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First Human Bird Flu Death Confirmed in US; Overall Risk Remains Low
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FDA Adds Boxed Warning for Liver Injury to Fezolinetant
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FDA Approves IL-31 Inhibitor for Atopic Dermatitis
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
More Biologics May Be Breaking Through for COPD
New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.
The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.
The Biology Behind the Biologics
T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.
Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.
Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.
In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.
Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.
Fitting the Biologic to the Patient
Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.
Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.
In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.
Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.
Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.
In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.
Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.
In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.
Takeaways and Next Steps
“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.
Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.
Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.
Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.
Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.
Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).
A version of this article appeared on Medscape.com.
New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.
The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.
The Biology Behind the Biologics
T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.
Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.
Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.
In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.
Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.
Fitting the Biologic to the Patient
Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.
Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.
In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.
Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.
Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.
In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.
Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.
In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.
Takeaways and Next Steps
“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.
Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.
Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.
Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.
Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.
Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).
A version of this article appeared on Medscape.com.
New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.
The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.
The Biology Behind the Biologics
T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.
Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.
Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.
In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.
Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.
Fitting the Biologic to the Patient
Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.
Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.
In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.
Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.
Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.
In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.
Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.
In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.
Takeaways and Next Steps
“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.
Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.
Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.
Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.
Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.
Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).
A version of this article appeared on Medscape.com.
Pertussis Cases Spike in November
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
RSV Infections Take Toll on Adults
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Slim Silver Lining Appears for STI Rates
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Shoulder Pain Pointers for Primary Care
The causes of shoulder pain may be as common as a traumatic injury or as rare as a systemic inflammatory condition, according to the American Academy of Orthopaedic Surgeons. The combination of joints, tendons, and muscles that make up the shoulder can present diagnostic and clinical challenges, but several experts shared their tips for management.
Evaluation and Diagnosis
Rotator cuff tendinopathy/tendinitis and subacromial bursitis are typically the most common causes of shoulder pain presenting to a primary care provider, said Jason Kolfenbach, MD, a rheumatologist at UC Health, Denver, Colorado, in an interview. “Other causes of shoulder pain may include acromioclavicular osteoarthritis, biceps tendinitis (often a secondary process in the setting of rotator cuff disease), and true glenohumeral joint osteoarthritis,” he said.
Experts estimate that as much as 80% of shoulder pain involves the muscles, tendons, and ligaments surrounding the joint, rather than true arthritis, said Kolfenbach, who was a co-author of a Medscape slideshow on evaluating shoulder pain. In the slideshow, the authors noted that proper evaluation is needed for successful pain management. Some patients may do well with nonsteroidal anti-inflammatory drugs (NSAIDs), rest, ice, and physical therapy, but more serious conditions may require steroids, disease-modifying antirheumatic drugs, or surgery.
If a patient’s joint pain with active range of motion is relieved when an examiner supports the affected limb (passive range of motion), the cause is more likely related to muscles, tendons, or ligaments, Kolfenbach said.
Primary care providers may not be familiar with examination maneuvers to diagnose shoulder pain, although they are often tasked with evaluating and managing these patients, said Kolfenbach.
Education focused on practical aspects of these maneuvers may help improve primary care confidence in utilizing them and lead to more appropriate ordering of imaging testing and better pain management plans for patients, he said.
However, “If there is concern for a true intra-articular process, plain radiographs are recommended to determine if there is loss of cartilage space and/or other anatomic drivers of pain,” he noted. “Even in conditions of documented intra-articular arthritis, such as osteoarthritis, weakness, and atrophy of the surrounding musculature can contribute to joint disability and pain,” he said. For these patients, referral to physical therapy for periarticular strengthening can provide pain relief, he added.
Pinning Down the Pain Point
The many different structures within the shoulder that can cause pain make diagnosis a challenge, Nicole Angelo, DO, MS, a physiatrist at the Hospital for Special Surgery, New York City, said in an interview.
Potential sources of pain include the joint of the shoulder itself, the structures within it (labrum, capsule, and ligaments), and the surrounding rotator cuff muscles and tendons, she said. Patients also may experience overlapping pain referred from the neck (cervical spine) related to nerve irritation (cervical radiculopathy) or arthritis, she noted.
“A patient’s history, including mechanism and acuity of injury, as well as exam, specifically weakness in certain movements,” can help determine whether advanced imaging and surgical intervention may be required,” Angelo told this news organization.
Frozen shoulder is the most missed diagnosis of shoulder pain in primary care, Brian Feeley, MD, chief of sports medicine and shoulder surgery at the University of California, San Francisco (UCSF), said in an interview.
