TOPLINE:

After lung cancer screening (LCS), imaging, and invasive procedures were performed 31.9% and 2.8% of the time, respectively. Complications during invasive procedures occurred in 30.6% of cases. 

METHODOLOGY:

• Researchers analyzed data from 9266 patients aged 55-80 years who completed at least one LCS with low-dose CT (LDCT) between 2014 and 2018.
• This study used data from the PROSPR Lung Consortium.
• Results were compared with findings from the National Lung Screening Trial (NLST), a large study of smokers published in 2011.

TAKEAWAY:

• In total, 2956 patients (31.9%) underwent follow-up imaging, including CT, LDCT, MRI, or PET; 180 (0.02%) had invasive procedures, including needle biopsy, bronchoscopy, mediastinoscopy or mediastinotomy, or thoracoscopy.
• Within 30 days after an invasive diagnostic procedure, 55 of 180 patients (30.6%) experienced complications; 20.6% were major, 8.3% were intermediate, and 1.7% were minor.
• Complication rates after invasive procedures were higher in PROSPR than the NLST (30.6% vs 17.7%).
• Compared with all patients, those with an abnormal LCS were slightly older, more likely to currently smoke, reported more packs of cigarettes smoked daily, and had more comorbid conditions.
• In 2013, the US Preventive Services Task Force recommended annual LCS for certain people who smoke, on the basis of findings from the NLST.

IN PRACTICE:

“We observed higher rates of both invasive procedures and complications than those observed in NLST, highlighting the need for practice-based strategies to assess variations in the quality of care and to prioritize LCS among those patients most likely to receive a net benefit from screening in relation to potential complications and other harms,” the researchers wrote. 

SOURCE:

Katharine A. Rendle, PhD, MSW, MPH, with Perelman School of Medicine, University of Pennsylvania, is the study’s corresponding author. The study was published online in Annals of Internal Medicine.

LIMITATIONS:

This study was retrospective, and data were analyzed using procedural coding. In addition, the NLST based abnormal findings on different criteria from those used in clinical practice (Lung-RADS), making direct comparison of patients difficult. Patients in PROSPR were older, more likely to be currently smoking, and had higher rates of comorbid conditions compared with patients in the NLST. 

DISCLOSURES:

This study was supported by grants from the National Cancer Institute and the Gordon and Betty Moore Foundation.

TOPLINE:

After lung cancer screening (LCS), imaging, and invasive procedures were performed 31.9% and 2.8% of the time, respectively. Complications during invasive procedures occurred in 30.6% of cases. 

METHODOLOGY:

• Researchers analyzed data from 9266 patients aged 55-80 years who completed at least one LCS with low-dose CT (LDCT) between 2014 and 2018.
• This study used data from the PROSPR Lung Consortium.
• Results were compared with findings from the National Lung Screening Trial (NLST), a large study of smokers published in 2011.

TAKEAWAY:

• In total, 2956 patients (31.9%) underwent follow-up imaging, including CT, LDCT, MRI, or PET; 180 (0.02%) had invasive procedures, including needle biopsy, bronchoscopy, mediastinoscopy or mediastinotomy, or thoracoscopy.
• Within 30 days after an invasive diagnostic procedure, 55 of 180 patients (30.6%) experienced complications; 20.6% were major, 8.3% were intermediate, and 1.7% were minor.
• Complication rates after invasive procedures were higher in PROSPR than the NLST (30.6% vs 17.7%).
• Compared with all patients, those with an abnormal LCS were slightly older, more likely to currently smoke, reported more packs of cigarettes smoked daily, and had more comorbid conditions.
• In 2013, the US Preventive Services Task Force recommended annual LCS for certain people who smoke, on the basis of findings from the NLST.

IN PRACTICE:

“We observed higher rates of both invasive procedures and complications than those observed in NLST, highlighting the need for practice-based strategies to assess variations in the quality of care and to prioritize LCS among those patients most likely to receive a net benefit from screening in relation to potential complications and other harms,” the researchers wrote. 

SOURCE:

Katharine A. Rendle, PhD, MSW, MPH, with Perelman School of Medicine, University of Pennsylvania, is the study’s corresponding author. The study was published online in Annals of Internal Medicine.

LIMITATIONS:

This study was retrospective, and data were analyzed using procedural coding. In addition, the NLST based abnormal findings on different criteria from those used in clinical practice (Lung-RADS), making direct comparison of patients difficult. Patients in PROSPR were older, more likely to be currently smoking, and had higher rates of comorbid conditions compared with patients in the NLST. 

DISCLOSURES:

This study was supported by grants from the National Cancer Institute and the Gordon and Betty Moore Foundation.

TOPLINE:

After lung cancer screening (LCS), imaging, and invasive procedures were performed 31.9% and 2.8% of the time, respectively. Complications during invasive procedures occurred in 30.6% of cases. 

