User login
BREEZE-AD-PEDS: First data for baricitinib in childhood eczema reported
The oral Janus kinase
After 16 weeks of treatment, the primary endpoint – an Investigators Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline – was met by 41.7% of patients given 2 mg (those younger than age 10) or 4 mg of baricitinib (those aged 10-17 years), the highest dose studied in each of those two age groups.
By comparison, the primary endpoint was met in 16.4% of children in the placebo group (P < .001).
Baricitinib is approved for the treatment of AD in adults in many countries, Antonio Torrelo, MD, of the Hospital Infantil Niño Jesús, Madrid, said at the annual congress of the European Academy of Dermatology and Venereology. It was approved by the U.S. Food and Drug Administration for treating adults with severe alopecia areata in June and is under FDA review for the treatment of AD.
The phase 3 BREEZE-AD-PEDS trial
BREEZE-AD-PEDS was a randomized, double-blind trial that evaluated the safety and efficacy of baricitinib in 483 children and adolescents with moderate to severe AD. Participants were aged 2-17 years. Those aged 2-5 years had been diagnosed with AD for at least 6 months; if they were older, they had been diagnosed for at least 12 months.
Three dosing levels of baricitinib were tested: 121 patients were given a low dose, which was 0.5 mg/day in children aged 2 to less than 10 years and 1 mg/day in those aged 10 to less than 18 years. A medium dose – 1 mg/day in the younger children and 2 mg/day in the older children – was given to 120 children, while a high dose – 2 mg/day and 4 mg/day, respectively – was given to another 120 children.
Topical treatments were permitted, although for entry into the trial, participants had to have had an inadequate response to steroids and an inadequate or no response to topical calcineurin inhibitors. In all groups, age, gender, race, geographic region, age at diagnosis of AD, and duration of AD “were more or less similar,” Dr. Torello said.
Good results, but only with highest dose
The primary IGA endpoint was reached by 25.8% of children in the medium-dose group and by 18.2% in the low-dose group. Neither result was statistically significant in comparison with placebo (16.4%).
When breaking down the results between different ages, “the results in the IGA scores are consistent in both age subgroups – below 10 years and over 10 years,” Dr. Torello noted. The results are also consistent across body weights (< 20 kg, 20-60 kg, and > 60 kg), he added.
Among those treated with the high dose of baricitinib, Eczema Area and Severity Index (EASI) 75% and 95% improvement scores were reached in 52.5% and 30% of patients, respectively. Corresponding figures for the medium dose were 40% and 21.7%; for the low baricitinib dose, 32.2% and 11.6%; and for placebo, 32% and 12.3%. Again, only the results for the highest baricitinib dose were significant in comparison with placebo.
A similar pattern was seen for improvement in itch, and there was a 75% improvement in Scoring Atopic Dermatitis (SCORAD75) results.
Safety of baricitinib in children
The labeling for JAK inhibitors that have been approved to date, including baricitinib, include a boxed warning regarding risks for thrombosis, major adverse cardiovascular events, and all-cause mortality. The warning is based on use by patients with rheumatoid arthritis.
Dr. Torello summarized baricitinib’s safety profile in the trial as being “consistent with the well-known safety profile for baricitinib in adults with moderate to severe atopic dermatitis.”
In the study, no severe adverse effects were noted, and no new safety signals were observed, he said. The rate of any treatment-emergent effect among patients was around 50% and was similar across all baricitinib and placebo groups. Study discontinuations because of a side effect were more frequent in the placebo arm (1.6% of patients) than in the baricitinib low-, medium-, and high-dose arms (0.8%, 0%, and 0.8%, respectively).
There were no cases of deep-vein thrombosis, pulmonary embolism, or other adverse effects of special interest, including major adverse cardiovascular events, gastrointestinal perforations, and opportunistic infections, Dr. Torrelo said.
No patient experienced elevations in liver enzyme levels, although there were some cases of elevated creatinine phosphokinase levels (16% in the placebo group and 19% in the baricitinib arms altogether) that were not from muscle injury. There was a possible increase in low-density cholesterol level (3.3% of those taking placebo vs. 10.1% of baricitinib-treated patients).