Frozen shoulder, also known as adhesive capsulitis, can mimic many other conditions including rotator cuff problems, shoulder arthritis, and biceps problems, Feeley said. “When people have a loss of active and passive range of motion and no evidence of arthritis on x-rays, their diagnosis is most likely frozen shoulder,” he said.
Another challenge for primary care providers is identifying the severity of rotator cuff problems, Feeley said. “I like to think of rotator cuff problems along a spectrum — impingement is inflammation above the rotator cuff and suggests an imbalance between rotator cuff strength and deltoid strength,” said Feeley. “Partial thickness tears are often normal age-related problems but can be a source of pain,” he added.
However, full-thickness tears encompass a range of problems, from very small asymptomatic holes in the rotator cuff to massive tears that require shoulder replacement, Feeley explained. “Tendinopathy, or changes in the collagen organization in the tendon of the rotator cuff, sounds problematic, but most often is either incidental or part of aging,” he added.
When Shoulder Pain Isn’t Caused by the Shoulder
Primary care patients presenting with shoulder pain may in fact have a neck or spine problem instead, Feeley told this news organization. “Pain that is in the shoulder blade area or down the arm and into the fingers is usually coming from the neck/cervical spine,” he said.
In some cases, shoulder pain stems from the joints below the shoulder, including the elbow, because of arthritis, tennis elbow (lateral epicondylopathy), or golfer’s elbow (medial epicondylopathy), said Angelo. “Conditions of the elbow and neck can also affect shoulder mechanics or cause someone to use the joint more or less frequently,” she said. The interconnections between the neck and joints of the upper extremity, including referral patterns, complicate the diagnosis of shoulder pain; therefore, careful history-taking and examination of joints both above and below the shoulder are essential, she added.
Conservative Care
Shoulder problems often can be managed conservatively with therapeutic exercise focused on maintaining range of motion of the shoulder and strengthening the musculature around the shoulder, Angelo said. “Often, working with a physical therapist to address the mechanics of how the shoulder is moving and how the muscles are firing can help decrease pain and help patients meet their functional goals,” said Angelo. “Injections into the joint, the bursa adjacent to the rotator cuff, and, at times, into the tendons themselves can also be beneficial in relieving pain and improving function,” she said.
In some cases, a short, consistent course of anti-inflammatory medications can be part of a conservative strategy for the management of shoulder pain, Angelo noted.
“Utilizing these medications on an as-needed basis can also help patients improve their ability to sleep, perform their daily activities, and participate in physical therapy,” she said. A course of physical therapy that promotes maintaining shoulder range of motion, strengthening of the rotator cuff musculature, and working on the mechanics between the scapula and humerus is a good first step for most shoulder conditions, Angelo told this news organization.
“If there is concern due to recent trauma, significant weakness, or new/persistent numbness, referral to a specialist should be considered,” she said. If conservative measures including analgesics and exercise have failed to improve shoulder pain, advanced imaging and further interventional treatment may be necessary, Angelo added.
Most shoulder problems can and should be managed nonoperatively, Feeley said. Surgery should be reserved for patients whose shoulder pain has not improved with nonoperative care in most situations, he said. “It is often surprising for patients to hear, but most things in the shoulder actually get better without surgery, and changes on MRI are often normal for age,” Feeley noted. For example, more than 80% of individuals older than 50 will show signs of a labral tear or arthritis in the acromioclavicular joint, he said. “These are incidental findings that don’t need treatment,” he added.
More research is needed to develop more medications to manage pain for all musculoskeletal conditions, including shoulder pain, said Feeley. “But for now, for patients with shoulder pain, I tend to recommend a combination of Tylenol and an NSAID to improve inflammation and reduce pain, and a guided [physical] therapy program at home or in person. The combination of both usually will be successful,” he said.
Postsurgical Shoulder Pain
“For patients who have shoulder surgery, the techniques to manage pain around surgery have improved tremendously over the last decade, particularly with multimodal pain management and nerve blocks,” Feeley told this news organization. These advances have tremendously reduced the need for narcotics for pain management beyond the first 72 hours after surgery, he said. “I strongly recommend patients and primary care doctors to stop all narcotics as soon as possible after shoulder surgery, since they are not nearly as effective for management of pain after the first few days, and they should never be used as a sleep aid,” he emphasized.
