up 14% of cases nationally, rising from 13% the week before and reversing a decline that started in mid-October, the AAP/CHA data show.

The two groups continue to note the rarity of severe illness in children, but the number of deaths nationally had its biggest 1-week increase since late July, as the total rose from 123 to 133 in the 42 states reporting such data by age, as well as New York City. The cumulative hospitalization rate for children decreased slightly in the past week and is now down to 1.6% in the 23 states (and NYC) with available data, the AAP and CHA said.

The AAP called on elected leaders to enact a national strategy to combat the spread of the virus and urged health authorities to do more to collect data on longer-term impacts on children.

“Most natural disasters have an end, but this pandemic has gone on for over 8 months, and is likely to continue to disrupt our lives for many more. We’re very concerned about how this will impact all children, including toddlers who are missing key educational opportunities, as well as adolescents who may be at higher risk for anxiety and depression,” Dr. Goza said.

rfranki@mdedge.com

Over 818,000 plans were selected for the 2021 coverage year during the first week, Nov.1-7, of this year’s open enrollment on the federal health insurance exchange, according to the Centers for Medicare & Medicaid Services.

The bulk of those plans, nearly 79%, were renewals by consumers who had coverage through the federal exchange this year. The balance covers new plans selected by individuals who were not covered through HealthCare.gov this year, the CMS noted in a written statement.

The total enrollment for week 1 marks a considerable increase over last year’s first week of open enrollment, which saw approximately 177,000 plans selected, but Nov. 1 fell on a Friday in 2019, so that total represents only 2 days since weeks are tracked as running from Sunday to Saturday, the CMS explained.

For the 2021 benefit year, the HealthCare.gov platform covers 36 states, down from 38 for the 2020 benefit year, because New Jersey and Pennsylvania have “transitioned to their own state-based exchange platforms,” the CMS noted, adding that the two accounted for 7% of all plans selected last year.

“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS said, and its weekly snapshot “does not report the number of consumers who have paid premiums to effectuate their enrollment.”

This year’s open-enrollment period on HealthCare.gov is scheduled to conclude Dec. 15.

rfranki@mdedge.com

Over 818,000 plans were selected for the 2021 coverage year during the first week, Nov.1-7, of this year’s open enrollment on the federal health insurance exchange, according to the Centers for Medicare & Medicaid Services.

The bulk of those plans, nearly 79%, were renewals by consumers who had coverage through the federal exchange this year. The balance covers new plans selected by individuals who were not covered through HealthCare.gov this year, the CMS noted in a written statement.

The total enrollment for week 1 marks a considerable increase over last year’s first week of open enrollment, which saw approximately 177,000 plans selected, but Nov. 1 fell on a Friday in 2019, so that total represents only 2 days since weeks are tracked as running from Sunday to Saturday, the CMS explained.

For the 2021 benefit year, the HealthCare.gov platform covers 36 states, down from 38 for the 2020 benefit year, because New Jersey and Pennsylvania have “transitioned to their own state-based exchange platforms,” the CMS noted, adding that the two accounted for 7% of all plans selected last year.

“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS said, and its weekly snapshot “does not report the number of consumers who have paid premiums to effectuate their enrollment.”

This year’s open-enrollment period on HealthCare.gov is scheduled to conclude Dec. 15.

rfranki@mdedge.com

Over 818,000 plans were selected for the 2021 coverage year during the first week, Nov.1-7, of this year’s open enrollment on the federal health insurance exchange, according to the Centers for Medicare & Medicaid Services.

The bulk of those plans, nearly 79%, were renewals by consumers who had coverage through the federal exchange this year. The balance covers new plans selected by individuals who were not covered through HealthCare.gov this year, the CMS noted in a written statement.

The total enrollment for week 1 marks a considerable increase over last year’s first week of open enrollment, which saw approximately 177,000 plans selected, but Nov. 1 fell on a Friday in 2019, so that total represents only 2 days since weeks are tracked as running from Sunday to Saturday, the CMS explained.

For the 2021 benefit year, the HealthCare.gov platform covers 36 states, down from 38 for the 2020 benefit year, because New Jersey and Pennsylvania have “transitioned to their own state-based exchange platforms,” the CMS noted, adding that the two accounted for 7% of all plans selected last year.

“The final number of plan selections associated with enrollment activity during a reporting period may change due to plan modifications or cancellations,” CMS said, and its weekly snapshot “does not report the number of consumers who have paid premiums to effectuate their enrollment.”

This year’s open-enrollment period on HealthCare.gov is scheduled to conclude Dec. 15.

rfranki@mdedge.com

The Moderna mRNA-1273 vaccine, in development to prevent COVID-19, yielded 94.5% efficacy in early results and is generally well tolerated, the company announced early Monday. The product can be stored at refrigeration temperatures common to many physician offices, pharmacies, and hospitals.

The first interim results of the phase 3 COVE trial included 95 participants with confirmed COVID-19. An independent data safety monitoring board, which was appointed by the National Institutes of Health, informed Moderna that 90 of the patients who were positive for COVID-19 were in a placebo group and that 5 patients were in the mRNA-1273 vaccine group, resulting in a vaccine efficacy of 94.5% (P < .0001).

Interim data included 11 patients with severe COVID-19, all of whom were in the placebo group.

“This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna, said in a statement.

The vaccine met its primary study endpoint, which was based on adjudicated data that were collected starting 2 weeks after the second dose of mRNA-1273. The interim study population included people who could be at higher risk for COVID-19, including 15 adults aged 65 years and older and 20 participants from diverse communities.
 

Safety data

The DSMB also reviewed safety data for the COVE study interim results. The vaccine was generally safe and well tolerated, as determined on the basis of solicited adverse events. Most adverse events were mild to moderate and were generally short-lived, according to a company news release.

Injection-site pain was reported in 2.7% of participants after the first dose. After the second dose, 9.7% of participants reported fatigue, 8.9% reported myalgia, 5.2% reported arthralgia, 4.5% reported headache, 4.1% reported pain, and 2.0% reported erythema or redness at the injection site.

Moderna plans to request emergency-use authorization (EUA) from the Food and Drug Administration in the coming weeks. The company expects that the EUA will be based on more data from the COVE study, including a final analysis of 151 patients with a median follow-up of more than 2 months. Moderna also plans to seek authorizations from global regulatory agencies.

The company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States by the end of the year. In addition, the company says it remains on track to manufacture between 500 million and 1 billion doses globally in 2021.

