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Consider housing insecurity, other issues when managing challenging skin diseases in children, expert says

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Thu, 08/24/2023 - 13:02

Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

 

 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

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Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

 

 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

Treating chronic pediatric skin diseases requires an understanding of the barriers that many children face in obtaining the consistent health care they need, according to a pediatric dermatologist who addressed the annual meeting of the Society for Pediatric Dermatology.

As a general principle for treating chronic skin conditions in children who are not doing well, it is reasonable to draw out information about a patient’s access to adequate housing, nutrition, and other basic needs, George Hightower, MD, PhD, of the division of pediatric and adolescent dermatology, University of California, San Diego, said at the meeting.

“We need conversations about where patients play, learn, and rest their heads at night,” said Dr. Hightower, who conducts research in this area. Fundamental components of well-being, such as stable housing and secure access to nutrition “are inseparable” from a child’s health, he noted.

“What are the stakes?” he asked. For many children, these factors might mean the difference between effective and poor control of the diseases for which the patient is seeking care.

To illustrate the point, Dr. Hightower used hidradenitis suppurativa (HS), a disease that appears to be on the rise among adolescents, as an example of why patient circumstances matter and should be considered. A complex disorder that is more prevalent in resource-poor communities, HS is difficult to control, often requiring extended periods of treatment with medications that can involve complex dosing or regular infusions.

“There is a need for medical providers to help the patient plan for this chronic illness,” said Dr. Hightower, referring to the importance of close follow-up. In adolescents, HS can be sufficiently disruptive from both the physical and psychological perspective that poor control can “derail future aspirations” by complicating educational endeavors and social interactions.

Dr. Hightower acknowledged that simply documenting housing insecurity or other issues does not solve these problems, but he does believe that developing a sensitivity to these obstacles to health care is a first step. It is a process that should permeate into medical training, health care research, and strategies to improve outcomes.

“The connections between fair housing and clinical practice may appear tenuous and inconsequential to the care provided by medical specialists,” Dr. Hightower said, but he emphasized that there are clear consequences when these factors contribute to inadequate control of such diseases as HS. As a source of missed appointments and disjointed care, an unstable home life can be an important barrier to disease control – and because of scarring nodules, fistulae, pain, school absences, and social isolation, complications can be dire.

Solutions to insecure housing are not typically available to an individual clinician, but the awareness that this can be a factor can help both physicians and patients begin to think about the role this plays in impairing recovery and what solutions might be found to modify the impact. Awareness not just among individual clinicians but a broader consortium of those working to improve health care outcomes is needed to “challenge the way we are doing medicine,” he said.

While conversations about the social determinants of health, including access to resources within patients’ neighborhoods, schools, and environment, can demonstrate concern about how to address obstacles, it can also be part of a reorientation to think beyond treatment for the underlying pathology alone. Eliciting trust and emphasizing the importance of environmental barriers to adequate care can be positive steps on the path to solutions.


 

 

 

Participatory action research

Relevant to this orientation, Dr. Hightower spoke about participatory action research (PAR), which provides a framework for patients to participate in the planning of clinical studies to effect change, not just serve as subjects in these studies.

The assumption of PAR is that “all people have valuable knowledge about their lives and experiences,” Dr. Hightower said. From this assumption, individuals who have been historically marginalized by race, income, or other factors can help define the problems from the patient’s perspective and, from there, create studies to seek solutions.

PAR is consistent with a patient-centered approach to medical care, which Dr. Hightower called “the future of medicine.” It involves a big-picture approach to look beyond disease pathology and symptoms to factors that might be creating susceptibility to disease and undermining health care.

Organized medicine alone cannot solve the cause of social inequities leading to disparate risks for disease and risks of inadequate health care, but Dr. Hightower argued that these inequities should not be ignored. He believes medical trainees should learn how to elicit information about the barriers to adequate health care and be aware of solutions, such as fair housing policies.

While he believes that PAR is an example of a pathway to problem solving, he suggested that a comprehensive approach requires an effective method of communication between providers and patients that would lead to a collaborative and mutually reinforcing approach.

“How do we ensure that individuals from communities most impacted by health disparities are treated fairly and empowered to address these disparities?” Dr. Hightower asked. He said that this is the direction of his own research and the issues that inhibit adequate treatment of many dermatologic diseases, as well as other types of disease, in childhood.

