Dermatology

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.

Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.

“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.

The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.

“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.

The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.

“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.

The report lists new medications for treatment and gives an algorithm for managing head lice cases.

“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.

This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.

“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says. 

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

The oral Janus kinase (JAK) inhibitor baricitinib appears to improve symptoms of atopic dermatitis (AD) in children aged 2 years and up, as indicated by data from the phase 3 BREEZE-AD-PEDS trial.

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 (JAK) inhibitor baricitinib appears to improve symptoms of atopic dermatitis (AD) in children aged 2 years and up, as indicated by data from the phase 3 BREEZE-AD-PEDS trial.

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 (JAK) inhibitor baricitinib appears to improve symptoms of atopic dermatitis (AD) in children aged 2 years and up, as indicated by data from the phase 3 BREEZE-AD-PEDS trial.

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.

Mounting evidence suggests that a higher density of Demodex mites on the skin may play a role in the development of papules and pustules associated with rosacea, a narrative review proposes.

According to the author, Fabienne Forton, MD, PhD, a dermatologist based in Brussels, recent studies suggest that Demodex induces two opposite actions on host immunity: A defensive immune response aimed at eliminating the mite and an immunosuppressive action aimed at favoring its own proliferation. “Moreover, the initial defensive immune response is likely diverted towards benefit for the mite, via T-cell exhaustion induced by the immunosuppressive properties of vascular endothelial growth factor (VEGF), which may also explain the favorable influence that the altered vascular background of rosacea seems to exert on Demodex proliferation,” she wrote in the review, which was published in JEADV, the Journal of the European Academy of Dermatology and Venereology.

Courtesy National Rosacea Society

She presented several arguments for and against a causal role of Demodex in rosacea. Three on the “for” side are:

High Demodex densities (Dds) are observed in almost all cases of rosacea with papulopustules (PPR). Dr. Forton pointed out that Demodex proliferation presents in as many as 98.6% of cases of PPR when two consecutive standardized skin surface biopsies (SSSBs) are performed (Acta Derm Venereol. 2017;97:242-8). “Dds in patients with PPR are as high as those in patients with demodicosis, much higher than in healthy skin and other facial dermatoses (except when these are associated with demodicosis [as is often the case with seborrheic dermatitis and acne vulgaris]),” she wrote.

The Demodex mite has the elements necessary to stimulate the host’s innate and adaptative immune system. Dr. Forton characterized Demodex as “the only microorganism found in abundance in almost all subjects with PPR, which can, in addition, alter the skin barrier. To feed and move around, Demodex mites attack the epidermal wall of the pilosebaceous follicles mechanically (via their stylets, mouth palps and motor palps) and chemically (through enzymes secreted from salivary glands for pre-oral digestion).”

The Demodex mite stimulates the immune system (which ultimately results in phymatous changes). A healthy immune system, including T helper 17 cells, seems necessary to adequately control mite proliferation. Dr. Forton noted that researchers have observed a perivascular and perifollicular infiltrate in people with rosacea, “which invades the epidermis and is often associated with the presence of Demodex. The lympho-histiocytic perifollicular infiltrate is correlated with the presence and the numbers of mites inside the follicles, and giant cell granulomas can be seen around intradermal Demodex mites, which attempt to phagocytize the mites.”

The three arguments that she presented against a causal role of Demodex in rosacea are the following:

No relationship with the mite was observed in two early histological studies. Rosacea biopsies conducted in these two analyses, published in 1969 and 1988, showed only mild infiltrate, with few parasites and no inflammation around the infested follicles.

However, she countered, “these data are now obsolete, because it has since been clearly demonstrated that the perifollicular infiltrate is a characteristic of rosacea, that this infiltrate is statistically related to the presence and the number of Demodex mites, and that high Dds are observed in almost all subjects with PPR.”

Demodex is not always associated with inflammatory symptoms. This argument holds that Demodex is present in all individuals and can be observed in very high densities without causing significant symptoms. Studies that support this viewpoint include the following: J Eur Acad Dermatol Venereol. 2001;15:441–4 and J Zhejiang Univ Sci B. 2011;12:998-1007.

