Dermatology

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

SAN DIEGO – When parents bring their children to Caroline Piggott, MD, to evaluate a suspicious mole on the scalp or other body location, the vast majority turn out to be benign, because the incidence of melanoma is rare, especially before puberty.

“Only 1%-2% of all melanomas in the world are in children, so most of my job is to provide reassurance,” Dr. Piggott, a pediatric dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. “Few pediatric studies exist. Why? Because children are excluded from most melanoma clinical trials. Our management is based mainly on adult National Comprehensive Cancer Network guidelines.”

Doug Brunk/MDedge News

To help parents identify melanoma, clinicians typically recommend the “ABCDE” rule, for Asymmetry, Border irregularity, Color variation (especially dark or multiple colors), Diameter greater than 6 mm, and Evolving (is it changing, bleeding or painful?).

While Dr. Piggott considers the standard ABCDE rules as important – especially in older children and teenagers – researchers led by Kelly M. Cordoro, MD, professor of dermatology at the University of California, San Francisco, proposed a modified ABCD criteria based on evaluating a cohort of 60 children who were diagnosed with melanoma and 10 who were diagnosed with ambiguous melanocytic tumors treated as melanoma before age 20 years at UCSF from 1984 to 2009.

The researchers divided patients into two groups: those aged 0-10 years (19; group A) and those aged 11-19 years (51; group B), and found that 60% of children in group A and 40% of those in group B did not present with conventional ABCDE criteria for children. Of the 60 melanoma patients, 10 died. Of these, 9 were older than age 10, and 70% had amelanotic lesions. Based on their analysis of clinical, histopathologic, and outcomes data, Dr. Cordoro and colleagues proposed additional ABCD criteria in which A stands for stands Amelanotic; B for Bleeding or Bump; C for Color uniformity, and D for De novo or any Diameter.

“This doesn’t mean you throw the old ABCDE criteria out the window,” Dr. Piggott said. “It means that you use this modified criteria in conjunction with the conventional ABCDE rules.”

Risk factors for melanoma in children are like those in adults, and include a family history of melanoma, large/giant congenital nevi, the presence of many atypical appearing nevi, having Fitzpatrick skin types I or II, a history of blistering sunburns, and the presence of genetic anomalies such as xeroderma pigmentosum.

According to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program, melanoma incidence increased in all individuals in the United States aged 0-19 years from 1973 to 2009. Key risk factors included White race, female sex, and living in a SEER registry categorized as low UVB exposure. Over the study period, boys experienced increased incidence rates of melanoma on the face and trunk, while girls experienced increased incidence rates of melanoma on the lower limbs and hip.

More recently, researchers extracted data from 988,103 cases of invasive melanoma in the 2001-2015 SEER database to determine the age-specific incidence of melanoma in the United States. In 2015, 83,362 cases of invasive melanoma were reported for all ages. Of these, only 67 cases were younger than age 10, while 251 were between the ages of 10 and 19 and 1,973 were young adults between the ages of 20 and 29.

In other findings, between 2006 and 2015, the overall incidence of invasive melanoma for all ages increased from 200 million to 229 cases per million person-years. “However, there were statistically significant decreases in melanoma incidence for individuals aged 10-19 years and for those aged 10-29 years,” said Dr. Piggott, who was not involved with the study. “The hypothesis is that public health efforts encouraging against sun exposure and tanning bed use may be influencing melanoma incidence in younger populations. What is interesting, though, is that young adult women have twice the melanoma risk as young adult men.”

In a separate study, researchers prospectively followed 60 melanoma-prone families for up to 40 years to evaluate the risk of pediatric melanoma in those with and without cyclin-dependent kinase inhibitor 2A (CDKN2A) mutations. Regardless of their CDKN2A status, the percentage of pediatric melanoma cases was 6- to 28-fold higher among melanoma-prone families, compared with the general population. In addition, families who were CDKN2A positive had a significantly higher rate of pediatric melanoma cases compared with those who were CDKN2A negative (11.1% vs. 2.5%; P = .004).

As for treating pediatric melanoma, the standard of care is similar to that for adults: usually wide local surgical excision of the primary lesion, depending on depth. Clinicians typically follow adult parameters for sentinel lymph node biopsy, such as lesion depth and ulceration.

“We know that a positive sentinel node does have prognostic value, but there is great debate on whether to do a lymph node dissection if the sentinel lymph node is positive,” Dr. Piggott said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. “This is determined on a case-by-case basis. We consider factors such as, are the nodes palpable? Is there evidence on ultrasound? But there are no formal guidelines.”

Limited studies of systemic therapy in children exist because this population is excluded from most melanoma clinical trials. “In the past, interferon was sometimes used,” she said. “But in recent years, as with adults, we have started to use targeted immunologic therapy. This is usually managed by a tertiary academic oncology center.”

The chance of surviving pediatric melanoma is good if caught early. As in adults, the stage correlates strongly with survival, and distant metastases carry a poor prognosis.

In 2020, researchers published a retrospective, multicenter review of 38 cases of fatal pediatric melanoma between 1994 and 2017. The analysis was limited to individuals 20 years of age and younger who were cared for at 12 academic medical centers. Of the 38 patients, 42% were male, 58% were female, and 57% were White. In addition, 19% were Hispanic, “which is a larger percentage than fatalities in adult [Hispanic] populations with melanoma,” said Dr. Piggott, who was not involved in the study.

The mean age at diagnosis was 12.7 years, the mean age at death was 15.6 , and the mean survival time after diagnosis was about 35 months. Of the 16 cases with known identifiable subtypes, 50% were nodular, 31% were superficial spreading, and 19% were spitzoid melanoma. In addition, one-quarter of melanomas arose in association with congenital melanocytic nevi.

“The good news is that there are only 38 total cases of fatal pediatric melanoma between 12 academic centers over a 23-year period,” Dr. Piggott said. “Thanks goodness the number is that low.”

Dr. Piggott reported having no relevant disclosures.

SAN DIEGO – When parents bring their children to Caroline Piggott, MD, to evaluate a suspicious mole on the scalp or other body location, the vast majority turn out to be benign, because the incidence of melanoma is rare, especially before puberty.

“Only 1%-2% of all melanomas in the world are in children, so most of my job is to provide reassurance,” Dr. Piggott, a pediatric dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. “Few pediatric studies exist. Why? Because children are excluded from most melanoma clinical trials. Our management is based mainly on adult National Comprehensive Cancer Network guidelines.”

Doug Brunk/MDedge News

To help parents identify melanoma, clinicians typically recommend the “ABCDE” rule, for Asymmetry, Border irregularity, Color variation (especially dark or multiple colors), Diameter greater than 6 mm, and Evolving (is it changing, bleeding or painful?).

While Dr. Piggott considers the standard ABCDE rules as important – especially in older children and teenagers – researchers led by Kelly M. Cordoro, MD, professor of dermatology at the University of California, San Francisco, proposed a modified ABCD criteria based on evaluating a cohort of 60 children who were diagnosed with melanoma and 10 who were diagnosed with ambiguous melanocytic tumors treated as melanoma before age 20 years at UCSF from 1984 to 2009.

The researchers divided patients into two groups: those aged 0-10 years (19; group A) and those aged 11-19 years (51; group B), and found that 60% of children in group A and 40% of those in group B did not present with conventional ABCDE criteria for children. Of the 60 melanoma patients, 10 died. Of these, 9 were older than age 10, and 70% had amelanotic lesions. Based on their analysis of clinical, histopathologic, and outcomes data, Dr. Cordoro and colleagues proposed additional ABCD criteria in which A stands for stands Amelanotic; B for Bleeding or Bump; C for Color uniformity, and D for De novo or any Diameter.

“This doesn’t mean you throw the old ABCDE criteria out the window,” Dr. Piggott said. “It means that you use this modified criteria in conjunction with the conventional ABCDE rules.”

Risk factors for melanoma in children are like those in adults, and include a family history of melanoma, large/giant congenital nevi, the presence of many atypical appearing nevi, having Fitzpatrick skin types I or II, a history of blistering sunburns, and the presence of genetic anomalies such as xeroderma pigmentosum.