Craig Burkhart, MD, director of a private pediatric and adolescent dermatology practice in Cary, N.C., said that Dr. Hightower’s message is relevant. The value of considering and addressing the psychological well-being of patients of any age is not a new concept, but he acknowledged that he, for one, has not routinely inquired about obstacles to follow-up care if there is a signal that this might be an issue.

“As dermatologists, we focus on the acute complaints. We want to make the patient better,” said Dr. Burkhart, who moderated the session in which Dr. Hightower spoke. He agreed with Dr. Hightower that environmental factors make a difference on the road to recovery for a patient, and his presentation was a good reminder, he said, to consider the patient’s circumstances when response to treatment is inadequate, particularly in chronic diseases like HS, for which comprehensive care and close follow-up are needed.

Dr. Hightower and Dr. Burkhart report no potential conflicts of interest.

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Dupilumab gains off-label uses as clinicians turn to drug for more indications

Article Type
Changed
Wed, 08/23/2023 - 13:16

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.



Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

 

 

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.



Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

 

 

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.



Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

 

 

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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EMA validates marketing authorization application for delgocitinib cream

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Tue, 08/22/2023 - 11:18

The European Medicines Agency has validated the marketing authorization application for delgocitinib cream, for the treatment of adults with chronic moderate to severe hand eczema, which marks the beginning of the review process for the treatment by the EMA’s Committee for Medicinal Products for Human Use.

Delgocitinib is an investigational topical pan–Janus kinase inhibitor that inhibits activation of the JAK-STAT pathway.



The development follows results reported from two phase 3 clinical trials known as DELTA 1 and DELTA 2, which evaluated the safety and efficacy of delgocitinib cream applications twice per day compared with a vehicle cream in adults with mild to severe chronic hand eczema. Results of DELTA 1 were presented at the 2023 annual meeting of the American Academy of Dermatology. A multisite, open-label extension trial known as DELTA 3 is still in progress.

According to a press release from LEO Pharma, which is developing the product, the efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority. In 2020, the drug was granted fast-track designation by the Food and Drug Administration for the potential treatment of adults with moderate to severe chronic hand eczema. There are currently no treatment options available in the United States specifically approved for treating the condition.



 

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The European Medicines Agency has validated the marketing authorization application for delgocitinib cream, for the treatment of adults with chronic moderate to severe hand eczema, which marks the beginning of the review process for the treatment by the EMA’s Committee for Medicinal Products for Human Use.

Delgocitinib is an investigational topical pan–Janus kinase inhibitor that inhibits activation of the JAK-STAT pathway.



The development follows results reported from two phase 3 clinical trials known as DELTA 1 and DELTA 2, which evaluated the safety and efficacy of delgocitinib cream applications twice per day compared with a vehicle cream in adults with mild to severe chronic hand eczema. Results of DELTA 1 were presented at the 2023 annual meeting of the American Academy of Dermatology. A multisite, open-label extension trial known as DELTA 3 is still in progress.

According to a press release from LEO Pharma, which is developing the product, the efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority. In 2020, the drug was granted fast-track designation by the Food and Drug Administration for the potential treatment of adults with moderate to severe chronic hand eczema. There are currently no treatment options available in the United States specifically approved for treating the condition.



 

The European Medicines Agency has validated the marketing authorization application for delgocitinib cream, for the treatment of adults with chronic moderate to severe hand eczema, which marks the beginning of the review process for the treatment by the EMA’s Committee for Medicinal Products for Human Use.

Delgocitinib is an investigational topical pan–Janus kinase inhibitor that inhibits activation of the JAK-STAT pathway.



The development follows results reported from two phase 3 clinical trials known as DELTA 1 and DELTA 2, which evaluated the safety and efficacy of delgocitinib cream applications twice per day compared with a vehicle cream in adults with mild to severe chronic hand eczema. Results of DELTA 1 were presented at the 2023 annual meeting of the American Academy of Dermatology. A multisite, open-label extension trial known as DELTA 3 is still in progress.

According to a press release from LEO Pharma, which is developing the product, the efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority. In 2020, the drug was granted fast-track designation by the Food and Drug Administration for the potential treatment of adults with moderate to severe chronic hand eczema. There are currently no treatment options available in the United States specifically approved for treating the condition.



