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Unique residency track focuses on rural placement of graduates
BOSTON – As a former active-duty cavalry officer in the U.S. Army who served a 15-month tour in Iraq in 2003, Adam C. Byrd, MD, isn’t easily rattled.
On any given day, as the only dermatologist in his hometown of Louisville, Miss., which has a population of about 6,500, he sees 35-40 patients who present with conditions ranging from an infantile hemangioma to dermatomyositis and porphyria cutanea tarda. Being the go-to specialist for hundreds of miles with no on-site lab and no immediate personal access to Mohs surgeons and other subspecialists might unnerve some dermatologists, but not him.
“They’re a text message away, but they’re not in my office,” he said during a session on rural dermatology at the annual meeting of the American Academy of Dermatology. “I don’t have a mid-level practitioner, either. It’s just me and the residents, so it can be somewhat isolating. But in a rural area, you’re doing your patients a disservice if you can’t handle broad-spectrum medical dermatology. I consider myself a family dermatologist; I do a little bit of everything.” This includes prescribing treatments ranging from methotrexate for psoriasis, psoriatic arthritis, eczema, and other conditions; cyclosporine and azathioprine for pediatric eczema; propranolol for infantile hemangiomas; to IV infusions for dermatomyositis; phlebotomy for porphyria cutanea tarda; and biologics.
With no on-site pathology lab, Dr. Byrd sends specimens twice a week to the University of Mississippi Medical Center in Jackson via FedEx to be read. “I have to wait 3 days for results instead of 2,” he said. At the end of each workday, he personally carries microbiology samples to Winston Medical Center in Louisville – the area’s only hospital and where he was born – for processing.
After completing a 5-year integrated internal medicine-dermatology residency at the University of Minnesota in 2016, Dr. Byrd worked with Robert T. Brodell, MD, who chairs the department of dermatology at UMMC, and other university officials to open a satellite clinic in Louisville, where he provides full-spectrum skin care for Northern Mississippians. The clinic, located about 95 miles from UMMC’s “mothership” in Jackson, has become a vital training ground for the university, which created the only rural-specific dermatology residency of the 142 accredited dermatology programs in the United States. Of the three to four residents accepted per year, one is a rural track resident who spends 3-month–long rotations at rural clinic sites such as Dr. Byrd’s during each of the 3 years of general dermatology training, and the remaining 9 months of each year alongside their non–rural track coresidents.
One of the program’s rural track residents, Joshua R. Ortego, MD, worked in Dr. Byrd’s clinic during PGY-2. “It’s unique for one attending and one resident to work together for 3 months straight,” said Dr. Ortego, who grew up in Bay St. Louis on the Gulf Coast of Mississippi, which has a population of about 9,200. “Dr. Byrd learns our weaknesses and knows our strengths and areas for improvement. You get close. And there’s continuity; you see some patients back. With all the shuffling in the traditional dermatology residency model, sometimes you’re not seeing patients for follow-up appointments. But here you do.”
Rural dermatology track residents who rotate through Dr. Byrd’s Louisville clinic spend each Monday at the main campus in Jackson for a continuity clinic and didactics with non–rural track residents, “which allows for collegiality,” Dr. Ortego said. “My coresidents are like family; it would be hard to spend 3 months or even a year away from family like that.” The department foots the cost of lodging in a Louisville hotel 4 nights per week during these 3 months of training.
Dr. Ortego said that he performed a far greater number of procedures during PGY-2, compared with the averages performed in UMMC’s general dermatology rotation: 75 excisions (vs. 17), 71 repairs (vs. 15), and 23 excisions on the face or scalp (vs. none). He also cared for patients who presented with advanced disease because of access issues, and others with rare conditions. For example, in one afternoon clinic he and Dr. Byrd saw two patients with porphyria cutanea tarda, and one case each of dermatomyositis, bullous pemphigoid, and pyoderma gangrenosum. “We have an autoimmune blistering disease clinic in Jackson, but patients don’t want to drive there,” he said.