According to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program, melanoma incidence increased in all individuals in the United States aged 0-19 years from 1973 to 2009. Key risk factors included White race, female sex, and living in a SEER registry categorized as low UVB exposure. Over the study period, boys experienced increased incidence rates of melanoma on the face and trunk, while girls experienced increased incidence rates of melanoma on the lower limbs and hip.

More recently, researchers extracted data from 988,103 cases of invasive melanoma in the 2001-2015 SEER database to determine the age-specific incidence of melanoma in the United States. In 2015, 83,362 cases of invasive melanoma were reported for all ages. Of these, only 67 cases were younger than age 10, while 251 were between the ages of 10 and 19 and 1,973 were young adults between the ages of 20 and 29.

In other findings, between 2006 and 2015, the overall incidence of invasive melanoma for all ages increased from 200 million to 229 cases per million person-years. “However, there were statistically significant decreases in melanoma incidence for individuals aged 10-19 years and for those aged 10-29 years,” said Dr. Piggott, who was not involved with the study. “The hypothesis is that public health efforts encouraging against sun exposure and tanning bed use may be influencing melanoma incidence in younger populations. What is interesting, though, is that young adult women have twice the melanoma risk as young adult men.”

In a separate study, researchers prospectively followed 60 melanoma-prone families for up to 40 years to evaluate the risk of pediatric melanoma in those with and without cyclin-dependent kinase inhibitor 2A (CDKN2A) mutations. Regardless of their CDKN2A status, the percentage of pediatric melanoma cases was 6- to 28-fold higher among melanoma-prone families, compared with the general population. In addition, families who were CDKN2A positive had a significantly higher rate of pediatric melanoma cases compared with those who were CDKN2A negative (11.1% vs. 2.5%; P = .004).

As for treating pediatric melanoma, the standard of care is similar to that for adults: usually wide local surgical excision of the primary lesion, depending on depth. Clinicians typically follow adult parameters for sentinel lymph node biopsy, such as lesion depth and ulceration.

“We know that a positive sentinel node does have prognostic value, but there is great debate on whether to do a lymph node dissection if the sentinel lymph node is positive,” Dr. Piggott said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. “This is determined on a case-by-case basis. We consider factors such as, are the nodes palpable? Is there evidence on ultrasound? But there are no formal guidelines.”

Limited studies of systemic therapy in children exist because this population is excluded from most melanoma clinical trials. “In the past, interferon was sometimes used,” she said. “But in recent years, as with adults, we have started to use targeted immunologic therapy. This is usually managed by a tertiary academic oncology center.”

The chance of surviving pediatric melanoma is good if caught early. As in adults, the stage correlates strongly with survival, and distant metastases carry a poor prognosis.

In 2020, researchers published a retrospective, multicenter review of 38 cases of fatal pediatric melanoma between 1994 and 2017. The analysis was limited to individuals 20 years of age and younger who were cared for at 12 academic medical centers. Of the 38 patients, 42% were male, 58% were female, and 57% were White. In addition, 19% were Hispanic, “which is a larger percentage than fatalities in adult [Hispanic] populations with melanoma,” said Dr. Piggott, who was not involved in the study.

The mean age at diagnosis was 12.7 years, the mean age at death was 15.6 , and the mean survival time after diagnosis was about 35 months. Of the 16 cases with known identifiable subtypes, 50% were nodular, 31% were superficial spreading, and 19% were spitzoid melanoma. In addition, one-quarter of melanomas arose in association with congenital melanocytic nevi.

“The good news is that there are only 38 total cases of fatal pediatric melanoma between 12 academic centers over a 23-year period,” Dr. Piggott said. “Thanks goodness the number is that low.”

Dr. Piggott reported having no relevant disclosures.

SAN DIEGO – When parents bring their children to Caroline Piggott, MD, to evaluate a suspicious mole on the scalp or other body location, the vast majority turn out to be benign, because the incidence of melanoma is rare, especially before puberty.

“Only 1%-2% of all melanomas in the world are in children, so most of my job is to provide reassurance,” Dr. Piggott, a pediatric dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. “Few pediatric studies exist. Why? Because children are excluded from most melanoma clinical trials. Our management is based mainly on adult National Comprehensive Cancer Network guidelines.”

Doug Brunk/MDedge News

To help parents identify melanoma, clinicians typically recommend the “ABCDE” rule, for Asymmetry, Border irregularity, Color variation (especially dark or multiple colors), Diameter greater than 6 mm, and Evolving (is it changing, bleeding or painful?).

While Dr. Piggott considers the standard ABCDE rules as important – especially in older children and teenagers – researchers led by Kelly M. Cordoro, MD, professor of dermatology at the University of California, San Francisco, proposed a modified ABCD criteria based on evaluating a cohort of 60 children who were diagnosed with melanoma and 10 who were diagnosed with ambiguous melanocytic tumors treated as melanoma before age 20 years at UCSF from 1984 to 2009.

The researchers divided patients into two groups: those aged 0-10 years (19; group A) and those aged 11-19 years (51; group B), and found that 60% of children in group A and 40% of those in group B did not present with conventional ABCDE criteria for children. Of the 60 melanoma patients, 10 died. Of these, 9 were older than age 10, and 70% had amelanotic lesions. Based on their analysis of clinical, histopathologic, and outcomes data, Dr. Cordoro and colleagues proposed additional ABCD criteria in which A stands for stands Amelanotic; B for Bleeding or Bump; C for Color uniformity, and D for De novo or any Diameter.

“This doesn’t mean you throw the old ABCDE criteria out the window,” Dr. Piggott said. “It means that you use this modified criteria in conjunction with the conventional ABCDE rules.”

Risk factors for melanoma in children are like those in adults, and include a family history of melanoma, large/giant congenital nevi, the presence of many atypical appearing nevi, having Fitzpatrick skin types I or II, a history of blistering sunburns, and the presence of genetic anomalies such as xeroderma pigmentosum.

According to an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program, melanoma incidence increased in all individuals in the United States aged 0-19 years from 1973 to 2009. Key risk factors included White race, female sex, and living in a SEER registry categorized as low UVB exposure. Over the study period, boys experienced increased incidence rates of melanoma on the face and trunk, while girls experienced increased incidence rates of melanoma on the lower limbs and hip.

More recently, researchers extracted data from 988,103 cases of invasive melanoma in the 2001-2015 SEER database to determine the age-specific incidence of melanoma in the United States. In 2015, 83,362 cases of invasive melanoma were reported for all ages. Of these, only 67 cases were younger than age 10, while 251 were between the ages of 10 and 19 and 1,973 were young adults between the ages of 20 and 29.

In other findings, between 2006 and 2015, the overall incidence of invasive melanoma for all ages increased from 200 million to 229 cases per million person-years. “However, there were statistically significant decreases in melanoma incidence for individuals aged 10-19 years and for those aged 10-29 years,” said Dr. Piggott, who was not involved with the study. “The hypothesis is that public health efforts encouraging against sun exposure and tanning bed use may be influencing melanoma incidence in younger populations. What is interesting, though, is that young adult women have twice the melanoma risk as young adult men.”

In a separate study, researchers prospectively followed 60 melanoma-prone families for up to 40 years to evaluate the risk of pediatric melanoma in those with and without cyclin-dependent kinase inhibitor 2A (CDKN2A) mutations. Regardless of their CDKN2A status, the percentage of pediatric melanoma cases was 6- to 28-fold higher among melanoma-prone families, compared with the general population. In addition, families who were CDKN2A positive had a significantly higher rate of pediatric melanoma cases compared with those who were CDKN2A negative (11.1% vs. 2.5%; P = .004).

As for treating pediatric melanoma, the standard of care is similar to that for adults: usually wide local surgical excision of the primary lesion, depending on depth. Clinicians typically follow adult parameters for sentinel lymph node biopsy, such as lesion depth and ulceration.

“We know that a positive sentinel node does have prognostic value, but there is great debate on whether to do a lymph node dissection if the sentinel lymph node is positive,” Dr. Piggott said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. “This is determined on a case-by-case basis. We consider factors such as, are the nodes palpable? Is there evidence on ultrasound? But there are no formal guidelines.”