Managing pain during recovery from shoulder surgery also involves about 6 weeks in a sling to protect the repair, followed by 6 weeks of active motion but no strengthening, then 3 months of strengthening exercises, he said.
Shoulder pain resources for patients: https://www.hss.edu/condition-list_shoulder-pain-causes.asp
Feeley’s 10-minute video on shoulder examination and pain assessment at the UCSF 14th Annual Primary Care Sports Medicine Conference, 2019: Video on the Essential Shoulder Exam
Kolfenbach disclosed receiving royalties from Elsevier for being the editor of Rheumatology Secrets and Wolters Kluwer for authoring several articles on UpToDate. Feeley and Angelo had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The causes of shoulder pain may be as common as a traumatic injury or as rare as a systemic inflammatory condition, according to the American Academy of Orthopaedic Surgeons. The combination of joints, tendons, and muscles that make up the shoulder can present diagnostic and clinical challenges, but several experts shared their tips for management.
Evaluation and Diagnosis
Rotator cuff tendinopathy/tendinitis and subacromial bursitis are typically the most common causes of shoulder pain presenting to a primary care provider, said Jason Kolfenbach, MD, a rheumatologist at UC Health, Denver, Colorado, in an interview. “Other causes of shoulder pain may include acromioclavicular osteoarthritis, biceps tendinitis (often a secondary process in the setting of rotator cuff disease), and true glenohumeral joint osteoarthritis,” he said.
Experts estimate that as much as 80% of shoulder pain involves the muscles, tendons, and ligaments surrounding the joint, rather than true arthritis, said Kolfenbach, who was a co-author of a Medscape slideshow on evaluating shoulder pain. In the slideshow, the authors noted that proper evaluation is needed for successful pain management. Some patients may do well with nonsteroidal anti-inflammatory drugs (NSAIDs), rest, ice, and physical therapy, but more serious conditions may require steroids, disease-modifying antirheumatic drugs, or surgery.
If a patient’s joint pain with active range of motion is relieved when an examiner supports the affected limb (passive range of motion), the cause is more likely related to muscles, tendons, or ligaments, Kolfenbach said.
Primary care providers may not be familiar with examination maneuvers to diagnose shoulder pain, although they are often tasked with evaluating and managing these patients, said Kolfenbach.
Education focused on practical aspects of these maneuvers may help improve primary care confidence in utilizing them and lead to more appropriate ordering of imaging testing and better pain management plans for patients, he said.
However, “If there is concern for a true intra-articular process, plain radiographs are recommended to determine if there is loss of cartilage space and/or other anatomic drivers of pain,” he noted. “Even in conditions of documented intra-articular arthritis, such as osteoarthritis, weakness, and atrophy of the surrounding musculature can contribute to joint disability and pain,” he said. For these patients, referral to physical therapy for periarticular strengthening can provide pain relief, he added.
Pinning Down the Pain Point
The many different structures within the shoulder that can cause pain make diagnosis a challenge, Nicole Angelo, DO, MS, a physiatrist at the Hospital for Special Surgery, New York City, said in an interview.
Potential sources of pain include the joint of the shoulder itself, the structures within it (labrum, capsule, and ligaments), and the surrounding rotator cuff muscles and tendons, she said. Patients also may experience overlapping pain referred from the neck (cervical spine) related to nerve irritation (cervical radiculopathy) or arthritis, she noted.
“A patient’s history, including mechanism and acuity of injury, as well as exam, specifically weakness in certain movements,” can help determine whether advanced imaging and surgical intervention may be required,” Angelo told this news organization.
Frozen shoulder is the most missed diagnosis of shoulder pain in primary care, Brian Feeley, MD, chief of sports medicine and shoulder surgery at the University of California, San Francisco (UCSF), said in an interview.
Frozen shoulder, also known as adhesive capsulitis, can mimic many other conditions including rotator cuff problems, shoulder arthritis, and biceps problems, Feeley said. “When people have a loss of active and passive range of motion and no evidence of arthritis on x-rays, their diagnosis is most likely frozen shoulder,” he said.
Another challenge for primary care providers is identifying the severity of rotator cuff problems, Feeley said. “I like to think of rotator cuff problems along a spectrum — impingement is inflammation above the rotator cuff and suggests an imbalance between rotator cuff strength and deltoid strength,” said Feeley. “Partial thickness tears are often normal age-related problems but can be a source of pain,” he added.