Then there are the perks that come with practicing in a rural area, including ready access to hiking, fishing, hunting, and spending time with family and friends. “Rural residents should be comfortable with the lifestyle,” he said. “Some cities don’t have the same amenities as San Francisco or Boston, but not everyone requires that. They just love where they’re from.”
The residency’s structure is designed to address the dire shortage of rural-based dermatologists in the United States. A study published in 2018 found that the difference in dermatologist density between metropolitan and rural counties in the United States increased from 3.41 per 100,000 people (3.47 vs. 0.065 per 100,000 people) in 1995 to 4.03 per 100, 000 people (4.11 vs. 0.085 per 100,000 people in 2013; P = .053). That’s about 40 times the number of dermatologists in metro areas, compared with rural areas.
Residents enrolled in UMMC’s rural dermatology track are expected to serve at least 3 years at a rural location upon graduation at a site mutually agreed upon by the resident and the UMMC. Dr. Ortego plans to practice in Bay St. Louis after completing his residency. “The idea is that you’re happy, that you’re in your hometown,” he said.
According to Dr. Byrd, the 3-year commitment brings job security to rural track residents in their preferred location while meeting the demands of an underserved population. “We are still tweaking this,” he said of the residency track, which includes plans to establish more satellite clinics in other areas of rural Mississippi. “Our department chair does not have 100% control over hiring and office expansion. We are subject to the Mississippi Institutions of Higher Learning, which is a branch of the state government. This has to be addressed at the council of chairs and university chancellor level and even state government. It can be done, but you really must be dedicated.”
Meanwhile, the effect that dermatologists like Dr. Byrd have on citizens of his area of rural Mississippi is palpable. Many refuse to travel outside of Louisville city limits to see a specialist, so when surgery for a suspicious lesion is indicated, they tell him, “You’re going to do it, or it’s not going to get done,” said Dr. Byrd, who continues to serve in the Mississippi Army National Guard as a field surgeon. “I don’t say ‘no’ a whole lot.” He refers patients to Mohs micrographic surgery colleagues in Jackson daily and is transparent with patients who hesitate to elect Mohs surgery. “I’ll say, ‘I can do the job, but there’s a higher risk of positive margins, and a Mohs surgeon could do a much better job.’”
He acknowledged that rural dermatology “isn’t for everyone. It requires a physician that has a good training foundation in medical and surgical dermatology, someone with a ‘can do’ attitude and a healthy level of confidence. I try to do the best for my patients. It’s endearing when they trust you.”
Mary Logue, MD, who practices dermatology in Minot, N.D., finds the structure of UMMC’s rural dermatology track inspiring. Upon completing her dermatology residency at the University of New Mexico, where she remains on the volunteer faculty, she had hoped to return to serve the community of Gallup, N.M., and help bridge the gap in dermatology health care access for residents of rural New Mexico, especially those on Native American reservations. That opportunity never transpired, but Dr. Logue was able to pursue her passion for rural medicine in North Dakota.
“It is my hope that more programs will implement a similar structure to UMMC’s rural dermatology track and get more dermatologists practicing in rural areas,” Dr. Logue told this news organization. “They have developed a very practical and financially sustainable model, which I think every state could benefit from.”
She added that the UMMC “has found a way to bring dermatology to disadvantaged rural communities while also addressing the problem of underrepresented minorities in medicine. Medical students of color and medical students from rural communities are the least represented groups in dermatology, but the most likely to return to their communities to practice. Every day I see patients with adverse dermatologic outcomes as a direct result of lack of access to a dermatologist. This is happening across the country, which is why the efforts of UMMC Dermatology and their department chair, Dr. Brodell, are so important.”
BOSTON – As a former active-duty cavalry officer in the U.S. Army who served a 15-month tour in Iraq in 2003, Adam C. Byrd, MD, isn’t easily rattled.
