Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

Mycosis Fungoides: Measured Approach Key to Treatment

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Tue, 10/08/2024 - 12:35

— When patients of Aaron Mangold, MD, first learn they have mycosis fungoides (MF), the most common form of primary cutaneous T-cell lymphoma (CTCL), some are concerned about whether the diagnosis means a shortened life expectancy.

“In most cases, mycosis fungoides will not shorten one’s life, but it can cause significant symptoms,” Dr. Mangold, codirector of the multidisciplinary cutaneous lymphoma clinic at Mayo Clinic, Scottsdale, Arizona, said at the annual meeting of the Pacific Dermatologic Association. “For early-stage disease, I think of it more like diabetes; this is really a chronic disease” that unlikely will be fatal but may be associated with increased morbidity as the disease progresses, and “the overall goal of therapy should be disease control to increase quality of life.”

courtesy Dr. Aaron Mangold
Dr. Aaron Mangold

Patient- and lymphoma-specific factors drive the choice of therapy. The focus for patients with early-stage disease, Dr. Mangold said, is to treat comorbidities and symptoms, such as itch or skin pain, maximize their quality of life, and consider the potential for associated toxicities of therapy as the disease progresses. Start with the least toxic, targeted, nonimmunosuppressive therapy, “then work toward more toxic immunosuppressive therapies,” he advised. “Use toxic agents just long enough to control the disease, then transition to a maintenance regimen with less toxic immunosuppressive agents.”
 

When Close Follow-Up Is Advised

According to unpublished data from PROCLIPI (the Prospective Cutaneous Lymphoma International Prognostic Index) study presented at the fifth World Congress of Cutaneous Lymphomas earlier in 2024, the following factors warrant consideration for close follow-up and more aggressive treatment: Nodal enlargement greater than 15 mm, age over 60 years, presence of plaques, and large-cell transformation in skin. “These are some of the stigmata in early disease that might guide you toward referring” a patient to a CTCL expert, Dr. Mangold said. (Consensus-based recommendations on the management of MF in children were published in August of 2024.)

According to Dr. Mangold, topical/skin-directed therapies are best for early-stage disease or in combination with systemic therapies in advanced disease. For early-stage disease, one of his preferred options is daily application of a skin moisturizer plus a topical corticosteroid such as clobetasol, halobetasol, or augmented betamethasone, then evaluating the response at 3 months. “This is a cheap option, and we see response rates as high as 90%,” he said. “I don’t often see steroid atrophy when treating patients with active MF. There’s a tendency to think, ‘I don’t want to overtreat.’ I think you can be aggressive. If you look in the literature, people typically pulse twice daily for a couple of weeks with a 1-week break.”

Mechlorethamine, a topical alkylating gel approved in 2013 for the treatment of early-stage MF, is an option when patients fail to respond to topical steroids, prefer to avoid steroids, or have thick, plaque-like disease. With mechlorethamine, it is important to “start slow and be patient,” Dr. Mangold said. “Real-world data shows that it takes 12-18 months to get a good response. Counsel patients that they are likely to get a rash, and that the risk of rash is dose dependent.”

Other treatment options to consider include imiquimod, which can be used for single refractory spots. He typically recommends application 5 days per week with titration up to daily if tolerated for up to 3 months. “Treat until you get a brisk immune response,” he said. “We’ve seen patients with durable, long-term responses.”
 

 

 

UVB Phototherapy Effective

For patients with stage IB disease, topical therapies are less practical and may be focused on refractory areas of disease. Narrow-band UVB phototherapy is the most practical and cost-effective treatment, Dr. Mangold said. Earlier-stage patch disease responds to phototherapy in up to 80% of cases, while plaque-stage disease responds in up to half of cases. “More frequent use of phototherapy may decrease time to clearance, but overall response is similar.”

Dr. Mangold recommends phototherapy 2-3 days per week, titrating up to a maximal response dose, and maintaining that dose for about 3 months. Maintenance involves tapering the phototherapy dose to a minimal dose with continued response. “The goal is to prevent relapse,” he said.

For patients with MF of stage IIB and higher, he considers total skin electron beam therapy, an oral retinoid with phototherapy, systemic agents, and focal radiation with systemic treatment. One of his go-to systemic options is bexarotene, which he uses for early-stage disease refractory to treatment or for less aggressive advanced disease. “We typically use a low dose ... and about half of patients respond,” Dr. Mangold said. The time to response is about 6 months. Bexarotene causes elevated lipids and low thyroid function, so he initiates patients on fenofibrate and levothyroxine at baseline.

Another systemic option is brentuximab vedotin, a monoclonal antibody that targets cells with CD30 expression, which is typically administered in a specialty center every 3 weeks for up to 16 cycles. “In practice, we often use six to eight cycles to avoid neuropathy,” he said. “It’s a good debulking agent, the time to response is 6-9 weeks, and it has a sustained response of 60%.” Neuropathy can occur with treatment, but improves over time.

Other systemic options for MF include romidepsin, mogamulizumab, and extracorporeal photopheresis used in erythrodermic disease.
 

Radiation An Option in Some Cases

Dr. Mangold noted that low doses of radiation therapy can effectively treat MF lesions in as little as one dose. “We can use it as a cure for a single spot or to temporarily treat the disease while other therapies are being started,” he said. Long-term side effects need to be considered when using radiation. “The more radiation, the more side effects.”

Dr. Mangold disclosed that he is an investigator for Sun Pharmaceutical, Solagenix, Elorac, miRagen, Kyowa Kirin, the National Clinical Trials Network, and CRISPR Therapeutics. He has also received consulting fees/honoraria from Kirin and Solagenix.

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

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— When patients of Aaron Mangold, MD, first learn they have mycosis fungoides (MF), the most common form of primary cutaneous T-cell lymphoma (CTCL), some are concerned about whether the diagnosis means a shortened life expectancy.

“In most cases, mycosis fungoides will not shorten one’s life, but it can cause significant symptoms,” Dr. Mangold, codirector of the multidisciplinary cutaneous lymphoma clinic at Mayo Clinic, Scottsdale, Arizona, said at the annual meeting of the Pacific Dermatologic Association. “For early-stage disease, I think of it more like diabetes; this is really a chronic disease” that unlikely will be fatal but may be associated with increased morbidity as the disease progresses, and “the overall goal of therapy should be disease control to increase quality of life.”

courtesy Dr. Aaron Mangold
Dr. Aaron Mangold

Patient- and lymphoma-specific factors drive the choice of therapy. The focus for patients with early-stage disease, Dr. Mangold said, is to treat comorbidities and symptoms, such as itch or skin pain, maximize their quality of life, and consider the potential for associated toxicities of therapy as the disease progresses. Start with the least toxic, targeted, nonimmunosuppressive therapy, “then work toward more toxic immunosuppressive therapies,” he advised. “Use toxic agents just long enough to control the disease, then transition to a maintenance regimen with less toxic immunosuppressive agents.”
 