Is there a role for baricitinib?
“Baricitinib is a potential therapeutic option with a favorable benefit-to-risk profile for children between 2 and 18 years who have moderate to severe atopic dermatitis, and candidates for systemic therapy,” Dr. Torrelo said. “No single drug is capable to treat every patient with atopic dermatitis,” he added in discussing the possible place of baricitinib in pediatric practice.
“There are patients who do not respond to dupilumab, who apparently respond later to JAK inhibitors,” he noted.
“We are trying to work phenotypically, trying to learn what kind of patients – especially children who have a more heterogeneous disease than adults – can be better treated with JAK inhibitors or dupilumab.” There may be other important considerations in choosing a treatment in children, Dr. Torrelo said, including that JAK inhibitors can be given orally, while dupilumab is administered by injection.
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in Irvine, Calif., pointed out that “only the higher dose is significantly more effective than placebo.”
In his view, “the potentially severe adverse events are not worth the risk compared to more effective agents, such as dupilumab, in this pediatric population,” added Dr. Wu, who recently authored a review of the role of JAK inhibitors in skin disease. He was not involved with the baricitinib study.
The study was funded by Eli Lilly in collaboration with Incyte. Dr. Torello has participated in advisory boards and/or has served as a principal investigator in clinical trials for AbbVie, Eli Lilly and Company, Novartis, Pfizer, Pierre Fabre, and Sanofi. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
The oral Janus kinase
After 16 weeks of treatment, the primary endpoint – an Investigators Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline – was met by 41.7% of patients given 2 mg (those younger than age 10) or 4 mg of baricitinib (those aged 10-17 years), the highest dose studied in each of those two age groups.
By comparison, the primary endpoint was met in 16.4% of children in the placebo group (P < .001).
Baricitinib is approved for the treatment of AD in adults in many countries, Antonio Torrelo, MD, of the Hospital Infantil Niño Jesús, Madrid, said at the annual congress of the European Academy of Dermatology and Venereology. It was approved by the U.S. Food and Drug Administration for treating adults with severe alopecia areata in June and is under FDA review for the treatment of AD.
The phase 3 BREEZE-AD-PEDS trial
BREEZE-AD-PEDS was a randomized, double-blind trial that evaluated the safety and efficacy of baricitinib in 483 children and adolescents with moderate to severe AD. Participants were aged 2-17 years. Those aged 2-5 years had been diagnosed with AD for at least 6 months; if they were older, they had been diagnosed for at least 12 months.
Three dosing levels of baricitinib were tested: 121 patients were given a low dose, which was 0.5 mg/day in children aged 2 to less than 10 years and 1 mg/day in those aged 10 to less than 18 years. A medium dose – 1 mg/day in the younger children and 2 mg/day in the older children – was given to 120 children, while a high dose – 2 mg/day and 4 mg/day, respectively – was given to another 120 children.
Topical treatments were permitted, although for entry into the trial, participants had to have had an inadequate response to steroids and an inadequate or no response to topical calcineurin inhibitors. In all groups, age, gender, race, geographic region, age at diagnosis of AD, and duration of AD “were more or less similar,” Dr. Torello said.
Good results, but only with highest dose
The primary IGA endpoint was reached by 25.8% of children in the medium-dose group and by 18.2% in the low-dose group. Neither result was statistically significant in comparison with placebo (16.4%).
When breaking down the results between different ages, “the results in the IGA scores are consistent in both age subgroups – below 10 years and over 10 years,” Dr. Torello noted. The results are also consistent across body weights (< 20 kg, 20-60 kg, and > 60 kg), he added.
Among those treated with the high dose of baricitinib, Eczema Area and Severity Index (EASI) 75% and 95% improvement scores were reached in 52.5% and 30% of patients, respectively. Corresponding figures for the medium dose were 40% and 21.7%; for the low baricitinib dose, 32.2% and 11.6%; and for placebo, 32% and 12.3%. Again, only the results for the highest baricitinib dose were significant in comparison with placebo.
A similar pattern was seen for improvement in itch, and there was a 75% improvement in Scoring Atopic Dermatitis (SCORAD75) results.