Moderna is developing distribution plans in conjunction with the Centers for Disease Control and Prevention, the federal government’s Operation Warp Speed, and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government.
 

Refrigeration requirements

The mRNA-1273 vaccine can be shipped and stored for up to 6 months at –20° C (about –4° F), a temperature maintained in most home or medical freezers, according to Moderna. The company expects that, after the product thaws, it will remain stable at standard refrigerator temperatures of 2°-8° C (36°-46° F) for up to 30 days within the 6-month shelf life.

Because the mRNA-1273 vaccine is stable at these refrigerator temperatures, it can be stored at most physicians’ offices, pharmacies, and hospitals, the company noted. In contrast, the similar Pfizer BTN162b2 vaccine – early results for which showed a 90% efficacy rate – requires shipment and storage at “deep-freeze” conditions of –70° C or –80° C, which is more challenging from a logistic point of view.

Moderna’s mRNA-1273 can be kept at room temperature for up to 12 hours after removal from a refrigerator for patient administration. The vaccine will not require dilution prior to use.

More than 30,000 people aged older than 18 years in the United States are enrolled in the COVE study. The research is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health & Human Services.

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

The Moderna mRNA-1273 vaccine, in development to prevent COVID-19, yielded 94.5% efficacy in early results and is generally well tolerated, the company announced early Monday. The product can be stored at refrigeration temperatures common to many physician offices, pharmacies, and hospitals.

The first interim results of the phase 3 COVE trial included 95 participants with confirmed COVID-19. An independent data safety monitoring board, which was appointed by the National Institutes of Health, informed Moderna that 90 of the patients who were positive for COVID-19 were in a placebo group and that 5 patients were in the mRNA-1273 vaccine group, resulting in a vaccine efficacy of 94.5% (P < .0001).

Interim data included 11 patients with severe COVID-19, all of whom were in the placebo group.

“This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna, said in a statement.

The vaccine met its primary study endpoint, which was based on adjudicated data that were collected starting 2 weeks after the second dose of mRNA-1273. The interim study population included people who could be at higher risk for COVID-19, including 15 adults aged 65 years and older and 20 participants from diverse communities.
 

Safety data

The DSMB also reviewed safety data for the COVE study interim results. The vaccine was generally safe and well tolerated, as determined on the basis of solicited adverse events. Most adverse events were mild to moderate and were generally short-lived, according to a company news release.

Injection-site pain was reported in 2.7% of participants after the first dose. After the second dose, 9.7% of participants reported fatigue, 8.9% reported myalgia, 5.2% reported arthralgia, 4.5% reported headache, 4.1% reported pain, and 2.0% reported erythema or redness at the injection site.

Moderna plans to request emergency-use authorization (EUA) from the Food and Drug Administration in the coming weeks. The company expects that the EUA will be based on more data from the COVE study, including a final analysis of 151 patients with a median follow-up of more than 2 months. Moderna also plans to seek authorizations from global regulatory agencies.

The company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States by the end of the year. In addition, the company says it remains on track to manufacture between 500 million and 1 billion doses globally in 2021.

Moderna is developing distribution plans in conjunction with the Centers for Disease Control and Prevention, the federal government’s Operation Warp Speed, and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government.
 

Refrigeration requirements

The mRNA-1273 vaccine can be shipped and stored for up to 6 months at –20° C (about –4° F), a temperature maintained in most home or medical freezers, according to Moderna. The company expects that, after the product thaws, it will remain stable at standard refrigerator temperatures of 2°-8° C (36°-46° F) for up to 30 days within the 6-month shelf life.

Because the mRNA-1273 vaccine is stable at these refrigerator temperatures, it can be stored at most physicians’ offices, pharmacies, and hospitals, the company noted. In contrast, the similar Pfizer BTN162b2 vaccine – early results for which showed a 90% efficacy rate – requires shipment and storage at “deep-freeze” conditions of –70° C or –80° C, which is more challenging from a logistic point of view.

Moderna’s mRNA-1273 can be kept at room temperature for up to 12 hours after removal from a refrigerator for patient administration. The vaccine will not require dilution prior to use.

More than 30,000 people aged older than 18 years in the United States are enrolled in the COVE study. The research is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health & Human Services.

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

The Moderna mRNA-1273 vaccine, in development to prevent COVID-19, yielded 94.5% efficacy in early results and is generally well tolerated, the company announced early Monday. The product can be stored at refrigeration temperatures common to many physician offices, pharmacies, and hospitals.

The first interim results of the phase 3 COVE trial included 95 participants with confirmed COVID-19. An independent data safety monitoring board, which was appointed by the National Institutes of Health, informed Moderna that 90 of the patients who were positive for COVID-19 were in a placebo group and that 5 patients were in the mRNA-1273 vaccine group, resulting in a vaccine efficacy of 94.5% (P < .0001).

Interim data included 11 patients with severe COVID-19, all of whom were in the placebo group.

“This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna, said in a statement.

The vaccine met its primary study endpoint, which was based on adjudicated data that were collected starting 2 weeks after the second dose of mRNA-1273. The interim study population included people who could be at higher risk for COVID-19, including 15 adults aged 65 years and older and 20 participants from diverse communities.
 

Safety data

The DSMB also reviewed safety data for the COVE study interim results. The vaccine was generally safe and well tolerated, as determined on the basis of solicited adverse events. Most adverse events were mild to moderate and were generally short-lived, according to a company news release.

Injection-site pain was reported in 2.7% of participants after the first dose. After the second dose, 9.7% of participants reported fatigue, 8.9% reported myalgia, 5.2% reported arthralgia, 4.5% reported headache, 4.1% reported pain, and 2.0% reported erythema or redness at the injection site.

Moderna plans to request emergency-use authorization (EUA) from the Food and Drug Administration in the coming weeks. The company expects that the EUA will be based on more data from the COVE study, including a final analysis of 151 patients with a median follow-up of more than 2 months. Moderna also plans to seek authorizations from global regulatory agencies.

The company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States by the end of the year. In addition, the company says it remains on track to manufacture between 500 million and 1 billion doses globally in 2021.

Moderna is developing distribution plans in conjunction with the Centers for Disease Control and Prevention, the federal government’s Operation Warp Speed, and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government.
 

