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Omalizumab for Food Allergies: What PCPs Should Know
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
AAP Updates Guidance on Vaccine Communication and Hesitancy
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
FROM PEDIATRICS
Do Kids With an October Birthday Have Protection From Flu?
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
FDA Removes Harmful Chemicals From Food Packaging
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Climate Change and AD: New Review Shows Negative Impacts and Unknowns
A new . But it also showed the extent to which research is lacking.
“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
A new . But it also showed the extent to which research is lacking.
“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
A new . But it also showed the extent to which research is lacking.
“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.
“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”
Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology.
Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.
“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.
Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”
Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
Mixed Results, But Negative Impacts Overall
The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.
The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.
Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.
In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.
Studies From 10 Countries Reviewed
Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.
Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.
“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”
In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”
The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
The Need to Better Track AD, Anticipate Clinical Impact
“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.
More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.
There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”
She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.
The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.
The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.
More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.
Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.
FROM ALLERGY
National Rapid Genome Testing Program Benefits NICU Care
TOPLINE:
A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.
METHODOLOGY:
- Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
- A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.
TAKEAWAY:
- Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
- Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
- The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
- Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.
IN PRACTICE:
Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.
SOURCE:
The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.
LIMITATIONS:
The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.
DISCLOSURES:
The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.
METHODOLOGY:
- Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
- A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.
TAKEAWAY:
- Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
- Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
- The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
- Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.
IN PRACTICE:
Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.
SOURCE:
The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.
LIMITATIONS:
The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.
DISCLOSURES:
The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A national study in Israel demonstrates the feasibility and diagnostic benefits of rapid trio genome sequencing in critically ill neonates.
METHODOLOGY:
- Researchers conducted a prospective, multicenter cohort study from October 2021 to December 2022, involving all Israeli medical genetics institutes and neonatal intensive care units.
- A total of 130 critically ill neonates suspected of having a genetic disorder were enrolled, with rapid genome sequencing results expected within 10 days.
TAKEAWAY:
- Rapid trio genome sequencing diagnosed 50% of the neonates with disease-causing variants, including 12 chromosomal and 52 monogenic conditions.
- Another 11% had variants of unknown significance that were suspected to be disease-causing, and 1% had a novel gene suspected of causing disease.
- The mean turnaround time for the rapid reports was 7 days, demonstrating the feasibility of implementing rapid genome sequencing in a national healthcare setting, the researchers said.
- Genomic testing led to a change in clinical management for 22% of the neonates, which shows the clinical utility of this approach to diagnosis, they said.
IN PRACTICE:
Genetic testing may identify patients who are candidates for precision medical treatment and inform family planning, which is “critical for families with a severely affected or deceased child,” the study authors wrote.
SOURCE:
The corresponding author for the study was Daphna Marom, MD, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. It was published online on February 22, 2024, in JAMA Network Open.
LIMITATIONS:
The study’s reliance on voluntary participation may have introduced referral bias, potentially affecting the diagnostic rates. The long-term impact of diagnosis on survival, growth, and development remains to be evaluated. Bioinformatics tools have limitations, as shown by the missed detection of maternal uniparental disomy in one case of a hypotonic infant with Prader-Willi syndrome, the researchers noted. Clinical judgment is still essential, they said.
DISCLOSURES:
The study was sponsored by a collaboration between the Israeli Ministry of Health, Illumina, and the Genomics Center at the Tel Aviv Sourasky Medical Center. Illumina provided reagents, bioinformatics tools, and editorial assistance. Study authors disclosed financial ties to Illumina.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
Florida’s Stance on Measles Upends Expert Guidance
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Amid an ongoing measles outbreak in Florida possibly sparked by vaccine hesitancy, the state’s surgeon general Joseph Ladapo, MD, is contradicting public health guidance of encouraging quarantine of unvaccinated children.
Rather than requesting that parents keep children unvaccinated against measles home from school or to get their children vaccinated, both critical tools in containing an outbreak, Dr. Ladapo has advised parents to do whatever they think is best. Pediatricians and infectious disease specialists fear a free-for-all will fuel the spread of the highly infectious virus, including in their own clinics.