Safety of baricitinib in children
The labeling for JAK inhibitors that have been approved to date, including baricitinib, include a boxed warning regarding risks for thrombosis, major adverse cardiovascular events, and all-cause mortality. The warning is based on use by patients with rheumatoid arthritis.
Dr. Torello summarized baricitinib’s safety profile in the trial as being “consistent with the well-known safety profile for baricitinib in adults with moderate to severe atopic dermatitis.”
In the study, no severe adverse effects were noted, and no new safety signals were observed, he said. The rate of any treatment-emergent effect among patients was around 50% and was similar across all baricitinib and placebo groups. Study discontinuations because of a side effect were more frequent in the placebo arm (1.6% of patients) than in the baricitinib low-, medium-, and high-dose arms (0.8%, 0%, and 0.8%, respectively).
There were no cases of deep-vein thrombosis, pulmonary embolism, or other adverse effects of special interest, including major adverse cardiovascular events, gastrointestinal perforations, and opportunistic infections, Dr. Torrelo said.
No patient experienced elevations in liver enzyme levels, although there were some cases of elevated creatinine phosphokinase levels (16% in the placebo group and 19% in the baricitinib arms altogether) that were not from muscle injury. There was a possible increase in low-density cholesterol level (3.3% of those taking placebo vs. 10.1% of baricitinib-treated patients).
Is there a role for baricitinib?
“Baricitinib is a potential therapeutic option with a favorable benefit-to-risk profile for children between 2 and 18 years who have moderate to severe atopic dermatitis, and candidates for systemic therapy,” Dr. Torrelo said. “No single drug is capable to treat every patient with atopic dermatitis,” he added in discussing the possible place of baricitinib in pediatric practice.
“There are patients who do not respond to dupilumab, who apparently respond later to JAK inhibitors,” he noted.
“We are trying to work phenotypically, trying to learn what kind of patients – especially children who have a more heterogeneous disease than adults – can be better treated with JAK inhibitors or dupilumab.” There may be other important considerations in choosing a treatment in children, Dr. Torrelo said, including that JAK inhibitors can be given orally, while dupilumab is administered by injection.
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in Irvine, Calif., pointed out that “only the higher dose is significantly more effective than placebo.”
In his view, “the potentially severe adverse events are not worth the risk compared to more effective agents, such as dupilumab, in this pediatric population,” added Dr. Wu, who recently authored a review of the role of JAK inhibitors in skin disease. He was not involved with the baricitinib study.
The study was funded by Eli Lilly in collaboration with Incyte. Dr. Torello has participated in advisory boards and/or has served as a principal investigator in clinical trials for AbbVie, Eli Lilly and Company, Novartis, Pfizer, Pierre Fabre, and Sanofi. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
The oral Janus kinase
After 16 weeks of treatment, the primary endpoint – an Investigators Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline – was met by 41.7% of patients given 2 mg (those younger than age 10) or 4 mg of baricitinib (those aged 10-17 years), the highest dose studied in each of those two age groups.
By comparison, the primary endpoint was met in 16.4% of children in the placebo group (P < .001).
Baricitinib is approved for the treatment of AD in adults in many countries, Antonio Torrelo, MD, of the Hospital Infantil Niño Jesús, Madrid, said at the annual congress of the European Academy of Dermatology and Venereology. It was approved by the U.S. Food and Drug Administration for treating adults with severe alopecia areata in June and is under FDA review for the treatment of AD.
The phase 3 BREEZE-AD-PEDS trial
BREEZE-AD-PEDS was a randomized, double-blind trial that evaluated the safety and efficacy of baricitinib in 483 children and adolescents with moderate to severe AD. Participants were aged 2-17 years. Those aged 2-5 years had been diagnosed with AD for at least 6 months; if they were older, they had been diagnosed for at least 12 months.
Three dosing levels of baricitinib were tested: 121 patients were given a low dose, which was 0.5 mg/day in children aged 2 to less than 10 years and 1 mg/day in those aged 10 to less than 18 years. A medium dose – 1 mg/day in the younger children and 2 mg/day in the older children – was given to 120 children, while a high dose – 2 mg/day and 4 mg/day, respectively – was given to another 120 children.