On any given day, as the only dermatologist in his hometown of Louisville, Miss., which has a population of about 6,500, he sees 35-40 patients who present with conditions ranging from an infantile hemangioma to dermatomyositis and porphyria cutanea tarda. Being the go-to specialist for hundreds of miles with no on-site lab and no immediate personal access to Mohs surgeons and other subspecialists might unnerve some dermatologists, but not him.
“They’re a text message away, but they’re not in my office,” he said during a session on rural dermatology at the annual meeting of the American Academy of Dermatology. “I don’t have a mid-level practitioner, either. It’s just me and the residents, so it can be somewhat isolating. But in a rural area, you’re doing your patients a disservice if you can’t handle broad-spectrum medical dermatology. I consider myself a family dermatologist; I do a little bit of everything.” This includes prescribing treatments ranging from methotrexate for psoriasis, psoriatic arthritis, eczema, and other conditions; cyclosporine and azathioprine for pediatric eczema; propranolol for infantile hemangiomas; to IV infusions for dermatomyositis; phlebotomy for porphyria cutanea tarda; and biologics.
With no on-site pathology lab, Dr. Byrd sends specimens twice a week to the University of Mississippi Medical Center in Jackson via FedEx to be read. “I have to wait 3 days for results instead of 2,” he said. At the end of each workday, he personally carries microbiology samples to Winston Medical Center in Louisville – the area’s only hospital and where he was born – for processing.
After completing a 5-year integrated internal medicine-dermatology residency at the University of Minnesota in 2016, Dr. Byrd worked with Robert T. Brodell, MD, who chairs the department of dermatology at UMMC, and other university officials to open a satellite clinic in Louisville, where he provides full-spectrum skin care for Northern Mississippians. The clinic, located about 95 miles from UMMC’s “mothership” in Jackson, has become a vital training ground for the university, which created the only rural-specific dermatology residency of the 142 accredited dermatology programs in the United States. Of the three to four residents accepted per year, one is a rural track resident who spends 3-month–long rotations at rural clinic sites such as Dr. Byrd’s during each of the 3 years of general dermatology training, and the remaining 9 months of each year alongside their non–rural track coresidents.
One of the program’s rural track residents, Joshua R. Ortego, MD, worked in Dr. Byrd’s clinic during PGY-2. “It’s unique for one attending and one resident to work together for 3 months straight,” said Dr. Ortego, who grew up in Bay St. Louis on the Gulf Coast of Mississippi, which has a population of about 9,200. “Dr. Byrd learns our weaknesses and knows our strengths and areas for improvement. You get close. And there’s continuity; you see some patients back. With all the shuffling in the traditional dermatology residency model, sometimes you’re not seeing patients for follow-up appointments. But here you do.”
Rural dermatology track residents who rotate through Dr. Byrd’s Louisville clinic spend each Monday at the main campus in Jackson for a continuity clinic and didactics with non–rural track residents, “which allows for collegiality,” Dr. Ortego said. “My coresidents are like family; it would be hard to spend 3 months or even a year away from family like that.” The department foots the cost of lodging in a Louisville hotel 4 nights per week during these 3 months of training.
Dr. Ortego said that he performed a far greater number of procedures during PGY-2, compared with the averages performed in UMMC’s general dermatology rotation: 75 excisions (vs. 17), 71 repairs (vs. 15), and 23 excisions on the face or scalp (vs. none). He also cared for patients who presented with advanced disease because of access issues, and others with rare conditions. For example, in one afternoon clinic he and Dr. Byrd saw two patients with porphyria cutanea tarda, and one case each of dermatomyositis, bullous pemphigoid, and pyoderma gangrenosum. “We have an autoimmune blistering disease clinic in Jackson, but patients don’t want to drive there,” he said.
Then there are the perks that come with practicing in a rural area, including ready access to hiking, fishing, hunting, and spending time with family and friends. “Rural residents should be comfortable with the lifestyle,” he said. “Some cities don’t have the same amenities as San Francisco or Boston, but not everyone requires that. They just love where they’re from.”