The outbreak has been traced to an elementary school in Weston and has so far sickened at least eight children, one of whom is younger than 5 years. According to the Centers for Disease Control and Prevention, roughly 91% of the 230,000-odd kindergarteners in Florida had received the requisite doses of the MMR vaccine, which also protects against mumps and rubella, for the 2022-2023 school year, below the 95% vaccination level which public health authorities believes confers herd immunity against measles. An estimated 4.5% of kindergarteners in the state have received an exemption for the vaccine, which prevents measles in 97% of the people who get the shots, for a lifetime. The first dose is given around age 13 months and the second when people are age 4 or 5 years and soon to enter school.
“If you’re vaccinated you have a very slim chance of getting the virus,” said Rana Alissa, MD, a pediatrician at University of Florida Health in Jacksonville.
An unvaccinated child has no protection against measles, and could spread it to others merely by sneezing or touching a surface. In a school setting, infection could spread to a teacher who cannot receive the measles vaccine due to a weakened immune system, or the unvaccinated child could spread the virus at a pediatric clinic or hospital when seeking care for measles unless the clinic staff takes rigorous steps to separate the child from other children. Some children at the clinic won’t be able to get the measles vaccine either because of immunodeficiency or perhaps having had a bone marrow transplant.
Assuming the unvaccinated child is healthy, the measles infection will run its course, and the child will then be immune to the disease, Dr. Alissa said. But meanwhile, the child could pose a significant risk to others.
“We’re not worried about the unvaccinated kids who are very healthy. We’re worried about the adults who did not get vaccinated and who are very sick,” said Dr. Alissa, vice president of the Florida chapter of the American Academy of Pediatrics (AAP). “We’re worried about the little kids who are less than 13 months old. We’re worried about the kids with immunodeficiency disorders.” The Florida chapter of the AAP encourages parents to get their children vaccinated against measles amid the ongoing outbreak.
“I wish our surgeon general was on the same page as us,” Dr. Alissa added, noting that she thinks misplaced vaccine hesitancy has caused some parents to forego a safe and effective vaccine for their children.
Never Too Late to Vaxx
Measles symptoms appear 10-14 days after exposure and can include sore throat, cough, runny nose, inflamed eyes, fever, and blotchy skin rashes. According to the Centers for Disease Control and Prevention (CDC), 20% of people who are unvaccinated against measles will be hospitalized for the virus if they contract it.
Given the incubation period for the virus, clinicians and public health officials recommend unvaccinated children isolate for 21 days after being exposed to measles at school. The advice applies to any unvaccinated child, whether because their parent opted against the vaccine or because they cannot safely receive the immunization.
This is the guidance that Surgeon General Ladapo is flouting.
“We have a public health system. They’re awesome. They’re the experts. Let’s use them,” Dr. Alissa noted. “Their recommendation is to keep the unvaccinated kids at home for 21 days when you have an outbreak.”
“We’re not calling him doctor anymore,” said Andrew Pavia, MD, chief of the Division of Pediatric Infectious Diseases at the University of Utah in Salt Lake City.
“Getting your kids immunized before they enter school is so critical,” added Dr. Pavia, because the 21-day quarantine period is onerous for children and parents alike.
In a February 26 statement, Marcus Plescia, MD, MPH, chief medical officer of the Association of State and Territorial Health Officials, said “well-established public health practice recommends that unvaccinated persons exposed to measles stay home for at least 21 days to prevent further growth of the outbreak. While this is undoubtedly disruptive to the persons impacted, imagine how much more disruptive it would be if measles takes hold again in the United States, spreading widely, and impacting children and communities across the entire nation.”
During an outbreak, it’s still possible to give a measles vaccine to a child who has not yet received the shots, Dr. Pavia stressed. But time is of the essence: Vaccination should occur within 72 hours of the first known measles case in a school.
“It’s not perfect, they may still get measles, but it will greatly decrease the severity,” Dr. Pavia said.