However, Dr. Forton pointed out that the normal, low-density presence of Demodex in the skin “does not contradict a pathogenic effect when it proliferates excessively or penetrates into the dermis. The absence of intense inflammatory symptoms when the Dd is very high does not negate its potential pathogenicity.”

Demodex proliferation could be a consequence rather than a cause. Dr. Forton cited a study, suggesting that inflammation could be responsible for alteration of the skin barrier, “which, secondarily, would favor proliferation of the parasites, as with skin affected by atopic dermatitis that becomes superinfected by Staphylococcus aureus”. On the other hand, she argued, “unlike S. aureus, Demodex does not require alteration of the skin barrier to implant or proliferate. It also does not require an inflammatory background.” She added that if mite proliferation was a consequence of clinical lesions, “the Demodex mite should logically proliferate in other inflammatory facial skin conditions, which is not the case.”

A Sept. 14 National Rosacea Society (NRS) press release featured the paper by Dr. Forton, titled, “Which Comes First, The Rosacea Blemish or The Mite?” In the release, Richard Gallo, MD, PhD, who chaired the NRS Expert Committee that updated the standard classification of rosacea in 2018, said that “growing knowledge of rosacea’s pathophysiology has established that a consistent multivariate disease process underlies its potential manifestations, and the clinical significance of each of these elements is increasing as more is understood.”

While the potential role of Demodex in rosacea has been controversial in the past, “these new insights suggest where it may play a role as a meaningful cofactor in the development of the disorder,” added Dr. Gallo, chair of the department of dermatology at the University of California, San Diego.

Dr. Forton reported having no financial disclosures.

Mounting evidence suggests that a higher density of Demodex mites on the skin may play a role in the development of papules and pustules associated with rosacea, a narrative review proposes.

According to the author, Fabienne Forton, MD, PhD, a dermatologist based in Brussels, recent studies suggest that Demodex induces two opposite actions on host immunity: A defensive immune response aimed at eliminating the mite and an immunosuppressive action aimed at favoring its own proliferation. “Moreover, the initial defensive immune response is likely diverted towards benefit for the mite, via T-cell exhaustion induced by the immunosuppressive properties of vascular endothelial growth factor (VEGF), which may also explain the favorable influence that the altered vascular background of rosacea seems to exert on Demodex proliferation,” she wrote in the review, which was published in JEADV, the Journal of the European Academy of Dermatology and Venereology.

Courtesy National Rosacea Society

She presented several arguments for and against a causal role of Demodex in rosacea. Three on the “for” side are:

High Demodex densities (Dds) are observed in almost all cases of rosacea with papulopustules (PPR). Dr. Forton pointed out that Demodex proliferation presents in as many as 98.6% of cases of PPR when two consecutive standardized skin surface biopsies (SSSBs) are performed (Acta Derm Venereol. 2017;97:242-8). “Dds in patients with PPR are as high as those in patients with demodicosis, much higher than in healthy skin and other facial dermatoses (except when these are associated with demodicosis [as is often the case with seborrheic dermatitis and acne vulgaris]),” she wrote.

The Demodex mite has the elements necessary to stimulate the host’s innate and adaptative immune system. Dr. Forton characterized Demodex as “the only microorganism found in abundance in almost all subjects with PPR, which can, in addition, alter the skin barrier. To feed and move around, Demodex mites attack the epidermal wall of the pilosebaceous follicles mechanically (via their stylets, mouth palps and motor palps) and chemically (through enzymes secreted from salivary glands for pre-oral digestion).”

The Demodex mite stimulates the immune system (which ultimately results in phymatous changes). A healthy immune system, including T helper 17 cells, seems necessary to adequately control mite proliferation. Dr. Forton noted that researchers have observed a perivascular and perifollicular infiltrate in people with rosacea, “which invades the epidermis and is often associated with the presence of Demodex. The lympho-histiocytic perifollicular infiltrate is correlated with the presence and the numbers of mites inside the follicles, and giant cell granulomas can be seen around intradermal Demodex mites, which attempt to phagocytize the mites.”

The three arguments that she presented against a causal role of Demodex in rosacea are the following:

No relationship with the mite was observed in two early histological studies. Rosacea biopsies conducted in these two analyses, published in 1969 and 1988, showed only mild infiltrate, with few parasites and no inflammation around the infested follicles.