Refrigeration requirements

The mRNA-1273 vaccine can be shipped and stored for up to 6 months at –20° C (about –4° F), a temperature maintained in most home or medical freezers, according to Moderna. The company expects that, after the product thaws, it will remain stable at standard refrigerator temperatures of 2°-8° C (36°-46° F) for up to 30 days within the 6-month shelf life.

Because the mRNA-1273 vaccine is stable at these refrigerator temperatures, it can be stored at most physicians’ offices, pharmacies, and hospitals, the company noted. In contrast, the similar Pfizer BTN162b2 vaccine – early results for which showed a 90% efficacy rate – requires shipment and storage at “deep-freeze” conditions of –70° C or –80° C, which is more challenging from a logistic point of view.

Moderna’s mRNA-1273 can be kept at room temperature for up to 12 hours after removal from a refrigerator for patient administration. The vaccine will not require dilution prior to use.

More than 30,000 people aged older than 18 years in the United States are enrolled in the COVE study. The research is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health & Human Services.

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

A panel convened by The Lancet has published a comprehensive report calling for major initiatives to improve diabetes prevention and care around the world.

The article was published online Nov. 12, just ahead of World Diabetes Day.

Of the 463 million people with diabetes worldwide in 2019, 80% live in low- and middle-income countries. The condition reduces life expectancy in middle-aged adults by 4-10 years, including increasing the risk of death from cardiovascular disease, kidney disease, and cancer by up to threefold. It is also a leading cause of nontraumatic amputation and blindness.

Use of evidence-based interventions, if implemented and managed properly, could prevent thousands of deaths globally every day, stressed the commission.

“There is an enormous amount of knowledge that we have amassed over the years. We need good preventive care and we need to ensure that diabetes patients, once diagnosed, have good continuous care. There is an urgent need for decision-makers, policymakers, and payers to make things happen,” the leader of the multidisciplinary commission, Juliana C.N. Chan, MBChB, MD, said in an interview.

And now diabetes has emerged as a major risk factor for death from COVID-19, particularly in the setting of inadequate glycemic control.

“COVID-19 has exposed the vulnerability of individuals with diabetes,” said Dr. Chan, of the Hong Kong Institute of Diabetes and Obesity. “We should use the pandemic as an opportunity to implement solutions.”
 

Physician education key, trickling down to field workers and patients

First on the agenda, she says, should be “physician education. There are many primary care providers and internal medicine physicians whose knowledge needs to be updated.”

“Then doctors need to transfer this information to other people, such as nurses and community field workers. We cannot just rely on doctors; we need to train nonmedics” so that knowledge about how to prevent, treat, and manage diabetes long term is communicated right down the health care chain, she explained.

“They need to know how to look at people’s eyes and feet, how to do blood and urine tests, and how to collect data. Then they need to educate patients on what they should be doing, on how to practice self-care,” she added.

“We need to change our way of thinking, redesign clinic flow and how you build a team. And those care teams need to know how to collect data, and then use that data to monitor patients and to stratify individual risk, to ensure that what has been said has been done, as well as to inform practice and policies” through, for example, the establishment of diabetes registers.

The focus needs to be on “lifelong integrated care, the right treatment at the right time,” she emphasized. History-taking, clinical and laboratory assessments, as well as monitoring of macrovascular and microvascular complications, comorbidities, and medications, are all key.

Just a few simple things, if properly implemented, could make a big difference, Dr. Chan stressed.

For example, implementing a structured lifestyle intervention and use of metformin can each prevent or delay type 2 diabetes in individuals with impaired glucose tolerance by 30%-50%, and sustained weight reduction in patients with obesity by 15 kg (33 lb) or more can induce remission of type 2 diabetes for up to 2 years.

And there are plenty of medications that are “very affordable even in low- and middle-income countries” to treat diabetes and associated risk factors, including metformin, “statins, and RAS inhibitors,” she noted.

For instance, the 10 low- and middle-income countries with the greatest burden of diabetes (China, India, Brazil, Mexico, Indonesia, Egypt, Pakistan, Bangladesh, Turkey, Thailand) account for 217 million cases of type 2 diabetes, representing nearly 50% of all diabetes cases.

The commission estimated that 3.2 million of these individuals would die in 3 years if not treated, with 1.3 million of these deaths due to cardiovascular disease.

By reducing hemoglobin A1c, blood pressure, and LDL-cholesterol through achieving a diagnosis rate of 50%, ensuring access to essential medicines in at least 70% of patients, and with a support system to sustain reductions in these risk factors over 3 years, up to 800,000 premature deaths could be avoided.
 

People with type 1 diabetes dying; WHO launches initiative

In an accompanying commentary (2020 Nov 12. doi: 10.1016/S0140-6736[20]32378-3), Katie Dain, chief executive officer of the Noncommunicable Diseases (NCD) Alliance, points out that only half of people living with diabetes around the world – and just one in seven in Africa – have reliable access to insulin.

“Lots of people with type 1 diabetes are still dying due to lack of insulin,” Dr. Chan said in an interview. “We need to elevate basic care to intermediate and ensure that basal-bolus insulin and glucose-monitoring tools are available and that patients are trained in self-care. In that way, 80% of type 1 diabetes deaths could be prevented.”

Ms. 3Dain agrees, stressing, “Political rhetoric and commitments have yet to translate into sufficient and sustainable action for people living with diabetes worldwide, and particularly for those in [low- and middle-income countries].”

The Lancet Commission document also emphasizes the importance of support for pregnant women with diabetes and attention to the psychosocial needs of people with diabetes.

And it stresses society-, population-, and community-based strategies for type 2 diabetes prevention including health awareness programs, food policies, and broad use of nonphysician personnel to deliver diabetes prevention efforts.

In tandem with World Diabetes Day, the World Health Organization will announce the development of the WHO Global Diabetes Compact, which will be launched in April 2021.

This will aim to implement the commission’s recommendations through partnerships with governments, care providers, patient advocates, and nongovernmental organizations.

Together, they will “support countries to mobilize resources and accelerate structural transformations, which will enable the scale-up of access to essential diabetes medicines and technologies, inclusion of diagnosis and treatment of diabetes in primary health care and universal health coverage packages, and reduction of major population-level diabetes risk factors such as obesity,” according to another Lancet editorial accompanying the report.

“The evidence-base for improving diabetes prevention and care is strong. The question now for diabetes advocates is how to achieve the comprehensive, systems-level change needed to translate this evidence into action.”