If some children won’t get vaccinated during an outbreak, their parents may call a pediatrician or hospital staff for help as measles symptoms take hold. Clinicians should advise everyone in the home who is older than 2 years to begin wearing N95 masks and gloves, Dr. Alissa said. And when the child comes into the clinic he or she should be examined in a separate room, ideally one with negative air pressure and frequent filtration, Dr. Alissa added. If not, any private room will do if nobody else uses the room for at least 2 hours afterward.
“Measles is phenomenally transmissible,” Dr. Pavia said. A person with the virus can infect 12 to 18 others who are not protected against the pathogen.
Someone with a severe reaction to measles could get an injection of intramuscular immunoglobulin, Dr. Pavia said, although this tends to be uncomfortable and expensive.
“The vaccine works. We almost got rid of measles,” Dr. Alissa said, although parents who choose to send their unvaccinated children to school can do so if they choose to.
“The fear of every pediatrician is to have a child die from this,” she said. “People who are sick, please stay at home.”
Dr. Pavia reported an advisory relationship with Sanofi Pasteur regarding an RSV vaccine. Dr. Alissa reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
New Trials in Leukemia and Lymphoma: Could Your Patient Benefit?
Several clinical trials in leukemia and lymphoma have started enrolling recently. Maybe one of your patients could benefit from taking part?
run by the Center for International Blood and Bone Marrow Transplant Research.
The purpose of the study is to test whether cyclophosphamide, which is given to prevent a dreaded complication of stem cell transplantation called graft-versus-host disease, can be safely reduced without increasing infection or reducing protection. All participants will receive cyclophosphamide on days 3 and 4 post transplant. One group will receive a reduced dose of cyclophosphamide (25 mg/kg per dose), and the other will be given a usual dose (37.5 mg/kg).
Sites in Michigan, Missouri, Oregon, Virginia, and Washington started recruiting for 190 participants in December 2023. Study centers in Florida, Massachusetts, New York, and Wisconsin are also planned. Infection-free survival is the primary endpoint, and overall survival is a secondary measure. Quality of life (QoL) is not recorded. More details at clinicaltrials.gov.
Untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Adults who are newly diagnosed with this type of cancer and have active disease may wish to consider a randomized, open-label, phase 3 trial testing an experimental Bruton tyrosine kinase (BTK) inhibitor, nemtabrutinib (from Merck Sharp & Dohme), against standard-of-care BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence).
BTK inhibitors target B-cell proliferation in B-cell cancers such as CLL/SLL and allow for chemotherapy-free treatment of some hematological malignancies. In this study, until disease progression, unacceptable toxicity, or another reason for discontinuation occurs, participants will take daily oral nemtabrutinib, ibrutinib, or acalabrutinib.
The study opened in December 2023 in Pennsylvania, Washington, Taiwan, Israel, and the United Kingdom seeking 1200 participants. The primary outcomes are objective response rate and progression-free survival. Overall survival is a secondary outcome, and QoL is not measured. More details at clinicaltrials.gov.
Relapsed or refractory leukemia with a KMT2A-gene rearrangement (KMT2A-r). Children aged 1 month to younger than 6 years with this diagnosis may be able to join an open-label, nonrandomized, Children’s Oncology Group phase 2 study to determine the most tolerable and/or effective dose of an experimental oral drug called revumenib when added to chemotherapy.
KMT2A-gene alterations are associated with a poor prognosis in leukemia. These alterations cause blood cells to dedifferentiate and start proliferating uncontrollably as leukemia cells. The expression of the damaged KMT2A gene relies on a protein called menin. Revumenib, from Syndax Pharmaceuticals, blocks menin and prevents expression of KMT2A.
Children in the study will receive two different regimens of revumenib in combination with chemotherapy for up to a year, or until disease progression or unacceptable toxicity, and will then be followed for up to 5 years. Trial centers in 12 US states opened their doors in January 2024 looking for 78 participants. Toxicities and minimal residual disease are the primary outcomes; overall survival is a secondary outcome, and QoL is not assessed. More details at clinicaltrials.gov.
