Atopic Dermatitis

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

All atopic diseases, as well as environmental and parental factors, appear to be linked with hand eczema (HE), a longitudinal study from Finland has shown.

“In this population-based study, all atopic diseases, not only atopic dermatitis, were found as individual risk factors for HE. In addition, female gender, obesity and mold exposure increased the risk of HE,” wrote Marjut Koskelo, MD, and her colleagues at the University of Oulu in Finland. Their report was published in Contact Dermatitis.

“Parental allergy was also a risk factor of offspring’s HE. Moderate or high physical activity as well as owning a dog appeared as protective factors of HE. No association was found between other lifestyle factors and HE,” they added.

Hand eczema is one of the most common skin disorders and is the most common occupational skin disease, the authors wrote. Many risk factors, including atopic dermatitis, are known to be linked with HE, but whether various other factors might also be linked has not been well studied.

The research team investigated the link between HE and atopic diseases, parental factors, environmental factors (exposure to mold, keeping animals), and lifestyle factors (physical activity, obesity, tobacco and alcohol use).

They analyzed data of people who took part in the Northern Finland Birth Cohort 1966 Study. The data, collected since 1965, includes details about 12,055 mothers in northern Finland who were expected to deliver babies in 1966, and their 12,058 live-born children. The children have been followed over the years with questionnaires and clinical examinations, and their parents have been followed by national registers and medical reports.

For the 46-year follow-up, 6,830 respondents aged 45-46 years, roughly half of them women, completed a 132-question form covering physical health, lifestyle, environmental factors, socioeconomic status, and history of hand eczema and other atopic diseases.

In the statistical analysis, the researchers adjusted for atopic dermatitis, asthma, allergic rhinoconjunctivitis, education level, body mass index, maternal BMI, parental allergy, physical activity, living on a farm, and mold exposure and symptoms.

Of the 900 respondents who reported having had HE, 592 (65.8%) were women and 308 (34.2%) were men (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.49-2.0).
 

Various factors linked with hand eczema risk

The authors found the following:

• Atopic diseases and HE were linked: atopic dermatitis (adjusted odds ratio [aOR], 9.66; 95% CI, 8.03-11.66), asthma (aOR, 1.38; 95% CI, 1.12-1.71), and allergic rhinoconjunctivitis (aOR, 1.28; 95% CI, 1.04-1.56). Sex did not affect the link between atopic diseases and HE.
• Respondents who reported visible mold or mold odor in their apartments had higher risk for HE than did those without a history of mold exposure (OR, 1.32; 95% CI, 1.07-1.61).
• Obesity was linked with HE (OR, 3.44; 95% CI, 1.05-22.8), but smoking status, alcohol intake, and education level were not statistically significant risk factors for HE.
• Participants who reported moderate or high physical activity had lower risk for HE (OR, 0.78; 95% CI, 0.64-0.94; and OR, 0.56; 95% CI, 0.33-0.91, respectively) than those who were less active.
• Parental allergy increased risk for HE (OR, 1.98; 95% CI, 1.70-2.30); as maternal age, BMI, and menarche age increased, so did the risk for the child’s HE, but the increases were not statistically significant; and no significant links were found between maternal tobacco smoking, parental asthma, birth weight, parity, gestational age, and HE.
• Dog owners had less risk for HE than did people without a dog (OR, 0.83; 95% CI, 0.71-0.97); links between cat or farm animal owners and HE were not significant.

“There is a strong association between hand eczema and atopic diseases,” Maya Jonas, MD, clinical assistant professor of dermatology at The Ohio State University Wexner Medical Center in Columbus, told this news organization.

“When evaluating patients with hand eczema, it is important to ask if they have a history of atopic dermatitis, asthma, or allergic rhinitis,” said Dr. Jonas, who was not involved in the study.

Elma Baron, MD, professor and director, Skin Study Center, department of dermatology, Case Western Reserve University, Cleveland, was surprised by the inverse link between physical activity and HE. 

“What struck me as interesting is the inverse association between hand eczema and physical activity, that greater physical activity will decrease the risk for hand eczema,” she said in an interview. “It’s an interesting finding that’s worth exploring.

“Dermatologists have also speculated about the association with the female gender, because women are more likely to be in situations that involve frequent hand washing or in occupations, such as hairdressing, that involve known irritants and allergens,” added Dr. Baron, who was not involved in the study.

The main weakness, she noted, is the reliance on self-reported diagnosis. “Hand eczema is a common condition, but the etiologies of reported hand eczema may vary.

“Being cognizant of these associations can help us prescribe appropriate medications and advise patients about how they can avoid exposures that will aggravate their condition,” Dr. Baron advised.