Dr. Chan has reported receiving grants from AstraZeneca, Lilly, Lee Powder, Hua Medicine, and Qualigenics, as well as grants and personal fees from Bayer, Boehringer Ingelheim, Sanofi, Novartis, Merck, and MSD outside the submitted work. She has reported being the chief executive officer (pro bono) of the Asia Diabetes Foundation and a cofounder of GemVCare. She also holds a patent for genetic markers for diabetes and its complications. Ms. Dain has reported no relevant financial relationships.
 

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

A panel convened by The Lancet has published a comprehensive report calling for major initiatives to improve diabetes prevention and care around the world.

The article was published online Nov. 12, just ahead of World Diabetes Day.

Of the 463 million people with diabetes worldwide in 2019, 80% live in low- and middle-income countries. The condition reduces life expectancy in middle-aged adults by 4-10 years, including increasing the risk of death from cardiovascular disease, kidney disease, and cancer by up to threefold. It is also a leading cause of nontraumatic amputation and blindness.

Use of evidence-based interventions, if implemented and managed properly, could prevent thousands of deaths globally every day, stressed the commission.

“There is an enormous amount of knowledge that we have amassed over the years. We need good preventive care and we need to ensure that diabetes patients, once diagnosed, have good continuous care. There is an urgent need for decision-makers, policymakers, and payers to make things happen,” the leader of the multidisciplinary commission, Juliana C.N. Chan, MBChB, MD, said in an interview.

And now diabetes has emerged as a major risk factor for death from COVID-19, particularly in the setting of inadequate glycemic control.

“COVID-19 has exposed the vulnerability of individuals with diabetes,” said Dr. Chan, of the Hong Kong Institute of Diabetes and Obesity. “We should use the pandemic as an opportunity to implement solutions.”
 

Physician education key, trickling down to field workers and patients

First on the agenda, she says, should be “physician education. There are many primary care providers and internal medicine physicians whose knowledge needs to be updated.”

“Then doctors need to transfer this information to other people, such as nurses and community field workers. We cannot just rely on doctors; we need to train nonmedics” so that knowledge about how to prevent, treat, and manage diabetes long term is communicated right down the health care chain, she explained.

“They need to know how to look at people’s eyes and feet, how to do blood and urine tests, and how to collect data. Then they need to educate patients on what they should be doing, on how to practice self-care,” she added.

“We need to change our way of thinking, redesign clinic flow and how you build a team. And those care teams need to know how to collect data, and then use that data to monitor patients and to stratify individual risk, to ensure that what has been said has been done, as well as to inform practice and policies” through, for example, the establishment of diabetes registers.

The focus needs to be on “lifelong integrated care, the right treatment at the right time,” she emphasized. History-taking, clinical and laboratory assessments, as well as monitoring of macrovascular and microvascular complications, comorbidities, and medications, are all key.

Just a few simple things, if properly implemented, could make a big difference, Dr. Chan stressed.

For example, implementing a structured lifestyle intervention and use of metformin can each prevent or delay type 2 diabetes in individuals with impaired glucose tolerance by 30%-50%, and sustained weight reduction in patients with obesity by 15 kg (33 lb) or more can induce remission of type 2 diabetes for up to 2 years.

And there are plenty of medications that are “very affordable even in low- and middle-income countries” to treat diabetes and associated risk factors, including metformin, “statins, and RAS inhibitors,” she noted.

For instance, the 10 low- and middle-income countries with the greatest burden of diabetes (China, India, Brazil, Mexico, Indonesia, Egypt, Pakistan, Bangladesh, Turkey, Thailand) account for 217 million cases of type 2 diabetes, representing nearly 50% of all diabetes cases.

The commission estimated that 3.2 million of these individuals would die in 3 years if not treated, with 1.3 million of these deaths due to cardiovascular disease.

By reducing hemoglobin A1c, blood pressure, and LDL-cholesterol through achieving a diagnosis rate of 50%, ensuring access to essential medicines in at least 70% of patients, and with a support system to sustain reductions in these risk factors over 3 years, up to 800,000 premature deaths could be avoided.
 

People with type 1 diabetes dying; WHO launches initiative

In an accompanying commentary (2020 Nov 12. doi: 10.1016/S0140-6736[20]32378-3), Katie Dain, chief executive officer of the Noncommunicable Diseases (NCD) Alliance, points out that only half of people living with diabetes around the world – and just one in seven in Africa – have reliable access to insulin.

“Lots of people with type 1 diabetes are still dying due to lack of insulin,” Dr. Chan said in an interview. “We need to elevate basic care to intermediate and ensure that basal-bolus insulin and glucose-monitoring tools are available and that patients are trained in self-care. In that way, 80% of type 1 diabetes deaths could be prevented.”

Ms. 3Dain agrees, stressing, “Political rhetoric and commitments have yet to translate into sufficient and sustainable action for people living with diabetes worldwide, and particularly for those in [low- and middle-income countries].”

The Lancet Commission document also emphasizes the importance of support for pregnant women with diabetes and attention to the psychosocial needs of people with diabetes.

And it stresses society-, population-, and community-based strategies for type 2 diabetes prevention including health awareness programs, food policies, and broad use of nonphysician personnel to deliver diabetes prevention efforts.

In tandem with World Diabetes Day, the World Health Organization will announce the development of the WHO Global Diabetes Compact, which will be launched in April 2021.

This will aim to implement the commission’s recommendations through partnerships with governments, care providers, patient advocates, and nongovernmental organizations.

Together, they will “support countries to mobilize resources and accelerate structural transformations, which will enable the scale-up of access to essential diabetes medicines and technologies, inclusion of diagnosis and treatment of diabetes in primary health care and universal health coverage packages, and reduction of major population-level diabetes risk factors such as obesity,” according to another Lancet editorial accompanying the report.

“The evidence-base for improving diabetes prevention and care is strong. The question now for diabetes advocates is how to achieve the comprehensive, systems-level change needed to translate this evidence into action.”

Dr. Chan has reported receiving grants from AstraZeneca, Lilly, Lee Powder, Hua Medicine, and Qualigenics, as well as grants and personal fees from Bayer, Boehringer Ingelheim, Sanofi, Novartis, Merck, and MSD outside the submitted work. She has reported being the chief executive officer (pro bono) of the Asia Diabetes Foundation and a cofounder of GemVCare. She also holds a patent for genetic markers for diabetes and its complications. Ms. Dain has reported no relevant financial relationships.
 