Previously untreated follicular lymphoma or diffuse large B-cell lymphoma. Adults with one of these types of lymphoma may be eligible for one of three open-label, randomized, phase 3 trials testing odronextamab (from Regeneron). This bispecific antibody is designed to ‘lock together’ CD20 on cancer cells with CD3-expressing cancer-killing T cells. It has shown anti-lymphoma activity in heavily pretreated patients.
Late in 2023, three phase 3 trials turned the spotlight on treatment-naive patients and started recruiting 2115 participants to assess odronextamab in this setting. The trial OLYMPIA-1 will compare odronextamab with standard-of-care rituximab (Rituxan) plus chemotherapy in follicular lymphoma. OLYMPIA-2 will test the drug in combination with chemotherapy, also in follicular lymphoma. OLYMPIA-3 will evaluate odronextamab plus chemotherapy against rituximab and chemotherapy in people with large B-cell lymphoma.
All study drugs, including odronextamab, will be administered by intravenous infusion, and participants will be followed for up to 5 years. Research centers across eight US states and Australia, Czechia, France, Italy, Poland, Spain, Turkey, and Thailand are currently accepting participants for the three trials. The primary outcomes are various measures of toxicity and complete response at 30 months in the follicular lymphoma studies and toxicity and progression-free survival in large B-cell lymphoma. All three trials are measuring overall survival and QoL as secondary endpoints.
Previously untreated stage II, III, or IV follicular lymphoma. Adults with this type of cancer may be eligible to participate in a randomized, open-label, phase 3 study testing whether an experimental therapy called epcoritamab (from AbbVie) improves disease response and is tolerable when added to standard therapy. For up to 120 weeks, one group of participants will receive a combination of intravenous rituximab and oral lenalidomide (Revlimid), while a second group will also receive subcutaneous injections of epcoritamab. Some participants may be offered investigators’ choice of chemotherapy as well.
Sites across Iowa, Maryland, Missouri, Ohio, Washington, and Montana started welcoming their 900 participants in February 2024. The primary outcome is complete response at 30 months. Overall survival and QoL are secondary outcomes. More details at clinicaltrials.gov.
Relapsed or refractory mantle cell lymphoma. Adults facing one of these clinical scenarios can join an Academic and Community Cancer Research United open label, phase 2 trial examining the effectiveness of combining tafasitamab (Monjuvi), lenalidomide, and venetoclax (Venclexta) for such patients.
Frontline therapy does not cure mantle cell lymphoma, and continued relapses are common. In this situation, treatments can include acalabrutinib, ibrutinib, stem cell transplantation, venetoclax, lenalidomide, and rituximab.
In this study, participants will take venetoclax and lenalidomide daily and receive intravenous tafasitamab every 2 weeks after an initial ramp-up period as per clinic standards. Participants will be followed for 5 years after entering the trial. The Mayo Clinic in Rochester, Minnesota, began recruiting the planned 100 trial participants in January 2024. The primary outcome is objective response rate; overall survival is a secondary outcome, and QoL will not be tracked. More details at clinicaltrials.gov.
All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).
A version of this article appeared on Medscape.com .
Several clinical trials in leukemia and lymphoma have started enrolling recently. Maybe one of your patients could benefit from taking part?
run by the Center for International Blood and Bone Marrow Transplant Research.
The purpose of the study is to test whether cyclophosphamide, which is given to prevent a dreaded complication of stem cell transplantation called graft-versus-host disease, can be safely reduced without increasing infection or reducing protection. All participants will receive cyclophosphamide on days 3 and 4 post transplant. One group will receive a reduced dose of cyclophosphamide (25 mg/kg per dose), and the other will be given a usual dose (37.5 mg/kg).