When Close Follow-Up Is Advised

According to unpublished data from PROCLIPI (the Prospective Cutaneous Lymphoma International Prognostic Index) study presented at the fifth World Congress of Cutaneous Lymphomas earlier in 2024, the following factors warrant consideration for close follow-up and more aggressive treatment: Nodal enlargement greater than 15 mm, age over 60 years, presence of plaques, and large-cell transformation in skin. “These are some of the stigmata in early disease that might guide you toward referring” a patient to a CTCL expert, Dr. Mangold said. (Consensus-based recommendations on the management of MF in children were published in August of 2024.)

According to Dr. Mangold, topical/skin-directed therapies are best for early-stage disease or in combination with systemic therapies in advanced disease. For early-stage disease, one of his preferred options is daily application of a skin moisturizer plus a topical corticosteroid such as clobetasol, halobetasol, or augmented betamethasone, then evaluating the response at 3 months. “This is a cheap option, and we see response rates as high as 90%,” he said. “I don’t often see steroid atrophy when treating patients with active MF. There’s a tendency to think, ‘I don’t want to overtreat.’ I think you can be aggressive. If you look in the literature, people typically pulse twice daily for a couple of weeks with a 1-week break.”

Mechlorethamine, a topical alkylating gel approved in 2013 for the treatment of early-stage MF, is an option when patients fail to respond to topical steroids, prefer to avoid steroids, or have thick, plaque-like disease. With mechlorethamine, it is important to “start slow and be patient,” Dr. Mangold said. “Real-world data shows that it takes 12-18 months to get a good response. Counsel patients that they are likely to get a rash, and that the risk of rash is dose dependent.”

Other treatment options to consider include imiquimod, which can be used for single refractory spots. He typically recommends application 5 days per week with titration up to daily if tolerated for up to 3 months. “Treat until you get a brisk immune response,” he said. “We’ve seen patients with durable, long-term responses.”
 

 

 

UVB Phototherapy Effective

For patients with stage IB disease, topical therapies are less practical and may be focused on refractory areas of disease. Narrow-band UVB phototherapy is the most practical and cost-effective treatment, Dr. Mangold said. Earlier-stage patch disease responds to phototherapy in up to 80% of cases, while plaque-stage disease responds in up to half of cases. “More frequent use of phototherapy may decrease time to clearance, but overall response is similar.”

Dr. Mangold recommends phototherapy 2-3 days per week, titrating up to a maximal response dose, and maintaining that dose for about 3 months. Maintenance involves tapering the phototherapy dose to a minimal dose with continued response. “The goal is to prevent relapse,” he said.

For patients with MF of stage IIB and higher, he considers total skin electron beam therapy, an oral retinoid with phototherapy, systemic agents, and focal radiation with systemic treatment. One of his go-to systemic options is bexarotene, which he uses for early-stage disease refractory to treatment or for less aggressive advanced disease. “We typically use a low dose ... and about half of patients respond,” Dr. Mangold said. The time to response is about 6 months. Bexarotene causes elevated lipids and low thyroid function, so he initiates patients on fenofibrate and levothyroxine at baseline.

Another systemic option is brentuximab vedotin, a monoclonal antibody that targets cells with CD30 expression, which is typically administered in a specialty center every 3 weeks for up to 16 cycles. “In practice, we often use six to eight cycles to avoid neuropathy,” he said. “It’s a good debulking agent, the time to response is 6-9 weeks, and it has a sustained response of 60%.” Neuropathy can occur with treatment, but improves over time.

Other systemic options for MF include romidepsin, mogamulizumab, and extracorporeal photopheresis used in erythrodermic disease.
 

Radiation An Option in Some Cases

Dr. Mangold noted that low doses of radiation therapy can effectively treat MF lesions in as little as one dose. “We can use it as a cure for a single spot or to temporarily treat the disease while other therapies are being started,” he said. Long-term side effects need to be considered when using radiation. “The more radiation, the more side effects.”

Dr. Mangold disclosed that he is an investigator for Sun Pharmaceutical, Solagenix, Elorac, miRagen, Kyowa Kirin, the National Clinical Trials Network, and CRISPR Therapeutics. He has also received consulting fees/honoraria from Kirin and Solagenix.

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

— When patients of Aaron Mangold, MD, first learn they have mycosis fungoides (MF), the most common form of primary cutaneous T-cell lymphoma (CTCL), some are concerned about whether the diagnosis means a shortened life expectancy.

“In most cases, mycosis fungoides will not shorten one’s life, but it can cause significant symptoms,” Dr. Mangold, codirector of the multidisciplinary cutaneous lymphoma clinic at Mayo Clinic, Scottsdale, Arizona, said at the annual meeting of the Pacific Dermatologic Association. “For early-stage disease, I think of it more like diabetes; this is really a chronic disease” that unlikely will be fatal but may be associated with increased morbidity as the disease progresses, and “the overall goal of therapy should be disease control to increase quality of life.”

courtesy Dr. Aaron Mangold
Dr. Aaron Mangold

Patient- and lymphoma-specific factors drive the choice of therapy. The focus for patients with early-stage disease, Dr. Mangold said, is to treat comorbidities and symptoms, such as itch or skin pain, maximize their quality of life, and consider the potential for associated toxicities of therapy as the disease progresses. Start with the least toxic, targeted, nonimmunosuppressive therapy, “then work toward more toxic immunosuppressive therapies,” he advised. “Use toxic agents just long enough to control the disease, then transition to a maintenance regimen with less toxic immunosuppressive agents.”
 

When Close Follow-Up Is Advised

According to unpublished data from PROCLIPI (the Prospective Cutaneous Lymphoma International Prognostic Index) study presented at the fifth World Congress of Cutaneous Lymphomas earlier in 2024, the following factors warrant consideration for close follow-up and more aggressive treatment: Nodal enlargement greater than 15 mm, age over 60 years, presence of plaques, and large-cell transformation in skin. “These are some of the stigmata in early disease that might guide you toward referring” a patient to a CTCL expert, Dr. Mangold said. (Consensus-based recommendations on the management of MF in children were published in August of 2024.)

According to Dr. Mangold, topical/skin-directed therapies are best for early-stage disease or in combination with systemic therapies in advanced disease. For early-stage disease, one of his preferred options is daily application of a skin moisturizer plus a topical corticosteroid such as clobetasol, halobetasol, or augmented betamethasone, then evaluating the response at 3 months. “This is a cheap option, and we see response rates as high as 90%,” he said. “I don’t often see steroid atrophy when treating patients with active MF. There’s a tendency to think, ‘I don’t want to overtreat.’ I think you can be aggressive. If you look in the literature, people typically pulse twice daily for a couple of weeks with a 1-week break.”