Limited studies of systemic therapy in children exist because this population is excluded from most melanoma clinical trials. “In the past, interferon was sometimes used,” she said. “But in recent years, as with adults, we have started to use targeted immunologic therapy. This is usually managed by a tertiary academic oncology center.”

The chance of surviving pediatric melanoma is good if caught early. As in adults, the stage correlates strongly with survival, and distant metastases carry a poor prognosis.

In 2020, researchers published a retrospective, multicenter review of 38 cases of fatal pediatric melanoma between 1994 and 2017. The analysis was limited to individuals 20 years of age and younger who were cared for at 12 academic medical centers. Of the 38 patients, 42% were male, 58% were female, and 57% were White. In addition, 19% were Hispanic, “which is a larger percentage than fatalities in adult [Hispanic] populations with melanoma,” said Dr. Piggott, who was not involved in the study.

The mean age at diagnosis was 12.7 years, the mean age at death was 15.6 , and the mean survival time after diagnosis was about 35 months. Of the 16 cases with known identifiable subtypes, 50% were nodular, 31% were superficial spreading, and 19% were spitzoid melanoma. In addition, one-quarter of melanomas arose in association with congenital melanocytic nevi.

“The good news is that there are only 38 total cases of fatal pediatric melanoma between 12 academic centers over a 23-year period,” Dr. Piggott said. “Thanks goodness the number is that low.”

Dr. Piggott reported having no relevant disclosures.

A new tool for predicting which patients with psoriasis will develop psoriatic arthritis (PsA) is showing promise for such clinical applications as early treatment in those at risk or trials to prevent PsA, according to a summary of progress at the annual meeting of the Canadian Rheumatology Association.

Based on current levels of sensitivity and specificity, psoriasis “can be predicted with reasonable accuracy,” reported Lihi Eder, MD, PhD, director of research in the rheumatology division at the University of Toronto.

The predictive method, called PRESTO (Prediction of Psoriatic Arthritis Tool), is based on variables readily available in clinical practice, according to Dr. Eder. Once values are assigned to the risk factors, the risk of PsA over a 1-year or 5-year time frame can be estimated with a calculator.

She called PRESTO the “first clinical tool for predicting PsA among psoriasis patients.”

The work on this tool began in 2006 when the International Psoriasis and Arthritis Research Team (IPART) initiated a prospectively collected cohort of psoriasis patients. To be enrolled, patients had to be free of signs and symptoms of arthritis upon examination by a rheumatologist. They were then invited to return annually for follow-up that again included screening for joint involvement by a rheumatologist.

At baseline and at follow-up evaluations, 13 predictors were evaluated. These involved psoriasis characteristics, such as nail pitting; symptoms, such as stiffness; comorbidities, such as additional inflammatory diseases; and laboratory values, such as upregulated markers of inflammation.

Symptoms and signs used to predict PsA

Dr. Eder and her colleagues applied regression models to select an optimal combination of variables weighted for predictive value. Variables offering predictive value included higher PASI (Psoriasis Area and Severity Index), greater fatigue score as measured by FACIT (Functional Assessment of Chronic Illness Therapy) score, greater morning stiffness, and greater pain.

When applied to 635 patients in the IPART cohort, in which there were 51 incident PsA cases over 1 year and 75 incident cases over 5 years, the area under the curve (AUC) for PRESTO at the cutoffs studied was 72% for the 1-year time window and 75% for the 5-year time window.

These levels are associated with adequate accuracy, according to Dr. Eder, who explained that “an AUC greater than 70% is considered reasonable” for clinical applicability.

Moreover, the cutoffs can be adjusted for the specific purpose of the predictive tool. For example, to screen patients for risk, lower cutoffs could be employed to increase sensitivity. In order to select patients for a clinical trial to prevent PsA, higher cutoffs could be employed to increase specificity.

But sensitivities and specificities move in opposite directions when cutoffs are adjusted. Showing data from the 5-year prediction model, Dr. Eder reported that specificities climbed from about 58% to 97% as cutoffs were increased. The sensitivities with these adjustments fell from 79% to 14%.

In general, Dr. Eder said there was “excellent calibration” for the cutoffs employed when they compared the predicted and observed rates of PsA according to quintile of predictive probability. The differences were particularly minor over a 1-year time period. Over the 5-year period, observed rates were somewhat higher than predicted in the fourth and fifth quintile, but, again, this discrepancy could be modified for specific applications with cutoff adjustments.

Validation studies are planned

Even though psoriasis patients in IPART represents one of the largest cohorts of prospectively collected psoriasis patients, Dr. Eder acknowledged that the sample size would be considered “moderate” for developing a predictive model. However, the fact that the data were collected prospectively using standardized methodology strengthens the findings and provides the basis for the next step.

“Validation studies are planned with external cohorts,” said Dr. Eder, who indicated that a viable tool for identifying psoriasis patients at risk for PsA is likely. Even if it is not employed routinely in its current form at the level of individual patient care, she predicted that it will have value at a research level for understanding the relationship of psoriasis to PsA.

Christopher T. Ritchlin, MD, a professor and researcher at the University of Rochester (N.Y.), agreed that PRESTO has important potential as a clinical tool. Dr. Ritchlin has been involved in the development of PRESTO but was not involved in the presentation made at the CRA annual meeting.

“The PRESTO tool has the ability to predict the 2- and 5-year risk of developing psoriatic arthritis, which is an important advance if confirmed,” he said in an interview. He pointed out that approximately 25%-30% who develop psoriasis will go on to develop PsA but until now there has been no way to identify them.

“This tool may provide a pathway to early intervention,” he said.

Dr. Eder has financial relationships with AbbVie, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, Sandoz, and UCB. Dr. Ritchlin has financial relationships with many of the same companies.

A new tool for predicting which patients with psoriasis will develop psoriatic arthritis (PsA) is showing promise for such clinical applications as early treatment in those at risk or trials to prevent PsA, according to a summary of progress at the annual meeting of the Canadian Rheumatology Association.

Based on current levels of sensitivity and specificity, psoriasis “can be predicted with reasonable accuracy,” reported Lihi Eder, MD, PhD, director of research in the rheumatology division at the University of Toronto.

The predictive method, called PRESTO (Prediction of Psoriatic Arthritis Tool), is based on variables readily available in clinical practice, according to Dr. Eder. Once values are assigned to the risk factors, the risk of PsA over a 1-year or 5-year time frame can be estimated with a calculator.

She called PRESTO the “first clinical tool for predicting PsA among psoriasis patients.”

The work on this tool began in 2006 when the International Psoriasis and Arthritis Research Team (IPART) initiated a prospectively collected cohort of psoriasis patients. To be enrolled, patients had to be free of signs and symptoms of arthritis upon examination by a rheumatologist. They were then invited to return annually for follow-up that again included screening for joint involvement by a rheumatologist.

At baseline and at follow-up evaluations, 13 predictors were evaluated. These involved psoriasis characteristics, such as nail pitting; symptoms, such as stiffness; comorbidities, such as additional inflammatory diseases; and laboratory values, such as upregulated markers of inflammation.

Symptoms and signs used to predict PsA

Dr. Eder and her colleagues applied regression models to select an optimal combination of variables weighted for predictive value. Variables offering predictive value included higher PASI (Psoriasis Area and Severity Index), greater fatigue score as measured by FACIT (Functional Assessment of Chronic Illness Therapy) score, greater morning stiffness, and greater pain.

When applied to 635 patients in the IPART cohort, in which there were 51 incident PsA cases over 1 year and 75 incident cases over 5 years, the area under the curve (AUC) for PRESTO at the cutoffs studied was 72% for the 1-year time window and 75% for the 5-year time window.

These levels are associated with adequate accuracy, according to Dr. Eder, who explained that “an AUC greater than 70% is considered reasonable” for clinical applicability.

Moreover, the cutoffs can be adjusted for the specific purpose of the predictive tool. For example, to screen patients for risk, lower cutoffs could be employed to increase sensitivity. In order to select patients for a clinical trial to prevent PsA, higher cutoffs could be employed to increase specificity.