The residency’s structure is designed to address the dire shortage of rural-based dermatologists in the United States. A study published in 2018 found that the difference in dermatologist density between metropolitan and rural counties in the United States increased from 3.41 per 100,000 people (3.47 vs. 0.065 per 100,000 people) in 1995 to 4.03 per 100, 000 people (4.11 vs. 0.085 per 100,000 people in 2013; P = .053). That’s about 40 times the number of dermatologists in metro areas, compared with rural areas.
Residents enrolled in UMMC’s rural dermatology track are expected to serve at least 3 years at a rural location upon graduation at a site mutually agreed upon by the resident and the UMMC. Dr. Ortego plans to practice in Bay St. Louis after completing his residency. “The idea is that you’re happy, that you’re in your hometown,” he said.
According to Dr. Byrd, the 3-year commitment brings job security to rural track residents in their preferred location while meeting the demands of an underserved population. “We are still tweaking this,” he said of the residency track, which includes plans to establish more satellite clinics in other areas of rural Mississippi. “Our department chair does not have 100% control over hiring and office expansion. We are subject to the Mississippi Institutions of Higher Learning, which is a branch of the state government. This has to be addressed at the council of chairs and university chancellor level and even state government. It can be done, but you really must be dedicated.”
Meanwhile, the effect that dermatologists like Dr. Byrd have on citizens of his area of rural Mississippi is palpable. Many refuse to travel outside of Louisville city limits to see a specialist, so when surgery for a suspicious lesion is indicated, they tell him, “You’re going to do it, or it’s not going to get done,” said Dr. Byrd, who continues to serve in the Mississippi Army National Guard as a field surgeon. “I don’t say ‘no’ a whole lot.” He refers patients to Mohs micrographic surgery colleagues in Jackson daily and is transparent with patients who hesitate to elect Mohs surgery. “I’ll say, ‘I can do the job, but there’s a higher risk of positive margins, and a Mohs surgeon could do a much better job.’”
He acknowledged that rural dermatology “isn’t for everyone. It requires a physician that has a good training foundation in medical and surgical dermatology, someone with a ‘can do’ attitude and a healthy level of confidence. I try to do the best for my patients. It’s endearing when they trust you.”
Mary Logue, MD, who practices dermatology in Minot, N.D., finds the structure of UMMC’s rural dermatology track inspiring. Upon completing her dermatology residency at the University of New Mexico, where she remains on the volunteer faculty, she had hoped to return to serve the community of Gallup, N.M., and help bridge the gap in dermatology health care access for residents of rural New Mexico, especially those on Native American reservations. That opportunity never transpired, but Dr. Logue was able to pursue her passion for rural medicine in North Dakota.
“It is my hope that more programs will implement a similar structure to UMMC’s rural dermatology track and get more dermatologists practicing in rural areas,” Dr. Logue told this news organization. “They have developed a very practical and financially sustainable model, which I think every state could benefit from.”
She added that the UMMC “has found a way to bring dermatology to disadvantaged rural communities while also addressing the problem of underrepresented minorities in medicine. Medical students of color and medical students from rural communities are the least represented groups in dermatology, but the most likely to return to their communities to practice. Every day I see patients with adverse dermatologic outcomes as a direct result of lack of access to a dermatologist. This is happening across the country, which is why the efforts of UMMC Dermatology and their department chair, Dr. Brodell, are so important.”
BOSTON – As a former active-duty cavalry officer in the U.S. Army who served a 15-month tour in Iraq in 2003, Adam C. Byrd, MD, isn’t easily rattled.
On any given day, as the only dermatologist in his hometown of Louisville, Miss., which has a population of about 6,500, he sees 35-40 patients who present with conditions ranging from an infantile hemangioma to dermatomyositis and porphyria cutanea tarda. Being the go-to specialist for hundreds of miles with no on-site lab and no immediate personal access to Mohs surgeons and other subspecialists might unnerve some dermatologists, but not him.