Sites in Michigan, Missouri, Oregon, Virginia, and Washington started recruiting for 190 participants in December 2023. Study centers in Florida, Massachusetts, New York, and Wisconsin are also planned. Infection-free survival is the primary endpoint, and overall survival is a secondary measure. Quality of life (QoL) is not recorded. More details at clinicaltrials.gov.
Untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Adults who are newly diagnosed with this type of cancer and have active disease may wish to consider a randomized, open-label, phase 3 trial testing an experimental Bruton tyrosine kinase (BTK) inhibitor, nemtabrutinib (from Merck Sharp & Dohme), against standard-of-care BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence).
BTK inhibitors target B-cell proliferation in B-cell cancers such as CLL/SLL and allow for chemotherapy-free treatment of some hematological malignancies. In this study, until disease progression, unacceptable toxicity, or another reason for discontinuation occurs, participants will take daily oral nemtabrutinib, ibrutinib, or acalabrutinib.
The study opened in December 2023 in Pennsylvania, Washington, Taiwan, Israel, and the United Kingdom seeking 1200 participants. The primary outcomes are objective response rate and progression-free survival. Overall survival is a secondary outcome, and QoL is not measured. More details at clinicaltrials.gov.
Relapsed or refractory leukemia with a KMT2A-gene rearrangement (KMT2A-r). Children aged 1 month to younger than 6 years with this diagnosis may be able to join an open-label, nonrandomized, Children’s Oncology Group phase 2 study to determine the most tolerable and/or effective dose of an experimental oral drug called revumenib when added to chemotherapy.
KMT2A-gene alterations are associated with a poor prognosis in leukemia. These alterations cause blood cells to dedifferentiate and start proliferating uncontrollably as leukemia cells. The expression of the damaged KMT2A gene relies on a protein called menin. Revumenib, from Syndax Pharmaceuticals, blocks menin and prevents expression of KMT2A.
Children in the study will receive two different regimens of revumenib in combination with chemotherapy for up to a year, or until disease progression or unacceptable toxicity, and will then be followed for up to 5 years. Trial centers in 12 US states opened their doors in January 2024 looking for 78 participants. Toxicities and minimal residual disease are the primary outcomes; overall survival is a secondary outcome, and QoL is not assessed. More details at clinicaltrials.gov.
Previously untreated follicular lymphoma or diffuse large B-cell lymphoma. Adults with one of these types of lymphoma may be eligible for one of three open-label, randomized, phase 3 trials testing odronextamab (from Regeneron). This bispecific antibody is designed to ‘lock together’ CD20 on cancer cells with CD3-expressing cancer-killing T cells. It has shown anti-lymphoma activity in heavily pretreated patients.
Late in 2023, three phase 3 trials turned the spotlight on treatment-naive patients and started recruiting 2115 participants to assess odronextamab in this setting. The trial OLYMPIA-1 will compare odronextamab with standard-of-care rituximab (Rituxan) plus chemotherapy in follicular lymphoma. OLYMPIA-2 will test the drug in combination with chemotherapy, also in follicular lymphoma. OLYMPIA-3 will evaluate odronextamab plus chemotherapy against rituximab and chemotherapy in people with large B-cell lymphoma.
All study drugs, including odronextamab, will be administered by intravenous infusion, and participants will be followed for up to 5 years. Research centers across eight US states and Australia, Czechia, France, Italy, Poland, Spain, Turkey, and Thailand are currently accepting participants for the three trials. The primary outcomes are various measures of toxicity and complete response at 30 months in the follicular lymphoma studies and toxicity and progression-free survival in large B-cell lymphoma. All three trials are measuring overall survival and QoL as secondary endpoints.
Previously untreated stage II, III, or IV follicular lymphoma. Adults with this type of cancer may be eligible to participate in a randomized, open-label, phase 3 study testing whether an experimental therapy called epcoritamab (from AbbVie) improves disease response and is tolerable when added to standard therapy. For up to 120 weeks, one group of participants will receive a combination of intravenous rituximab and oral lenalidomide (Revlimid), while a second group will also receive subcutaneous injections of epcoritamab. Some participants may be offered investigators’ choice of chemotherapy as well.