But sensitivities and specificities move in opposite directions when cutoffs are adjusted. Showing data from the 5-year prediction model, Dr. Eder reported that specificities climbed from about 58% to 97% as cutoffs were increased. The sensitivities with these adjustments fell from 79% to 14%.

In general, Dr. Eder said there was “excellent calibration” for the cutoffs employed when they compared the predicted and observed rates of PsA according to quintile of predictive probability. The differences were particularly minor over a 1-year time period. Over the 5-year period, observed rates were somewhat higher than predicted in the fourth and fifth quintile, but, again, this discrepancy could be modified for specific applications with cutoff adjustments.

Validation studies are planned

Even though psoriasis patients in IPART represents one of the largest cohorts of prospectively collected psoriasis patients, Dr. Eder acknowledged that the sample size would be considered “moderate” for developing a predictive model. However, the fact that the data were collected prospectively using standardized methodology strengthens the findings and provides the basis for the next step.

“Validation studies are planned with external cohorts,” said Dr. Eder, who indicated that a viable tool for identifying psoriasis patients at risk for PsA is likely. Even if it is not employed routinely in its current form at the level of individual patient care, she predicted that it will have value at a research level for understanding the relationship of psoriasis to PsA.

Christopher T. Ritchlin, MD, a professor and researcher at the University of Rochester (N.Y.), agreed that PRESTO has important potential as a clinical tool. Dr. Ritchlin has been involved in the development of PRESTO but was not involved in the presentation made at the CRA annual meeting.

“The PRESTO tool has the ability to predict the 2- and 5-year risk of developing psoriatic arthritis, which is an important advance if confirmed,” he said in an interview. He pointed out that approximately 25%-30% who develop psoriasis will go on to develop PsA but until now there has been no way to identify them.

“This tool may provide a pathway to early intervention,” he said.

Dr. Eder has financial relationships with AbbVie, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, Sandoz, and UCB. Dr. Ritchlin has financial relationships with many of the same companies.

A new tool for predicting which patients with psoriasis will develop psoriatic arthritis (PsA) is showing promise for such clinical applications as early treatment in those at risk or trials to prevent PsA, according to a summary of progress at the annual meeting of the Canadian Rheumatology Association.

Based on current levels of sensitivity and specificity, psoriasis “can be predicted with reasonable accuracy,” reported Lihi Eder, MD, PhD, director of research in the rheumatology division at the University of Toronto.

The predictive method, called PRESTO (Prediction of Psoriatic Arthritis Tool), is based on variables readily available in clinical practice, according to Dr. Eder. Once values are assigned to the risk factors, the risk of PsA over a 1-year or 5-year time frame can be estimated with a calculator.

She called PRESTO the “first clinical tool for predicting PsA among psoriasis patients.”

The work on this tool began in 2006 when the International Psoriasis and Arthritis Research Team (IPART) initiated a prospectively collected cohort of psoriasis patients. To be enrolled, patients had to be free of signs and symptoms of arthritis upon examination by a rheumatologist. They were then invited to return annually for follow-up that again included screening for joint involvement by a rheumatologist.

At baseline and at follow-up evaluations, 13 predictors were evaluated. These involved psoriasis characteristics, such as nail pitting; symptoms, such as stiffness; comorbidities, such as additional inflammatory diseases; and laboratory values, such as upregulated markers of inflammation.

Symptoms and signs used to predict PsA

Dr. Eder and her colleagues applied regression models to select an optimal combination of variables weighted for predictive value. Variables offering predictive value included higher PASI (Psoriasis Area and Severity Index), greater fatigue score as measured by FACIT (Functional Assessment of Chronic Illness Therapy) score, greater morning stiffness, and greater pain.

When applied to 635 patients in the IPART cohort, in which there were 51 incident PsA cases over 1 year and 75 incident cases over 5 years, the area under the curve (AUC) for PRESTO at the cutoffs studied was 72% for the 1-year time window and 75% for the 5-year time window.

These levels are associated with adequate accuracy, according to Dr. Eder, who explained that “an AUC greater than 70% is considered reasonable” for clinical applicability.

Moreover, the cutoffs can be adjusted for the specific purpose of the predictive tool. For example, to screen patients for risk, lower cutoffs could be employed to increase sensitivity. In order to select patients for a clinical trial to prevent PsA, higher cutoffs could be employed to increase specificity.

But sensitivities and specificities move in opposite directions when cutoffs are adjusted. Showing data from the 5-year prediction model, Dr. Eder reported that specificities climbed from about 58% to 97% as cutoffs were increased. The sensitivities with these adjustments fell from 79% to 14%.

In general, Dr. Eder said there was “excellent calibration” for the cutoffs employed when they compared the predicted and observed rates of PsA according to quintile of predictive probability. The differences were particularly minor over a 1-year time period. Over the 5-year period, observed rates were somewhat higher than predicted in the fourth and fifth quintile, but, again, this discrepancy could be modified for specific applications with cutoff adjustments.

Validation studies are planned

Even though psoriasis patients in IPART represents one of the largest cohorts of prospectively collected psoriasis patients, Dr. Eder acknowledged that the sample size would be considered “moderate” for developing a predictive model. However, the fact that the data were collected prospectively using standardized methodology strengthens the findings and provides the basis for the next step.

“Validation studies are planned with external cohorts,” said Dr. Eder, who indicated that a viable tool for identifying psoriasis patients at risk for PsA is likely. Even if it is not employed routinely in its current form at the level of individual patient care, she predicted that it will have value at a research level for understanding the relationship of psoriasis to PsA.

Christopher T. Ritchlin, MD, a professor and researcher at the University of Rochester (N.Y.), agreed that PRESTO has important potential as a clinical tool. Dr. Ritchlin has been involved in the development of PRESTO but was not involved in the presentation made at the CRA annual meeting.

“The PRESTO tool has the ability to predict the 2- and 5-year risk of developing psoriatic arthritis, which is an important advance if confirmed,” he said in an interview. He pointed out that approximately 25%-30% who develop psoriasis will go on to develop PsA but until now there has been no way to identify them.

“This tool may provide a pathway to early intervention,” he said.

Dr. Eder has financial relationships with AbbVie, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, Sandoz, and UCB. Dr. Ritchlin has financial relationships with many of the same companies.

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

This linear pattern of hyper-pigmented, often verrucous tissue oriented along Blaschko skin lines is typical for linear epidermal nevi (LEN). In some cases, lesions are not in a linear pattern and are actually in more of a localized or whorled pattern (called epidermal nevi).

LEN are usually present at birth, as in this individual. They are frequently seen on the head and neck region and are often asymptomatic. LEN are considered a birthmark that develops because of a genetic abnormality that typically affects keratinocytes. This genetic mutation only affects a portion of the body (mosaicism) without affecting the overall genetics of the individual. This is important to note because LEN do not typically have a hereditary component or implications for offspring. While usually asymptomatic and localized, LEN can be associated with extracutaneous and neurologic difficulties. In these situations, it is called epidermal nevus syndrome, and is more common if the LEN occur on the face or head.¹

Since LEN are usually asymptomatic, treatment is not required unless the lesions affect the function of adjacent structures, such as the eyes, lips, or nose. Due to their frequent presence on the face or other visible areas, some patients may choose to get these lesions treated for cosmetic purposes. In the past, full-thickness excision was recommended. Topical medications are ineffective, and superficial shave excision usually leads to recurrence. More recently, destructive laser treatments have been used, with success, to reduce the appearance of the lesions.²

This patient was not concerned about the appearance of the asymptomatic lesions and chose not to have any treatment.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Friday, Feb. 10, 2023, marked the first time a patient told me they had used ChatGPT to answer a medical question. I’ve been reluctant to write about this super-buzzy new AI chatbot, but I am starting to think it is the real deal. Just how powerful is it? Well, ChatGPT might in fact be writing this column right now. It isn’t. No really, it’s me. But if not for the few cues (“super-buzzy”) that you’ll recognize as my writing voice, there might not be any way for you to know if I wrote this or not.