However, full-thickness tears encompass a range of problems, from very small asymptomatic holes in the rotator cuff to massive tears that require shoulder replacement, Feeley explained. “Tendinopathy, or changes in the collagen organization in the tendon of the rotator cuff, sounds problematic, but most often is either incidental or part of aging,” he added.
When Shoulder Pain Isn’t Caused by the Shoulder
Primary care patients presenting with shoulder pain may in fact have a neck or spine problem instead, Feeley told this news organization. “Pain that is in the shoulder blade area or down the arm and into the fingers is usually coming from the neck/cervical spine,” he said.
In some cases, shoulder pain stems from the joints below the shoulder, including the elbow, because of arthritis, tennis elbow (lateral epicondylopathy), or golfer’s elbow (medial epicondylopathy), said Angelo. “Conditions of the elbow and neck can also affect shoulder mechanics or cause someone to use the joint more or less frequently,” she said. The interconnections between the neck and joints of the upper extremity, including referral patterns, complicate the diagnosis of shoulder pain; therefore, careful history-taking and examination of joints both above and below the shoulder are essential, she added.
Conservative Care
Shoulder problems often can be managed conservatively with therapeutic exercise focused on maintaining range of motion of the shoulder and strengthening the musculature around the shoulder, Angelo said. “Often, working with a physical therapist to address the mechanics of how the shoulder is moving and how the muscles are firing can help decrease pain and help patients meet their functional goals,” said Angelo. “Injections into the joint, the bursa adjacent to the rotator cuff, and, at times, into the tendons themselves can also be beneficial in relieving pain and improving function,” she said.
In some cases, a short, consistent course of anti-inflammatory medications can be part of a conservative strategy for the management of shoulder pain, Angelo noted.
“Utilizing these medications on an as-needed basis can also help patients improve their ability to sleep, perform their daily activities, and participate in physical therapy,” she said. A course of physical therapy that promotes maintaining shoulder range of motion, strengthening of the rotator cuff musculature, and working on the mechanics between the scapula and humerus is a good first step for most shoulder conditions, Angelo told this news organization.
“If there is concern due to recent trauma, significant weakness, or new/persistent numbness, referral to a specialist should be considered,” she said. If conservative measures including analgesics and exercise have failed to improve shoulder pain, advanced imaging and further interventional treatment may be necessary, Angelo added.
Most shoulder problems can and should be managed nonoperatively, Feeley said. Surgery should be reserved for patients whose shoulder pain has not improved with nonoperative care in most situations, he said. “It is often surprising for patients to hear, but most things in the shoulder actually get better without surgery, and changes on MRI are often normal for age,” Feeley noted. For example, more than 80% of individuals older than 50 will show signs of a labral tear or arthritis in the acromioclavicular joint, he said. “These are incidental findings that don’t need treatment,” he added.
More research is needed to develop more medications to manage pain for all musculoskeletal conditions, including shoulder pain, said Feeley. “But for now, for patients with shoulder pain, I tend to recommend a combination of Tylenol and an NSAID to improve inflammation and reduce pain, and a guided [physical] therapy program at home or in person. The combination of both usually will be successful,” he said.
Postsurgical Shoulder Pain
“For patients who have shoulder surgery, the techniques to manage pain around surgery have improved tremendously over the last decade, particularly with multimodal pain management and nerve blocks,” Feeley told this news organization. These advances have tremendously reduced the need for narcotics for pain management beyond the first 72 hours after surgery, he said. “I strongly recommend patients and primary care doctors to stop all narcotics as soon as possible after shoulder surgery, since they are not nearly as effective for management of pain after the first few days, and they should never be used as a sleep aid,” he emphasized.
Managing pain during recovery from shoulder surgery also involves about 6 weeks in a sling to protect the repair, followed by 6 weeks of active motion but no strengthening, then 3 months of strengthening exercises, he said.
Shoulder pain resources for patients: https://www.hss.edu/condition-list_shoulder-pain-causes.asp
Feeley’s 10-minute video on shoulder examination and pain assessment at the UCSF 14th Annual Primary Care Sports Medicine Conference, 2019: Video on the Essential Shoulder Exam
Kolfenbach disclosed receiving royalties from Elsevier for being the editor of Rheumatology Secrets and Wolters Kluwer for authoring several articles on UpToDate. Feeley and Angelo had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The causes of shoulder pain may be as common as a traumatic injury or as rare as a systemic inflammatory condition, according to the American Academy of Orthopaedic Surgeons. The combination of joints, tendons, and muscles that make up the shoulder can present diagnostic and clinical challenges, but several experts shared their tips for management.