However, she countered, “these data are now obsolete, because it has since been clearly demonstrated that the perifollicular infiltrate is a characteristic of rosacea, that this infiltrate is statistically related to the presence and the number of Demodex mites, and that high Dds are observed in almost all subjects with PPR.”

Demodex is not always associated with inflammatory symptoms. This argument holds that Demodex is present in all individuals and can be observed in very high densities without causing significant symptoms. Studies that support this viewpoint include the following: J Eur Acad Dermatol Venereol. 2001;15:441–4 and J Zhejiang Univ Sci B. 2011;12:998-1007.

However, Dr. Forton pointed out that the normal, low-density presence of Demodex in the skin “does not contradict a pathogenic effect when it proliferates excessively or penetrates into the dermis. The absence of intense inflammatory symptoms when the Dd is very high does not negate its potential pathogenicity.”

Demodex proliferation could be a consequence rather than a cause. Dr. Forton cited a study, suggesting that inflammation could be responsible for alteration of the skin barrier, “which, secondarily, would favor proliferation of the parasites, as with skin affected by atopic dermatitis that becomes superinfected by Staphylococcus aureus”. On the other hand, she argued, “unlike S. aureus, Demodex does not require alteration of the skin barrier to implant or proliferate. It also does not require an inflammatory background.” She added that if mite proliferation was a consequence of clinical lesions, “the Demodex mite should logically proliferate in other inflammatory facial skin conditions, which is not the case.”

A Sept. 14 National Rosacea Society (NRS) press release featured the paper by Dr. Forton, titled, “Which Comes First, The Rosacea Blemish or The Mite?” In the release, Richard Gallo, MD, PhD, who chaired the NRS Expert Committee that updated the standard classification of rosacea in 2018, said that “growing knowledge of rosacea’s pathophysiology has established that a consistent multivariate disease process underlies its potential manifestations, and the clinical significance of each of these elements is increasing as more is understood.”

While the potential role of Demodex in rosacea has been controversial in the past, “these new insights suggest where it may play a role as a meaningful cofactor in the development of the disorder,” added Dr. Gallo, chair of the department of dermatology at the University of California, San Diego.

Dr. Forton reported having no financial disclosures.

Mounting evidence suggests that a higher density of Demodex mites on the skin may play a role in the development of papules and pustules associated with rosacea, a narrative review proposes.

According to the author, Fabienne Forton, MD, PhD, a dermatologist based in Brussels, recent studies suggest that Demodex induces two opposite actions on host immunity: A defensive immune response aimed at eliminating the mite and an immunosuppressive action aimed at favoring its own proliferation. “Moreover, the initial defensive immune response is likely diverted towards benefit for the mite, via T-cell exhaustion induced by the immunosuppressive properties of vascular endothelial growth factor (VEGF), which may also explain the favorable influence that the altered vascular background of rosacea seems to exert on Demodex proliferation,” she wrote in the review, which was published in JEADV, the Journal of the European Academy of Dermatology and Venereology.

Courtesy National Rosacea Society

She presented several arguments for and against a causal role of Demodex in rosacea. Three on the “for” side are:

High Demodex densities (Dds) are observed in almost all cases of rosacea with papulopustules (PPR). Dr. Forton pointed out that Demodex proliferation presents in as many as 98.6% of cases of PPR when two consecutive standardized skin surface biopsies (SSSBs) are performed (Acta Derm Venereol. 2017;97:242-8). “Dds in patients with PPR are as high as those in patients with demodicosis, much higher than in healthy skin and other facial dermatoses (except when these are associated with demodicosis [as is often the case with seborrheic dermatitis and acne vulgaris]),” she wrote.

The Demodex mite has the elements necessary to stimulate the host’s innate and adaptative immune system. Dr. Forton characterized Demodex as “the only microorganism found in abundance in almost all subjects with PPR, which can, in addition, alter the skin barrier. To feed and move around, Demodex mites attack the epidermal wall of the pilosebaceous follicles mechanically (via their stylets, mouth palps and motor palps) and chemically (through enzymes secreted from salivary glands for pre-oral digestion).”