It’s perfectly OK if you’ve no clue what I’m talking about. ChatGPT is an AI chatbot that burst into public view just a couple months ago. Not your parent’s chatbot, this one is capable of answering questions in conversational language. It is jaw-droppingly good. Like Google, you can type in a question and it offers you answers. Rather than giving you a list of websites and a few Wikipedia blurbs, however, ChatGPT answers your question in human-like text. It can also create content on demand. For example, I asked it to write a Valentine poem to a dermatologist, and it gave me five stanzas starting with:

Oh gentle healer of skin so fair,
Your touch is soft and hands so rare,
With your skills and gentle care,
You make my heart skip with a flare.

Not good enough to send to my wife. But not bad.

If you ask it again, it will create a whole new one for you. Amusing, yes? What if you asked ChatGPT to explain psoriasis, or any medical condition for that matter, to a patient? The replies are quite good. Some even better than what I’m currently using for my patients. It can also offer treatment recommendations, vacation advice, and plan, with recipes, a dinner party for six with one vegan and one gluten-free couple. If you are a programmer, it can write code. Ask it for a Wordpress plugin to add to your website and your eyes will widen as you see it magically appear before you. What if you find that you just don’t like your daughter’s new boyfriend? Yep, it will write the text or email for you to help with this discussion. I’ve saved that one.

I tried “What are treatments for bullous pemphigoid that has been refractory to topical steroid, oral prednisone, and oral tetracyclines?” It replied with five ideas, including the standard methotrexate and azathioprine but also IVIG, Rituxan, even other biologics. Write an op note? Appeal a denied prior authorization to a payer? Write a clinic note for a complete skin exam? Check, check, check. Are you starting to think it might be the real deal, too?

Before we sell the farm though, there are significant limitations. Despite how swotty ChatGPT seems, it is not smart. That is, “it” has no idea what “it” is saying. ChatGPT is an incredibly sophisticated algorithm that has learned the probability of what word comes next in a conversation. To do so, it read the Internet. Billions (trillions?) of words make it possible to predict what is the best answer to any question. But – it’s only as good as the Internet, so there’s that. My patient who used ChatGPT has dissecting cellulitis and asked what to do for scarring alopecia. Some of the answers were reasonable, but some, such as transplanting hairs into the scarred areas, would not likely be helpful. That is unless ChatGPT knows something I don’t.

Having wasted hours of time playing with this thing rather than writing my column, I asked ChatGPT to write an article about itself in the style of Christopher Hitchens. It was nothing like his incisive and eloquent prose, but it wrote 500 words in a few seconds ending with:

“The reality is that there is no substitute for human interaction and empathy in the field of dermatology. Dermatologists must be cautious in their adoption of ChatGPT and ensure that they are not sacrificing the quality of patient care in the pursuit of efficiency and convenience.”

I’m not sure I could have said it better myself.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Friday, Feb. 10, 2023, marked the first time a patient told me they had used ChatGPT to answer a medical question. I’ve been reluctant to write about this super-buzzy new AI chatbot, but I am starting to think it is the real deal. Just how powerful is it? Well, ChatGPT might in fact be writing this column right now. It isn’t. No really, it’s me. But if not for the few cues (“super-buzzy”) that you’ll recognize as my writing voice, there might not be any way for you to know if I wrote this or not.

It’s perfectly OK if you’ve no clue what I’m talking about. ChatGPT is an AI chatbot that burst into public view just a couple months ago. Not your parent’s chatbot, this one is capable of answering questions in conversational language. It is jaw-droppingly good. Like Google, you can type in a question and it offers you answers. Rather than giving you a list of websites and a few Wikipedia blurbs, however, ChatGPT answers your question in human-like text. It can also create content on demand. For example, I asked it to write a Valentine poem to a dermatologist, and it gave me five stanzas starting with:

Oh gentle healer of skin so fair,
Your touch is soft and hands so rare,
With your skills and gentle care,
You make my heart skip with a flare.

Not good enough to send to my wife. But not bad.

If you ask it again, it will create a whole new one for you. Amusing, yes? What if you asked ChatGPT to explain psoriasis, or any medical condition for that matter, to a patient? The replies are quite good. Some even better than what I’m currently using for my patients. It can also offer treatment recommendations, vacation advice, and plan, with recipes, a dinner party for six with one vegan and one gluten-free couple. If you are a programmer, it can write code. Ask it for a Wordpress plugin to add to your website and your eyes will widen as you see it magically appear before you. What if you find that you just don’t like your daughter’s new boyfriend? Yep, it will write the text or email for you to help with this discussion. I’ve saved that one.

I tried “What are treatments for bullous pemphigoid that has been refractory to topical steroid, oral prednisone, and oral tetracyclines?” It replied with five ideas, including the standard methotrexate and azathioprine but also IVIG, Rituxan, even other biologics. Write an op note? Appeal a denied prior authorization to a payer? Write a clinic note for a complete skin exam? Check, check, check. Are you starting to think it might be the real deal, too?

Before we sell the farm though, there are significant limitations. Despite how swotty ChatGPT seems, it is not smart. That is, “it” has no idea what “it” is saying. ChatGPT is an incredibly sophisticated algorithm that has learned the probability of what word comes next in a conversation. To do so, it read the Internet. Billions (trillions?) of words make it possible to predict what is the best answer to any question. But – it’s only as good as the Internet, so there’s that. My patient who used ChatGPT has dissecting cellulitis and asked what to do for scarring alopecia. Some of the answers were reasonable, but some, such as transplanting hairs into the scarred areas, would not likely be helpful. That is unless ChatGPT knows something I don’t.

Having wasted hours of time playing with this thing rather than writing my column, I asked ChatGPT to write an article about itself in the style of Christopher Hitchens. It was nothing like his incisive and eloquent prose, but it wrote 500 words in a few seconds ending with:

“The reality is that there is no substitute for human interaction and empathy in the field of dermatology. Dermatologists must be cautious in their adoption of ChatGPT and ensure that they are not sacrificing the quality of patient care in the pursuit of efficiency and convenience.”

I’m not sure I could have said it better myself.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Friday, Feb. 10, 2023, marked the first time a patient told me they had used ChatGPT to answer a medical question. I’ve been reluctant to write about this super-buzzy new AI chatbot, but I am starting to think it is the real deal. Just how powerful is it? Well, ChatGPT might in fact be writing this column right now. It isn’t. No really, it’s me. But if not for the few cues (“super-buzzy”) that you’ll recognize as my writing voice, there might not be any way for you to know if I wrote this or not.

It’s perfectly OK if you’ve no clue what I’m talking about. ChatGPT is an AI chatbot that burst into public view just a couple months ago. Not your parent’s chatbot, this one is capable of answering questions in conversational language. It is jaw-droppingly good. Like Google, you can type in a question and it offers you answers. Rather than giving you a list of websites and a few Wikipedia blurbs, however, ChatGPT answers your question in human-like text. It can also create content on demand. For example, I asked it to write a Valentine poem to a dermatologist, and it gave me five stanzas starting with:

Oh gentle healer of skin so fair,
Your touch is soft and hands so rare,
With your skills and gentle care,
You make my heart skip with a flare.

Not good enough to send to my wife. But not bad.

If you ask it again, it will create a whole new one for you. Amusing, yes? What if you asked ChatGPT to explain psoriasis, or any medical condition for that matter, to a patient? The replies are quite good. Some even better than what I’m currently using for my patients. It can also offer treatment recommendations, vacation advice, and plan, with recipes, a dinner party for six with one vegan and one gluten-free couple. If you are a programmer, it can write code. Ask it for a Wordpress plugin to add to your website and your eyes will widen as you see it magically appear before you. What if you find that you just don’t like your daughter’s new boyfriend? Yep, it will write the text or email for you to help with this discussion. I’ve saved that one.

I tried “What are treatments for bullous pemphigoid that has been refractory to topical steroid, oral prednisone, and oral tetracyclines?” It replied with five ideas, including the standard methotrexate and azathioprine but also IVIG, Rituxan, even other biologics. Write an op note? Appeal a denied prior authorization to a payer? Write a clinic note for a complete skin exam? Check, check, check. Are you starting to think it might be the real deal, too?