METHODOLOGY:

• Researchers analyzed data from 9266 patients aged 55-80 years who completed at least one LCS with low-dose CT (LDCT) between 2014 and 2018.
• This study used data from the PROSPR Lung Consortium.
• Results were compared with findings from the National Lung Screening Trial (NLST), a large study of smokers published in 2011.

TAKEAWAY:

• In total, 2956 patients (31.9%) underwent follow-up imaging, including CT, LDCT, MRI, or PET; 180 (0.02%) had invasive procedures, including needle biopsy, bronchoscopy, mediastinoscopy or mediastinotomy, or thoracoscopy.
• Within 30 days after an invasive diagnostic procedure, 55 of 180 patients (30.6%) experienced complications; 20.6% were major, 8.3% were intermediate, and 1.7% were minor.
• Complication rates after invasive procedures were higher in PROSPR than the NLST (30.6% vs 17.7%).
• Compared with all patients, those with an abnormal LCS were slightly older, more likely to currently smoke, reported more packs of cigarettes smoked daily, and had more comorbid conditions.
• In 2013, the US Preventive Services Task Force recommended annual LCS for certain people who smoke, on the basis of findings from the NLST.

IN PRACTICE:

“We observed higher rates of both invasive procedures and complications than those observed in NLST, highlighting the need for practice-based strategies to assess variations in the quality of care and to prioritize LCS among those patients most likely to receive a net benefit from screening in relation to potential complications and other harms,” the researchers wrote. 

SOURCE:

Katharine A. Rendle, PhD, MSW, MPH, with Perelman School of Medicine, University of Pennsylvania, is the study’s corresponding author. The study was published online in Annals of Internal Medicine.

LIMITATIONS:

This study was retrospective, and data were analyzed using procedural coding. In addition, the NLST based abnormal findings on different criteria from those used in clinical practice (Lung-RADS), making direct comparison of patients difficult. Patients in PROSPR were older, more likely to be currently smoking, and had higher rates of comorbid conditions compared with patients in the NLST. 

DISCLOSURES:

This study was supported by grants from the National Cancer Institute and the Gordon and Betty Moore Foundation.

Delivered at 34 weeks’ gestation, Baby “Alex” had an enlarged liver and spleen on his initial newborn exam, poor tone, and a diffuse, peeling rash. Baby “Aaliyah” was born at term and appeared healthy. By 1 month of age, she was gaining weight poorly and developed copious nasal drainage and a salmon-colored rash on the soles of her feet.

The connection? Both babies were ultimately diagnosed with congenital syphilis. Infections in both babies could have been prevented if their mothers had been tested for syphilis and treated during pregnancy. Alex’s mom had no prenatal care. Aaliyah’s mom had tested negative for syphilis during her first trimester but had not been re-tested, despite sharing with her health care provider that she had a new sexual partner.

Alex and Aaliyah are representative of what Centers for Disease Control and Prevention (CDC) Chief Medical Officer Debra Houry, MD, MPH, calls a “family tragedy.” Cases of congenital syphilis are rising rapidly in the United States, reaching a 30-year high in 2021.¹ Cases increased by 755% between 2012 and 2021, from 335 in 2012 to 2,865 in 2021. In 2022, cases rose again: 3,761 cases of congenital syphilis were reported, including 231 stillbirths and 51 infant deaths. Infants with congenital syphilis are at risk for lifelong complications, including deafness, blindness, and intellectual disability.

Most of these cases were preventable. Congenital syphilis is rare when pregnant people complete adequate treatment at least 30 days before delivery. In 2022, lack of testing or timely testing contributed to 36.8% of congenital syphilis cases. Nearly 40% of birth parents of infected babies received inadequate treatment during pregnancy, and 11.2% received no treatment or treatment was not documented.

Cases of congenital syphilis have increased in all demographic groups and all US Census Bureau regions, but racial and geographic disparities exist, suggesting ongoing barriers to care related to social determinants of health. In 2021, the highest rates of congenital syphilis were among babies born to individuals who were non-Hispanic American Indian or Alaska Native (384 cases per 100,000 live births), non-Hispanic Native Hawaiian or other Pacific Islander (192 cases per 100,000 live births), and non-Hispanic Black or African American (169 cases per 100,000 live births). Six states had rates of congenital syphilis that exceeded 160 cases per 100,000 population, including Arizona, New Mexico, Louisiana, Mississippi, Texas, and Oklahoma. That is more than twice the national rate of 77.9 cases/100,000.
 

Reducing the Risk

To reduce rates of congenital syphilis in all people, barriers to testing must be eliminated. The CDC recommends that all pregnant people be tested early in pregnancy, with repeat testing at 28 weeks and at delivery for those at increased risk for infection based on individual risk factors or residence in a high-prevalence community. Rapid syphilis testing and treatment during pregnancy is recommended in settings such as emergency departments, syringe service programs, prisons/jails, and maternal and child health programs to minimize missed opportunities for care.