The Demodex mite stimulates the immune system (which ultimately results in phymatous changes). A healthy immune system, including T helper 17 cells, seems necessary to adequately control mite proliferation. Dr. Forton noted that researchers have observed a perivascular and perifollicular infiltrate in people with rosacea, “which invades the epidermis and is often associated with the presence of Demodex. The lympho-histiocytic perifollicular infiltrate is correlated with the presence and the numbers of mites inside the follicles, and giant cell granulomas can be seen around intradermal Demodex mites, which attempt to phagocytize the mites.”

The three arguments that she presented against a causal role of Demodex in rosacea are the following:

No relationship with the mite was observed in two early histological studies. Rosacea biopsies conducted in these two analyses, published in 1969 and 1988, showed only mild infiltrate, with few parasites and no inflammation around the infested follicles.

However, she countered, “these data are now obsolete, because it has since been clearly demonstrated that the perifollicular infiltrate is a characteristic of rosacea, that this infiltrate is statistically related to the presence and the number of Demodex mites, and that high Dds are observed in almost all subjects with PPR.”

Demodex is not always associated with inflammatory symptoms. This argument holds that Demodex is present in all individuals and can be observed in very high densities without causing significant symptoms. Studies that support this viewpoint include the following: J Eur Acad Dermatol Venereol. 2001;15:441–4 and J Zhejiang Univ Sci B. 2011;12:998-1007.

However, Dr. Forton pointed out that the normal, low-density presence of Demodex in the skin “does not contradict a pathogenic effect when it proliferates excessively or penetrates into the dermis. The absence of intense inflammatory symptoms when the Dd is very high does not negate its potential pathogenicity.”

Demodex proliferation could be a consequence rather than a cause. Dr. Forton cited a study, suggesting that inflammation could be responsible for alteration of the skin barrier, “which, secondarily, would favor proliferation of the parasites, as with skin affected by atopic dermatitis that becomes superinfected by Staphylococcus aureus”. On the other hand, she argued, “unlike S. aureus, Demodex does not require alteration of the skin barrier to implant or proliferate. It also does not require an inflammatory background.” She added that if mite proliferation was a consequence of clinical lesions, “the Demodex mite should logically proliferate in other inflammatory facial skin conditions, which is not the case.”

A Sept. 14 National Rosacea Society (NRS) press release featured the paper by Dr. Forton, titled, “Which Comes First, The Rosacea Blemish or The Mite?” In the release, Richard Gallo, MD, PhD, who chaired the NRS Expert Committee that updated the standard classification of rosacea in 2018, said that “growing knowledge of rosacea’s pathophysiology has established that a consistent multivariate disease process underlies its potential manifestations, and the clinical significance of each of these elements is increasing as more is understood.”

While the potential role of Demodex in rosacea has been controversial in the past, “these new insights suggest where it may play a role as a meaningful cofactor in the development of the disorder,” added Dr. Gallo, chair of the department of dermatology at the University of California, San Diego.

Dr. Forton reported having no financial disclosures.

MILAN – In the current spread of monkeypox among countries outside of Africa, this zoonotic orthopox DNA virus is sexually transmitted in more than 90% of cases, mostly among men having sex with men (MSM), and can produce severe skin and systemic symptoms but is rarely fatal, according to a breaking news presentation at the annual congress of the European Academy of Dermatology and Venereology.

Synthesizing data from 185 cases in Spain with several sets of recently published data, Alba Català, MD, a dermatologist at Centro Médico Teknon, Barcelona, said at the meeting that there have been only two deaths in Spain in the current epidemic. (As of Sept. 30, after the EADV meeting had concluded, a total of three deaths related to monkeypox in Spain and one death in the United States had been reported, according to the Centers for Disease Control and Prevention).

Hospitalizations have been uncommon, and in Spain, there were only four hospitalizations, according to data collected from the beginning of May through early August, she said. Almost all cases in this Spanish series were from men having high-risk sex with men. Upon screening, 76% had another sexually transmitted disease, including 41% infected with human immunodeficiency virus.
 

More than 40% of patients with monkeypox have HIV

These data are consistent with several other recently published studies, such as one that evaluated 528 infections in 16 non-African countries, including those in North America, South America, Europe, the Mideast, as well as Australia. In that survey, published in the New England Journal of Medicine, and covering cases between late April and late June, 2022, 41% were HIV positive. Of those who were HIV negative, 57% were taking a pre-exposure prophylaxis regimen of antiretroviral drugs to prevent HIV infection.