Sites across Iowa, Maryland, Missouri, Ohio, Washington, and Montana started welcoming their 900 participants in February 2024. The primary outcome is complete response at 30 months. Overall survival and QoL are secondary outcomes. More details at clinicaltrials.gov.
Relapsed or refractory mantle cell lymphoma. Adults facing one of these clinical scenarios can join an Academic and Community Cancer Research United open label, phase 2 trial examining the effectiveness of combining tafasitamab (Monjuvi), lenalidomide, and venetoclax (Venclexta) for such patients.
Frontline therapy does not cure mantle cell lymphoma, and continued relapses are common. In this situation, treatments can include acalabrutinib, ibrutinib, stem cell transplantation, venetoclax, lenalidomide, and rituximab.
In this study, participants will take venetoclax and lenalidomide daily and receive intravenous tafasitamab every 2 weeks after an initial ramp-up period as per clinic standards. Participants will be followed for 5 years after entering the trial. The Mayo Clinic in Rochester, Minnesota, began recruiting the planned 100 trial participants in January 2024. The primary outcome is objective response rate; overall survival is a secondary outcome, and QoL will not be tracked. More details at clinicaltrials.gov.
All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).
A version of this article appeared on Medscape.com .
Several clinical trials in leukemia and lymphoma have started enrolling recently. Maybe one of your patients could benefit from taking part?
run by the Center for International Blood and Bone Marrow Transplant Research.
The purpose of the study is to test whether cyclophosphamide, which is given to prevent a dreaded complication of stem cell transplantation called graft-versus-host disease, can be safely reduced without increasing infection or reducing protection. All participants will receive cyclophosphamide on days 3 and 4 post transplant. One group will receive a reduced dose of cyclophosphamide (25 mg/kg per dose), and the other will be given a usual dose (37.5 mg/kg).
Sites in Michigan, Missouri, Oregon, Virginia, and Washington started recruiting for 190 participants in December 2023. Study centers in Florida, Massachusetts, New York, and Wisconsin are also planned. Infection-free survival is the primary endpoint, and overall survival is a secondary measure. Quality of life (QoL) is not recorded. More details at clinicaltrials.gov.
Untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Adults who are newly diagnosed with this type of cancer and have active disease may wish to consider a randomized, open-label, phase 3 trial testing an experimental Bruton tyrosine kinase (BTK) inhibitor, nemtabrutinib (from Merck Sharp & Dohme), against standard-of-care BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence).
BTK inhibitors target B-cell proliferation in B-cell cancers such as CLL/SLL and allow for chemotherapy-free treatment of some hematological malignancies. In this study, until disease progression, unacceptable toxicity, or another reason for discontinuation occurs, participants will take daily oral nemtabrutinib, ibrutinib, or acalabrutinib.
The study opened in December 2023 in Pennsylvania, Washington, Taiwan, Israel, and the United Kingdom seeking 1200 participants. The primary outcomes are objective response rate and progression-free survival. Overall survival is a secondary outcome, and QoL is not measured. More details at clinicaltrials.gov.
Relapsed or refractory leukemia with a KMT2A-gene rearrangement (KMT2A-r). Children aged 1 month to younger than 6 years with this diagnosis may be able to join an open-label, nonrandomized, Children’s Oncology Group phase 2 study to determine the most tolerable and/or effective dose of an experimental oral drug called revumenib when added to chemotherapy.
KMT2A-gene alterations are associated with a poor prognosis in leukemia. These alterations cause blood cells to dedifferentiate and start proliferating uncontrollably as leukemia cells. The expression of the damaged KMT2A gene relies on a protein called menin. Revumenib, from Syndax Pharmaceuticals, blocks menin and prevents expression of KMT2A.
Children in the study will receive two different regimens of revumenib in combination with chemotherapy for up to a year, or until disease progression or unacceptable toxicity, and will then be followed for up to 5 years. Trial centers in 12 US states opened their doors in January 2024 looking for 78 participants. Toxicities and minimal residual disease are the primary outcomes; overall survival is a secondary outcome, and QoL is not assessed. More details at clinicaltrials.gov.