While pediatric clinicians rarely care for pregnant patients, they also have an essential role to play in reducing the adverse health outcomes associated with congenital syphilis. No infant should be discharged from the newborn nursery without confirming that the birth parent was tested for syphilis at least once and was treated appropriately if positive. Appropriate treatment during pregnancy is a single dose of benzathine penicillin G for primary, secondary, or early latent syphilis. Late-latent syphilis or syphilis of unknown duration is treated with three doses of benzathine penicillin G spaced 7-9 days apart. If the doses are given further than 9 days apart, treatment is considered inadequate, and the series of doses must be restarted. Benzathine penicillin G remains in short supply in the United States, but is the only drug recommended to treat syphilis during pregnancy.

Collaboration between obstetrical and newborn care providers is essential. Those who care for newborns need easy access to birthing parents’ syphilis treatment results. As more health care facilities implement routine syphilis testing at delivery, rapid syphilis testing must be available to avoid prolonging newborn hospital stays.

Pediatricians need to maintain an index of suspicion for congenital syphilis, regardless of maternal history, because symptomatic congenital syphilis can mimic a variety of infectious and noninfectious conditions. Most infected infants look normal at birth. While the majority of cases of congenital syphilis are identified in the newborn period, a 2021 paper published in Pediatrics described 84 infants born between 2014 and 2018 who were diagnosed beyond a month of age.² These represented 2.2% of all infants born with congenital syphilis. Common symptoms included rash, snuffles, and hepatomegaly. Sixty-nine percent of infants who had long bone radiographs obtained had findings consistent with congenital syphilis. Typical imaging findings include periostitis and demineralization of the metaphysis and diaphysis of long bones, although fractures can also occur. Case reports describe infants who presented with fractures and were initially evaluated for nonaccidental trauma.³

Another critical approach is to treat syphilis in people of childbearing age before pregnancy occurs. The CDC recommends syphilis testing for sexually active females 18-44 years of age and living in communities with high rates of syphilis. County-specific specific rates of syphilis rates are available at https://www.cdc.gov/nchhstp/atlas/syphilis/. Point-of-care tests are now available for syphilis and may facilitate timely treatment. 

Additional resources describing syphilis testing and treatment are available from the CDC and the American Academy of Pediatrics.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. (Also [email protected].)

References

1. McDonald R et al. Vital Signs: Missed Opportunities for Preventing Congenital Syphilis — United States, 2022. MMWR Morb Mortal Wkly Rep. 2023 Nov 17;72(46):1269-74. doi: 10.15585/mmwr.mm7246e1. 

2. Kimball A et al. Congenital Syphilis Diagnosed Beyond the Neonatal Period in the United States: 2014-2018. Pediatrics. 2021 Sep;148(3):e2020049080. doi: 10.1542/peds.2020-049080. 

3. Jacobs K et al. Congenital Syphilis Misdiagnosed as Suspected Nonaccidental Trauma. Pediatrics. 2019 Oct;144(4):e20191564. doi: 10.1542/peds.2019-1564. 

Delivered at 34 weeks’ gestation, Baby “Alex” had an enlarged liver and spleen on his initial newborn exam, poor tone, and a diffuse, peeling rash. Baby “Aaliyah” was born at term and appeared healthy. By 1 month of age, she was gaining weight poorly and developed copious nasal drainage and a salmon-colored rash on the soles of her feet.

The connection? Both babies were ultimately diagnosed with congenital syphilis. Infections in both babies could have been prevented if their mothers had been tested for syphilis and treated during pregnancy. Alex’s mom had no prenatal care. Aaliyah’s mom had tested negative for syphilis during her first trimester but had not been re-tested, despite sharing with her health care provider that she had a new sexual partner.

Alex and Aaliyah are representative of what Centers for Disease Control and Prevention (CDC) Chief Medical Officer Debra Houry, MD, MPH, calls a “family tragedy.” Cases of congenital syphilis are rising rapidly in the United States, reaching a 30-year high in 2021.¹ Cases increased by 755% between 2012 and 2021, from 335 in 2012 to 2,865 in 2021. In 2022, cases rose again: 3,761 cases of congenital syphilis were reported, including 231 stillbirths and 51 infant deaths. Infants with congenital syphilis are at risk for lifelong complications, including deafness, blindness, and intellectual disability.

Most of these cases were preventable. Congenital syphilis is rare when pregnant people complete adequate treatment at least 30 days before delivery. In 2022, lack of testing or timely testing contributed to 36.8% of congenital syphilis cases. Nearly 40% of birth parents of infected babies received inadequate treatment during pregnancy, and 11.2% received no treatment or treatment was not documented.

Cases of congenital syphilis have increased in all demographic groups and all US Census Bureau regions, but racial and geographic disparities exist, suggesting ongoing barriers to care related to social determinants of health. In 2021, the highest rates of congenital syphilis were among babies born to individuals who were non-Hispanic American Indian or Alaska Native (384 cases per 100,000 live births), non-Hispanic Native Hawaiian or other Pacific Islander (192 cases per 100,000 live births), and non-Hispanic Black or African American (169 cases per 100,000 live births). Six states had rates of congenital syphilis that exceeded 160 cases per 100,000 population, including Arizona, New Mexico, Louisiana, Mississippi, Texas, and Oklahoma. That is more than twice the national rate of 77.9 cases/100,000.
 