However, these data do not preclude a significant risk of nonsexual transmission, according to Dr. Català, who noted that respiratory transmission and transmission through nonsexual skin contact is well documented in endemic areas.

“The virus has no preference for a sexual orientation,” Dr. Català cautioned. Despite the consistency of the data in regard to a largely MSM transmission in the epidemic so far, “these data may change with further spread of infection in the community.”

Typically, the incubation period of monkeypox lasts several days before the invasive period, which is commonly accompanied by systemic complaints, particularly fever, headache, and often lymphadenopathy. These systemic features usually but not always precede cutaneous involvement, which is seen in more than 90% of patients, according to Dr. Català. In the Spanish series, mucocutaneous involvement was recorded in 100% of patients.

Monkeypox and smallpox

“The differential diagnosis might include other vesicular eruptions, such as those caused by varicella or smallpox,” reported Dr. Català, who noted that monkeypox and smallpox are related.

Cutaneous lesions often appear first at the site of infection, such as the genitalia, but typically spread in a secondary eruption that is pruritic and may take days to resolve, according to Dr. Català. She reported that single lesions are less common but do occur. While hundreds of lesions have been reported among cases in endemic areas, most patients had 25 lesions or fewer in the Spanish epidemic and other recent series.

Even though there is a common progression in which lesions begin in a papular stage before the vesicular and pustular stages in a given area, new eruptions can occur before a prior eruption develops scabs.

“Frequently, not all the patient’s lesions are in the same stage of development,” said Dr. Català, who explained that disease activity and its complications, such as proctitis, pharyngitis, and penile edema, can take weeks to resolve. Because of the highly invasive nature of monkeypox, it is appropriate to be alert to less common manifestations, such as ocular involvement.

Many of these and other complications, such as secondary bacterial infections, will require targeted treatment, but the mainstay of therapy for the dermatologic manifestations of monkeypox is symptomatic treatment that includes nonsteroidal anti-inflammatory drugs and analgesics.
 

Re-epithelialization reduces transmission risk

“A clean, moist environment can mitigate transmission potential by covering infectious sores and promoting the re-epithelialization of the damaged exanthem,” Dr. Català advised. Tecovirimat (TPOXX, ST-246), an antiviral drug for smallpox, is approved for treating monkeypox in Europe but not in the United States (but it is approved for smallpox in the United States). Another antiviral drug, brincidofovir (CMX001 or Tembexa), is approved for smallpox in the United States, but not in Europe, according to Dr. Català. (In the United States, no treatment is specifically approved for treating monkeypox, but antivirals developed for smallpox “may prove beneficial against monkeypox,” according to the CDC.)

But she advised weighing the risks and benefits of using either drug in any individual patient.

The data suggest that the risk of viral shedding persists until the late stages of the disease trajectory. “A person is considered infectious from the onset of clinical manifestations until all skin lesions have scabbed over and re-epithelization has occurred,” Dr. Català said.

The prolonged period of contagion might be one reason to expect monkeypox to be transmitted more generally than it is now, according to Boghuma K. Titanji, MD, PhD, assistant professor of infectious diseases, Emory University, Atlanta.

“The longer the outbreak persists, the more likely we will see cases reported in groups other than MSM who have been most affected so far,” said Dr. Titanji, the first author of a recently published review article on monkeypox in Open Forum Infectious Diseases.

However, he acknowledged that a COVID-like spread is not expected. “The spread of monkeypox requires close and prolonged contact and is generally inefficient via fomites and droplet modes of transmission,” Dr. Titanji said in an interview. “Spread in heterosexual networks and congregate settings like crowded jails where close contact is unavoidable remains a concern that we need to educate the public about and maintain a high level of vigilance for.”

Dr. Català and Dr. Titanji report no potential conflicts of interest.

MILAN – In the current spread of monkeypox among countries outside of Africa, this zoonotic orthopox DNA virus is sexually transmitted in more than 90% of cases, mostly among men having sex with men (MSM), and can produce severe skin and systemic symptoms but is rarely fatal, according to a breaking news presentation at the annual congress of the European Academy of Dermatology and Venereology.