Previously untreated follicular lymphoma or diffuse large B-cell lymphoma. Adults with one of these types of lymphoma may be eligible for one of three open-label, randomized, phase 3 trials testing odronextamab (from Regeneron). This bispecific antibody is designed to ‘lock together’ CD20 on cancer cells with CD3-expressing cancer-killing T cells. It has shown anti-lymphoma activity in heavily pretreated patients.
Late in 2023, three phase 3 trials turned the spotlight on treatment-naive patients and started recruiting 2115 participants to assess odronextamab in this setting. The trial OLYMPIA-1 will compare odronextamab with standard-of-care rituximab (Rituxan) plus chemotherapy in follicular lymphoma. OLYMPIA-2 will test the drug in combination with chemotherapy, also in follicular lymphoma. OLYMPIA-3 will evaluate odronextamab plus chemotherapy against rituximab and chemotherapy in people with large B-cell lymphoma.
All study drugs, including odronextamab, will be administered by intravenous infusion, and participants will be followed for up to 5 years. Research centers across eight US states and Australia, Czechia, France, Italy, Poland, Spain, Turkey, and Thailand are currently accepting participants for the three trials. The primary outcomes are various measures of toxicity and complete response at 30 months in the follicular lymphoma studies and toxicity and progression-free survival in large B-cell lymphoma. All three trials are measuring overall survival and QoL as secondary endpoints.
Previously untreated stage II, III, or IV follicular lymphoma. Adults with this type of cancer may be eligible to participate in a randomized, open-label, phase 3 study testing whether an experimental therapy called epcoritamab (from AbbVie) improves disease response and is tolerable when added to standard therapy. For up to 120 weeks, one group of participants will receive a combination of intravenous rituximab and oral lenalidomide (Revlimid), while a second group will also receive subcutaneous injections of epcoritamab. Some participants may be offered investigators’ choice of chemotherapy as well.
Sites across Iowa, Maryland, Missouri, Ohio, Washington, and Montana started welcoming their 900 participants in February 2024. The primary outcome is complete response at 30 months. Overall survival and QoL are secondary outcomes. More details at clinicaltrials.gov.
Relapsed or refractory mantle cell lymphoma. Adults facing one of these clinical scenarios can join an Academic and Community Cancer Research United open label, phase 2 trial examining the effectiveness of combining tafasitamab (Monjuvi), lenalidomide, and venetoclax (Venclexta) for such patients.
Frontline therapy does not cure mantle cell lymphoma, and continued relapses are common. In this situation, treatments can include acalabrutinib, ibrutinib, stem cell transplantation, venetoclax, lenalidomide, and rituximab.
In this study, participants will take venetoclax and lenalidomide daily and receive intravenous tafasitamab every 2 weeks after an initial ramp-up period as per clinic standards. Participants will be followed for 5 years after entering the trial. The Mayo Clinic in Rochester, Minnesota, began recruiting the planned 100 trial participants in January 2024. The primary outcome is objective response rate; overall survival is a secondary outcome, and QoL will not be tracked. More details at clinicaltrials.gov.
All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).
A version of this article appeared on Medscape.com .
FDA Approves 10th Humira Biosimilar, With Interchangeability
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).
This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.
Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.
Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.
Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot.
Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.
A version of this article appeared on Medscape.com.
Few Pediatricians Comfortable Treating Youth With OUD
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
An estimated 1 in 100 adolescents ages 12-17 years in the United States have an opioid use disorder (OUD). But fewer than 5% of adolescents with OUD get buprenorphine or naltrexone, though the treatments are recommended by the American Academy of Pediatrics (AAP), new data show.
Meanwhile, adolescent drug overdose deaths more than doubled between 2019 and 2021, with most involving opioids.