Mechlorethamine, a topical alkylating gel approved in 2013 for the treatment of early-stage MF, is an option when patients fail to respond to topical steroids, prefer to avoid steroids, or have thick, plaque-like disease. With mechlorethamine, it is important to “start slow and be patient,” Dr. Mangold said. “Real-world data shows that it takes 12-18 months to get a good response. Counsel patients that they are likely to get a rash, and that the risk of rash is dose dependent.”

Other treatment options to consider include imiquimod, which can be used for single refractory spots. He typically recommends application 5 days per week with titration up to daily if tolerated for up to 3 months. “Treat until you get a brisk immune response,” he said. “We’ve seen patients with durable, long-term responses.”
 

 

 

UVB Phototherapy Effective

For patients with stage IB disease, topical therapies are less practical and may be focused on refractory areas of disease. Narrow-band UVB phototherapy is the most practical and cost-effective treatment, Dr. Mangold said. Earlier-stage patch disease responds to phototherapy in up to 80% of cases, while plaque-stage disease responds in up to half of cases. “More frequent use of phototherapy may decrease time to clearance, but overall response is similar.”

Dr. Mangold recommends phototherapy 2-3 days per week, titrating up to a maximal response dose, and maintaining that dose for about 3 months. Maintenance involves tapering the phototherapy dose to a minimal dose with continued response. “The goal is to prevent relapse,” he said.

For patients with MF of stage IIB and higher, he considers total skin electron beam therapy, an oral retinoid with phototherapy, systemic agents, and focal radiation with systemic treatment. One of his go-to systemic options is bexarotene, which he uses for early-stage disease refractory to treatment or for less aggressive advanced disease. “We typically use a low dose ... and about half of patients respond,” Dr. Mangold said. The time to response is about 6 months. Bexarotene causes elevated lipids and low thyroid function, so he initiates patients on fenofibrate and levothyroxine at baseline.

Another systemic option is brentuximab vedotin, a monoclonal antibody that targets cells with CD30 expression, which is typically administered in a specialty center every 3 weeks for up to 16 cycles. “In practice, we often use six to eight cycles to avoid neuropathy,” he said. “It’s a good debulking agent, the time to response is 6-9 weeks, and it has a sustained response of 60%.” Neuropathy can occur with treatment, but improves over time.

Other systemic options for MF include romidepsin, mogamulizumab, and extracorporeal photopheresis used in erythrodermic disease.
 

Radiation An Option in Some Cases

Dr. Mangold noted that low doses of radiation therapy can effectively treat MF lesions in as little as one dose. “We can use it as a cure for a single spot or to temporarily treat the disease while other therapies are being started,” he said. Long-term side effects need to be considered when using radiation. “The more radiation, the more side effects.”

Dr. Mangold disclosed that he is an investigator for Sun Pharmaceutical, Solagenix, Elorac, miRagen, Kyowa Kirin, the National Clinical Trials Network, and CRISPR Therapeutics. He has also received consulting fees/honoraria from Kirin and Solagenix.

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

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Aspects of the Skin Microbiome Remain Elusive

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Mon, 09/30/2024 - 13:27

— Although it has been known for several years that more than 1000 species of bacteria from 19 different phyla inhabit the human skin — mainly the superficial epidermis and upper parts of the hair follicles — published studies specifically focusing on the skin microbiome remain limited. 

In one review of the topic, researchers from the National Institutes of Health wrote that the skin is composed of 1.8 million diverse habitats with an abundance of folds, invaginations, and specialized niches that support a wide range of microorganisms. “Many of these microorganisms are harmless and, in some cases, provide vital functions for us to live and they have not evolved over time,” Jill S. Waibel, MD, medical director of the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. 

Dr. Jill S. Waibel, Miami Dermatology and Laser Institute.
Dr. Jill S. Waibel

“This is complex ecosystem that we don’t really talk about,” she said. “There is wide topographical distribution of bacteria on skin sites. The bacteria we have on our head and neck area is different from that on our feet. There is also a lot of interpersonal variation of the skin microbiome, so one person may have a lot of one type of bacteria and not as much of another.” 
 

A Shield From Foreign Pathogens

At its core, Dr. Waibel continued, the skin microbiome functions as an interface between the human body and the environment, a physical barrier that prevents the invasion of foreign pathogens. The skin also provides a home to commensal microbiota. She likened the skin’s landscape to that of the tundra: “It’s desiccated, has poor nutrients, and it’s very acidic, thus pathogens have a hard time living on it,” she said. “However, our skin microorganisms have adapted to utilize the sparse nutrients available on the skin. That’s why I tell my patients, ‘don’t use a sugar scrub because you’re potentially feeding these bad bacteria.’ ” 

According to more recent research, the skin microbiota in healthy adults remains stable over time, despite environmental perturbations, and they have important roles in educating the innate and adaptive arms of the cutaneous immune system. “Some skin diseases are associated with an altered microbial state: dysbiosis,” said Dr. Waibel, subsection chief of dermatology at Baptist Health South Florida, Miami Beach. “Reversion of this may help prevent or treat the disease.” 

NIH researchers find thousands of new microorganisms living on human skin
Daryl Leja, National Human Genome Research Institute


She cited the following factors that influence the skin microbiome: 

  • Genetics affects the skin microbiome considerably. Individuals with autoimmune predispositions have different microbiota compared with those who don’t.
  • Climate, pollution, and hygiene practices the other influencing factors. “Even clothing can impact the microbiome, by causing the transfer of microorganisms,” she said.
  • Age and hormonal changes (particularly during puberty) and senescence alter the microbial landscape.
  • Systemic health conditions such as diabetes mellitus and irritable bowel disease, as well as cutaneous conditions like psoriasis and atopic dermatitis can also disrupt the skin microbiome.

Ingredients contained in soaps, antibiotics, and cosmetics can also cause skin dysbiosis, Dr. Waibel said. However, the integrity of the skin’s microbiome following dermatological procedures such as excisions, dermabrasion, laser therapy, and other physical procedures is less understood, according to a recent review of the topic. Phototherapy appears to be the most extensively studied, “and shows an increase in microbial diversity post-treatment,” she said. “Light treatments have been found to kill bacteria by inducing DNA damage. More studies need to be performed on specific wavelengths of light used, conditions being treated and individual patient differences.” 

According to the review’s authors, no change in the microbiome was observed in studies of debridement. “That was surprising, as it is a method to remove unhealthy tissue that often contains pathogenic bacteria,” Dr. Waibel said. “The big take-home message is that we need more research.” 

Dr. Waibel disclosed that she has conducted clinical trials for several device and pharmaceutical companies.
 