Before we sell the farm though, there are significant limitations. Despite how swotty ChatGPT seems, it is not smart. That is, “it” has no idea what “it” is saying. ChatGPT is an incredibly sophisticated algorithm that has learned the probability of what word comes next in a conversation. To do so, it read the Internet. Billions (trillions?) of words make it possible to predict what is the best answer to any question. But – it’s only as good as the Internet, so there’s that. My patient who used ChatGPT has dissecting cellulitis and asked what to do for scarring alopecia. Some of the answers were reasonable, but some, such as transplanting hairs into the scarred areas, would not likely be helpful. That is unless ChatGPT knows something I don’t.

Having wasted hours of time playing with this thing rather than writing my column, I asked ChatGPT to write an article about itself in the style of Christopher Hitchens. It was nothing like his incisive and eloquent prose, but it wrote 500 words in a few seconds ending with:

“The reality is that there is no substitute for human interaction and empathy in the field of dermatology. Dermatologists must be cautious in their adoption of ChatGPT and ensure that they are not sacrificing the quality of patient care in the pursuit of efficiency and convenience.”

I’m not sure I could have said it better myself.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

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

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

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

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

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

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

When administered subcutaneously every 2 weeks, secukinumab was effective at improving signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adults up to 52 weeks, results from two pivotal phase 3 clinical trials showed.

The findings build on week 16 data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety, and tolerability of the interleukin-17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS, and were presented at the 2022 annual congress of the European Academy of Dermatology and Venereology. In those studies, at 16 weeks, 42%-46% of patients achieved an HS Clinical Response (HiSCR) – the primary outcome measure in both trials. For the most recent analysis, which was published in The Lancet, investigators found that, at 52 weeks, 56.4% of patients in SUNSHINE and 65% of patients in SUNRISE who received secukinumab 300 mg every 2 weeks achieved a HiSCR, compared with 56.3% of patients in SUNSHINE and 62.2% of patients in SUNRISE who received secukinumab 300 mg every 4 weeks.

“This is great news for people with HS: it improves our knowledge about how to best treat patients today and leads us to new areas that will help us treat them even better in the future,” Alexa B. Kimball, MD, MPH, the lead investigator for both trials, said in an interview. “Dermatologists have been using biologics for decades. This data provides clinicians with information they can use to easily expand their HS management repertoire to include secukinumab.”

To date, the tumor necrosis factor inhibitor adalimumab is the only approved biologic therapy approved for the treatment of moderate-to-severe HS, in people aged 12 years and older.

The two trials were conducted in 40 countries, with SUNSHINE enrolling 541 patients, and SUNRISE enrolling 543. Patients in each study were randomized to one of three experimental arms: secukinumab 300 mg every 2 weeks after five weekly loading doses; secukinumab 300 mg every 4 weeks after five weekly loading doses; placebo dose every 2 weeks after five weekly placebo doses. The mean age was 37 years, about 55% were female, and about 76% were White (about 9% were Black and about 10% were Asian). Dr. Kimball, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Boston, and coauthors observed that the group that received secukinumab every 4 weeks did not meet the primary endpoint in the SUNSHINE trial, but it was met in the SUNRISE trial. “Research and subgroup analyses are required and might improve our understanding of the effect of patient characteristics on treatment response and further refine the dosing recommendations for different populations,” they wrote.

In a pooled analysis, 55.2% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 2 weeks had a reduction in pain as measured by the Patient’s Global Assessment of Skin Pain Numeric Rating Scale, compared with 53% of patients from SUNSHINE and SUNRISE who received secukinumab 300 mg every 4 weeks. The most common adverse events up to week 16 in both trials were headache, nasopharyngitis, and hidradenitis; no deaths occurred.

“One limitation of most studies in HS is that the placebo-controlled period is short, so the data obtained after that time is harder to interpret,” Dr. Kimball said in an interview. “In my experience, optimizing treatment can take almost a year and I hope we will see longer controlled periods in future studies.” Another limitation of the studies she acknowledged was a modest imbalance with respect to disease severity between the treatment groups at baseline. “It was a little surprising that some imbalances in the characteristics of randomized subjects in different arms of the study impacted efficacy levels,” she said. “We’ll need to continue to identify how to match patients and dosing regimens to get the best results.”

According to a press release from Novartis, trial results have been submitted to regulatory authorities in Europe and the United States, and decisions are expected in 2023. If approved, secukinumab will be the first and only IL-17 inhibitor for the treatment of moderate to severe HS.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, described HS as “an extraordinarily disabling, painful, deforming condition for which we only have one [Food and Drug Administration]–approved systemic therapy, requiring us to wear our ‘off-label bandit’ name tags proudly to tackle therapeutic challenges.

“Anecdotally,” he said, “we dabble with off-label biologics indicated for psoriasis in this setting, though limitations exist ranging from lack of large-scale clinical data to the recurring theme that psoriasis dosing typically doesn’t cut it, making access to said medications even more difficult. Investigators in this study addresses both gaps very effectively, and I for one welcome the implications and hopeful regulatory impact with open arms.”

The study was funded by Novartis. Dr. Kimball disclosed numerous conflicts of interest from various pharmaceutical companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

SAN DIEGO – According to the latest American Cancer Society (ACS) data, cutaneous melanoma was the 5th most common cancer in 2022, with an estimated 99,780 new cases and 7,650 deaths, following cancer of the colorectal area, lung and bronchus, prostate, and breast.

“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist who practices in Macon, Ga., said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”

In 2023, the ACS estimates that about 97,610 new melanomas will be diagnosed in the United States (58,120 men and 39,490 women), and about 7,990 people are expected to die of melanoma (5,420 men and 2,570 women). In addition, ACS data from 2017-2019 project that about 2.1% of men and women will be diagnosed with cutaneous melanoma in their lifetime. To date, more than 1.3 million people in the United States live with cutaneous melanoma, and the overall 5-year survival is 93.7%.

Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due primarily to sun exposure and to changing recreational behaviors and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3% to 7% per year, “which translates into a doubling of rates every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.

While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color. Blacks present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.

Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1, and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.

The main environmental risk factor for melanoma is exposure to ultraviolet radiation. “You can break it down in terms of whether this exposure is lifetime, intermittent intense UV exposure, from the use of tanning beds, or due to sunburns during childhood,” Dr. Kent said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. Other environmental risk factors include distance from the equator, having a high socioeconomic status, being immunosuppressed, and exposure to heavy metals, insecticides, or hormones.

In a recently published study, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1,212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than were first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than were first melanomas.

In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio [HR], 6.36 vs. 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03).

Second melanomas were also more strongly associated with a history of multiple skin cancer excisions than were first melanomas (HR, 2.63 vs. 1.86; P = .05). “Interestingly, there were no differences in UV exposure between the first primary and second primary melanoma groups,” said Dr. Kent, who was not involved with the study.

He noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey (NAMCS) found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits – even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said. “We as dermatologists have work to do to help educate them.”

Dr. Kent reported having no relevant disclosures.

SAN DIEGO – According to the latest American Cancer Society (ACS) data, cutaneous melanoma was the 5th most common cancer in 2022, with an estimated 99,780 new cases and 7,650 deaths, following cancer of the colorectal area, lung and bronchus, prostate, and breast.

“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist who practices in Macon, Ga., said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”

In 2023, the ACS estimates that about 97,610 new melanomas will be diagnosed in the United States (58,120 men and 39,490 women), and about 7,990 people are expected to die of melanoma (5,420 men and 2,570 women). In addition, ACS data from 2017-2019 project that about 2.1% of men and women will be diagnosed with cutaneous melanoma in their lifetime. To date, more than 1.3 million people in the United States live with cutaneous melanoma, and the overall 5-year survival is 93.7%.

Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due primarily to sun exposure and to changing recreational behaviors and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3% to 7% per year, “which translates into a doubling of rates every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.

While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color. Blacks present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.

Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1, and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.