Topical treatments were permitted, although for entry into the trial, participants had to have had an inadequate response to steroids and an inadequate or no response to topical calcineurin inhibitors. In all groups, age, gender, race, geographic region, age at diagnosis of AD, and duration of AD “were more or less similar,” Dr. Torello said.
Good results, but only with highest dose
The primary IGA endpoint was reached by 25.8% of children in the medium-dose group and by 18.2% in the low-dose group. Neither result was statistically significant in comparison with placebo (16.4%).
When breaking down the results between different ages, “the results in the IGA scores are consistent in both age subgroups – below 10 years and over 10 years,” Dr. Torello noted. The results are also consistent across body weights (< 20 kg, 20-60 kg, and > 60 kg), he added.
Among those treated with the high dose of baricitinib, Eczema Area and Severity Index (EASI) 75% and 95% improvement scores were reached in 52.5% and 30% of patients, respectively. Corresponding figures for the medium dose were 40% and 21.7%; for the low baricitinib dose, 32.2% and 11.6%; and for placebo, 32% and 12.3%. Again, only the results for the highest baricitinib dose were significant in comparison with placebo.
A similar pattern was seen for improvement in itch, and there was a 75% improvement in Scoring Atopic Dermatitis (SCORAD75) results.
Safety of baricitinib in children
The labeling for JAK inhibitors that have been approved to date, including baricitinib, include a boxed warning regarding risks for thrombosis, major adverse cardiovascular events, and all-cause mortality. The warning is based on use by patients with rheumatoid arthritis.
Dr. Torello summarized baricitinib’s safety profile in the trial as being “consistent with the well-known safety profile for baricitinib in adults with moderate to severe atopic dermatitis.”
In the study, no severe adverse effects were noted, and no new safety signals were observed, he said. The rate of any treatment-emergent effect among patients was around 50% and was similar across all baricitinib and placebo groups. Study discontinuations because of a side effect were more frequent in the placebo arm (1.6% of patients) than in the baricitinib low-, medium-, and high-dose arms (0.8%, 0%, and 0.8%, respectively).
There were no cases of deep-vein thrombosis, pulmonary embolism, or other adverse effects of special interest, including major adverse cardiovascular events, gastrointestinal perforations, and opportunistic infections, Dr. Torrelo said.
No patient experienced elevations in liver enzyme levels, although there were some cases of elevated creatinine phosphokinase levels (16% in the placebo group and 19% in the baricitinib arms altogether) that were not from muscle injury. There was a possible increase in low-density cholesterol level (3.3% of those taking placebo vs. 10.1% of baricitinib-treated patients).
Is there a role for baricitinib?
“Baricitinib is a potential therapeutic option with a favorable benefit-to-risk profile for children between 2 and 18 years who have moderate to severe atopic dermatitis, and candidates for systemic therapy,” Dr. Torrelo said. “No single drug is capable to treat every patient with atopic dermatitis,” he added in discussing the possible place of baricitinib in pediatric practice.
“There are patients who do not respond to dupilumab, who apparently respond later to JAK inhibitors,” he noted.
“We are trying to work phenotypically, trying to learn what kind of patients – especially children who have a more heterogeneous disease than adults – can be better treated with JAK inhibitors or dupilumab.” There may be other important considerations in choosing a treatment in children, Dr. Torrelo said, including that JAK inhibitors can be given orally, while dupilumab is administered by injection.
Asked to comment on the results, Jashin J. Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in Irvine, Calif., pointed out that “only the higher dose is significantly more effective than placebo.”
In his view, “the potentially severe adverse events are not worth the risk compared to more effective agents, such as dupilumab, in this pediatric population,” added Dr. Wu, who recently authored a review of the role of JAK inhibitors in skin disease. He was not involved with the baricitinib study.