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

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— Although it has been known for several years that more than 1000 species of bacteria from 19 different phyla inhabit the human skin — mainly the superficial epidermis and upper parts of the hair follicles — published studies specifically focusing on the skin microbiome remain limited. 

In one review of the topic, researchers from the National Institutes of Health wrote that the skin is composed of 1.8 million diverse habitats with an abundance of folds, invaginations, and specialized niches that support a wide range of microorganisms. “Many of these microorganisms are harmless and, in some cases, provide vital functions for us to live and they have not evolved over time,” Jill S. Waibel, MD, medical director of the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. 

Dr. Jill S. Waibel, Miami Dermatology and Laser Institute.
Dr. Jill S. Waibel

“This is complex ecosystem that we don’t really talk about,” she said. “There is wide topographical distribution of bacteria on skin sites. The bacteria we have on our head and neck area is different from that on our feet. There is also a lot of interpersonal variation of the skin microbiome, so one person may have a lot of one type of bacteria and not as much of another.” 
 

A Shield From Foreign Pathogens

At its core, Dr. Waibel continued, the skin microbiome functions as an interface between the human body and the environment, a physical barrier that prevents the invasion of foreign pathogens. The skin also provides a home to commensal microbiota. She likened the skin’s landscape to that of the tundra: “It’s desiccated, has poor nutrients, and it’s very acidic, thus pathogens have a hard time living on it,” she said. “However, our skin microorganisms have adapted to utilize the sparse nutrients available on the skin. That’s why I tell my patients, ‘don’t use a sugar scrub because you’re potentially feeding these bad bacteria.’ ” 

According to more recent research, the skin microbiota in healthy adults remains stable over time, despite environmental perturbations, and they have important roles in educating the innate and adaptive arms of the cutaneous immune system. “Some skin diseases are associated with an altered microbial state: dysbiosis,” said Dr. Waibel, subsection chief of dermatology at Baptist Health South Florida, Miami Beach. “Reversion of this may help prevent or treat the disease.” 

NIH researchers find thousands of new microorganisms living on human skin
Daryl Leja, National Human Genome Research Institute


She cited the following factors that influence the skin microbiome: 

  • Genetics affects the skin microbiome considerably. Individuals with autoimmune predispositions have different microbiota compared with those who don’t.
  • Climate, pollution, and hygiene practices the other influencing factors. “Even clothing can impact the microbiome, by causing the transfer of microorganisms,” she said.
  • Age and hormonal changes (particularly during puberty) and senescence alter the microbial landscape.
  • Systemic health conditions such as diabetes mellitus and irritable bowel disease, as well as cutaneous conditions like psoriasis and atopic dermatitis can also disrupt the skin microbiome.

Ingredients contained in soaps, antibiotics, and cosmetics can also cause skin dysbiosis, Dr. Waibel said. However, the integrity of the skin’s microbiome following dermatological procedures such as excisions, dermabrasion, laser therapy, and other physical procedures is less understood, according to a recent review of the topic. Phototherapy appears to be the most extensively studied, “and shows an increase in microbial diversity post-treatment,” she said. “Light treatments have been found to kill bacteria by inducing DNA damage. More studies need to be performed on specific wavelengths of light used, conditions being treated and individual patient differences.” 

According to the review’s authors, no change in the microbiome was observed in studies of debridement. “That was surprising, as it is a method to remove unhealthy tissue that often contains pathogenic bacteria,” Dr. Waibel said. “The big take-home message is that we need more research.” 

Dr. Waibel disclosed that she has conducted clinical trials for several device and pharmaceutical companies.
 

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

— Although it has been known for several years that more than 1000 species of bacteria from 19 different phyla inhabit the human skin — mainly the superficial epidermis and upper parts of the hair follicles — published studies specifically focusing on the skin microbiome remain limited. 

In one review of the topic, researchers from the National Institutes of Health wrote that the skin is composed of 1.8 million diverse habitats with an abundance of folds, invaginations, and specialized niches that support a wide range of microorganisms. “Many of these microorganisms are harmless and, in some cases, provide vital functions for us to live and they have not evolved over time,” Jill S. Waibel, MD, medical director of the Miami Dermatology and Laser Institute, said at the annual Masters of Aesthetics Symposium. 

Dr. Jill S. Waibel, Miami Dermatology and Laser Institute.
Dr. Jill S. Waibel

“This is complex ecosystem that we don’t really talk about,” she said. “There is wide topographical distribution of bacteria on skin sites. The bacteria we have on our head and neck area is different from that on our feet. There is also a lot of interpersonal variation of the skin microbiome, so one person may have a lot of one type of bacteria and not as much of another.” 
 

A Shield From Foreign Pathogens

At its core, Dr. Waibel continued, the skin microbiome functions as an interface between the human body and the environment, a physical barrier that prevents the invasion of foreign pathogens. The skin also provides a home to commensal microbiota. She likened the skin’s landscape to that of the tundra: “It’s desiccated, has poor nutrients, and it’s very acidic, thus pathogens have a hard time living on it,” she said. “However, our skin microorganisms have adapted to utilize the sparse nutrients available on the skin. That’s why I tell my patients, ‘don’t use a sugar scrub because you’re potentially feeding these bad bacteria.’ ” 

According to more recent research, the skin microbiota in healthy adults remains stable over time, despite environmental perturbations, and they have important roles in educating the innate and adaptive arms of the cutaneous immune system. “Some skin diseases are associated with an altered microbial state: dysbiosis,” said Dr. Waibel, subsection chief of dermatology at Baptist Health South Florida, Miami Beach. “Reversion of this may help prevent or treat the disease.” 

NIH researchers find thousands of new microorganisms living on human skin
Daryl Leja, National Human Genome Research Institute


She cited the following factors that influence the skin microbiome: 

  • Genetics affects the skin microbiome considerably. Individuals with autoimmune predispositions have different microbiota compared with those who don’t.
  • Climate, pollution, and hygiene practices the other influencing factors. “Even clothing can impact the microbiome, by causing the transfer of microorganisms,” she said.
  • Age and hormonal changes (particularly during puberty) and senescence alter the microbial landscape.
  • Systemic health conditions such as diabetes mellitus and irritable bowel disease, as well as cutaneous conditions like psoriasis and atopic dermatitis can also disrupt the skin microbiome.

Ingredients contained in soaps, antibiotics, and cosmetics can also cause skin dysbiosis, Dr. Waibel said. However, the integrity of the skin’s microbiome following dermatological procedures such as excisions, dermabrasion, laser therapy, and other physical procedures is less understood, according to a recent review of the topic. Phototherapy appears to be the most extensively studied, “and shows an increase in microbial diversity post-treatment,” she said. “Light treatments have been found to kill bacteria by inducing DNA damage. More studies need to be performed on specific wavelengths of light used, conditions being treated and individual patient differences.” 