The main environmental risk factor for melanoma is exposure to ultraviolet radiation. “You can break it down in terms of whether this exposure is lifetime, intermittent intense UV exposure, from the use of tanning beds, or due to sunburns during childhood,” Dr. Kent said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. Other environmental risk factors include distance from the equator, having a high socioeconomic status, being immunosuppressed, and exposure to heavy metals, insecticides, or hormones.

In a recently published study, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1,212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than were first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than were first melanomas.

In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio [HR], 6.36 vs. 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03).

Second melanomas were also more strongly associated with a history of multiple skin cancer excisions than were first melanomas (HR, 2.63 vs. 1.86; P = .05). “Interestingly, there were no differences in UV exposure between the first primary and second primary melanoma groups,” said Dr. Kent, who was not involved with the study.

He noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey (NAMCS) found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits – even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said. “We as dermatologists have work to do to help educate them.”

Dr. Kent reported having no relevant disclosures.

SAN DIEGO – According to the latest American Cancer Society (ACS) data, cutaneous melanoma was the 5th most common cancer in 2022, with an estimated 99,780 new cases and 7,650 deaths, following cancer of the colorectal area, lung and bronchus, prostate, and breast.

“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist who practices in Macon, Ga., said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”

In 2023, the ACS estimates that about 97,610 new melanomas will be diagnosed in the United States (58,120 men and 39,490 women), and about 7,990 people are expected to die of melanoma (5,420 men and 2,570 women). In addition, ACS data from 2017-2019 project that about 2.1% of men and women will be diagnosed with cutaneous melanoma in their lifetime. To date, more than 1.3 million people in the United States live with cutaneous melanoma, and the overall 5-year survival is 93.7%.

Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due primarily to sun exposure and to changing recreational behaviors and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3% to 7% per year, “which translates into a doubling of rates every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.

While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color. Blacks present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.

Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1, and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.

The main environmental risk factor for melanoma is exposure to ultraviolet radiation. “You can break it down in terms of whether this exposure is lifetime, intermittent intense UV exposure, from the use of tanning beds, or due to sunburns during childhood,” Dr. Kent said at the meeting, which was hosted by Scripps MD Anderson Cancer Center. Other environmental risk factors include distance from the equator, having a high socioeconomic status, being immunosuppressed, and exposure to heavy metals, insecticides, or hormones.

In a recently published study, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1,212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than were first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than were first melanomas.

In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio [HR], 6.36 vs. 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03).

Second melanomas were also more strongly associated with a history of multiple skin cancer excisions than were first melanomas (HR, 2.63 vs. 1.86; P = .05). “Interestingly, there were no differences in UV exposure between the first primary and second primary melanoma groups,” said Dr. Kent, who was not involved with the study.

He noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey (NAMCS) found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits – even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said. “We as dermatologists have work to do to help educate them.”

Dr. Kent reported having no relevant disclosures.

Patients with persistent upper-back itch from notalgia paresthetica may get some relief with oral difelikefalin, phase 2 data from a randomized, double-blinded placebo-controlled trial suggest.

However, side effects were significant and caused 19% in the intervention group to discontinue the trial versus 6% in the placebo group.

Results of the study were published online in the New England Journal of Medicine.

There is currently no treatment approved by the U.S. Food and Drug Administration for the common condition, which typically causes itch in the hard-to-reach area between the shoulder blades or mid-back.
 

Drug reduced moderate to severe itch

Difelikefalin – a selective kappa-opioid receptor agonist – is  FDA approved only as an injection for treating moderate to severe itch from chronic kidney disease in adults undergoing hemodialysis, and is marketed as Korsuva for that indication.

However, in a new trial, led by Brian S. Kim, MD, professor of dermatology and vice chair of research at the Icahn School of Medicine at Mount Sinai, New York, the drug gave moderate relief to patients with notalgia paresthetica who had moderate to severe itch.

Patients were randomly assigned 1:1 to receive oral difelikefalin 2 mg or a placebo twice daily for 8 weeks. The primary outcome was change in the weekly average of the daily 0-10 Worst Itch Numeric Rating Scale, for which 0 is “no itch” and 10 is “worst itch imaginable.”

Secondary clinical outcomes were itch-related quality-of-life and itch-related sleep measures.

The study included 126 patients; 62 received difelikefalin and 63 received placebo. One patient assigned to the difelikefalin group withdrew consent before the first dose.

The average baseline score on the Worst Itch scale was 7.6 (severe itch) in each group. Mean scores in the difelikefalin dropped by 4 points versus 2.4 points in the placebo group (95% confidence interval, −2.6 to −0.6; P = .001).

Difelikefalin did not help with sleep disturbance, compared with placebo, “except possibly in patients with impaired sleep at baseline,” the authors write. “Larger and longer trials are required to determine the effect and risks of difelikefalin treatment in this disorder.”

In a Mount Sinai press release, Dr. Kim, who is also director of the Lebwohl Center for Neuroinflammation and Sensation at Mount Sinai, called the team’s findings “encouraging.”

“The encouraging results achieved in this trial could reenergize the field and mark an important step toward improving symptoms of itch for patients with notalgia paresthetica,” he said.

Side effects ‘worrisome’

The main side effects reported included headaches, dizziness, constipation and increased urine output.

Shawn Kwatra, MD, director of the Johns Hopkins Itch Center, Baltimore, told this news organization that dizziness was “especially worrisome,” noting the average age of participants in the trial was 59-60 years. “We are very concerned about folks having falls or hip fractures,” he said.

“Things we use more commonly are topical steroids, topical capsaicin, the capsaicin patch, muscle strengthening, and gabapentin,” Dr. Kwatra said. “Off-label we use botulinum toxin (Botox) as well. I’m able to control” almost all of my notalgia paresthetica patients, he added.

In his view, for this type of drug, he said, “the right home for it is more for a generalized neuropathic pruritus or nociplastic itch vs. something very localized which is more amenable to topical therapies.”

He said that the associated central nervous system effects, such as dizziness and headache, “would limit therapeutic use to only the most severe cases in my mind.”

The trial was funded by Cara Therapeutics, manufacturer of difelikefalin.

Dr. Kim and coauthor Mark Lebwohl, MD, are paid consultants/advisers to Cara Therapeutics. Other coauthors also reported ties to Cara. Dr. Kwatra previously had done consulting work for Cara Therapeutics and is an advisory board member/consultant for AbbVie, Amgen, Arcutis Biotherapeutics, Aslan Pharmaceuticals, Castle Biosciences, Celldex Therapeutics, Galderma, Genzada Pharmaceuticals, Incyte Corporation, Johnson & Johnson, Leo Pharma, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, and Sanofi and has served as an investigator for Galderma, Incyte, Pfizer, and Sanofi.

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

Patients with persistent upper-back itch from notalgia paresthetica may get some relief with oral difelikefalin, phase 2 data from a randomized, double-blinded placebo-controlled trial suggest.

However, side effects were significant and caused 19% in the intervention group to discontinue the trial versus 6% in the placebo group.

Results of the study were published online in the New England Journal of Medicine.

There is currently no treatment approved by the U.S. Food and Drug Administration for the common condition, which typically causes itch in the hard-to-reach area between the shoulder blades or mid-back.
 

Drug reduced moderate to severe itch

Difelikefalin – a selective kappa-opioid receptor agonist – is  FDA approved only as an injection for treating moderate to severe itch from chronic kidney disease in adults undergoing hemodialysis, and is marketed as Korsuva for that indication.

However, in a new trial, led by Brian S. Kim, MD, professor of dermatology and vice chair of research at the Icahn School of Medicine at Mount Sinai, New York, the drug gave moderate relief to patients with notalgia paresthetica who had moderate to severe itch.

Patients were randomly assigned 1:1 to receive oral difelikefalin 2 mg or a placebo twice daily for 8 weeks. The primary outcome was change in the weekly average of the daily 0-10 Worst Itch Numeric Rating Scale, for which 0 is “no itch” and 10 is “worst itch imaginable.”

Secondary clinical outcomes were itch-related quality-of-life and itch-related sleep measures.