Reducing the Risk

To reduce rates of congenital syphilis in all people, barriers to testing must be eliminated. The CDC recommends that all pregnant people be tested early in pregnancy, with repeat testing at 28 weeks and at delivery for those at increased risk for infection based on individual risk factors or residence in a high-prevalence community. Rapid syphilis testing and treatment during pregnancy is recommended in settings such as emergency departments, syringe service programs, prisons/jails, and maternal and child health programs to minimize missed opportunities for care.

While pediatric clinicians rarely care for pregnant patients, they also have an essential role to play in reducing the adverse health outcomes associated with congenital syphilis. No infant should be discharged from the newborn nursery without confirming that the birth parent was tested for syphilis at least once and was treated appropriately if positive. Appropriate treatment during pregnancy is a single dose of benzathine penicillin G for primary, secondary, or early latent syphilis. Late-latent syphilis or syphilis of unknown duration is treated with three doses of benzathine penicillin G spaced 7-9 days apart. If the doses are given further than 9 days apart, treatment is considered inadequate, and the series of doses must be restarted. Benzathine penicillin G remains in short supply in the United States, but is the only drug recommended to treat syphilis during pregnancy.

Collaboration between obstetrical and newborn care providers is essential. Those who care for newborns need easy access to birthing parents’ syphilis treatment results. As more health care facilities implement routine syphilis testing at delivery, rapid syphilis testing must be available to avoid prolonging newborn hospital stays.

Pediatricians need to maintain an index of suspicion for congenital syphilis, regardless of maternal history, because symptomatic congenital syphilis can mimic a variety of infectious and noninfectious conditions. Most infected infants look normal at birth. While the majority of cases of congenital syphilis are identified in the newborn period, a 2021 paper published in Pediatrics described 84 infants born between 2014 and 2018 who were diagnosed beyond a month of age.² These represented 2.2% of all infants born with congenital syphilis. Common symptoms included rash, snuffles, and hepatomegaly. Sixty-nine percent of infants who had long bone radiographs obtained had findings consistent with congenital syphilis. Typical imaging findings include periostitis and demineralization of the metaphysis and diaphysis of long bones, although fractures can also occur. Case reports describe infants who presented with fractures and were initially evaluated for nonaccidental trauma.³

Another critical approach is to treat syphilis in people of childbearing age before pregnancy occurs. The CDC recommends syphilis testing for sexually active females 18-44 years of age and living in communities with high rates of syphilis. County-specific specific rates of syphilis rates are available at https://www.cdc.gov/nchhstp/atlas/syphilis/. Point-of-care tests are now available for syphilis and may facilitate timely treatment. 

Additional resources describing syphilis testing and treatment are available from the CDC and the American Academy of Pediatrics.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. (Also [email protected].)

References

1. McDonald R et al. Vital Signs: Missed Opportunities for Preventing Congenital Syphilis — United States, 2022. MMWR Morb Mortal Wkly Rep. 2023 Nov 17;72(46):1269-74. doi: 10.15585/mmwr.mm7246e1. 

2. Kimball A et al. Congenital Syphilis Diagnosed Beyond the Neonatal Period in the United States: 2014-2018. Pediatrics. 2021 Sep;148(3):e2020049080. doi: 10.1542/peds.2020-049080. 

3. Jacobs K et al. Congenital Syphilis Misdiagnosed as Suspected Nonaccidental Trauma. Pediatrics. 2019 Oct;144(4):e20191564. doi: 10.1542/peds.2019-1564. 

Delivered at 34 weeks’ gestation, Baby “Alex” had an enlarged liver and spleen on his initial newborn exam, poor tone, and a diffuse, peeling rash. Baby “Aaliyah” was born at term and appeared healthy. By 1 month of age, she was gaining weight poorly and developed copious nasal drainage and a salmon-colored rash on the soles of her feet.

The connection? Both babies were ultimately diagnosed with congenital syphilis. Infections in both babies could have been prevented if their mothers had been tested for syphilis and treated during pregnancy. Alex’s mom had no prenatal care. Aaliyah’s mom had tested negative for syphilis during her first trimester but had not been re-tested, despite sharing with her health care provider that she had a new sexual partner.

Alex and Aaliyah are representative of what Centers for Disease Control and Prevention (CDC) Chief Medical Officer Debra Houry, MD, MPH, calls a “family tragedy.” Cases of congenital syphilis are rising rapidly in the United States, reaching a 30-year high in 2021.¹ Cases increased by 755% between 2012 and 2021, from 335 in 2012 to 2,865 in 2021. In 2022, cases rose again: 3,761 cases of congenital syphilis were reported, including 231 stillbirths and 51 infant deaths. Infants with congenital syphilis are at risk for lifelong complications, including deafness, blindness, and intellectual disability.