According to the review’s authors, no change in the microbiome was observed in studies of debridement. “That was surprising, as it is a method to remove unhealthy tissue that often contains pathogenic bacteria,” Dr. Waibel said. “The big take-home message is that we need more research.” 

Dr. Waibel disclosed that she has conducted clinical trials for several device and pharmaceutical companies.
 

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

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New Options for Treating Atopic Dermatitis Available, and in Development

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Mon, 09/23/2024 - 11:50

— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

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— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

— If the number of recent drug approvals for atopic dermatitis (AD) is overwhelming, the future is unlikely to be any less challenging: According to the National Eczema Association, the current pipeline for AD includes 39 injectable medications, 21 oral agents, and 49 topicals, some with novel targets, like human umbilical cord blood derived stem cells.

“It’s amazing how many drugs are coming out for AD,” Robert Sidbury, MD, MPH, said at the annual meeting of the Pacific Dermatologic Association (PDA). Dr. Sidbury, chief of the Division of Dermatology at Seattle Children’s Hospital, Seattle, highlighted two agents for AD: Lebrikizumab and nemolizumab. Lebrikizumab is a monoclonal antibody that binds to interleukin (IL)-13 and is approved in Europe for the treatment of moderate to severe AD in patients aged ≥ 12 years. (On September 13, after the PDA meeting, lebrikizumab was approved by the Food and Drug Administration [FDA] for treatment of moderate to severe AD in adults and adolescents aged ≥ 12 years.)

Dr. Robert Sidbury

In two identical phase 3 trials known as ADvocate 1 and ADvocate 2, researchers randomly assigned 851 patients with moderate to severe AD in a 2:1 ratio to receive either lebrikizumab at a dose of 250 mg (loading dose of 500 mg at baseline and week 2) or placebo, administered subcutaneously every 2 weeks, through week 16. The primary outcome was an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. The researchers reported that an IGA score of 0 or 1 was achieved by 43.1% of patients in the lebrikizumab arm compared with 12.7% of those in the placebo arm.

“Those are good numbers,” said Dr. Sidbury, who was not involved with the study. Conjunctivitis occurred more often in those who received lebrikizumab compared with those who received placebo (7.4% vs 2.8%, respectively), “which is not surprising because it is an IL-13 agent,” he said.

In a subsequent study presented during the Revolutionizing Atopic Dermatitis meeting in the fall of 2023, researchers presented data on Eczema Severity and Area Index (EASI)-90 responses in the ADvocate trial participants, showing EASI-90 responses were sustained up to 38 weeks after lebrikizumab withdrawal, while serum concentrations were negligible. They found that between week 14 and week 32, approximately five serum concentration half-lives of the medication had elapsed since patients randomized to the withdrawal arm received their last dose of lebrikizumab, extending to approximately 11 half-lives by week 52. “That durability of response with next to no blood levels of drug in many of the study participants is interesting,” said Dr. Sidbury, who cochairs the current iteration of the American Academy of Dermatology Atopic Dermatitis Guidelines.

Nemolizumab is a neuroimmune response modulator that inhibits the IL-31 receptor and is approved in Japan for the treatment of itch associated with AD in patients aged ≥ 13 years. Results from two identical phase 3, randomized, controlled trials known as ARCADIA 1 and ARCADIA 2 found that 36% of patients in ARCADIA 1 and 38% in ARCADIA 2 achieved clear skin, compared with 25% and 26% of patients in the placebo group, respectively. (Nemolizumab was recently approved by the FDA for treating prurigo nodularis and is under FDA review for AD.)

In terms of safety, Dr. Sidbury, who is a member of the steering committee for the ARCADIA trials, said that nemolizumab has been “generally well tolerated;” with 1%-3% of study participants experiencing at least one serious treatment-emergent adverse event that included asthma exacerbation, facial edema, and peripheral edema. “The latest data are reassuring but we are watching these safety concerns carefully,” he said.

Dr. Sidbury disclosed that he is an investigator for Regeneron, Pfizer, Galderma, UCB, and Castle; a consultant for Lilly, Leo, Arcutis, and Dermavant; and a member of the speaker’s bureau for Beiersdorf.
 

A version of this article appeared on Medscape.com.

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Expert Warns of Problems with Large Language Models in Dermatology

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Wed, 09/18/2024 - 13:45

HUNTINGTON BEACH, CALIF. — When Roxana Daneshjou, MD, PhD, began reviewing responses to an exploratory survey she and her colleagues created on dermatologists’ use of large language models (LLMs) such as ChatGPT in clinical practice, she was both surprised and alarmed.

Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.

courtesy Dr. Roxana Daneshjou
Dr. Roxana Daneshjou

Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”

When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”

The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”

Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”



To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.

The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.

On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.

Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.

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

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HUNTINGTON BEACH, CALIF. — When Roxana Daneshjou, MD, PhD, began reviewing responses to an exploratory survey she and her colleagues created on dermatologists’ use of large language models (LLMs) such as ChatGPT in clinical practice, she was both surprised and alarmed.

Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.

courtesy Dr. Roxana Daneshjou
Dr. Roxana Daneshjou

Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”

When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”

The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”

Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”



To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.

The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.

On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.

Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.

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

HUNTINGTON BEACH, CALIF. — When Roxana Daneshjou, MD, PhD, began reviewing responses to an exploratory survey she and her colleagues created on dermatologists’ use of large language models (LLMs) such as ChatGPT in clinical practice, she was both surprised and alarmed.

Of the 134 respondents who completed the survey, 87 (65%) reported using LLMs in a clinical setting. Of those 87 respondents, 17 (20%) used LMMs daily, 28 (32%) weekly, 5 (6%) monthly, and 37 (43%) rarely. That represents “pretty significant usage,” Dr. Daneshjou, assistant professor of biomedical data science and dermatology at Stanford University, Palo Alto, California, said at the annual meeting of the Pacific Dermatologic Association.

courtesy Dr. Roxana Daneshjou
Dr. Roxana Daneshjou

Most of the respondents reported using LLMs for patient care (79%), followed by administrative tasks (74%), medical records (43%), and education (18%), “which can be problematic,” she said. “These models are not appropriate to use for patient care.”

When asked about their thoughts on the accuracy of LLMs, 58% of respondents deemed them to be “somewhat accurate” and 7% viewed them as “extremely accurate.”

The overall survey responses raise concern because LLMs “are not trained for accuracy; they are trained initially as a next-word predictor on large bodies of tech data,” Dr. Daneshjou said. “LLMs are already being implemented but have the potential to cause harm and bias, and I believe they will if we implement them the way things are rolling out right now. I don’t understand why we’re implementing something without any clinical trial or showing that it improves care before we throw untested technology into our healthcare system.”