Evaluation and Diagnosis
Rotator cuff tendinopathy/tendinitis and subacromial bursitis are typically the most common causes of shoulder pain presenting to a primary care provider, said Jason Kolfenbach, MD, a rheumatologist at UC Health, Denver, Colorado, in an interview. “Other causes of shoulder pain may include acromioclavicular osteoarthritis, biceps tendinitis (often a secondary process in the setting of rotator cuff disease), and true glenohumeral joint osteoarthritis,” he said.
Experts estimate that as much as 80% of shoulder pain involves the muscles, tendons, and ligaments surrounding the joint, rather than true arthritis, said Kolfenbach, who was a co-author of a Medscape slideshow on evaluating shoulder pain. In the slideshow, the authors noted that proper evaluation is needed for successful pain management. Some patients may do well with nonsteroidal anti-inflammatory drugs (NSAIDs), rest, ice, and physical therapy, but more serious conditions may require steroids, disease-modifying antirheumatic drugs, or surgery.
If a patient’s joint pain with active range of motion is relieved when an examiner supports the affected limb (passive range of motion), the cause is more likely related to muscles, tendons, or ligaments, Kolfenbach said.
Primary care providers may not be familiar with examination maneuvers to diagnose shoulder pain, although they are often tasked with evaluating and managing these patients, said Kolfenbach.
Education focused on practical aspects of these maneuvers may help improve primary care confidence in utilizing them and lead to more appropriate ordering of imaging testing and better pain management plans for patients, he said.
However, “If there is concern for a true intra-articular process, plain radiographs are recommended to determine if there is loss of cartilage space and/or other anatomic drivers of pain,” he noted. “Even in conditions of documented intra-articular arthritis, such as osteoarthritis, weakness, and atrophy of the surrounding musculature can contribute to joint disability and pain,” he said. For these patients, referral to physical therapy for periarticular strengthening can provide pain relief, he added.
Pinning Down the Pain Point
The many different structures within the shoulder that can cause pain make diagnosis a challenge, Nicole Angelo, DO, MS, a physiatrist at the Hospital for Special Surgery, New York City, said in an interview.
Potential sources of pain include the joint of the shoulder itself, the structures within it (labrum, capsule, and ligaments), and the surrounding rotator cuff muscles and tendons, she said. Patients also may experience overlapping pain referred from the neck (cervical spine) related to nerve irritation (cervical radiculopathy) or arthritis, she noted.
“A patient’s history, including mechanism and acuity of injury, as well as exam, specifically weakness in certain movements,” can help determine whether advanced imaging and surgical intervention may be required,” Angelo told this news organization.
Frozen shoulder is the most missed diagnosis of shoulder pain in primary care, Brian Feeley, MD, chief of sports medicine and shoulder surgery at the University of California, San Francisco (UCSF), said in an interview.
Frozen shoulder, also known as adhesive capsulitis, can mimic many other conditions including rotator cuff problems, shoulder arthritis, and biceps problems, Feeley said. “When people have a loss of active and passive range of motion and no evidence of arthritis on x-rays, their diagnosis is most likely frozen shoulder,” he said.
Another challenge for primary care providers is identifying the severity of rotator cuff problems, Feeley said. “I like to think of rotator cuff problems along a spectrum — impingement is inflammation above the rotator cuff and suggests an imbalance between rotator cuff strength and deltoid strength,” said Feeley. “Partial thickness tears are often normal age-related problems but can be a source of pain,” he added.
However, full-thickness tears encompass a range of problems, from very small asymptomatic holes in the rotator cuff to massive tears that require shoulder replacement, Feeley explained. “Tendinopathy, or changes in the collagen organization in the tendon of the rotator cuff, sounds problematic, but most often is either incidental or part of aging,” he added.
When Shoulder Pain Isn’t Caused by the Shoulder
Primary care patients presenting with shoulder pain may in fact have a neck or spine problem instead, Feeley told this news organization. “Pain that is in the shoulder blade area or down the arm and into the fingers is usually coming from the neck/cervical spine,” he said.
In some cases, shoulder pain stems from the joints below the shoulder, including the elbow, because of arthritis, tennis elbow (lateral epicondylopathy), or golfer’s elbow (medial epicondylopathy), said Angelo. “Conditions of the elbow and neck can also affect shoulder mechanics or cause someone to use the joint more or less frequently,” she said. The interconnections between the neck and joints of the upper extremity, including referral patterns, complicate the diagnosis of shoulder pain; therefore, careful history-taking and examination of joints both above and below the shoulder are essential, she added.