Most of these cases were preventable. Congenital syphilis is rare when pregnant people complete adequate treatment at least 30 days before delivery. In 2022, lack of testing or timely testing contributed to 36.8% of congenital syphilis cases. Nearly 40% of birth parents of infected babies received inadequate treatment during pregnancy, and 11.2% received no treatment or treatment was not documented.

Cases of congenital syphilis have increased in all demographic groups and all US Census Bureau regions, but racial and geographic disparities exist, suggesting ongoing barriers to care related to social determinants of health. In 2021, the highest rates of congenital syphilis were among babies born to individuals who were non-Hispanic American Indian or Alaska Native (384 cases per 100,000 live births), non-Hispanic Native Hawaiian or other Pacific Islander (192 cases per 100,000 live births), and non-Hispanic Black or African American (169 cases per 100,000 live births). Six states had rates of congenital syphilis that exceeded 160 cases per 100,000 population, including Arizona, New Mexico, Louisiana, Mississippi, Texas, and Oklahoma. That is more than twice the national rate of 77.9 cases/100,000.
 

Reducing the Risk

To reduce rates of congenital syphilis in all people, barriers to testing must be eliminated. The CDC recommends that all pregnant people be tested early in pregnancy, with repeat testing at 28 weeks and at delivery for those at increased risk for infection based on individual risk factors or residence in a high-prevalence community. Rapid syphilis testing and treatment during pregnancy is recommended in settings such as emergency departments, syringe service programs, prisons/jails, and maternal and child health programs to minimize missed opportunities for care.

While pediatric clinicians rarely care for pregnant patients, they also have an essential role to play in reducing the adverse health outcomes associated with congenital syphilis. No infant should be discharged from the newborn nursery without confirming that the birth parent was tested for syphilis at least once and was treated appropriately if positive. Appropriate treatment during pregnancy is a single dose of benzathine penicillin G for primary, secondary, or early latent syphilis. Late-latent syphilis or syphilis of unknown duration is treated with three doses of benzathine penicillin G spaced 7-9 days apart. If the doses are given further than 9 days apart, treatment is considered inadequate, and the series of doses must be restarted. Benzathine penicillin G remains in short supply in the United States, but is the only drug recommended to treat syphilis during pregnancy.

Collaboration between obstetrical and newborn care providers is essential. Those who care for newborns need easy access to birthing parents’ syphilis treatment results. As more health care facilities implement routine syphilis testing at delivery, rapid syphilis testing must be available to avoid prolonging newborn hospital stays.

Pediatricians need to maintain an index of suspicion for congenital syphilis, regardless of maternal history, because symptomatic congenital syphilis can mimic a variety of infectious and noninfectious conditions. Most infected infants look normal at birth. While the majority of cases of congenital syphilis are identified in the newborn period, a 2021 paper published in Pediatrics described 84 infants born between 2014 and 2018 who were diagnosed beyond a month of age.² These represented 2.2% of all infants born with congenital syphilis. Common symptoms included rash, snuffles, and hepatomegaly. Sixty-nine percent of infants who had long bone radiographs obtained had findings consistent with congenital syphilis. Typical imaging findings include periostitis and demineralization of the metaphysis and diaphysis of long bones, although fractures can also occur. Case reports describe infants who presented with fractures and were initially evaluated for nonaccidental trauma.³

Another critical approach is to treat syphilis in people of childbearing age before pregnancy occurs. The CDC recommends syphilis testing for sexually active females 18-44 years of age and living in communities with high rates of syphilis. County-specific specific rates of syphilis rates are available at https://www.cdc.gov/nchhstp/atlas/syphilis/. Point-of-care tests are now available for syphilis and may facilitate timely treatment. 

Additional resources describing syphilis testing and treatment are available from the CDC and the American Academy of Pediatrics.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. (Also [email protected].)

References

1. McDonald R et al. Vital Signs: Missed Opportunities for Preventing Congenital Syphilis — United States, 2022. MMWR Morb Mortal Wkly Rep. 2023 Nov 17;72(46):1269-74. doi: 10.15585/mmwr.mm7246e1. 

2. Kimball A et al. Congenital Syphilis Diagnosed Beyond the Neonatal Period in the United States: 2014-2018. Pediatrics. 2021 Sep;148(3):e2020049080. doi: 10.1542/peds.2020-049080. 

3. Jacobs K et al. Congenital Syphilis Misdiagnosed as Suspected Nonaccidental Trauma. Pediatrics. 2019 Oct;144(4):e20191564. doi: 10.1542/peds.2019-1564. 

Key clinical point: A significant association was observed between atopic dermatitis (AD) and poorer cognitive function in men, and familial characteristics exerted a confounding effect on this association.

Major finding: After effectively controlling for familial environmental confounding factors and addressing genetic influences, AD in men was significantly associated with poorer cognitive function (regression coefficient −0.04; 95% CI −0.07 to −0.003).

Study details: This sibling-comparison study included 1,687,038 men who underwent a military conscription examination at 17-22 years of age, of which 25,995 were diagnosed with AD.