The study included 126 patients; 62 received difelikefalin and 63 received placebo. One patient assigned to the difelikefalin group withdrew consent before the first dose.

The average baseline score on the Worst Itch scale was 7.6 (severe itch) in each group. Mean scores in the difelikefalin dropped by 4 points versus 2.4 points in the placebo group (95% confidence interval, −2.6 to −0.6; P = .001).

Difelikefalin did not help with sleep disturbance, compared with placebo, “except possibly in patients with impaired sleep at baseline,” the authors write. “Larger and longer trials are required to determine the effect and risks of difelikefalin treatment in this disorder.”

In a Mount Sinai press release, Dr. Kim, who is also director of the Lebwohl Center for Neuroinflammation and Sensation at Mount Sinai, called the team’s findings “encouraging.”

“The encouraging results achieved in this trial could reenergize the field and mark an important step toward improving symptoms of itch for patients with notalgia paresthetica,” he said.

Side effects ‘worrisome’

The main side effects reported included headaches, dizziness, constipation and increased urine output.

Shawn Kwatra, MD, director of the Johns Hopkins Itch Center, Baltimore, told this news organization that dizziness was “especially worrisome,” noting the average age of participants in the trial was 59-60 years. “We are very concerned about folks having falls or hip fractures,” he said.

“Things we use more commonly are topical steroids, topical capsaicin, the capsaicin patch, muscle strengthening, and gabapentin,” Dr. Kwatra said. “Off-label we use botulinum toxin (Botox) as well. I’m able to control” almost all of my notalgia paresthetica patients, he added.

In his view, for this type of drug, he said, “the right home for it is more for a generalized neuropathic pruritus or nociplastic itch vs. something very localized which is more amenable to topical therapies.”

He said that the associated central nervous system effects, such as dizziness and headache, “would limit therapeutic use to only the most severe cases in my mind.”

The trial was funded by Cara Therapeutics, manufacturer of difelikefalin.

Dr. Kim and coauthor Mark Lebwohl, MD, are paid consultants/advisers to Cara Therapeutics. Other coauthors also reported ties to Cara. Dr. Kwatra previously had done consulting work for Cara Therapeutics and is an advisory board member/consultant for AbbVie, Amgen, Arcutis Biotherapeutics, Aslan Pharmaceuticals, Castle Biosciences, Celldex Therapeutics, Galderma, Genzada Pharmaceuticals, Incyte Corporation, Johnson & Johnson, Leo Pharma, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, and Sanofi and has served as an investigator for Galderma, Incyte, Pfizer, and Sanofi.

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

Patients with persistent upper-back itch from notalgia paresthetica may get some relief with oral difelikefalin, phase 2 data from a randomized, double-blinded placebo-controlled trial suggest.

However, side effects were significant and caused 19% in the intervention group to discontinue the trial versus 6% in the placebo group.

Results of the study were published online in the New England Journal of Medicine.

There is currently no treatment approved by the U.S. Food and Drug Administration for the common condition, which typically causes itch in the hard-to-reach area between the shoulder blades or mid-back.
 

Drug reduced moderate to severe itch

Difelikefalin – a selective kappa-opioid receptor agonist – is  FDA approved only as an injection for treating moderate to severe itch from chronic kidney disease in adults undergoing hemodialysis, and is marketed as Korsuva for that indication.

However, in a new trial, led by Brian S. Kim, MD, professor of dermatology and vice chair of research at the Icahn School of Medicine at Mount Sinai, New York, the drug gave moderate relief to patients with notalgia paresthetica who had moderate to severe itch.

Patients were randomly assigned 1:1 to receive oral difelikefalin 2 mg or a placebo twice daily for 8 weeks. The primary outcome was change in the weekly average of the daily 0-10 Worst Itch Numeric Rating Scale, for which 0 is “no itch” and 10 is “worst itch imaginable.”

Secondary clinical outcomes were itch-related quality-of-life and itch-related sleep measures.

The study included 126 patients; 62 received difelikefalin and 63 received placebo. One patient assigned to the difelikefalin group withdrew consent before the first dose.

The average baseline score on the Worst Itch scale was 7.6 (severe itch) in each group. Mean scores in the difelikefalin dropped by 4 points versus 2.4 points in the placebo group (95% confidence interval, −2.6 to −0.6; P = .001).

Difelikefalin did not help with sleep disturbance, compared with placebo, “except possibly in patients with impaired sleep at baseline,” the authors write. “Larger and longer trials are required to determine the effect and risks of difelikefalin treatment in this disorder.”

In a Mount Sinai press release, Dr. Kim, who is also director of the Lebwohl Center for Neuroinflammation and Sensation at Mount Sinai, called the team’s findings “encouraging.”

“The encouraging results achieved in this trial could reenergize the field and mark an important step toward improving symptoms of itch for patients with notalgia paresthetica,” he said.

Side effects ‘worrisome’

The main side effects reported included headaches, dizziness, constipation and increased urine output.

Shawn Kwatra, MD, director of the Johns Hopkins Itch Center, Baltimore, told this news organization that dizziness was “especially worrisome,” noting the average age of participants in the trial was 59-60 years. “We are very concerned about folks having falls or hip fractures,” he said.

“Things we use more commonly are topical steroids, topical capsaicin, the capsaicin patch, muscle strengthening, and gabapentin,” Dr. Kwatra said. “Off-label we use botulinum toxin (Botox) as well. I’m able to control” almost all of my notalgia paresthetica patients, he added.

In his view, for this type of drug, he said, “the right home for it is more for a generalized neuropathic pruritus or nociplastic itch vs. something very localized which is more amenable to topical therapies.”

He said that the associated central nervous system effects, such as dizziness and headache, “would limit therapeutic use to only the most severe cases in my mind.”

The trial was funded by Cara Therapeutics, manufacturer of difelikefalin.

Dr. Kim and coauthor Mark Lebwohl, MD, are paid consultants/advisers to Cara Therapeutics. Other coauthors also reported ties to Cara. Dr. Kwatra previously had done consulting work for Cara Therapeutics and is an advisory board member/consultant for AbbVie, Amgen, Arcutis Biotherapeutics, Aslan Pharmaceuticals, Castle Biosciences, Celldex Therapeutics, Galderma, Genzada Pharmaceuticals, Incyte Corporation, Johnson & Johnson, Leo Pharma, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, and Sanofi and has served as an investigator for Galderma, Incyte, Pfizer, and Sanofi.

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

The prevalence of contact allergy triggered by a common product preservative, isothiazolinone, has decreased in Europe while it has increased in North America, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.

“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.

Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
 

Common ingredients worldwide

Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.

A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.

Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
 

Patch test data reveal latest trends

To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.

They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.

Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:

• In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
• In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
• In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.

Divergent contact allergy trends linked to regulatory approaches

The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.

Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.

That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.

The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
 

Policy implications for contact allergy

MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.

“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.

Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.

“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.

“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”

“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.

She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.

“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
 

Has MI contact allergy in North America peaked?

“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”

New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.

“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”

Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.

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

The prevalence of contact allergy triggered by a common product preservative, isothiazolinone, has decreased in Europe while it has increased in North America, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.

“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.

Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
 

Common ingredients worldwide

Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.

A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.

Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
 

Patch test data reveal latest trends

To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.

They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.

Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:

• In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
• In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
• In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.

Divergent contact allergy trends linked to regulatory approaches

The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.

Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.

That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.

The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
 

Policy implications for contact allergy

MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.

“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.

Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.

“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.

“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”

“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.

She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.

“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
 

Has MI contact allergy in North America peaked?

“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”

New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.

“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”

Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.

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

The prevalence of contact allergy triggered by a common product preservative, isothiazolinone, has decreased in Europe while it has increased in North America, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.

“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.

Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
 

Common ingredients worldwide

Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.

A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.

Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
 

Patch test data reveal latest trends

To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.

They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.

Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:

• In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
• In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
• In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.

Divergent contact allergy trends linked to regulatory approaches

The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.

Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.

That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.

The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
 

Policy implications for contact allergy

MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.

“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.

Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.

“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.

“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”

“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.

She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.

“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
 

Has MI contact allergy in North America peaked?

“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”

New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.

“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”

Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.

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