Conservative Care
Shoulder problems often can be managed conservatively with therapeutic exercise focused on maintaining range of motion of the shoulder and strengthening the musculature around the shoulder, Angelo said. “Often, working with a physical therapist to address the mechanics of how the shoulder is moving and how the muscles are firing can help decrease pain and help patients meet their functional goals,” said Angelo. “Injections into the joint, the bursa adjacent to the rotator cuff, and, at times, into the tendons themselves can also be beneficial in relieving pain and improving function,” she said.
In some cases, a short, consistent course of anti-inflammatory medications can be part of a conservative strategy for the management of shoulder pain, Angelo noted.
“Utilizing these medications on an as-needed basis can also help patients improve their ability to sleep, perform their daily activities, and participate in physical therapy,” she said. A course of physical therapy that promotes maintaining shoulder range of motion, strengthening of the rotator cuff musculature, and working on the mechanics between the scapula and humerus is a good first step for most shoulder conditions, Angelo told this news organization.
“If there is concern due to recent trauma, significant weakness, or new/persistent numbness, referral to a specialist should be considered,” she said. If conservative measures including analgesics and exercise have failed to improve shoulder pain, advanced imaging and further interventional treatment may be necessary, Angelo added.
Most shoulder problems can and should be managed nonoperatively, Feeley said. Surgery should be reserved for patients whose shoulder pain has not improved with nonoperative care in most situations, he said. “It is often surprising for patients to hear, but most things in the shoulder actually get better without surgery, and changes on MRI are often normal for age,” Feeley noted. For example, more than 80% of individuals older than 50 will show signs of a labral tear or arthritis in the acromioclavicular joint, he said. “These are incidental findings that don’t need treatment,” he added.
More research is needed to develop more medications to manage pain for all musculoskeletal conditions, including shoulder pain, said Feeley. “But for now, for patients with shoulder pain, I tend to recommend a combination of Tylenol and an NSAID to improve inflammation and reduce pain, and a guided [physical] therapy program at home or in person. The combination of both usually will be successful,” he said.
Postsurgical Shoulder Pain
“For patients who have shoulder surgery, the techniques to manage pain around surgery have improved tremendously over the last decade, particularly with multimodal pain management and nerve blocks,” Feeley told this news organization. These advances have tremendously reduced the need for narcotics for pain management beyond the first 72 hours after surgery, he said. “I strongly recommend patients and primary care doctors to stop all narcotics as soon as possible after shoulder surgery, since they are not nearly as effective for management of pain after the first few days, and they should never be used as a sleep aid,” he emphasized.
Managing pain during recovery from shoulder surgery also involves about 6 weeks in a sling to protect the repair, followed by 6 weeks of active motion but no strengthening, then 3 months of strengthening exercises, he said.
Shoulder pain resources for patients: https://www.hss.edu/condition-list_shoulder-pain-causes.asp
Feeley’s 10-minute video on shoulder examination and pain assessment at the UCSF 14th Annual Primary Care Sports Medicine Conference, 2019: Video on the Essential Shoulder Exam
Kolfenbach disclosed receiving royalties from Elsevier for being the editor of Rheumatology Secrets and Wolters Kluwer for authoring several articles on UpToDate. Feeley and Angelo had no relevant financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Dupilumab Beneficial When Antihistamines Fall Short for Chronic Spontaneous Urticaria
based on data from 151 individuals.
“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.
Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.
In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.
The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).
Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).
In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).
Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.
The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”
If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.
No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”
More Research Needed to Fine-Tune Management
An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.
Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”
“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.
“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.”
Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron.
On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.
The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
based on data from 151 individuals.
“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.
Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.
In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.
The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).
Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).
In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).
Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.
The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”
If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.
No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”
More Research Needed to Fine-Tune Management
An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.
Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”
“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.
“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.”
Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron.
On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.
The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
based on data from 151 individuals.
“Approximately 50% of patients with chronic spontaneous urticaria do not respond to antihistamines,” said Thomas B. Casale, MD, professor of internal medicine at the University of South Florida, Tampa, in an interview. Omalizumab, the only biologic approved for this condition, is not effective in all patients, and additional treatment options are needed, added Casale, the lead author who presented the new data, at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting.