Disclosures: This study was sponsored by grants from the Swedish Research Council for Health, Working Life, and Welfare (Forte) and the UK Economic and Social Research Council. L von Kobyletzki declared being a consultant for and receiving research funding from various organizations. The other authors declared no conflicts of interest.

Source: Smith KA et al. Atopic dermatitis and cognitive function: A sibling comparison study among males in Sweden. Br J Dermatol. 2024 (Jan 3). doi: 10.1093/bjd/ljae004

Key clinical point: A significant association was observed between atopic dermatitis (AD) and poorer cognitive function in men, and familial characteristics exerted a confounding effect on this association.

Major finding: After effectively controlling for familial environmental confounding factors and addressing genetic influences, AD in men was significantly associated with poorer cognitive function (regression coefficient −0.04; 95% CI −0.07 to −0.003).

Study details: This sibling-comparison study included 1,687,038 men who underwent a military conscription examination at 17-22 years of age, of which 25,995 were diagnosed with AD.

Disclosures: This study was sponsored by grants from the Swedish Research Council for Health, Working Life, and Welfare (Forte) and the UK Economic and Social Research Council. L von Kobyletzki declared being a consultant for and receiving research funding from various organizations. The other authors declared no conflicts of interest.

Source: Smith KA et al. Atopic dermatitis and cognitive function: A sibling comparison study among males in Sweden. Br J Dermatol. 2024 (Jan 3). doi: 10.1093/bjd/ljae004

Key clinical point: A significant association was observed between atopic dermatitis (AD) and poorer cognitive function in men, and familial characteristics exerted a confounding effect on this association.

Major finding: After effectively controlling for familial environmental confounding factors and addressing genetic influences, AD in men was significantly associated with poorer cognitive function (regression coefficient −0.04; 95% CI −0.07 to −0.003).

Study details: This sibling-comparison study included 1,687,038 men who underwent a military conscription examination at 17-22 years of age, of which 25,995 were diagnosed with AD.

Disclosures: This study was sponsored by grants from the Swedish Research Council for Health, Working Life, and Welfare (Forte) and the UK Economic and Social Research Council. L von Kobyletzki declared being a consultant for and receiving research funding from various organizations. The other authors declared no conflicts of interest.

Source: Smith KA et al. Atopic dermatitis and cognitive function: A sibling comparison study among males in Sweden. Br J Dermatol. 2024 (Jan 3). doi: 10.1093/bjd/ljae004

Key clinical point: Patients with atopic dermatitis (AD), especially moderate-to-severe AD, had an increased prevalence of inflammatory bowel disease (IBD).

Major finding: A significant association was observed between IBD and AD (adjusted odds ratio [aOR] 3.89; P = .0169); however, when stratified by AD severity, only moderate-to-severe AD was found to be associated with IBD (aOR 4.45; P = .0102).

Study details: Findings are from a retrospective observational study including 364 patients with AD and 725 matched control individuals without AD.

Disclosures: This study was sponsored by an independent investigator grant from AbbVie. Two authors declared serving as investigators for or receiving honoraria or fees as consultants or advisory board members from various organizations, including AbbVie. The other authors declared no conflicts of interest.

Source: Rom H et al. The association between atopic dermatitis and inflammatory bowel disease in adults: A cross-sectional study in a specialized atopic dermatitis clinic. J Eur Acad Dermatol Venereol. 2023 (Dec 21). doi: 10.1111/jdv.19769

Key clinical point: Patients with atopic dermatitis (AD), especially moderate-to-severe AD, had an increased prevalence of inflammatory bowel disease (IBD).

Major finding: A significant association was observed between IBD and AD (adjusted odds ratio [aOR] 3.89; P = .0169); however, when stratified by AD severity, only moderate-to-severe AD was found to be associated with IBD (aOR 4.45; P = .0102).

Study details: Findings are from a retrospective observational study including 364 patients with AD and 725 matched control individuals without AD.

Disclosures: This study was sponsored by an independent investigator grant from AbbVie. Two authors declared serving as investigators for or receiving honoraria or fees as consultants or advisory board members from various organizations, including AbbVie. The other authors declared no conflicts of interest.

Source: Rom H et al. The association between atopic dermatitis and inflammatory bowel disease in adults: A cross-sectional study in a specialized atopic dermatitis clinic. J Eur Acad Dermatol Venereol. 2023 (Dec 21). doi: 10.1111/jdv.19769

Key clinical point: Patients with atopic dermatitis (AD), especially moderate-to-severe AD, had an increased prevalence of inflammatory bowel disease (IBD).

Major finding: A significant association was observed between IBD and AD (adjusted odds ratio [aOR] 3.89; P = .0169); however, when stratified by AD severity, only moderate-to-severe AD was found to be associated with IBD (aOR 4.45; P = .0102).

Study details: Findings are from a retrospective observational study including 364 patients with AD and 725 matched control individuals without AD.

Disclosures: This study was sponsored by an independent investigator grant from AbbVie. Two authors declared serving as investigators for or receiving honoraria or fees as consultants or advisory board members from various organizations, including AbbVie. The other authors declared no conflicts of interest.