The authors recommend further related studies.

The authors, Dr. Jonas, and Dr. Baron report no relevant financial relationships. The study was not funded.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that twice-daily application of emollients within the first 8 weeks of life significantly reduces the cumulative incidence of atopic dermatitis (AD) among infants at high risk for the condition, at least within the first year of life.

The single-center STOP-AD clinical trial recruited term infants within 4 days of birth who were at high risk for AD, as determined on the basis of a parent-reported history of the disease or asthma or allergic rhinitis. Infants were randomly assigned to undergo either a standard skin care routine (control group; n = 160) or twice-daily emollient application for the first 8 weeks of life (intervention group; n = 161).

In the intervention group, infants received an emollient that was specifically formulated for AD-prone skin. The control group received standard skin care advice, which did not include specific advice on bathing frequency or regular emollient use.

The mean age of the infants at randomization was 1.9 days. A total of 41 infants in the intervention group and 20 infants in the control group were withdrawn from the study. Most withdrawals (80%) occurred prior to the 2-week visit.

At 12 months, the cumulative incidence of AD was 32.8% in the intervention group and 46.4% in the control group (P = .036). The investigators note that daily emollient use was associated with a 29% lower risk of cumulative AD at 1 year in comparison with the control intervention.

No significant difference was observed between the groups regarding the incidence of parent-reported skin infections during the treatment period (5.0% vs. 5.7%; P > .05).

Study investigator Jonathan O’Brien Hourihane, MBBS, of the Royal College of Surgeons in Dublin, said in an interview that previously published findings from the BASELINE study supported the rationale for the early use of emollients in infancy to prevent AD.

The investigators of the BASELINE study found that skin barrier function, as measured by transepidermal water loss, increased from birth to 8 weeks but then became stable at 6 months. These observations suggest that the period during early infancy “could be a critical window in which to protect the skin barrier” of infants at risk for AD, Dr. Hourihane added.

Dr. Hourihane, who serves as the head of department of pediatrics at the Royal College of Surgeons, explained that the long-term clinical burden of AD is often more significant if the condition begins earlier in life, underscoring the importance of early prevention and control.

“The casual role [of AD] in other allergic conditions remains suspected but not proven, but its association is clear,” he said. He noted that infants with eczema “also have poorer sleep, and the condition causes increased family disruption,” highlighting the far-reaching burden of AD.

Commenting on the study, Adelaide Hebert, MD, professor of pediatric dermatology at the University of Texas, Houston, said in an interview that the barrier defect observed in AD is one of the prime areas to address as a means of controlling the chronic, relapsing disorder. She noted that the use of emollients can repair this defective barrier.

“Early initiation of emollients has the potential to reduce dryness, itching, transgression of allergens, and infectious agents,” explained Dr. Hebert, who wasn’t involved in the study. “Emollient application also allows the parent to inspect the skin surface and address any challenges in a timely manner.”

In the STOP-AD trial, Dr. Hourihane and colleagues also found that, among patients with loss-of-function (LoF) mutations in the filaggrin gene (FLG), the prevalence of AD at 6 and 12 months seemed to be a higher than among patients with the wild-type gene, but the difference did not reach statistical significance.

Commenting on this finding, Dr. Hebert noted that LoF FLG mutation carriers may benefit especially from emollient use, given that LoF mutations in FLG is associated with reduced production of natural moisturizing factors in the skin.

Regarding future research directions, Dr. Hourihane stated that there is a need for replication and validation of the findings in studies that include infants from different ethnic backgrounds as well as those from various social settings. These studies should also include variable treatment windows to determine both short- and longer-term effects of emollient use in this population, Dr. Hourihane explained.

Dr. Hourihane added that he and the investigators do not yet understand which aspect of the study’s program was key for reducing the incidence of AD in the first year of life. “The timing of emollient initiation, the duration of treatment, the products, or maybe just a combination of these” could be possible explanations.

The study was independently supported. Dr. Hourihand reported receiving grant funding from Aimmune Therapeutics and DBV Technologies. Dr. Hebert reported no relevant financial relationships.

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

The Janus kinase (JAK) family has become a popular target for novel drug development. There are four JAK subunits, JAK1, JAK2, JAK3, and TYK2, each playing different roles in vital immunologic, hematologic, and homeostatic functions. A wide array of topical JAK-inhibitors has been or are currently being investigated for the treatment of AD, each with different profiles of selectivity across the JAK family.