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

A panel convened by The Lancet has published a comprehensive report calling for major initiatives to improve diabetes prevention and care around the world.

The article was published online Nov. 12, just ahead of World Diabetes Day.

Of the 463 million people with diabetes worldwide in 2019, 80% live in low- and middle-income countries. The condition reduces life expectancy in middle-aged adults by 4-10 years, including increasing the risk of death from cardiovascular disease, kidney disease, and cancer by up to threefold. It is also a leading cause of nontraumatic amputation and blindness.

Use of evidence-based interventions, if implemented and managed properly, could prevent thousands of deaths globally every day, stressed the commission.

“There is an enormous amount of knowledge that we have amassed over the years. We need good preventive care and we need to ensure that diabetes patients, once diagnosed, have good continuous care. There is an urgent need for decision-makers, policymakers, and payers to make things happen,” the leader of the multidisciplinary commission, Juliana C.N. Chan, MBChB, MD, said in an interview.

And now diabetes has emerged as a major risk factor for death from COVID-19, particularly in the setting of inadequate glycemic control.

“COVID-19 has exposed the vulnerability of individuals with diabetes,” said Dr. Chan, of the Hong Kong Institute of Diabetes and Obesity. “We should use the pandemic as an opportunity to implement solutions.”
 

Physician education key, trickling down to field workers and patients

First on the agenda, she says, should be “physician education. There are many primary care providers and internal medicine physicians whose knowledge needs to be updated.”

“Then doctors need to transfer this information to other people, such as nurses and community field workers. We cannot just rely on doctors; we need to train nonmedics” so that knowledge about how to prevent, treat, and manage diabetes long term is communicated right down the health care chain, she explained.

“They need to know how to look at people’s eyes and feet, how to do blood and urine tests, and how to collect data. Then they need to educate patients on what they should be doing, on how to practice self-care,” she added.

“We need to change our way of thinking, redesign clinic flow and how you build a team. And those care teams need to know how to collect data, and then use that data to monitor patients and to stratify individual risk, to ensure that what has been said has been done, as well as to inform practice and policies” through, for example, the establishment of diabetes registers.

The focus needs to be on “lifelong integrated care, the right treatment at the right time,” she emphasized. History-taking, clinical and laboratory assessments, as well as monitoring of macrovascular and microvascular complications, comorbidities, and medications, are all key.

Just a few simple things, if properly implemented, could make a big difference, Dr. Chan stressed.

For example, implementing a structured lifestyle intervention and use of metformin can each prevent or delay type 2 diabetes in individuals with impaired glucose tolerance by 30%-50%, and sustained weight reduction in patients with obesity by 15 kg (33 lb) or more can induce remission of type 2 diabetes for up to 2 years.

And there are plenty of medications that are “very affordable even in low- and middle-income countries” to treat diabetes and associated risk factors, including metformin, “statins, and RAS inhibitors,” she noted.

For instance, the 10 low- and middle-income countries with the greatest burden of diabetes (China, India, Brazil, Mexico, Indonesia, Egypt, Pakistan, Bangladesh, Turkey, Thailand) account for 217 million cases of type 2 diabetes, representing nearly 50% of all diabetes cases.

The commission estimated that 3.2 million of these individuals would die in 3 years if not treated, with 1.3 million of these deaths due to cardiovascular disease.

By reducing hemoglobin A1c, blood pressure, and LDL-cholesterol through achieving a diagnosis rate of 50%, ensuring access to essential medicines in at least 70% of patients, and with a support system to sustain reductions in these risk factors over 3 years, up to 800,000 premature deaths could be avoided.
 

People with type 1 diabetes dying; WHO launches initiative

In an accompanying commentary (2020 Nov 12. doi: 10.1016/S0140-6736[20]32378-3), Katie Dain, chief executive officer of the Noncommunicable Diseases (NCD) Alliance, points out that only half of people living with diabetes around the world – and just one in seven in Africa – have reliable access to insulin.

“Lots of people with type 1 diabetes are still dying due to lack of insulin,” Dr. Chan said in an interview. “We need to elevate basic care to intermediate and ensure that basal-bolus insulin and glucose-monitoring tools are available and that patients are trained in self-care. In that way, 80% of type 1 diabetes deaths could be prevented.”

Ms. 3Dain agrees, stressing, “Political rhetoric and commitments have yet to translate into sufficient and sustainable action for people living with diabetes worldwide, and particularly for those in [low- and middle-income countries].”

The Lancet Commission document also emphasizes the importance of support for pregnant women with diabetes and attention to the psychosocial needs of people with diabetes.

And it stresses society-, population-, and community-based strategies for type 2 diabetes prevention including health awareness programs, food policies, and broad use of nonphysician personnel to deliver diabetes prevention efforts.

In tandem with World Diabetes Day, the World Health Organization will announce the development of the WHO Global Diabetes Compact, which will be launched in April 2021.

This will aim to implement the commission’s recommendations through partnerships with governments, care providers, patient advocates, and nongovernmental organizations.

Together, they will “support countries to mobilize resources and accelerate structural transformations, which will enable the scale-up of access to essential diabetes medicines and technologies, inclusion of diagnosis and treatment of diabetes in primary health care and universal health coverage packages, and reduction of major population-level diabetes risk factors such as obesity,” according to another Lancet editorial accompanying the report.

“The evidence-base for improving diabetes prevention and care is strong. The question now for diabetes advocates is how to achieve the comprehensive, systems-level change needed to translate this evidence into action.”

Dr. Chan has reported receiving grants from AstraZeneca, Lilly, Lee Powder, Hua Medicine, and Qualigenics, as well as grants and personal fees from Bayer, Boehringer Ingelheim, Sanofi, Novartis, Merck, and MSD outside the submitted work. She has reported being the chief executive officer (pro bono) of the Asia Diabetes Foundation and a cofounder of GemVCare. She also holds a patent for genetic markers for diabetes and its complications. Ms. Dain has reported no relevant financial relationships.
 

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

Dr. Karen Breach Washington returns to the Pediatric News editorial advisory board after a 10-year hiatus. She currently is employed as a medical director at WellCare of North Carolina/Centene. Her career spans 32 years in Charlotte, N.C., where she has practiced pediatrics and held medical director positions in a large health care system and a managed care organization, as well as worked in private practice and in a public health clinic.