Source: Rom H et al. The association between atopic dermatitis and inflammatory bowel disease in adults: A cross-sectional study in a specialized atopic dermatitis clinic. J Eur Acad Dermatol Venereol. 2023 (Dec 21). doi: 10.1111/jdv.19769

Key clinical point: The majority of tralokinumab-treated patients with moderate-to-severe atopic dermatitis (AD) attained physician- and patient-reported outcomes over 32 weeks of observation, highlighting the multidimensional efficacy of tralokinumab in real-world settings.

Major finding: The proportion of patients achieving a ≥75% improvement in the baseline Eczema Area and Severity Index (EASI) score increased significantly from 42% at week 4 to 76% at week 32 (P = .0075). A similar trend was observed for patient-reported outcomes. At week 16, at least one real-world therapeutic endpoint was achieved by 88% of patients treated with tralokinumab.

Study details: Findings are from a multicenter real-world retrospective cohort study including 194 patients with moderate-to-severe AD who were treated with tralokinumab for ≥16 weeks.

Disclosures: This study did not receive any funding. Several authors declared serving as speakers, consultants, or scientific advisors; receiving personal fees, speaker’s honoraria, or travel support, or having other ties with various pharmaceutical companies.

Source: Chiricozzi A et al for the MEDaCoTRA Study Group. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: Results from a multicentric, multinational, retrospective, cohort study. Expert Opin Biol Ther. 2023;23(12):1307-1315 (Dec 18). doi: 10.1080/14712598.2023.2292627

Key clinical point: The majority of tralokinumab-treated patients with moderate-to-severe atopic dermatitis (AD) attained physician- and patient-reported outcomes over 32 weeks of observation, highlighting the multidimensional efficacy of tralokinumab in real-world settings.

Major finding: The proportion of patients achieving a ≥75% improvement in the baseline Eczema Area and Severity Index (EASI) score increased significantly from 42% at week 4 to 76% at week 32 (P = .0075). A similar trend was observed for patient-reported outcomes. At week 16, at least one real-world therapeutic endpoint was achieved by 88% of patients treated with tralokinumab.

Study details: Findings are from a multicenter real-world retrospective cohort study including 194 patients with moderate-to-severe AD who were treated with tralokinumab for ≥16 weeks.

Disclosures: This study did not receive any funding. Several authors declared serving as speakers, consultants, or scientific advisors; receiving personal fees, speaker’s honoraria, or travel support, or having other ties with various pharmaceutical companies.

Source: Chiricozzi A et al for the MEDaCoTRA Study Group. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: Results from a multicentric, multinational, retrospective, cohort study. Expert Opin Biol Ther. 2023;23(12):1307-1315 (Dec 18). doi: 10.1080/14712598.2023.2292627

Key clinical point: The majority of tralokinumab-treated patients with moderate-to-severe atopic dermatitis (AD) attained physician- and patient-reported outcomes over 32 weeks of observation, highlighting the multidimensional efficacy of tralokinumab in real-world settings.

Major finding: The proportion of patients achieving a ≥75% improvement in the baseline Eczema Area and Severity Index (EASI) score increased significantly from 42% at week 4 to 76% at week 32 (P = .0075). A similar trend was observed for patient-reported outcomes. At week 16, at least one real-world therapeutic endpoint was achieved by 88% of patients treated with tralokinumab.

Study details: Findings are from a multicenter real-world retrospective cohort study including 194 patients with moderate-to-severe AD who were treated with tralokinumab for ≥16 weeks.

Disclosures: This study did not receive any funding. Several authors declared serving as speakers, consultants, or scientific advisors; receiving personal fees, speaker’s honoraria, or travel support, or having other ties with various pharmaceutical companies.

Source: Chiricozzi A et al for the MEDaCoTRA Study Group. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: Results from a multicentric, multinational, retrospective, cohort study. Expert Opin Biol Ther. 2023;23(12):1307-1315 (Dec 18). doi: 10.1080/14712598.2023.2292627

Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib treatment over 12 weeks significantly decreased the cutaneous expression of selected genes involved in inflammation, epidermal hyperplasia, and T-helper (Th) 2 and Th22 immune responses in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Compared with placebo, 12-week abrocitinib treatment led to a dose-dependent reduction in the cutaneous expression of genes involved in inflammation (MMP-12), epidermal hyperplasia (KRT16), Th2 (CCL17 and CCL18), and Th22 (S100A8, S100A9, and S100A12) responses (all P < .05).

Study details: Findings are from the phase 2a JADE MOA trial including patients with moderate-to-severe AD who were randomly assigned to receive 100 mg (n = 16) or 200 mg (n = 14) abrocitinib monotherapy or placebo (n = 16) daily for 12 weeks.

Disclosures: This study was sponsored by Pfizer Inc. Several authors declared being on the advisory board of; serving as consultants, advisors, or speakers for; or receiving honoraria or grants from Pfizer or others. Seven authors declared being current or former employees and shareholders of Pfizer.