The study was funded by Eli Lilly in collaboration with Incyte. Dr. Torello has participated in advisory boards and/or has served as a principal investigator in clinical trials for AbbVie, Eli Lilly and Company, Novartis, Pfizer, Pierre Fabre, and Sanofi. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
Study identifies skin biomarkers that predict newborn eczema risk
It might be possible to develop a simple test to identify newborn children who are at risk of later developing atopic dermatitis (AD), according to findings from a Danish prospective birth cohort study.
but also for having more severe disease.
“We are able to identify predictive immune biomarkers of atopic dermatitis using a noninvasive method that was not associated with any pain,” one of the study’s investigators, Anne-Sofie Halling, MD, said at a press briefing at the annual congress of the European Academy of Dermatology and Venereology.
“Importantly, we were able to predict atopic dermatitis occurring months after [sample] collection,” said Dr. Halling, who works at Bispebjerg Hospital and is a PhD student at the University of Copenhagen.
These findings could hopefully be used to help identify children “so that preventive strategies can target these children ... and decrease the incidence of this common disease,” she added.
AD is caused “by a complex interplay between skin barrier dysfunction and immune dysregulation,” Dr. Halling said, and it is “the first step in the so-called atopic march, where children also develop food allergy, asthma, and rhinitis.” Almost all cases of AD begin during the first years of life. Approximately 15%-20% of children can be affected, she noted, emphasizing the high burden of the disease and pointing out that strategies are shifting toward trying to prevent the disease in those at risk.
Copenhagen BABY cohort
This is where the BABY study comes in, Dr. Halling said. The study enrolled 450 children at birth and followed them until age 2 years. Gene mutation testing was performed at enrollment. All children underwent skin examination, and skin samples were taken using tape strips. Tape strips were applied to the back of the hand of children born at term and between the shoulder blades on the back of children who were premature.
Skin examinations were repeated, and skin samples were obtained again at age 2 months. They were taken again only if there were any signs of AD. For those diagnosed with AD, disease severity was assessed using the Eczema Area and Severity Index (EASI) by the treating physician. Children were excluded if they had AD at the time the tape strip testing was due to be performed.
Comparing term and preterm children
Dr. Halling noted that analyses were performed separately for the 300 children born at term and for the 150 who were preterm.
The prevalence of AD was higher among children born at term than among the preterm children (34.6% vs. 21.2%), and the median time to onset was shorter (6 months vs. 8 months). There were also differences in the EASI scores among those who developed AD; median scores were higher in the children born at term than in the preterm children (4.1 vs. 1.6).
More children born at term than preterm children had moderate to severe AD (23.3% vs. 8%), Dr. Halling reported.
TARC, IL-8, and IL-18 predictive of AD
Multiple immune biomarkers were tested, including various cytokines and filaggrin degradation products. On examination of skin samples collected at birth, no particular biomarkers were found at higher levels among children who developed AD in comparison with those who did not develop AD.
With regard to biomarkers examined in skin samples at 2 months of age, however, the results were different, Dr. Halling said. One particular cytokine, thymus and activation-regulated chemokine (TARC), was seen to double the risk of AD in the first 2 years of a child’s life.
This doubled risk was seen not only among the children born at term but also among those born preterm, although the data were only significant with regard to the children born at term.
The unadjusted hazard ratios and adjusted HRs (adjusted for parental atopy and filaggrin gene mutations) in term children were 2.11 (95% confidence interval, 1.36-3.26; P = .0008) and 1.85 (95% CI, 1.18-2.89; P = .007), respectively.
For preterm children, the HRs were 2.23 (95% CI, 0.85-5.86; P = .1) and 2.60 (95% CI, 0.98-6.85; P =.05), respectively.
These findings were in line with findings of other studies, Dr. Halling said. “It is well recognized that TARC is currently the best biomarker in patients with established atopic dermatitis.” Moreover, she reported that TARC was associated with a cumulative increase in the risk for AD and that levels were found to be higher in children in whom onset occurred at a later age than among those diagnosed before 6 months of age.
“This is important, as these findings shows that TARC levels predict atopic dermatitis that occurred many months later,” Dr. Halling said.
And, in term-born children at least, TARC upped the chances that the severity of AD would be greater than had it not been present (adjusted HR, 4.65; 95% CI, 1.91-11.31; P = .0007).