A native of North Babylon, N.Y., she received her undergraduate degree at Hofstra University, Hempstead, N.Y., and her medical degree at George Washington University, Washington. Dr. Breach Washington has been an advocate for children, access to health care, and diversity and inclusion.

An active member of the American Academy of Pediatrics, Dr. Breach Washington served as an elected representative to the AAP National Nominating Committee, following her term as president of the North Carolina chapter of the AAP.

She is a past pediatric section chair of the National Medical Association and past president of the Charlotte Medical, Dental, and Pharmaceutical Society. She has served on the boards of the Simmons Branch YMCA, the Mecklenburg County Medical Society, and the Teen Health Connection (a facility of Carolinas Medical Center), plus many associated committees.

Dr. Breach Washington serves the community as an active life member of Alpha Kappa Alpha Sorority, Jack and Jill of America, and a member of The Links. She is the recipient of several awards for her commitment to diversity and inclusion, philanthropy, and community service.

Dr. Breach Washington is married and has an adult daughter. She is an avid fan of all sports, a dancer, and enjoys theater, fine dining, and travel.

Dr. Karen Breach Washington returns to the Pediatric News editorial advisory board after a 10-year hiatus. She currently is employed as a medical director at WellCare of North Carolina/Centene. Her career spans 32 years in Charlotte, N.C., where she has practiced pediatrics and held medical director positions in a large health care system and a managed care organization, as well as worked in private practice and in a public health clinic.

A native of North Babylon, N.Y., she received her undergraduate degree at Hofstra University, Hempstead, N.Y., and her medical degree at George Washington University, Washington. Dr. Breach Washington has been an advocate for children, access to health care, and diversity and inclusion.

An active member of the American Academy of Pediatrics, Dr. Breach Washington served as an elected representative to the AAP National Nominating Committee, following her term as president of the North Carolina chapter of the AAP.

She is a past pediatric section chair of the National Medical Association and past president of the Charlotte Medical, Dental, and Pharmaceutical Society. She has served on the boards of the Simmons Branch YMCA, the Mecklenburg County Medical Society, and the Teen Health Connection (a facility of Carolinas Medical Center), plus many associated committees.

Dr. Breach Washington serves the community as an active life member of Alpha Kappa Alpha Sorority, Jack and Jill of America, and a member of The Links. She is the recipient of several awards for her commitment to diversity and inclusion, philanthropy, and community service.

Dr. Breach Washington is married and has an adult daughter. She is an avid fan of all sports, a dancer, and enjoys theater, fine dining, and travel.

Dr. Karen Breach Washington returns to the Pediatric News editorial advisory board after a 10-year hiatus. She currently is employed as a medical director at WellCare of North Carolina/Centene. Her career spans 32 years in Charlotte, N.C., where she has practiced pediatrics and held medical director positions in a large health care system and a managed care organization, as well as worked in private practice and in a public health clinic.

A native of North Babylon, N.Y., she received her undergraduate degree at Hofstra University, Hempstead, N.Y., and her medical degree at George Washington University, Washington. Dr. Breach Washington has been an advocate for children, access to health care, and diversity and inclusion.

An active member of the American Academy of Pediatrics, Dr. Breach Washington served as an elected representative to the AAP National Nominating Committee, following her term as president of the North Carolina chapter of the AAP.

She is a past pediatric section chair of the National Medical Association and past president of the Charlotte Medical, Dental, and Pharmaceutical Society. She has served on the boards of the Simmons Branch YMCA, the Mecklenburg County Medical Society, and the Teen Health Connection (a facility of Carolinas Medical Center), plus many associated committees.

Dr. Breach Washington serves the community as an active life member of Alpha Kappa Alpha Sorority, Jack and Jill of America, and a member of The Links. She is the recipient of several awards for her commitment to diversity and inclusion, philanthropy, and community service.

Dr. Breach Washington is married and has an adult daughter. She is an avid fan of all sports, a dancer, and enjoys theater, fine dining, and travel.

Almost 60% of patients with biopsy-confirmed nonalcoholic steatohepatitis and liver fibrosis showed resolution of NASH after treatment with semaglutide, according to a phase 2, double-blind, randomized, placebo-controlled trial published in the New England Journal of Medicine and presented at the 2020 American Association for the Study of Liver Diseases (AASLD) meeting.

“This bodes well for further study of semaglutide and is supported further by marked improvements in weight, glycemic control and lipid profile,” commented the study’s senior author Philip N. Newsome, PhD, FRCPE, of the University of Birmingham (England), in an interview.

The highest daily dose (0.4 mg) of the glucagonlike peptide-1 (GLP-1) receptor agonist, semaglutide, which is approved for the treatment of type 2 diabetes, led to levels of NASH resolution “which are higher than any previously demonstrated,” noted Dr. Newsome. “This was also accompanied by improvement in noninvasive markers of liver fibrosis and also less fibrosis progression, compared to placebo.”

“I think this represents an exciting advance and will, if confirmed in further studies, mark a step-change in our management of patients with NASH,” he added.

The multicenter study, conducted at 143 sites in 16 countries, included 320 patients, aged 18-75 years, with or without type 2 diabetes, who had histologic evidence of NASH and stage 1-3 liver fibrosis.

They were randomized in a 3:3:3:1:1:1 ratio to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg, or placebo for 72 weeks.

The primary endpoint was resolution of NASH and no worsening of fibrosis, with a secondary endpoint being improvement of fibrosis by at least one stage without worsening of NASH.

The study found 40% of patients in the 0.1-mg semaglutide group, 36% in the 0.2-mg group, and 59% in the 0.4-mg group achieved NASH resolution with no worsening of fibrosis, compared with 17% of the placebo group (odds ratio, 6.87; P < .001 for the highest semaglutide dose). However, the treatment did not lead to significant between-group differences in the secondary endpoint, which occurred in 43% of patients on the highest semaglutide dose compared to 33% in the placebo group (OR, 1.42; P = .48).

Treatment with semaglutide also resulted in dose-dependent reductions in body weight, as well as in glycated hemoglobin levels. Bodyweight was reduced by a mean of 5% in the 0.1-mg semaglutide group, followed by mean reductions of 9% and 13% in the 0.2-mg and 0.4-mg groups respectively. This compared to a mean reduction of 1% in the placebo group.

Similarly, glycated hemoglobin levels among patients with type 2 diabetes dropped by 0.63, 1.07, and 1.15 percentage points in the 0.1-mg, 0.2-mg, and 0.4-mg semaglutide groups respectively, compared with a drop of 0.01 percentage point in the placebo group.