Ruxolitinib is a preferential JAK1 and JAK2 inhibitor. Oral ruxolitinib is currently approved for the treatment of myelofibrosis. Topical ruxolitinib cream is also approved in the United States for the treatment of mild-to-moderate AD and, more recently, vitiligo.

Blauvelt and colleagues published the findings from a post hoc analysis of data related to itch responses from two randomized, double-blind, vehicle-controlled, phase 3 studies of patients with mild-to-moderate AD. Topical ruxolitinib applied twice daily led to a significant increase in the proportion of patients achieving at least a 2-point or 4-point reduction in Peak Pruritus Numeric Rating Scale (PP-NRS) within 12 hours of initial application and continued improvements out to week 8. Patients treated with ruxolitinib cream were also significantly more likely to achieve an itch-free state and faster reductions in itch compared with vehicle. Rapid improvement of itch is an important feature for any topical therapy that may be used as needed for AD flares.

Brepocitinib is a preferential JAK1 and tyrosine kinase 2 inhibitor. Oral brepocitinib is currently under investigation for several immune-mediated disorders, including dermatomyositis and lupus. Topical brepocitinib cream was also studied in a randomized, double-blind, vehicle-controlled, phase 2 study of patients with mild-to-moderate AD. Brepocitinib cream applied daily or twice daily led to significant decreases in the Eczema Area and Severity Index (EASI), increases in the proportion of patients who achieved Investigator Global Assessment (IGA) scores of clear or almost clear, EASI-75 responses, and 2-point or 4-point reductions in PP-NRS. Overall, topical brepocitinib was well tolerated. Though more studies are needed, topical brepocitinib may become an important addition to our toolbox for managing AD and perhaps other chronic inflammatory skin diseases.

Let's move along to yet another novel mechanism studied in AD: ectoine. Ectoine is a naturally derived chemical from some bacteria that can act as an osmolyte and protect organisms from osmotic stress. It is used in some skin care products because it can protect against xerosis and ultraviolet exposure. Alexopoulos and colleagues published the results of a randomized, single-blind, vehicle-controlled study of a novel cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) in children with mild-to-moderate AD. At week 4, application of EHA cream led to significant decreases in SCORing AD (SCORAD) and IGA scores compared with vehicle cream as well all secondary outcome measures. EHA cream was well-tolerated overall, with most adverse events being cutaneous and mild.

All of these topical agents were studied as "reactive" therapies, ie, to be applied to active AD lesions. It would be nice to have approaches that can also prevent AD. Ní Chaoimh and colleagues published findings from the STOP AD trial that examined whether routine application of emollients in the first 8 weeks of life can prevent AD at age 12 months. They found that early emollient use resulted in significantly lower incidence of AD and similar rates of skin infections at age 12 months. Previous studies found mixed results regarding the efficacy of routine application of emollients in newborns. Though more studies are needed, these results are promising and suggest that early life use of emollients could be a cheap, feasible, and effective option to prevent AD.

The Janus kinase (JAK) family has become a popular target for novel drug development. There are four JAK subunits, JAK1, JAK2, JAK3, and TYK2, each playing different roles in vital immunologic, hematologic, and homeostatic functions. A wide array of topical JAK-inhibitors has been or are currently being investigated for the treatment of AD, each with different profiles of selectivity across the JAK family.

Ruxolitinib is a preferential JAK1 and JAK2 inhibitor. Oral ruxolitinib is currently approved for the treatment of myelofibrosis. Topical ruxolitinib cream is also approved in the United States for the treatment of mild-to-moderate AD and, more recently, vitiligo.

Blauvelt and colleagues published the findings from a post hoc analysis of data related to itch responses from two randomized, double-blind, vehicle-controlled, phase 3 studies of patients with mild-to-moderate AD. Topical ruxolitinib applied twice daily led to a significant increase in the proportion of patients achieving at least a 2-point or 4-point reduction in Peak Pruritus Numeric Rating Scale (PP-NRS) within 12 hours of initial application and continued improvements out to week 8. Patients treated with ruxolitinib cream were also significantly more likely to achieve an itch-free state and faster reductions in itch compared with vehicle. Rapid improvement of itch is an important feature for any topical therapy that may be used as needed for AD flares.

Brepocitinib is a preferential JAK1 and tyrosine kinase 2 inhibitor. Oral brepocitinib is currently under investigation for several immune-mediated disorders, including dermatomyositis and lupus. Topical brepocitinib cream was also studied in a randomized, double-blind, vehicle-controlled, phase 2 study of patients with mild-to-moderate AD. Brepocitinib cream applied daily or twice daily led to significant decreases in the Eczema Area and Severity Index (EASI), increases in the proportion of patients who achieved Investigator Global Assessment (IGA) scores of clear or almost clear, EASI-75 responses, and 2-point or 4-point reductions in PP-NRS. Overall, topical brepocitinib was well tolerated. Though more studies are needed, topical brepocitinib may become an important addition to our toolbox for managing AD and perhaps other chronic inflammatory skin diseases.