Increased levels of interleukin-8 (IL-8) and IL-18 at 2 months of age were also found to be predictive of having moderate to severe AD. The risk was more than double in comparison with those in whom levels were not increased, again only in term-born children.
‘Stimulating and interesting findings’
These data are “very stimulating and interesting,” Dedee Murrell, MD, professor and head of the department of dermatology at St. George Hospital, University of New South Wales, Sydney, observed at the press briefing.
“You found this significant association mainly in the newborn children born at term, and the association in the preterm babies wasn’t as high. Is that anything to do with how they were taken care of in the hospital?” Dr. Murrell asked.
“That’s a really good question,” Dr. Halling said. “Maybe they need to be exposed for a month or two before we are actually able to identify which children will develop atopic dermatitis.”
The study was funded by the Lundbeck Foundation. Dr. Halling has acted as a consultant for Coloplast and as a speaker for Leo Pharma. Dr. Murrell has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It might be possible to develop a simple test to identify newborn children who are at risk of later developing atopic dermatitis (AD), according to findings from a Danish prospective birth cohort study.
but also for having more severe disease.
“We are able to identify predictive immune biomarkers of atopic dermatitis using a noninvasive method that was not associated with any pain,” one of the study’s investigators, Anne-Sofie Halling, MD, said at a press briefing at the annual congress of the European Academy of Dermatology and Venereology.
“Importantly, we were able to predict atopic dermatitis occurring months after [sample] collection,” said Dr. Halling, who works at Bispebjerg Hospital and is a PhD student at the University of Copenhagen.
These findings could hopefully be used to help identify children “so that preventive strategies can target these children ... and decrease the incidence of this common disease,” she added.
AD is caused “by a complex interplay between skin barrier dysfunction and immune dysregulation,” Dr. Halling said, and it is “the first step in the so-called atopic march, where children also develop food allergy, asthma, and rhinitis.” Almost all cases of AD begin during the first years of life. Approximately 15%-20% of children can be affected, she noted, emphasizing the high burden of the disease and pointing out that strategies are shifting toward trying to prevent the disease in those at risk.
Copenhagen BABY cohort
This is where the BABY study comes in, Dr. Halling said. The study enrolled 450 children at birth and followed them until age 2 years. Gene mutation testing was performed at enrollment. All children underwent skin examination, and skin samples were taken using tape strips. Tape strips were applied to the back of the hand of children born at term and between the shoulder blades on the back of children who were premature.
Skin examinations were repeated, and skin samples were obtained again at age 2 months. They were taken again only if there were any signs of AD. For those diagnosed with AD, disease severity was assessed using the Eczema Area and Severity Index (EASI) by the treating physician. Children were excluded if they had AD at the time the tape strip testing was due to be performed.
Comparing term and preterm children
Dr. Halling noted that analyses were performed separately for the 300 children born at term and for the 150 who were preterm.
The prevalence of AD was higher among children born at term than among the preterm children (34.6% vs. 21.2%), and the median time to onset was shorter (6 months vs. 8 months). There were also differences in the EASI scores among those who developed AD; median scores were higher in the children born at term than in the preterm children (4.1 vs. 1.6).
More children born at term than preterm children had moderate to severe AD (23.3% vs. 8%), Dr. Halling reported.
TARC, IL-8, and IL-18 predictive of AD
Multiple immune biomarkers were tested, including various cytokines and filaggrin degradation products. On examination of skin samples collected at birth, no particular biomarkers were found at higher levels among children who developed AD in comparison with those who did not develop AD.
With regard to biomarkers examined in skin samples at 2 months of age, however, the results were different, Dr. Halling said. One particular cytokine, thymus and activation-regulated chemokine (TARC), was seen to double the risk of AD in the first 2 years of a child’s life.
This doubled risk was seen not only among the children born at term but also among those born preterm, although the data were only significant with regard to the children born at term.
The unadjusted hazard ratios and adjusted HRs (adjusted for parental atopy and filaggrin gene mutations) in term children were 2.11 (95% confidence interval, 1.36-3.26; P = .0008) and 1.85 (95% CI, 1.18-2.89; P = .007), respectively.