Scott E. Hadland, MD, MPH, with the Division of Adolescent and Young Adult Medicine at Mass General for Children in Boston, and colleagues detailed the extent of the treatment gap and barriers to prescribing and caring for youth with OUD in primary care in a research letter published February 26 in JAMA Pediatrics.
Dr. Hadland’s team mailed 1,681 US pediatricians a survey and the response rate was 43.0%. Researchers included in the sample 474 primary care pediatricians who care for adolescents.
Who Should Treat OUD?
Most respondents (average age, 49.5; 74.0% female) agreed or strongly agreed that it is their responsibility to identify substance use disorders (93.9%) and refer patients to treatment (97.4%).
Fewer agreed or strongly agreed that it is their responsibility to treat substance use disorders (20.3%) or prescribe medications (12.4%). Fewer than half of the respondents said they felt prepared or very prepared to counsel adolescents on opioid use (48.3%) compared with those comfortable counseling on alcohol (87.1%), cannabis (81.7%), and e-cigarette use (80.1%; P < .001).
Pediatricians were less likely to provide counseling (63.0%) and more likely to refer patients to care off-site (71.8%) for opioid use than for alcohol (87.7% and 51.7%); cannabis (88.9% and 45.4%); or e-cigarette use (91.6% and 26.5%) (P < .001 for all comparisons).
Training Lacking in Residency Programs
“These results reveal an opportunity for greater workforce training in line with a 2019 survey showing fewer than 1 in 3 US pediatric residency programs included education on prescribing OUD medications,” the authors wrote. Training focused on treating OUD in primary care, including prescribing medications and addressing possible misperceptions, may be needed,” they noted.
The survey predated the elimination in 2023 of the federal buprenorphine waiver requirement, which made prescribing buprenorphine easier, so these results do not reflect any changes from that elimination, they wrote.
Sharon Levy, MD, MPH, chief of the Division of Addiction Medicine at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School in Boston, who was not part of this study, said more education on addiction medicine is needed for general pediatricians.
She said it’s time to push beyond the current framework of Screening, Brief Intervention, Referral to Treatment (SBIRT), because that doesn’t include “prescribing medications to manage withdrawal or suppress cravings or the use of lab testing, both of which could be accomplished in primary care.”
Dr. Levy said she considers substance use disorders the same way she considers other chronic conditions: Most patients can be treated in primary care. “Specialty care and higher levels of care need to be available for patients who are most complicated and/or having a flare of their condition.”
“In my opinion, most teens with opioid use disorder can and should be treated in primary care. I worry about referring teens with opioid use disorder to get medication somewhere else because there are few places that deliver this service to this age group. Additionally, teens and families are not always willing to pursue a referral, and many will get lost along the way.”
Promising Models
At Boston Children’s, she said, the Division of Addiction Medicine has created a consultation call line that primary care providers can call for help with any questions about teen substance use.
After running the consultation for about a year, she said, the program wanted to add ways to help patients directly and hired and trained social workers who can see pediatric patients with substance use problems for counseling via telemedicine. “The program also now supports group therapy for pediatric patients and parents, so that primary care providers can refer patients directly to group therapy,” Dr. Levy said.
The growth of telehealth since the pandemic may allow for new models of care.
“For example, now our Adolescent Substance Use and Addiction Program at Boston Children’s Hospital can provide services, including medication induction and follow-up, virtually,” Dr. Levy said. “This allows us to treat young people anywhere in the state. There have been instances in which a primary care provider referred us patients with OUD and then partnered with us, including performing physicals for teens who could not get to Boston to see us in person. At the end of the day, the more models we can come up with the better.”
Dr. Hadland reported honoraria from the AAP outside the submitted work. Two coauthors reported receiving salary support from the AAP during the conduct of the study. A coauthor reported serving as the chair of the AAP Committee on Substance Use and Prevention outside the submitted work. This work was supported by a grant from the Conrad N. Hilton Foundation via the AAP. Dr. Sharon Levy’s husband, Ofer Levy, MD, PhD, is director of the Precision Vaccines Program at Boston Children’s Hospital.
FROM JAMA PEDIATRICS