Let's move along to yet another novel mechanism studied in AD: ectoine. Ectoine is a naturally derived chemical from some bacteria that can act as an osmolyte and protect organisms from osmotic stress. It is used in some skin care products because it can protect against xerosis and ultraviolet exposure. Alexopoulos and colleagues published the results of a randomized, single-blind, vehicle-controlled study of a novel cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) in children with mild-to-moderate AD. At week 4, application of EHA cream led to significant decreases in SCORing AD (SCORAD) and IGA scores compared with vehicle cream as well all secondary outcome measures. EHA cream was well-tolerated overall, with most adverse events being cutaneous and mild.

All of these topical agents were studied as "reactive" therapies, ie, to be applied to active AD lesions. It would be nice to have approaches that can also prevent AD. Ní Chaoimh and colleagues published findings from the STOP AD trial that examined whether routine application of emollients in the first 8 weeks of life can prevent AD at age 12 months. They found that early emollient use resulted in significantly lower incidence of AD and similar rates of skin infections at age 12 months. Previous studies found mixed results regarding the efficacy of routine application of emollients in newborns. Though more studies are needed, these results are promising and suggest that early life use of emollients could be a cheap, feasible, and effective option to prevent AD.

The Janus kinase (JAK) family has become a popular target for novel drug development. There are four JAK subunits, JAK1, JAK2, JAK3, and TYK2, each playing different roles in vital immunologic, hematologic, and homeostatic functions. A wide array of topical JAK-inhibitors has been or are currently being investigated for the treatment of AD, each with different profiles of selectivity across the JAK family.

Ruxolitinib is a preferential JAK1 and JAK2 inhibitor. Oral ruxolitinib is currently approved for the treatment of myelofibrosis. Topical ruxolitinib cream is also approved in the United States for the treatment of mild-to-moderate AD and, more recently, vitiligo.

Blauvelt and colleagues published the findings from a post hoc analysis of data related to itch responses from two randomized, double-blind, vehicle-controlled, phase 3 studies of patients with mild-to-moderate AD. Topical ruxolitinib applied twice daily led to a significant increase in the proportion of patients achieving at least a 2-point or 4-point reduction in Peak Pruritus Numeric Rating Scale (PP-NRS) within 12 hours of initial application and continued improvements out to week 8. Patients treated with ruxolitinib cream were also significantly more likely to achieve an itch-free state and faster reductions in itch compared with vehicle. Rapid improvement of itch is an important feature for any topical therapy that may be used as needed for AD flares.

Brepocitinib is a preferential JAK1 and tyrosine kinase 2 inhibitor. Oral brepocitinib is currently under investigation for several immune-mediated disorders, including dermatomyositis and lupus. Topical brepocitinib cream was also studied in a randomized, double-blind, vehicle-controlled, phase 2 study of patients with mild-to-moderate AD. Brepocitinib cream applied daily or twice daily led to significant decreases in the Eczema Area and Severity Index (EASI), increases in the proportion of patients who achieved Investigator Global Assessment (IGA) scores of clear or almost clear, EASI-75 responses, and 2-point or 4-point reductions in PP-NRS. Overall, topical brepocitinib was well tolerated. Though more studies are needed, topical brepocitinib may become an important addition to our toolbox for managing AD and perhaps other chronic inflammatory skin diseases.

Let's move along to yet another novel mechanism studied in AD: ectoine. Ectoine is a naturally derived chemical from some bacteria that can act as an osmolyte and protect organisms from osmotic stress. It is used in some skin care products because it can protect against xerosis and ultraviolet exposure. Alexopoulos and colleagues published the results of a randomized, single-blind, vehicle-controlled study of a novel cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) in children with mild-to-moderate AD. At week 4, application of EHA cream led to significant decreases in SCORing AD (SCORAD) and IGA scores compared with vehicle cream as well all secondary outcome measures. EHA cream was well-tolerated overall, with most adverse events being cutaneous and mild.

All of these topical agents were studied as "reactive" therapies, ie, to be applied to active AD lesions. It would be nice to have approaches that can also prevent AD. Ní Chaoimh and colleagues published findings from the STOP AD trial that examined whether routine application of emollients in the first 8 weeks of life can prevent AD at age 12 months. They found that early emollient use resulted in significantly lower incidence of AD and similar rates of skin infections at age 12 months. Previous studies found mixed results regarding the efficacy of routine application of emollients in newborns. Though more studies are needed, these results are promising and suggest that early life use of emollients could be a cheap, feasible, and effective option to prevent AD.