For preterm children, the HRs were 2.23 (95% CI, 0.85-5.86; P = .1) and 2.60 (95% CI, 0.98-6.85; P =.05), respectively.
These findings were in line with findings of other studies, Dr. Halling said. “It is well recognized that TARC is currently the best biomarker in patients with established atopic dermatitis.” Moreover, she reported that TARC was associated with a cumulative increase in the risk for AD and that levels were found to be higher in children in whom onset occurred at a later age than among those diagnosed before 6 months of age.
“This is important, as these findings shows that TARC levels predict atopic dermatitis that occurred many months later,” Dr. Halling said.
And, in term-born children at least, TARC upped the chances that the severity of AD would be greater than had it not been present (adjusted HR, 4.65; 95% CI, 1.91-11.31; P = .0007).
Increased levels of interleukin-8 (IL-8) and IL-18 at 2 months of age were also found to be predictive of having moderate to severe AD. The risk was more than double in comparison with those in whom levels were not increased, again only in term-born children.
‘Stimulating and interesting findings’
These data are “very stimulating and interesting,” Dedee Murrell, MD, professor and head of the department of dermatology at St. George Hospital, University of New South Wales, Sydney, observed at the press briefing.
“You found this significant association mainly in the newborn children born at term, and the association in the preterm babies wasn’t as high. Is that anything to do with how they were taken care of in the hospital?” Dr. Murrell asked.
“That’s a really good question,” Dr. Halling said. “Maybe they need to be exposed for a month or two before we are actually able to identify which children will develop atopic dermatitis.”
The study was funded by the Lundbeck Foundation. Dr. Halling has acted as a consultant for Coloplast and as a speaker for Leo Pharma. Dr. Murrell has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It might be possible to develop a simple test to identify newborn children who are at risk of later developing atopic dermatitis (AD), according to findings from a Danish prospective birth cohort study.
but also for having more severe disease.
“We are able to identify predictive immune biomarkers of atopic dermatitis using a noninvasive method that was not associated with any pain,” one of the study’s investigators, Anne-Sofie Halling, MD, said at a press briefing at the annual congress of the European Academy of Dermatology and Venereology.
“Importantly, we were able to predict atopic dermatitis occurring months after [sample] collection,” said Dr. Halling, who works at Bispebjerg Hospital and is a PhD student at the University of Copenhagen.
These findings could hopefully be used to help identify children “so that preventive strategies can target these children ... and decrease the incidence of this common disease,” she added.
AD is caused “by a complex interplay between skin barrier dysfunction and immune dysregulation,” Dr. Halling said, and it is “the first step in the so-called atopic march, where children also develop food allergy, asthma, and rhinitis.” Almost all cases of AD begin during the first years of life. Approximately 15%-20% of children can be affected, she noted, emphasizing the high burden of the disease and pointing out that strategies are shifting toward trying to prevent the disease in those at risk.
Copenhagen BABY cohort
This is where the BABY study comes in, Dr. Halling said. The study enrolled 450 children at birth and followed them until age 2 years. Gene mutation testing was performed at enrollment. All children underwent skin examination, and skin samples were taken using tape strips. Tape strips were applied to the back of the hand of children born at term and between the shoulder blades on the back of children who were premature.
Skin examinations were repeated, and skin samples were obtained again at age 2 months. They were taken again only if there were any signs of AD. For those diagnosed with AD, disease severity was assessed using the Eczema Area and Severity Index (EASI) by the treating physician. Children were excluded if they had AD at the time the tape strip testing was due to be performed.
Comparing term and preterm children
Dr. Halling noted that analyses were performed separately for the 300 children born at term and for the 150 who were preterm.
The prevalence of AD was higher among children born at term than among the preterm children (34.6% vs. 21.2%), and the median time to onset was shorter (6 months vs. 8 months). There were also differences in the EASI scores among those who developed AD; median scores were higher in the children born at term than in the preterm children (4.1 vs. 1.6).
More children born at term than preterm children had moderate to severe AD (23.3% vs. 8%), Dr. Halling reported.