Meanwhile, Epic and Microsoft are collaborating to bring AI technology to electronic health records, she said, and Epic is building more than 100 new AI features for physicians and patients. “I think it’s important for every physician and trainee to understand what is going on in the realm of AI,” said Dr. Daneshjou, who is an associate editor for the monthly journal NEJM AI. “Be involved in the conversation because we are the clinical experts, and a lot of people making decisions and building tools do not have the clinical expertise.”



To further illustrate her concerns, Dr. Daneshjou referenced a red teaming event she and her colleagues held with computer scientists, biomedical data scientists, engineers, and physicians across multiple specialties to identify issues related to safety, bias, factual errors, and/or security issues in GPT-3.5, GPT-4, and GPT-4 with internet. The goal was to mimic clinical health scenarios, ask the LLM to respond, and have the team members review the accuracy of LLM responses.

The participants found that nearly 20% of LLM responses were inappropriate. For example, in one task, an LLM was asked to calculate a RegiSCAR score for Drug Reaction With Eosinophilia and Systemic Symptoms for a patient, but the response included an incorrect score for eosinophilia. “That’s why these tools can be so dangerous because you’re reading along and everything seems right, but there might be something so minor that can impact patient care and you might miss it,” Dr. Daneshjou said.

On a related note, she advised against dermatologists uploading images into GPT-4 Vision, an LLM that can analyze images and provide textual responses to questions about them, and she recommends not using GPT-4 Vision for any diagnostic support. At this time, “GPT-4 Vision overcalls malignancies, and the specificity and sensitivity are not very good,” she explained.

Dr. Daneshjou disclosed that she has served as an adviser to MDalgorithms and Revea and has received consulting fees from Pfizer, L’Oréal, Frazier Healthcare Partners, and DWA and research funding from UCB.

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

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FDA Approves IL-13 inhibitor for Atopic Dermatitis

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Mon, 09/16/2024 - 10:35

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

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The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).



According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

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Acne: Positive Outcomes Described With Laser Treatment

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Tue, 09/10/2024 - 12:17

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

 

After Arash Moradzadeh, MD, treated the first 100 consecutive patients in his practice with a 1726-nm laser (AviClear) following its Food and Drug Administration (FDA) clearance for the treatment of mild to severe acne vulgaris in March of 2022, 90% experienced clearance at 1 year.

“Combining the AviClear with medical therapy and energy-based devices provides the best outcomes,” Dr. Moradzadeh, who practices facial and plastic surgery in Beverly Hills, California, said at the Controversies & Conversations in Laser & Cosmetic Surgery annual symposium. “You have to do all 300 pulses per treatment, and you do need to use settings of 19.5-21.5 J/cm2 to get a great result.”

Dr. Arash Moradzadeh


AviClear became the first 1726-nm laser cleared by the FDA for the treatment of mild to severe acne vulgaris, followed a few months later by clearance of the 1926-nm laser, the Accure Acne Laser System. But few long-term “real-world” studies of these two devices exist, according to Dr. Moradzadeh.

The protocol for Dr. Moradzadeh’s study included three AviClear treatments spaced 3-4 weeks apart combined with medical therapy and other energy-based devices such as a near-infrared Nd:YAG laser (Laser Genesis) and a non-ablative fractional laser (LaseMD Ultra), with follow-up at 1 month, 3 months, 6 months, 1 year, 1.5 years, and 2 years. Pain management options included acetaminophen, a numbing cream, and pre- and post-contact cooling.

Of the 100 patients, 90 were clear at 1 year, six patients were almost clear at 1 year, three patients were nonresponders, and one patient was lost to follow-up, Dr. Moradzadeh reported. “Two of the three nonresponders did not receive the full 300 pulses per treatment,” but all three cleared with isotretinoin treatment, he said. “What we now know from talking with other providers is that you really have to do all 300 pulses to get the best results.”

Of the 90 patients who achieved clearance, 80 remained clear at 1.5-2 years, and 10 are almost clear or have mild acne. “Of these, eight are adult females with hormonal acne and two are teenage males,” he said. “All 10 cleared with a fourth AviClear treatment and lifestyle modifications that included the elimination of whey, creatine, and skin care products containing vitamin E combined with vitamin C.”

During a question-and-answer session following the presentation, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, Massachusetts, said that general dermatologists have been slow to adopt the AviClear and Accure devices for treating patients with acne “because, for the most part, they are experts at treating acne with all the tools they have. They’re not used to using devices. They’re not used to having patients pay out of pocket for a treatment that is not covered by insurance. They don’t feel comfortable with that discussion.”

For example, the 14 dermatologists at SkinCare Physicians “almost never prescribe the 1726-nm devices for acne because it’s not in their sweet spot,” Dr. Dover continued, noting that one issue is that acne experts want more data.

In the experience of Nazanin Saedi, MD, clinical associate professor of dermatology at Thomas Jefferson University, Philadelphia, the 1726-nm laser devices for acne “fit nicely for women of childbearing age who have acne and don’t want to go on Accutane [isotretinoin], and also for teenagers who are either going to be noncompliant with Accutane or their parents are worried about side effects and the potential impacts on growth,” she said at the meeting. “That’s where we’ve found patients coming in wanting to do these treatments, and how it offers something that the medical treatments are lacking.”

Regarding concerns about out-of-pocket costs for AviClear or Accure treatments, Roy G. Geronemus, MD, who directs the Laser & Skin Surgery Center of New York, New York City, advised considering the long-term benefits. “If you calculate it out, it really is cost-effective to use the 1726-nm devices if you consider the copays, the cost of over-the-counter topicals, as well as the cost of prescription medications,” Dr. Geronemus said. “Over the long term, you are saving money for the patient.”

Dr. Dover acknowledged that was “a valid and important point,” but said that when the topic is discussed with general dermatologists who treat a lot of patients with acne, “they say patients are more willing to pay a copay [for a prescription] ... than write a check for $800 or $1000 per visit.”

The recently updated American Academy of Dermatology’s guidelines of care for the management of acne vulgaris, published in January 2024, characterized the available evidence as “insufficient” to develop a recommendation on the use of laser and light-based devices for the treatment of acne. Although the 1726-nm laser was cleared by the FDA for acne treatment in 2022, the authors of the guidelines wrote that “its evidence was not evaluated in the current guidelines due to lack of a randomized, controlled trial.”

Dr. Moradzadeh disclosed that he is a key opinion leader for Acclaro, Benev, Lutronic, Sofwave, and Cutera, the manufacturer for AviClear. Dr. Dover reported that he is a consultant for Cutera and performs research for the company. Dr. Saedi disclosed that she is a consultant to, a member of the advisory board for, and/or has received equipment and research support from many device and pharmaceutical companies. Dr. Geronemus disclosed that he is a member of the medical advisory board for and/or is an investigator for many device and pharmaceutical companies, including Accure. He also holds stock in the company.