Synthesizing data from 185 cases in Spain with several sets of recently published data, Alba Català, MD, a dermatologist at Centro Médico Teknon, Barcelona, said at the meeting that there have been only two deaths in Spain in the current epidemic. (As of Sept. 30, after the EADV meeting had concluded, a total of three deaths related to monkeypox in Spain and one death in the United States had been reported, according to the Centers for Disease Control and Prevention).

Hospitalizations have been uncommon, and in Spain, there were only four hospitalizations, according to data collected from the beginning of May through early August, she said. Almost all cases in this Spanish series were from men having high-risk sex with men. Upon screening, 76% had another sexually transmitted disease, including 41% infected with human immunodeficiency virus.
 

More than 40% of patients with monkeypox have HIV

These data are consistent with several other recently published studies, such as one that evaluated 528 infections in 16 non-African countries, including those in North America, South America, Europe, the Mideast, as well as Australia. In that survey, published in the New England Journal of Medicine, and covering cases between late April and late June, 2022, 41% were HIV positive. Of those who were HIV negative, 57% were taking a pre-exposure prophylaxis regimen of antiretroviral drugs to prevent HIV infection.

However, these data do not preclude a significant risk of nonsexual transmission, according to Dr. Català, who noted that respiratory transmission and transmission through nonsexual skin contact is well documented in endemic areas.

“The virus has no preference for a sexual orientation,” Dr. Català cautioned. Despite the consistency of the data in regard to a largely MSM transmission in the epidemic so far, “these data may change with further spread of infection in the community.”

Typically, the incubation period of monkeypox lasts several days before the invasive period, which is commonly accompanied by systemic complaints, particularly fever, headache, and often lymphadenopathy. These systemic features usually but not always precede cutaneous involvement, which is seen in more than 90% of patients, according to Dr. Català. In the Spanish series, mucocutaneous involvement was recorded in 100% of patients.

Monkeypox and smallpox

“The differential diagnosis might include other vesicular eruptions, such as those caused by varicella or smallpox,” reported Dr. Català, who noted that monkeypox and smallpox are related.

Cutaneous lesions often appear first at the site of infection, such as the genitalia, but typically spread in a secondary eruption that is pruritic and may take days to resolve, according to Dr. Català. She reported that single lesions are less common but do occur. While hundreds of lesions have been reported among cases in endemic areas, most patients had 25 lesions or fewer in the Spanish epidemic and other recent series.

Even though there is a common progression in which lesions begin in a papular stage before the vesicular and pustular stages in a given area, new eruptions can occur before a prior eruption develops scabs.

“Frequently, not all the patient’s lesions are in the same stage of development,” said Dr. Català, who explained that disease activity and its complications, such as proctitis, pharyngitis, and penile edema, can take weeks to resolve. Because of the highly invasive nature of monkeypox, it is appropriate to be alert to less common manifestations, such as ocular involvement.

Many of these and other complications, such as secondary bacterial infections, will require targeted treatment, but the mainstay of therapy for the dermatologic manifestations of monkeypox is symptomatic treatment that includes nonsteroidal anti-inflammatory drugs and analgesics.
 

Re-epithelialization reduces transmission risk

“A clean, moist environment can mitigate transmission potential by covering infectious sores and promoting the re-epithelialization of the damaged exanthem,” Dr. Català advised. Tecovirimat (TPOXX, ST-246), an antiviral drug for smallpox, is approved for treating monkeypox in Europe but not in the United States (but it is approved for smallpox in the United States). Another antiviral drug, brincidofovir (CMX001 or Tembexa), is approved for smallpox in the United States, but not in Europe, according to Dr. Català. (In the United States, no treatment is specifically approved for treating monkeypox, but antivirals developed for smallpox “may prove beneficial against monkeypox,” according to the CDC.)

But she advised weighing the risks and benefits of using either drug in any individual patient.

The data suggest that the risk of viral shedding persists until the late stages of the disease trajectory. “A person is considered infectious from the onset of clinical manifestations until all skin lesions have scabbed over and re-epithelization has occurred,” Dr. Català said.

The prolonged period of contagion might be one reason to expect monkeypox to be transmitted more generally than it is now, according to Boghuma K. Titanji, MD, PhD, assistant professor of infectious diseases, Emory University, Atlanta.