Source: Guttman-Yassky E et al. Effect of abrocitinib on skin biomarkers in patients with moderate-to-severe atopic dermatitis. Allergy. 2023 (Dec 18). doi: 10.1111/all.15969

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Abrocitinib as monotherapy or in combination with topical therapy improves skin pain in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: Abrocitinib vs placebo led to a significantly greater dose-dependent least squares mean change in Pruritus and Symptoms Assessment for AD (PSAAD) skin pain score from baseline to as early as week 1 that were sustained through week 12 or 16 (nominal P < .05). A greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score < 2) with abrocitinib vs placebo (nominal P < .05).

Study details: This post hoc analysis of five phase 2/3 trials included 1822 patients with moderate-to-severe AD (age ≥ 12 years) treated with 100 mg or 200 mg abrocitinib as monotherapy or in combination with topical therapy or placebo for 12 or 16 weeks.

Disclosures: This study was funded by Pfizer Inc., USA. Six authors declared being employees and stockholders of Pfizer. The other authors declared receiving research or travel grants or having other ties with various sources, including Pfizer.

Source: Thyssen JP et al. Abrocitinib provides rapid and sustained improvement in skin pain and is associated with improved quality of life outcomes in adult and adolescent patients with moderate-to-severe atopic dermatitis. Dermatology. 2023 (Dec 11). doi: 10.1159/000535285

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: Allergic contact dermatitis (ACD) is an important comorbidity in patients with atopic dermatitis (AD) and leads to the maintenance and aggravation of their dermatosis, with a high frequency of ACD observed to textile dyes, isothiazolinones, and fragrances.

Major finding: Contact sensitization was significantly associated with facial involvement (P = .04) and a longer duration of AD (P = .005). The most frequent allergen was textile dye mix (24.70%) followed by nickel (20.21%), cobalt (12.70%), and methylchlorisothiazolinone+methylisothiazolinone (8.50%). The avoidance of relevant allergens led to a significant reduction in the Scoring of Atopic Dermatitis (SCORAD) scores at 6 months (P < .001).

Study details: This longitudinal prospective study included 93 patients with AD (age > 2 years) who were patch-tested with the 2019 European baseline series and the corticosteroid series, 60.2% of whom had positive patch test results.

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

Source: Trimeche K et al. Contact allergy in atopic dermatitis: A prospective study on prevalence, incriminated allergens and clinical insights. Contact Dermatitis. 2023 (Dec 27). doi: 10.1111/cod.14494

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: The overall improvement in skin clearance and itch reduction suggested a preference for 30 mg upadacitinib over dupilumab and that for 15 mg or 30 mg upadacitinib over placebo in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 24, the aggregate response benefit for skin clearance and itch, respectively, was 32.5% and 25.8% higher with 30 mg upadacitinib vs dupilumab. The benefit favored upadacitinib over dupilumab as early as week 4. Moreover, 15 and 30 mg upadacitinib showed similar benefits over placebo.

Study details: This post hoc analysis of the data from phase 3 studies (Heads Up, Measure Up 1, and Measure Up 2) included 2356 patients with moderate-to-severe AD who received upadacitinib, dupilumab, or placebo.

Disclosures: This study was sponsored by AbbVie. Five authors declared being employees of or owning stock or stock options in AbbVie. Several authors declared being consultants, speakers, or advisors of or having other ties with various sources, including AbbVie.

Source: Silverberg JI et al. Aggregate response benefit in skin clearance and itch reduction with upadacitinib or dupilumab in patients with moderate-to-severe atopic dermatitis. Dermatitis. 2023 (Dec 18). doi: 10.1089/derm.2023.0153

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924

Key clinical point: Rademikibart administered at 2-week (Q2W) and 4-week (Q4W) intervals was well-tolerated and effective in improving the overall symptoms in adults with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the least squares mean percent reductions in the Eczema Area Severity Index scores with 300 mg Q2W (−63.0%; P = .0007), 150 mg Q2W (−57.6%; P = .0067), and 300 mg Q4W (−63.5%; P = .0004) rademikibart were significantly higher than that with placebo (−39.7%). Treatment-emergent adverse event rates were similar with rademikibart (48.2%) and placebo (53.6%).

Study details: This phase 2 trial included 226 anti-interleukin (IL)-4Ra/IL-13 treatment-naive adults with moderate-to-severe AD who were randomly assigned (1:1:1:1) to receive rademikibart (300 mg Q2W, 150 mg Q2W, or 300 mg Q4W) or placebo for 16 weeks following a 600 mg loading dose of rademikibart or placebo, respectively, on day 1.

Disclosures: This study was funded by Connect Biopharma. Ten authors declared being employees or shareholders of Connect Biopharma. The other authors declared being consultants of or having other ties with various sources, including Connect Biopharma.

Source: Silverberg JI et al. Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4Rα, in adults with moderate-to-severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2023 (Dec 27). doi: 10.1016/j.jaci.2023.11.924