“The fact that the percentage of patients who had an improvement in fibrosis stage was not significantly higher with semaglutide than with placebo – despite a greater benefit with respect to NASH resolution and dose-dependent weight loss – was unexpected, given that previous studies have suggested that resolution of NASH and improvements in activity scores for the components of nonalcoholic fatty liver disease are associated with regression of fibrosis,” wrote the authors. “However, the temporal association among NASH resolution, weight loss, and improvement in fibrosis stage is not fully understood. It is possible that the current trial was not of sufficient duration for improvements in fibrosis stage to become apparent.”

The authors also noted that the safety profile of semaglutide was “consistent with that observed in patients with type 2 diabetes in other trials and with the known effects of GLP-1 receptor agonists,” with gastrointestinal disorders being the most commonly reported.

Nausea, constipation, and vomiting were reported more often in the 0.4-mg semaglutide group than in the placebo group (nausea, 42% vs. 11%; constipation, 22% vs. 12%; and vomiting, 15% vs. 2%).

The overall incidence of benign, malignant, or unspecified neoplasms was 15% in the treatment groups versus 8% in the placebo group.

Rowen K. Zetterman, MD, who was not involved with the study, noted that “treatment of NASH is currently limited, and no therapies have yet been approved by the Food and Drug Administration.”

The findings are “important but not yet exciting,” added Dr. Zetterman, who is professor emeritus of internal medicine and associate vice chancellor for strategic planning for the University of Nebraska Medical Center, Omaha.

“Though reversal of liver fibrosis was not noted, the resolution of hepatic inflammation and liver cell injury by semaglutide suggests it may be slowing disease progression,” said Dr. Zetterman, who also serves on the editorial advisory board of Internal Medicine News. This “warrants additional studies where longer treatment with semaglutide may prove reversal of fibrosis and/or prevention of progression to cirrhosis.”

The study was sponsored by Novo Nordisk. Dr. Newsome reported disclosures related to Novo Nordisk during the conduct of the study, and to Boehringer Ingelheim, Bristol-Myers Squibb, Echosens, Gilead, Pfizer, Pharmaxis, and Poxel. Several of the other study authors reported receiving fees and grants from various pharmaceutical companies, including Novo Nordisk One author reported pending patents for the use of semaglutide. Dr. Zetterman had no relevant disclosures.

SOURCE: Newsome PN et al. N Engl J Med. 2020 Nov 13. doi: 10.1056/NEJMoa2028395.

Almost 60% of patients with biopsy-confirmed nonalcoholic steatohepatitis and liver fibrosis showed resolution of NASH after treatment with semaglutide, according to a phase 2, double-blind, randomized, placebo-controlled trial published in the New England Journal of Medicine and presented at the 2020 American Association for the Study of Liver Diseases (AASLD) meeting.

“This bodes well for further study of semaglutide and is supported further by marked improvements in weight, glycemic control and lipid profile,” commented the study’s senior author Philip N. Newsome, PhD, FRCPE, of the University of Birmingham (England), in an interview.

The highest daily dose (0.4 mg) of the glucagonlike peptide-1 (GLP-1) receptor agonist, semaglutide, which is approved for the treatment of type 2 diabetes, led to levels of NASH resolution “which are higher than any previously demonstrated,” noted Dr. Newsome. “This was also accompanied by improvement in noninvasive markers of liver fibrosis and also less fibrosis progression, compared to placebo.”

“I think this represents an exciting advance and will, if confirmed in further studies, mark a step-change in our management of patients with NASH,” he added.

The multicenter study, conducted at 143 sites in 16 countries, included 320 patients, aged 18-75 years, with or without type 2 diabetes, who had histologic evidence of NASH and stage 1-3 liver fibrosis.

They were randomized in a 3:3:3:1:1:1 ratio to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg, or placebo for 72 weeks.

The primary endpoint was resolution of NASH and no worsening of fibrosis, with a secondary endpoint being improvement of fibrosis by at least one stage without worsening of NASH.

The study found 40% of patients in the 0.1-mg semaglutide group, 36% in the 0.2-mg group, and 59% in the 0.4-mg group achieved NASH resolution with no worsening of fibrosis, compared with 17% of the placebo group (odds ratio, 6.87; P < .001 for the highest semaglutide dose). However, the treatment did not lead to significant between-group differences in the secondary endpoint, which occurred in 43% of patients on the highest semaglutide dose compared to 33% in the placebo group (OR, 1.42; P = .48).

Treatment with semaglutide also resulted in dose-dependent reductions in body weight, as well as in glycated hemoglobin levels. Bodyweight was reduced by a mean of 5% in the 0.1-mg semaglutide group, followed by mean reductions of 9% and 13% in the 0.2-mg and 0.4-mg groups respectively. This compared to a mean reduction of 1% in the placebo group.

Similarly, glycated hemoglobin levels among patients with type 2 diabetes dropped by 0.63, 1.07, and 1.15 percentage points in the 0.1-mg, 0.2-mg, and 0.4-mg semaglutide groups respectively, compared with a drop of 0.01 percentage point in the placebo group.

“The fact that the percentage of patients who had an improvement in fibrosis stage was not significantly higher with semaglutide than with placebo – despite a greater benefit with respect to NASH resolution and dose-dependent weight loss – was unexpected, given that previous studies have suggested that resolution of NASH and improvements in activity scores for the components of nonalcoholic fatty liver disease are associated with regression of fibrosis,” wrote the authors. “However, the temporal association among NASH resolution, weight loss, and improvement in fibrosis stage is not fully understood. It is possible that the current trial was not of sufficient duration for improvements in fibrosis stage to become apparent.”

The authors also noted that the safety profile of semaglutide was “consistent with that observed in patients with type 2 diabetes in other trials and with the known effects of GLP-1 receptor agonists,” with gastrointestinal disorders being the most commonly reported.

Nausea, constipation, and vomiting were reported more often in the 0.4-mg semaglutide group than in the placebo group (nausea, 42% vs. 11%; constipation, 22% vs. 12%; and vomiting, 15% vs. 2%).

The overall incidence of benign, malignant, or unspecified neoplasms was 15% in the treatment groups versus 8% in the placebo group.