TARC, IL-8, and IL-18 predictive of AD
Multiple immune biomarkers were tested, including various cytokines and filaggrin degradation products. On examination of skin samples collected at birth, no particular biomarkers were found at higher levels among children who developed AD in comparison with those who did not develop AD.
With regard to biomarkers examined in skin samples at 2 months of age, however, the results were different, Dr. Halling said. One particular cytokine, thymus and activation-regulated chemokine (TARC), was seen to double the risk of AD in the first 2 years of a child’s life.
This doubled risk was seen not only among the children born at term but also among those born preterm, although the data were only significant with regard to the children born at term.
The unadjusted hazard ratios and adjusted HRs (adjusted for parental atopy and filaggrin gene mutations) in term children were 2.11 (95% confidence interval, 1.36-3.26; P = .0008) and 1.85 (95% CI, 1.18-2.89; P = .007), respectively.
For preterm children, the HRs were 2.23 (95% CI, 0.85-5.86; P = .1) and 2.60 (95% CI, 0.98-6.85; P =.05), respectively.
These findings were in line with findings of other studies, Dr. Halling said. “It is well recognized that TARC is currently the best biomarker in patients with established atopic dermatitis.” Moreover, she reported that TARC was associated with a cumulative increase in the risk for AD and that levels were found to be higher in children in whom onset occurred at a later age than among those diagnosed before 6 months of age.
“This is important, as these findings shows that TARC levels predict atopic dermatitis that occurred many months later,” Dr. Halling said.
And, in term-born children at least, TARC upped the chances that the severity of AD would be greater than had it not been present (adjusted HR, 4.65; 95% CI, 1.91-11.31; P = .0007).
Increased levels of interleukin-8 (IL-8) and IL-18 at 2 months of age were also found to be predictive of having moderate to severe AD. The risk was more than double in comparison with those in whom levels were not increased, again only in term-born children.
‘Stimulating and interesting findings’
These data are “very stimulating and interesting,” Dedee Murrell, MD, professor and head of the department of dermatology at St. George Hospital, University of New South Wales, Sydney, observed at the press briefing.
“You found this significant association mainly in the newborn children born at term, and the association in the preterm babies wasn’t as high. Is that anything to do with how they were taken care of in the hospital?” Dr. Murrell asked.
“That’s a really good question,” Dr. Halling said. “Maybe they need to be exposed for a month or two before we are actually able to identify which children will develop atopic dermatitis.”
The study was funded by the Lundbeck Foundation. Dr. Halling has acted as a consultant for Coloplast and as a speaker for Leo Pharma. Dr. Murrell has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
FDA approves dupilumab for treatment of prurigo nodularis
The according to a press release from the manufacturers.
Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).
Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.
The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.*
In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.
Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.
Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.
A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.
Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.
The studies were supported by Regeneron and Sanofi.
A version of this article first appeared on Medscape.com.
*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint.
The according to a press release from the manufacturers.
Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).
Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.
The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.*
In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.
Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.
Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.
A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.
Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.
The studies were supported by Regeneron and Sanofi.
A version of this article first appeared on Medscape.com.
*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint.
The according to a press release from the manufacturers.
Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).
Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.
The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.*
In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.
Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.
Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.
A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.
Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.
The studies were supported by Regeneron and Sanofi.
A version of this article first appeared on Medscape.com.
*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint.
Many factors linked with higher, lower risk for hand eczema
“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.
“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.
“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.
FROM CONTACT DERMATITIS
Early emollient use reduces dermatitis in at-risk infants
Recent study findings published in Allergy (2022 Aug 23. doi: 10.1111/all.15491) suggest that
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
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
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.
FROM ALLERGY
Commentary: New Topical Approaches Hit the Spots (and the Itch) for AD, October 2022
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.
Commentary: Something for Everyone in AD Treatment, September 2022
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 earns EU recommendation to expand age range for atopic dermatitis to include adolescents
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.
Meta-analysis demonstrates potential of probiotics in reducing atopic dermatitis disease severity
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
Real-world characteristics of patients with moderate-to-severe atopic dermatitis receiving dupilumab
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