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617

Let's start with tralokinumab. I previously had the privilege of being lead author on a study of the efficacy of tralokinumab beyond week 16 — the ECZTRA3 study.¹ ECZTRA3 studied tralokinumab at the approved dose (600 mg loading dose followed by 300 mg every other week) vs placebo with concomitant topical corticosteroids (TCS) for an initial 16-week treatment period. Patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 or 75% improvement in the Eczema Area and Severity Index (EASI-75) response were then randomly assigned again to receive 300 mg tralokinumab either continuously at every-other-week intervals or a prolonged interval of every 4 weeks (again with concomitant TCS).

With ECZTRA3, we found that patients continued to improve on tralokinumab + TCS well beyond week 16, with increased EASI-75 responses (week 16: 56%; week 32: 70.2%) and sustained or increased improvement across multiple patient-reported outcomes. Together, these results indicate that clinical responses may take more than 16 weeks to achieve with tralokinumab. In addition, some patients may be able to maintain clinical responses using fewer injections at 4-week intervals. This may allow tailoring dosing to individual patient needs. In fact, tralokinumab is approved in the United States and other regions with the option of every-2-week or every-4-week maintenance dosing in patients who have a good clinical response at week 16.

Since AD can be a lifelong disease, we expect that some patients will need to remain on various therapies for extended periods of time, perhaps many years, in order to maintain long-term control. It is imperative that any long-term treatment demonstrate a good long-term safety and efficacy profile. Blauvelt and colleagues published 2-year interim results from the ongoing ECZTEND long-term, open-label extension study of tralokinumab. They showed no new safety signals and stable rates of adverse events compared with earlier time points. Additionally, they showed that 82.5% of patients treated with open-label tralokinumab + TCS for 2 years maintained EASI-75 responses. These data are reassuring and support the potential use of tralokinumab as a long-term treatment option in AD.

While dupilumab is not approved for every-4-week maintenance dosing, a recent study by Spekhorst and colleagues confirmed that dupilumab can also be safely and effectively administered at intervals of every 4 weeks or every 6-8 weeks. Analyzing data from the BioDay real-world observational registry, they found that among patients who achieved good clinical responses (EASI scores ≤ 7) after 52 weeks of treatment with dupilumab administered every 2 weeks, many patients were able to maintain those responses at 3 months after the interval of administration was increased to every 4 weeks (> 80%) or 6-8 weeks (93.3%). These real-world data confirm the results previously observed in the phase 3 SOLO-CONTINUE study² and support the use of maintenance dosing of dupilumab at prolonged intervals, though such use would technically be considered off-label.

Let’s also review some new data for abrocitinib, a once-daily oral preferential Janus kinase (JAK) 1 inhibitor. Reich and colleagues reported results from a phase 3 trial of adults with moderate-to-severe AD that compared the safety and efficacy of oral abrocitinib at the higher 200 mg dose vs subcutaneous dupilumab over 26 weeks. They found that more patients achieved ≥ 4-point improvement in the Peak Pruritus Numerical Rating Scale score at week 2 with 200 mg abrocitinib compared with 300 mg dupilumab every other week (48% vs 26%). There were also improved EASI-90 responses at week 4 (29% vs 15%). A dose of 200 mg abrocitinib was also significantly more effective than dupilumab for a number of additional investigator- and patient-reported outcomes. In general, abrocitinib had a faster onset of treatment benefit than dupilumab. However, treatment-emergent adverse events were more common with abrocitinib compared with dupilumab (74% vs 65%). Dupilumab was associated with more ocular adverse events (eg, conjunctivitis), whereas abrocitinib was associated with more headaches, nausea, and herpes zoster infections. These results provide important insights into the comparative effectiveness of treatments in moderate-to-severe AD. Of note, this study compared the higher dose of abrocitinib (200 mg) vs dupilumab. However, in the United States, the FDA-approved label recommends initiating abrocitinib therapy with the lower 100 mg dose and increasing to 200 mg only in those who had an inadequate response to 100 mg.

Additional References

1. Silverberg JI, Toth D, Bieber T, et al, for the ECZTRA 3 study investigators. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: Results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463. Doi: 10.1111/bjd.19573

2. Worm M, Simpson EL, Thaçi D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients with atopic dermatitis: A randomized clinical trial. JAMA Dermatol. 2020;156(2):131-143. Doi: 10.1001/jamadermatol.2019.3617

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015