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

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Topical Tapinarof and Roflumilast for Psoriasis: Where Do they Fit In?

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. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

 

. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk
Dr. Jashin J. Wu

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

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Topical Treatment Provides a Noninvasive Option for Pyogenic Granuloma in Children

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— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

 

— Mounting evidence suggests that using topical timolol to treat a pyogenic granuloma (PG) may spare children from undergoing a surgical procedure, especially if the PG is small and on the face, according to Julie Dhossche, MD.

A PG is a common, benign vascular tumor that often occurs in children under 5 years of age, “usually in a very inconvenient spot, like the cheek,” Dr. Dhossche, a pediatric dermatologist at Oregon Health & Science University (OHSU), Portland, said at the annual meeting of the Pacific Dermatologic Association. “It can bleed a lot. Often, parents take their child to the emergency department for unstoppable bleeding. Our first-line treatment is often surgical: shave removal, electrocautery, or excision.”

courtesy Dr. Julie Dhossche
Dr. Julie Dhossche

Several case reports about the use of the topical form of timolol, a nonselective beta-adrenergic antagonist, for PG have been published in the medical literature including a case series of seven patients (six were treated with topical timolol). The authors of the case series hypothesized that a beta-blocker may be effective for PGs by causing vasoconstriction that stops bleeding.

In addition, Dr. Dhossche and colleagues retrospectively evaluated 92 children with a mean age of 4.5 years who were treated with topical timolol for PG at OHSU from 2010 to 2020. The results were presented in an abstract at the 2022 Pediatric Dermatology Research Alliance annual conference.

At the initial visit, 80 of 92 (87%) children were treated with timolol only, 6 of 92 (6.5%) underwent a procedure, and 6 of 92 (6.5%) were treated with timolol and a procedure. The researchers observed that of the 80 patients who received timolol monotherapy, 42 (52.5%) were spared a procedural intervention. “So, we have had some success with this,” she said. “It can also help with bleeding episodes if you are waiting for a procedure.”
 

Surgery May Still Be Needed

For PGs, she applies one drop of timolol to the lesion under occlusion with DuoDERM or a similar dressing, which is repeated every 1-3 days depending on how long the dressing stays on. “It may take 3-4 months of this treatment to clear,” she said.

If topical timolol doesn’t stop the PG from bleeding, or if parents elect for surgical removal, “some tears [during removal of the lesion] may be inevitable,” Dr. Dhossche said. “My goal is to make it as good of an experience as it can be, by being very confident and offering lots of smiles, pretreatment with topical lidocaine for 20-30 minutes, icing, and formulating an alliance with parents” to help calm nerves, “knowing if that doesn’t work, I might need help from my colleagues in pediatric sedation.”



Choice of language matters when describing to children what to expect during a procedure, she continued. For example, instead of saying, “it will feel like a bee sting,” say, “some kids say it is uncomfortable like a pinch and some kids say it’s not so bad.” And, when describing the size of a needle or an incision, instead of saying, “it’s as big as ...” say, “it’s as small as ...”

As described in a 2020 paper published in Pediatric Dermatology, proper comfort positioning of children during in-office dermatologic procedures is also key, which can include having the parent or caregiver hug a child during removal of a PG, Dr. Dhossche said. “You want to optimize distractions for the patient while you do the procedure. This is the time to bring out your iPhone, iPad, or enlist help from a certified child life specialist if you have one at your institution.”

When she administers injections to children, “I don’t lie about the shot, but I do hide the actual needle from sight, if possible,” she said. “I’ll say, ‘you’ll feel a pinch.’ Vibration tools can help while you’re injecting.” She showed an image of a vibrating light-up children’s toothbrush she found on Amazon for $10 “that has served me well. It’s also kind of a tension diffuser.”

Dr. Dhossche reported having no financial disclosures.

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

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Managing Vitiligo: Combination Therapies, New Treatments

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When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.

“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”

As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.

Dr. Shiu
Dr. Jessica Shiu


There are two main subtypes of vitiligo. The segmental form is unilateral and presents in younger people, while the more common nonsegmental form usually involves both sides of the body and can involve different sites. “Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.


“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”

The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.

“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinibupadacitinibpovorcitinib, and baricitinib on vitiligo are underway.

Combining Phototherapy With Topical Treatment

A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”

 

 

Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”

While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”

For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”

Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
 

Tissue, Cellular Grafts

Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.

The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.

In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”

Dr. Shiu disclosed that she received research support from AbbVie.
 

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

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When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.

“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”

As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.

Dr. Shiu
Dr. Jessica Shiu


There are two main subtypes of vitiligo. The segmental form is unilateral and presents in younger people, while the more common nonsegmental form usually involves both sides of the body and can involve different sites. “Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.


“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”

The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.

“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinibupadacitinibpovorcitinib, and baricitinib on vitiligo are underway.

Combining Phototherapy With Topical Treatment

A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”

 

 

Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”

While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”

For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”

Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
 

Tissue, Cellular Grafts

Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.

The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.

In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”

Dr. Shiu disclosed that she received research support from AbbVie.
 

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

 

When patients with vitiligo see Jessica Shiu, MD, PhD, for the first time, some mention that prior healthcare providers have told them that vitiligo is merely a cosmetic issue — much to her dismay.

“Vitiligo is not a cosmetic disease,” Dr. Shiu, assistant professor of dermatology at the University of California, Irvine, said at the annual meeting of the Pacific Dermatologic Association. “It is associated with significant depression, stigmatization, and low self-esteem. I have patients who say that vitiligo has affected their marriage ... In certain cultures, it also affects their job prospects.”

As the most common pigmentary disorder, vitiligo is an autoimmune condition that often results in the recruitment of CD8+ T cells into the skin. These cells destroy melanocytes, depleting melanocytes in the epidermis. “Over time, this results in milky white patches of skin that we often see in our patients,” Dr. Shiu said.

Dr. Shiu
Dr. Jessica Shiu


There are two main subtypes of vitiligo. The segmental form is unilateral and presents in younger people, while the more common nonsegmental form usually involves both sides of the body and can involve different sites. “Depending on the site that is involved, the nonsegmental form can be further divided into focal, acrofacial, mucosal, generalized, and universal subtypes,” she said. The first step in your initial management is to determine if the vitiligo is active or stable, which can be challenging. Clinical signs of active disease include the presence of trichome vitiligo, confetti vitiligo, and koebnerization.


“Another sign of active disease is when patients tell you that their vitiligo is expanding rapidly,” Dr. Shiu added. “Stable vitiligo is more difficult to define. Many patients think their lesions don’t change, but we’re now appreciating that there can be some sites in those patients such as the hands and feet that are more susceptible to change in activity.” In general, she noted, vitiligo is considered stable when there is no change in activity for at least 12 months, and “lesions are usually completely depigmented with sharp borders.”