Dupilumab (Dupixent), a fully human monoclonal antibody that targets the interleukin (IL)–4 and IL-13 pathways, is currently approved in the United States for the treatment of several allergy and dermatology indications, including atopic dermatitis, severe asthma exacerbations, chronic rhinosinusitis with nasal polyps, and prurigo nodularis.
In the study, known as LIBERTY-CSU CUPID Study C, researchers randomized 74 patients with CSU aged 6 years or older to add-on dupilumab subcutaneously every 2 weeks and 77 to placebo. (Patients were omalizumab-naive and had symptomatic CSU, despite treatment with up to four times the approved dose of standard-of-care H1-antihistamines.) Dupilumab doses were 300 mg for adults and adolescents weighing ≥ 60 kg or 200 mg for adolescents weighing < 60 kg and children weighing ≥ 30 kg.
The primary outcomes were Itch Severity Score over 7 days (ISS7; range, 0-21) and Urticaria Activity Score over 7 days (UAS7; range, 0-42).
Over the 24-week study period, patients in the dupilumab group showed significantly greater change from baseline than those in the placebo group on both measures, with least squares mean changes of 8.6 vs 6.1 for ISS7 and 15.9 vs 11.2 for UAS7 (P = .02 for both).
In addition, at 24 weeks, significantly more patients in the dupilumab group than in the placebo group achieved well-controlled disease based on a UAS of 6 or lower (41% vs 23%; P = .005). Significantly more dupilumab-treated patients also achieved a complete response (defined as a UAS of 0), compared with placebo-treated patients (30% vs 18%; P = .02).
Overall rates of treatment-emergent adverse events were 53% for both groups, and safety data were mainly consistent with dupilumab’s known safety profile, the researchers wrote.
The findings were not surprising, as a previous related study, LIBERTY-CSU CUPID Study A, showed that dupilumab was effective for CSU, Casale told this news organization. “This replicate study confirms the previous study and provides evidence for regulatory approval.”
If approved by the Food and Drug Administration (FDA), “dupilumab will provide another therapeutic option for patients with chronic urticaria unresponsive to antihistamines,” Casale commented.
No new safety signals occurred, and the ability to self-administer the medication at home provides an advantage for patients, he added. As for additional research, “analysis of patient characteristics and potential biomarkers that would predict responsiveness is needed.”
More Research Needed to Fine-Tune Management
An unmet need persists for patients with CSU whose disease is not adequately controlled by higher-dose H1-antihistamines, Robert G. Micheletti, MD, associate professor of dermatology and medicine at the University of Pennsylvania, Philadelphia, said in an interview. “It is important not only to identify effective add-on therapies for these patients but also to generate data to support insurance coverage and drug access,” said Micheletti, who was not involved in the study.
Also referring to the similar findings reported in the LIBERTY-CSU CUPID Study A, Micheletti said, “as in the earlier study, the results demonstrate significantly reduced itch and urticaria in treated patients compared to placebo.”
“While many providers currently prescribe dupilumab off-label for refractory CSU, FDA approval would improve access to the drug for patients who need it and provide an alternative for patients who may not be good candidates for omalizumab,” he added. However, more research is needed to define optimal management of patients with CSU with inadequate response to omalizumab.
“The LIBERTY-CSU CUPID Study B showed a small improvement in itch severity and urticaria activity among such patients receiving dupilumab,” he noted. “Future work should aim to identify biomarkers and other features predictive of response to various therapies.”
Study B involved patients with CSU who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab, according to Regeneron.
On November 15, after the ACAAI meeting had ended, the company announced that the FDA had accepted the resubmission of an application for approval of dupilumab for the treatment of CSU in adults and pediatric patients aged 12 years or older not adequately controlled with H1-antihistamines.
The study was supported and sponsored by Sanofi and Regeneron Pharmaceuticals. Casale disclosed serving as a consultant for ALK, ARS Pharma, AstraZeneca, Bryn Pharma, Celgene, Eli Lilly, Genentech, GSK, Jasper, Novartis, Regeneron, and Sanofi and as a speaker for Genentech and Regeneron. Micheletti had no relevant financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM ACAAI 2024
New Cause of Sexually Transmitted Fungal Infection Reported in MSM
A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.
“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.
“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.
The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.
All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.
Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.
Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.”
Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.
“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.”
Encourage Reporting and Identify New Infections
“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.
“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.
In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.”
Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.
The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”
“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.
Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.”
Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.
The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.
“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.
“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.
The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.
All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.
Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.
Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.”
Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.
“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.”
Encourage Reporting and Identify New Infections
“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.
“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.
In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.”
Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.
The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”
“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.
Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.”
Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.
The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
A dermatophyte known as Trichophyton mentagrophytes genotype VII (TMVII) has been identified as the cause of an emerging sexually transmitted fungal infection in four adults in the United States, according to a paper published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
TMVII is a sexually transmitted fungus that causes genital tinea; the fungus might be misidentified as eczema, psoriasis, or other dermatologic conditions, Jason E. Zucker, MD, an infectious disease specialist at Columbia University Irving Medical Center, New York City, and colleagues wrote.
“Dermatophyte infections, including TMVII, are spread through direct skin-to-skin contact,” corresponding author Avrom S. Caplan, MD, a dermatologist at New York University Grossman School of Medicine, New York City, said in an interview.
“In the United States, to our knowledge, the infection has only been in MSM [men who have sex with men], but there have been reports of TMVII in Europe in non-MSM patients, including among patients who traveled to Southeast Asia for sex tourism or partners of people who have been infected with TMVII,” he said.
The four patients were diagnosed with tinea between April 2024 and July 2024, and fungal cultures and DNA sequencing identified TMVII as the cause of the infection. All four patients were cisgender men aged 30-39 years from New York City who reported recent sexual contact with other men; one was a sex worker, two had sex with each other, and one reported recent travel to Europe.
All four patients presented with rashes on the face, buttocks, or genitals; all were successfully treated with antifungals, the authors wrote.
Individuals with genital lesions who are sexually active should be seen by a healthcare provider, and TMVII should be considered, especially in the event of scaly, itchy, or inflamed rashes elsewhere on the body, Caplan told this news organization.
Additionally, “If someone presents for a medical evaluation and has ringworm on the buttocks, face, or elsewhere, especially if they are sexually active, the question of TMVII should arise, and the patient should be asked about possible genital lesions as well,” he said. “Any patient diagnosed with an STI [sexually transmitted infection], including MSM patients, should be evaluated appropriately for other STIs including TMVII.”
Continued surveillance and monitoring are needed to track TMVII and to better understand emerging infections, Caplan told this news organization. Clinicians can find more information and a dermatophyte registry via the American Academy of Dermatology websites on emerging diseases in general and dermatophytes in particular.
“We also need better access to testing and more rapid confirmatory testing to detect emerging dermatophyte strains and monitor antifungal resistance patterns,” Caplan added. “At this time, we do not have evidence to suggest there is antifungal resistance in TMVII, which also distinguishes it from T indotineae.”
Encourage Reporting and Identify New Infections
“Emerging infections can mimic noninfectious disease processes, which can make the diagnosis challenging,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at the University of Tennessee Health Science Center, Memphis, said in an interview.
“Monitoring emerging infections can be difficult if the cases are not reported and if the disease is not widespread,” Mazumder noted. Educating clinicians with case reports and encouraging them to report unusual cases to public health helps to overcome this challenge.
In the clinical setting, skin lesions that fail to respond or worsen with the application of topical steroids could be a red flag for TMVII, Mazumder told this news organization. “Since the skin findings of TMVII can closely resemble noninfectious processes such as eczema or psoriasis, the use of topical corticosteroids may have already been tried before the diagnosis of TMVII is considered.”
Also, location matters in making the diagnosis. TMVII lesions occur on the face, genitals, extremities, trunk, and buttocks. Obtaining a thorough sexual history is important because the fungus spreads from close contact through sexual exposure, Mazumder added.
The most effective treatment for TMVII infections remains to be determined, Mazumder said. “Treatment considerations such as combination treatment with oral and topical antifungal medications vs oral antifungal medication alone is something that needs further research along with the best treatment duration.”
“Determining the rate of transmissibility between contacts, when someone is considered to be the most infectious, how long someone is considered infectious once infected, and rates of reinfection are questions that may benefit from further study,” she added.
Although the current cases are reported in MSM, determining how TMVII affects other patient populations will be interesting as more cases are reported, said Mazumder. “Further understanding of how different degrees of immunosuppression affect TMVII disease course is another important consideration.”
Finally, determining the rate of long-term sequelae from TMVII infection and the rate of bacterial co-infection will help better understand TMVII, she said.
The researchers had no financial conflicts to disclose. Mazumder had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM THE MMWR