 

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Elevated serum levels of thymic stromal lymphopoietin in patients with atopic dermatitis

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Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

 

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Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

 

Key clinical point: Serum levels of thymic stromal lymphopoietin (TSLP) are significantly elevated in patients with atopic dermatitis (AD), with the levels being significantly higher in adults than in children and increasing significantly corresponding to the severity of AD.

Major finding: Patients with AD vs control individuals had significantly higher serum levels of TSLP (standardized mean difference [SMD] 2.21; P < .001). Serum TSLP levels were significantly higher in adults vs children with AD (P = .02) and had a significant positive association with AD severity (mild: SMD 1.15; P = .025; moderate: SMD 2.48; P = .024; severe: SMD 8.28; P = .000002).

Study details: The data come from a meta-analysis of 14 studies involving 1032 patients with AD and 416 control individuals without AD.

Disclosures: This study was funded by the Universidad Nacional Autónoma de México. The authors declared no conflicts of interest.

Source: García-Reyes MM et al. Serum thymic stromal lymphopoietin (TSLP) levels in atopic dermatitis patients: A systematic review and meta-analysis. Clin Exp Med. 2023 (Jul 29). doi: 10.1007/s10238-023-01147-5

 

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Long-term dupilumab therapy safe and effective in pediatric atopic dermatitis, shows meta-analysis

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Thu, 08/24/2023 - 14:53

Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

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Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

Key clinical point: Dupilumab demonstrates favorable efficacy and manageable safety in pediatric patients with atopic dermatitis (AD), with greater improvements in clinical signs observed with an increase in the treatment duration.

Major finding: The overall pooled Eczema Area and Severity Index (EASI) 75 response rate was 57.4% (95% CI 48.1%-66.2%), whereas an Investigator's Global Assessment score of 0 or 1 was achieved by 35.2% (29.3%-41.5%) of patients. EASI 75 response rates were 26.8% (95% CI 20.7%-33.9%) and 84.9% (95% CI 79.6%-89.0%) after 2-8 weeks and 32-52 weeks of treatment, respectively. Treatment-emergent adverse events were mostly mild-to-moderate in severity.

Study details: This meta-analysis included 18 studies (7 clinical and 11 observational) involving 1275 children and adolescents with AD.

Disclosures: This study was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Xu Y et al. Efficacy and safety profile of dupilumab for the treatment of atopic dermatitis in children and adolescents: A systematic review and meta-analysis. Pediatr Dermatol. 2023 (Aug 2). doi: 10.1111/pde.15398

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Dupilumab maintains efficacy despite dose reduction in persistently-controlled atopic dermatitis

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Thu, 08/24/2023 - 14:53

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

 

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Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

 

Key clinical point: Reduction in dupilumab dose to every 3 or 4 weeks does not decrease its efficacy in patients with persistently-controlled atopic dermatitis (AD), with clinical outcome measures remaining stable over time.

Major finding: After 144 weeks, similar to patients receiving 300 mg dupilumab every 2 weeks, those receiving 300 mg dupilumab every 3 and 4 weeks had significantly decreased mean Eczema Area and Severity Index, Severity Scoring of Atopic Dermatitis, Pruritus Numerical Rating Scale, and Sleep Numerical Rating Scale scores (all P < .05).

Study details: This multicenter retrospective observational study included 54 patients age ≥ 16 years with controlled moderate-to-severe AD treated with dupilumab for ≥ 1 year who were assigned to receive 300 mg dupilumab every 2 weeks (n = 27), 3 weeks (n = 17), or 4 weeks (n = 10).

Disclosures: This study received no specific funding from any sources. The authors declared no conflicts of interest.

Source: Sánchez-García V et al. Evaluation of dupilumab dosing regimen in patients with persistently controlled atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 17). doi: 10.1111/jdv.19348

 

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Dupilumab + TCS confers rapid and sustained improvement in atopic dermatitis severity in children

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Thu, 08/24/2023 - 14:53

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

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Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

Key clinical point: Dupilumab + low-potency topical corticosteroids (TCS) led to rapid and sustained improvement in disease severity in all anatomical regions (head and neck, trunk, upper extremities, and lower extremities) in children with moderate-to-severe atopic dermatitis (AD).