Rowen K. Zetterman, MD, who was not involved with the study, noted that “treatment of NASH is currently limited, and no therapies have yet been approved by the Food and Drug Administration.”

The findings are “important but not yet exciting,” added Dr. Zetterman, who is professor emeritus of internal medicine and associate vice chancellor for strategic planning for the University of Nebraska Medical Center, Omaha.

“Though reversal of liver fibrosis was not noted, the resolution of hepatic inflammation and liver cell injury by semaglutide suggests it may be slowing disease progression,” said Dr. Zetterman, who also serves on the editorial advisory board of Internal Medicine News. This “warrants additional studies where longer treatment with semaglutide may prove reversal of fibrosis and/or prevention of progression to cirrhosis.”

The study was sponsored by Novo Nordisk. Dr. Newsome reported disclosures related to Novo Nordisk during the conduct of the study, and to Boehringer Ingelheim, Bristol-Myers Squibb, Echosens, Gilead, Pfizer, Pharmaxis, and Poxel. Several of the other study authors reported receiving fees and grants from various pharmaceutical companies, including Novo Nordisk One author reported pending patents for the use of semaglutide. Dr. Zetterman had no relevant disclosures.

SOURCE: Newsome PN et al. N Engl J Med. 2020 Nov 13. doi: 10.1056/NEJMoa2028395.

Almost 60% of patients with biopsy-confirmed nonalcoholic steatohepatitis and liver fibrosis showed resolution of NASH after treatment with semaglutide, according to a phase 2, double-blind, randomized, placebo-controlled trial published in the New England Journal of Medicine and presented at the 2020 American Association for the Study of Liver Diseases (AASLD) meeting.

“This bodes well for further study of semaglutide and is supported further by marked improvements in weight, glycemic control and lipid profile,” commented the study’s senior author Philip N. Newsome, PhD, FRCPE, of the University of Birmingham (England), in an interview.

The highest daily dose (0.4 mg) of the glucagonlike peptide-1 (GLP-1) receptor agonist, semaglutide, which is approved for the treatment of type 2 diabetes, led to levels of NASH resolution “which are higher than any previously demonstrated,” noted Dr. Newsome. “This was also accompanied by improvement in noninvasive markers of liver fibrosis and also less fibrosis progression, compared to placebo.”

“I think this represents an exciting advance and will, if confirmed in further studies, mark a step-change in our management of patients with NASH,” he added.

The multicenter study, conducted at 143 sites in 16 countries, included 320 patients, aged 18-75 years, with or without type 2 diabetes, who had histologic evidence of NASH and stage 1-3 liver fibrosis.

They were randomized in a 3:3:3:1:1:1 ratio to receive once-daily subcutaneous semaglutide at a dose of 0.1, 0.2, or 0.4 mg, or placebo for 72 weeks.

The primary endpoint was resolution of NASH and no worsening of fibrosis, with a secondary endpoint being improvement of fibrosis by at least one stage without worsening of NASH.

The study found 40% of patients in the 0.1-mg semaglutide group, 36% in the 0.2-mg group, and 59% in the 0.4-mg group achieved NASH resolution with no worsening of fibrosis, compared with 17% of the placebo group (odds ratio, 6.87; P < .001 for the highest semaglutide dose). However, the treatment did not lead to significant between-group differences in the secondary endpoint, which occurred in 43% of patients on the highest semaglutide dose compared to 33% in the placebo group (OR, 1.42; P = .48).

Treatment with semaglutide also resulted in dose-dependent reductions in body weight, as well as in glycated hemoglobin levels. Bodyweight was reduced by a mean of 5% in the 0.1-mg semaglutide group, followed by mean reductions of 9% and 13% in the 0.2-mg and 0.4-mg groups respectively. This compared to a mean reduction of 1% in the placebo group.

Similarly, glycated hemoglobin levels among patients with type 2 diabetes dropped by 0.63, 1.07, and 1.15 percentage points in the 0.1-mg, 0.2-mg, and 0.4-mg semaglutide groups respectively, compared with a drop of 0.01 percentage point in the placebo group.

“The fact that the percentage of patients who had an improvement in fibrosis stage was not significantly higher with semaglutide than with placebo – despite a greater benefit with respect to NASH resolution and dose-dependent weight loss – was unexpected, given that previous studies have suggested that resolution of NASH and improvements in activity scores for the components of nonalcoholic fatty liver disease are associated with regression of fibrosis,” wrote the authors. “However, the temporal association among NASH resolution, weight loss, and improvement in fibrosis stage is not fully understood. It is possible that the current trial was not of sufficient duration for improvements in fibrosis stage to become apparent.”

The authors also noted that the safety profile of semaglutide was “consistent with that observed in patients with type 2 diabetes in other trials and with the known effects of GLP-1 receptor agonists,” with gastrointestinal disorders being the most commonly reported.

Nausea, constipation, and vomiting were reported more often in the 0.4-mg semaglutide group than in the placebo group (nausea, 42% vs. 11%; constipation, 22% vs. 12%; and vomiting, 15% vs. 2%).

The overall incidence of benign, malignant, or unspecified neoplasms was 15% in the treatment groups versus 8% in the placebo group.

Rowen K. Zetterman, MD, who was not involved with the study, noted that “treatment of NASH is currently limited, and no therapies have yet been approved by the Food and Drug Administration.”

The findings are “important but not yet exciting,” added Dr. Zetterman, who is professor emeritus of internal medicine and associate vice chancellor for strategic planning for the University of Nebraska Medical Center, Omaha.

“Though reversal of liver fibrosis was not noted, the resolution of hepatic inflammation and liver cell injury by semaglutide suggests it may be slowing disease progression,” said Dr. Zetterman, who also serves on the editorial advisory board of Internal Medicine News. This “warrants additional studies where longer treatment with semaglutide may prove reversal of fibrosis and/or prevention of progression to cirrhosis.”

The study was sponsored by Novo Nordisk. Dr. Newsome reported disclosures related to Novo Nordisk during the conduct of the study, and to Boehringer Ingelheim, Bristol-Myers Squibb, Echosens, Gilead, Pfizer, Pharmaxis, and Poxel. Several of the other study authors reported receiving fees and grants from various pharmaceutical companies, including Novo Nordisk One author reported pending patents for the use of semaglutide. Dr. Zetterman had no relevant disclosures.

SOURCE: Newsome PN et al. N Engl J Med. 2020 Nov 13. doi: 10.1056/NEJMoa2028395.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.