“The longer the outbreak persists, the more likely we will see cases reported in groups other than MSM who have been most affected so far,” said Dr. Titanji, the first author of a recently published review article on monkeypox in Open Forum Infectious Diseases.

However, he acknowledged that a COVID-like spread is not expected. “The spread of monkeypox requires close and prolonged contact and is generally inefficient via fomites and droplet modes of transmission,” Dr. Titanji said in an interview. “Spread in heterosexual networks and congregate settings like crowded jails where close contact is unavoidable remains a concern that we need to educate the public about and maintain a high level of vigilance for.”

Dr. Català and Dr. Titanji report no potential conflicts of interest.

MILAN – In the current spread of monkeypox among countries outside of Africa, this zoonotic orthopox DNA virus is sexually transmitted in more than 90% of cases, mostly among men having sex with men (MSM), and can produce severe skin and systemic symptoms but is rarely fatal, according to a breaking news presentation at the annual congress of the European Academy of Dermatology and Venereology.

Synthesizing data from 185 cases in Spain with several sets of recently published data, Alba Català, MD, a dermatologist at Centro Médico Teknon, Barcelona, said at the meeting that there have been only two deaths in Spain in the current epidemic. (As of Sept. 30, after the EADV meeting had concluded, a total of three deaths related to monkeypox in Spain and one death in the United States had been reported, according to the Centers for Disease Control and Prevention).

Hospitalizations have been uncommon, and in Spain, there were only four hospitalizations, according to data collected from the beginning of May through early August, she said. Almost all cases in this Spanish series were from men having high-risk sex with men. Upon screening, 76% had another sexually transmitted disease, including 41% infected with human immunodeficiency virus.
 

More than 40% of patients with monkeypox have HIV

These data are consistent with several other recently published studies, such as one that evaluated 528 infections in 16 non-African countries, including those in North America, South America, Europe, the Mideast, as well as Australia. In that survey, published in the New England Journal of Medicine, and covering cases between late April and late June, 2022, 41% were HIV positive. Of those who were HIV negative, 57% were taking a pre-exposure prophylaxis regimen of antiretroviral drugs to prevent HIV infection.

However, these data do not preclude a significant risk of nonsexual transmission, according to Dr. Català, who noted that respiratory transmission and transmission through nonsexual skin contact is well documented in endemic areas.

“The virus has no preference for a sexual orientation,” Dr. Català cautioned. Despite the consistency of the data in regard to a largely MSM transmission in the epidemic so far, “these data may change with further spread of infection in the community.”

Typically, the incubation period of monkeypox lasts several days before the invasive period, which is commonly accompanied by systemic complaints, particularly fever, headache, and often lymphadenopathy. These systemic features usually but not always precede cutaneous involvement, which is seen in more than 90% of patients, according to Dr. Català. In the Spanish series, mucocutaneous involvement was recorded in 100% of patients.

Monkeypox and smallpox

“The differential diagnosis might include other vesicular eruptions, such as those caused by varicella or smallpox,” reported Dr. Català, who noted that monkeypox and smallpox are related.

Cutaneous lesions often appear first at the site of infection, such as the genitalia, but typically spread in a secondary eruption that is pruritic and may take days to resolve, according to Dr. Català. She reported that single lesions are less common but do occur. While hundreds of lesions have been reported among cases in endemic areas, most patients had 25 lesions or fewer in the Spanish epidemic and other recent series.

Even though there is a common progression in which lesions begin in a papular stage before the vesicular and pustular stages in a given area, new eruptions can occur before a prior eruption develops scabs.

“Frequently, not all the patient’s lesions are in the same stage of development,” said Dr. Català, who explained that disease activity and its complications, such as proctitis, pharyngitis, and penile edema, can take weeks to resolve. Because of the highly invasive nature of monkeypox, it is appropriate to be alert to less common manifestations, such as ocular involvement.

Many of these and other complications, such as secondary bacterial infections, will require targeted treatment, but the mainstay of therapy for the dermatologic manifestations of monkeypox is symptomatic treatment that includes nonsteroidal anti-inflammatory drugs and analgesics.
 