Major finding: The dupilumab + TCS vs placebo + TCS group had a significant improvement in least-squares mean Eczema Area and Severity Index scores in all 4 anatomical regions by week 2 (all P < .0001) that sustained throughout the 16-week treatment.

Study details: This post hoc analysis of the LIBERTY AD PRESCHOOL trial included 162 children (age, 6 months-5 years) with moderate-to-severe AD who were randomly assigned to receive dupilumab + low-potency TCS or placebo + low-potency TCS every 4 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Five authors declared being employees or stockholders of Sanofi/Regeneron. The rest declared serving as consultants, investigators, speakers, or advisory board members for and receiving grants or personal fees from various sources, including Sanofi and Regeneron.

Source: Siegfried EC et al. Dupilumab treatment leads to rapid and consistent improvement of atopic dermatitis in all anatomical regions in patients aged 6 months to 5 years. Dermatol Ther (Heidelb). 2023 (Jul 22). doi: 10.1007/s13555-023-00960-w

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Early emollient bathing is tied to the development of atopic dermatitis by 2 years of age

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Thu, 08/24/2023 - 14:53

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

 

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Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

 

Key clinical point: Emollient bathing at 2 months is significantly associated with the development of atopic dermatitis (AD) by 2 years of age.

Major finding: The odds of developing AD were significantly higher among infants who had emollient baths and frequent (> 1 time weekly) emollient application at 2 months of age compared with infants who had neither at 6 months (adjusted odds ratio [aOR] 1.74; P =  .038), 12 months (aOR 2.59; P < .001), and 24 months (aOR 1.87; P = .009) of age.

Study details: Findings are from a secondary analysis of the observational Cork BASELINE Birth Cohort Study and included 1505 healthy firstborn term infants who did or did not receive emollient baths and did or did not have emollients applied frequently at 2 months of age.

Disclosures: This study was supported by the Science Foundation Ireland and Johnson & Johnson Santé Beauté France. J O’B Hourihane declared receiving research funding, speaker fees, and consulting fees from various sources.

Source: O'Connor C et al. Early emollient bathing is associated with subsequent atopic dermatitis in an unselected birth cohort study. Pediatr Allergy Immunol. 2023;34(7):e13998 (Jul 18). doi: 10.1111/pai.13998

 

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Cannabis use is more prevalent in patients with atopic dermatitis

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Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

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Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

Key clinical point: The likelihood of using cannabis was significantly higher, whereas that of using e-cigarettes and regular cigarettes was significantly lower, in patients with atopic dermatitis (AD).

Major finding: Patients with AD vs control individuals without AD were significantly more likely to use cannabis (adjusted odds ratio [aOR] 1.49; P < .01) but less likely to use e-cigarettes (aOR 0.71; P < .01) and regular cigarettes (aOR 0.65; P < .01). No significant association was observed between AD and hallucinogen (P = .60), opioid (P = .07), and stimulant (P = .20) use.

Study details: This nested case-control study included 13,756 patients with AD and 55,024 age-, race/ethnicity-, and sex-matched control individuals without AD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Joshi TP et al. Association of atopic dermatitis with substance use disorders: A case-control study in the All of Us Research Program. J Am Acad Dermatol. 2023 (Jul 13). doi: 10.1016/j.jaad.2023.06.051

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Abrocitinib is safe and effective against difficult-to-treat atopic dermatitis in daily practice

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Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

 

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Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

 

Key clinical point: Switching to abrocitinib after failing to respond to other Janus kinase inhibitors (JAKs) or biologics improved clinical outcomes in patients with moderate-to-severe atopic dermatitis (AD), without compromising safety.

Major finding: At a median follow-up of 28 weeks, abrocitinib led to a significant decrease in median Eczema Area and Severity Index and Investigator’s Global Assessment scores (both P < .0001). At least one adverse event, generally mild, occurred in 60.9% of patients.

Study details: This prospective observational study included 41 adult patients with moderate-to-severe AD previously treated with conventional immunosuppressants, targeted therapies, or both, with most having failed to respond with biologics or other JAKi; the patients received 100 mg or 200 mg abrocitinib once daily.

Disclosures: This study did not receive any funding. D Hijnen declared serving as an investigator and consultant for various organizations. The other authors declared no conflicts of interest.

Source: Olydam JI et al. Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. J Eur Acad Dermatol Venereol. 2023 (Jul 21). doi: 10.1111/jdv.19378

 

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