The level of vitiligo disease activity drives medical management. For patients with nonsegmental vitiligo who have clinical signs of active disease, the first goal is to stabilize the active disease and stop further spread of depigmentation. “This is key because losing pigment can occur very quickly, but gaining pigment back is a very slow process,” she said. Stabilization involves suppressing immune responses with topical steroids, topical calcineurin inhibitors, or 1.5% ruxolitinib cream, a JAK inhibitor that became the first Food and Drug Administration (FDA)–approved pharmacologic treatment for nonsegmental vitiligo, in 2022, for patients aged 12 years or older.

“The choice here depends somewhat on insurance coverage and shared decision-making with the patient,” Dr. Shiu said. Meanwhile, clinical trials evaluating the effect of the oral JAK inhibitors ritlecitinibupadacitinibpovorcitinib, and baricitinib on vitiligo are underway.

Combining Phototherapy With Topical Treatment

A mainstay therapy for nonsegmental vitiligo is phototherapy, which can induce the migration of melanocyte stem cells from hair follicles. “There’s good data to show that combining topical treatment with phototherapy can augment the repigmentation that you see,” she said. “So if it’s possible, try to add phototherapy for your vitiligo patients, but sometimes, logistics for that are a challenge.”

 

 

Discussing treatment expectations with patients is key because it can take up to 1 year to see a significant response with topical immunosuppressants and narrowband ultraviolet B treatment. The head and neck areas are often the first sites to repigment, she said, followed by the extremities or the trunk. “The hands and feet are generally last; they are usually the most stubborn areas,” Dr. Shiu said. “Even when you do see repigmentation, it usually happens on the dorsal surfaces. The tips of the fingers and toes are difficult to repigment. Luckily, the face is one of the top responders, so that helps a lot.”

While some treatment efforts result in “complete and beautiful” repigmentation, she added, many yield uneven and incomplete results. “We don’t understand why repigmentation occurs in some areas but not in others,” she said. “We don’t have any biomarkers for treatment response. That is something we are looking into.”

For a patient with rapidly progressing active disease, consider an oral steroid mini-pulse 2 consecutive days per week for a maximum of 3-6 months. “I usually recommend that patients do this on Saturday and Sunday,” Dr. Shiu said. “Studies have shown this strategy can halt progression in 85%-91% of cases if patients are on it for at least 3 months.”

Relapse after successful repigmentation occurs in about 40% of cases following discontinuation of treatment, so she recommends biweekly application of 0.1% tacrolimus ointment as maintenance therapy. “Studies have shown this is enough to decrease the relapse rate to around 9%,” she said.
 

Tissue, Cellular Grafts

Surgical repigmentation strategies rely on transplanting normal skin to areas affected by vitiligo. In general, more than 50% of patients achieve more than 80% repigmentation. Options are divided into tissue grafts vs cellular grafts. “The old methods are tissue grafting such as punch grafting, tissue blister grafting, and spit thickness grafting, which can treat limited areas of skin,” Dr. Shiu said. Newer approaches include cellular grafting using the melanocyte-keratinocyte transplantation procedure, which can treat larger areas of skin.

The main drawback of this approach is that it is expensive and there is no insurance code for it, “but I hope that this becomes an option for our patients in the future because data indicate that repigmentation is maintained for up to 72 months after treatment,” she said.

In June 2023, an autologous cell harvesting device known as RECELL received FDA approval for repigmentation of stable vitiligo lesions. According to a press release from the manufacturer, AVITA Medical, a clinician “prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo.”

Dr. Shiu disclosed that she received research support from AbbVie.
 

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

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Focusing on Value in Social Media Posts

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Fri, 09/06/2024 - 15:52

— Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie
Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.



Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

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— Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie
Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.



Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

— Posting on social media may not be your cup of tea, but in the opinion of Jessica G. Labadie, MD, avoiding a presence on platforms like Facebook, X, Instagram, or YouTube means missing an opportunity to educate patients about dermatologic procedures and to dispel misinformation from nonmedical influencers.

“Over the past 2 decades, there has been a surge in social media use,” Dr. Labadie, a dermatologist who practices in Chestnut Hill, Massachusetts, said at the Controversies & Conversations in Laser & Cosmetic Surgery symposium. “Most of our patients use social media to find their doctors, and it plays a role in how our patients form their decision about whether to have a cosmetic procedure or not. Doctors, especially dermatologists, continue to actively participate in this ‘skinfluencer’ trend.”

courtesy Dr. Jessica G. Labadie
Dr. Jessica G. Labadie

According to a review of social media’s impact on aesthetic medicine, use of social media by American adults increased from 5% in 2005 to 72% in 2020, and 77% of patients search for a physician online. The review’s authors cited YouTube as the most popular platform among adults and noted that social media ranks as the sixth top factor for a patient deciding whether to have a laser procedure.

Dr. Labadie, who is also an assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said several factors should be considered when establishing and maintaining a social media presence, starting with personal ones. “Your followers are not your patients yet, and just because you may have thousands of followers does not necessarily mean that you’re busier in the clinic,” she said. “Be careful if you combine professional and personal accounts; be careful of those parasocial relationships that can form. Your followers tend to learn a lot about you. Posting can take a lot of time; it can take away from your clinical duties. Do you want to make your account private or public? There are pros and cons to both.”

Ethics also play a role. “Be transparent in your disclosure forms, especially if you’re posting ‘before’ and ‘after’ images of patients,” advised Dr. Labadie, who described herself as a social media minimalist. “Stay true to yourself in your posts, and always prioritize safety over posting.”

Don’t forget legal obligations. “Social media can facilitate a passive income, but make sure this isn’t impacting any conflicts of interest, and make sure that you meticulously follow any Health Insurance Portability and Accountability Act regulations,” she said. She also cautioned against violating intellectual property rights and making false claims about a product or procedure.



Deciding which platforms to use and what voice or tone to adopt requires some soul-searching. “What is your brand?” Dr. Labadie asked. “How do you want to portray yourself? Does your social media brand match your office brand? Does it match who you are as a provider and the type of patient you wish to attract? Would you prefer to have one collective social media presence as an office or multiple provider accounts?”

Being mindful of how your patients perceive and use social media in relation to their dermatologic concerns is also important. “What are your patients viewing on social media, and how is it affecting their decisions?” Dr. Labadie asked. “Are they coming in asking for something that is not right for what they need? At the end of the day, you are their doctor, and it’s your duty to treat the patients and not the trend.”

She encouraged dermatologists to “aim for high value and accurate posts coupled with high popularity and reach.” She added that “this is really the future of getting our research out there to the public. Academic notoriety is not enough. Our professional societies and skinfluencer colleagues need to get involved to help promote our expert research.”

Dr. Labadie reported having no financial disclosures.

A version of this article appeared on Medscape.com.

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