Re-epithelialization reduces transmission risk

“A clean, moist environment can mitigate transmission potential by covering infectious sores and promoting the re-epithelialization of the damaged exanthem,” Dr. Català advised. Tecovirimat (TPOXX, ST-246), an antiviral drug for smallpox, is approved for treating monkeypox in Europe but not in the United States (but it is approved for smallpox in the United States). Another antiviral drug, brincidofovir (CMX001 or Tembexa), is approved for smallpox in the United States, but not in Europe, according to Dr. Català. (In the United States, no treatment is specifically approved for treating monkeypox, but antivirals developed for smallpox “may prove beneficial against monkeypox,” according to the CDC.)

But she advised weighing the risks and benefits of using either drug in any individual patient.

The data suggest that the risk of viral shedding persists until the late stages of the disease trajectory. “A person is considered infectious from the onset of clinical manifestations until all skin lesions have scabbed over and re-epithelization has occurred,” Dr. Català said.

The prolonged period of contagion might be one reason to expect monkeypox to be transmitted more generally than it is now, according to Boghuma K. Titanji, MD, PhD, assistant professor of infectious diseases, Emory University, Atlanta.

“The longer the outbreak persists, the more likely we will see cases reported in groups other than MSM who have been most affected so far,” said Dr. Titanji, the first author of a recently published review article on monkeypox in Open Forum Infectious Diseases.

However, he acknowledged that a COVID-like spread is not expected. “The spread of monkeypox requires close and prolonged contact and is generally inefficient via fomites and droplet modes of transmission,” Dr. Titanji said in an interview. “Spread in heterosexual networks and congregate settings like crowded jails where close contact is unavoidable remains a concern that we need to educate the public about and maintain a high level of vigilance for.”

Dr. Català and Dr. Titanji report no potential conflicts of interest.

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

A skin protection training program for hairdressers may reduce the risk of hand eczema, new data suggest.

The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.

Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.

Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.

Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.

“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.

Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.

The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.

Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.

The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.

The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
 

Prevalence of OHE dropped after program

The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.

In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.

There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).

The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.

“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.

Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.

He highlighted the following advice from the authors:

• Gloves should be used when washing, dyeing, bleaching, and creating perms.
• Disposable gloves should never be reused.
• Gloves should be used only as long as necessary.
• Rings should not be worn at work.
• Cotton gloves should be worn underneath protective gloves.
• For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
• Nitrile gloves should be used without rubber accelerators.

“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”

The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports no relevant financial relationships.

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

A skin protection training program for hairdressers may reduce the risk of hand eczema, new data suggest.

The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.

Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.

Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.

Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.

“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.

Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.

The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.

Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.

The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.

The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
 

Prevalence of OHE dropped after program

The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.

In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.

There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).

The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.

“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.

Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.

He highlighted the following advice from the authors:

• Gloves should be used when washing, dyeing, bleaching, and creating perms.
• Disposable gloves should never be reused.
• Gloves should be used only as long as necessary.
• Rings should not be worn at work.
• Cotton gloves should be worn underneath protective gloves.
• For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
• Nitrile gloves should be used without rubber accelerators.

“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”

The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports no relevant financial relationships.

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

A skin protection training program for hairdressers may reduce the risk of hand eczema, new data suggest.

The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.

Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.

Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.

Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.

“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.

Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.

The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.

Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.

The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.

The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
 

Prevalence of OHE dropped after program

The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.

In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.

There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).

The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.

“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.

Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.

He highlighted the following advice from the authors:

• Gloves should be used when washing, dyeing, bleaching, and creating perms.
• Disposable gloves should never be reused.
• Gloves should be used only as long as necessary.
• Rings should not be worn at work.
• Cotton gloves should be worn underneath protective gloves.
• For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
• Nitrile gloves should be used without rubber accelerators.

“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”

The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports 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.

In the study, the Barrier Dysfunction in Atopic Newborns Study (BABY), several biomarkers were found in the skin cells of newborns that were predictive not only for having AD 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.

In the study, the Barrier Dysfunction in Atopic Newborns Study (BABY), several biomarkers were found in the skin cells of newborns that were predictive not only for having AD 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.

In the study, the Barrier Dysfunction in Atopic Newborns Study (BABY), several biomarkers were found in the skin cells of newborns that were predictive not only for having AD 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.

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, 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 Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, 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 Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, 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. 

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.