“They’re a text message away, but they’re not in my office,” he said during a session on rural dermatology at the annual meeting of the American Academy of Dermatology. “I don’t have a mid-level practitioner, either. It’s just me and the residents, so it can be somewhat isolating. But in a rural area, you’re doing your patients a disservice if you can’t handle broad-spectrum medical dermatology. I consider myself a family dermatologist; I do a little bit of everything.” This includes prescribing treatments ranging from methotrexate for psoriasis, psoriatic arthritis, eczema, and other conditions; cyclosporine and azathioprine for pediatric eczema; propranolol for infantile hemangiomas; to IV infusions for dermatomyositis; phlebotomy for porphyria cutanea tarda; and biologics.
With no on-site pathology lab, Dr. Byrd sends specimens twice a week to the University of Mississippi Medical Center in Jackson via FedEx to be read. “I have to wait 3 days for results instead of 2,” he said. At the end of each workday, he personally carries microbiology samples to Winston Medical Center in Louisville – the area’s only hospital and where he was born – for processing.
After completing a 5-year integrated internal medicine-dermatology residency at the University of Minnesota in 2016, Dr. Byrd worked with Robert T. Brodell, MD, who chairs the department of dermatology at UMMC, and other university officials to open a satellite clinic in Louisville, where he provides full-spectrum skin care for Northern Mississippians. The clinic, located about 95 miles from UMMC’s “mothership” in Jackson, has become a vital training ground for the university, which created the only rural-specific dermatology residency of the 142 accredited dermatology programs in the United States. Of the three to four residents accepted per year, one is a rural track resident who spends 3-month–long rotations at rural clinic sites such as Dr. Byrd’s during each of the 3 years of general dermatology training, and the remaining 9 months of each year alongside their non–rural track coresidents.
One of the program’s rural track residents, Joshua R. Ortego, MD, worked in Dr. Byrd’s clinic during PGY-2. “It’s unique for one attending and one resident to work together for 3 months straight,” said Dr. Ortego, who grew up in Bay St. Louis on the Gulf Coast of Mississippi, which has a population of about 9,200. “Dr. Byrd learns our weaknesses and knows our strengths and areas for improvement. You get close. And there’s continuity; you see some patients back. With all the shuffling in the traditional dermatology residency model, sometimes you’re not seeing patients for follow-up appointments. But here you do.”
Rural dermatology track residents who rotate through Dr. Byrd’s Louisville clinic spend each Monday at the main campus in Jackson for a continuity clinic and didactics with non–rural track residents, “which allows for collegiality,” Dr. Ortego said. “My coresidents are like family; it would be hard to spend 3 months or even a year away from family like that.” The department foots the cost of lodging in a Louisville hotel 4 nights per week during these 3 months of training.
Dr. Ortego said that he performed a far greater number of procedures during PGY-2, compared with the averages performed in UMMC’s general dermatology rotation: 75 excisions (vs. 17), 71 repairs (vs. 15), and 23 excisions on the face or scalp (vs. none). He also cared for patients who presented with advanced disease because of access issues, and others with rare conditions. For example, in one afternoon clinic he and Dr. Byrd saw two patients with porphyria cutanea tarda, and one case each of dermatomyositis, bullous pemphigoid, and pyoderma gangrenosum. “We have an autoimmune blistering disease clinic in Jackson, but patients don’t want to drive there,” he said.
Then there are the perks that come with practicing in a rural area, including ready access to hiking, fishing, hunting, and spending time with family and friends. “Rural residents should be comfortable with the lifestyle,” he said. “Some cities don’t have the same amenities as San Francisco or Boston, but not everyone requires that. They just love where they’re from.”
The residency’s structure is designed to address the dire shortage of rural-based dermatologists in the United States. A study published in 2018 found that the difference in dermatologist density between metropolitan and rural counties in the United States increased from 3.41 per 100,000 people (3.47 vs. 0.065 per 100,000 people) in 1995 to 4.03 per 100, 000 people (4.11 vs. 0.085 per 100,000 people in 2013; P = .053). That’s about 40 times the number of dermatologists in metro areas, compared with rural areas.
Residents enrolled in UMMC’s rural dermatology track are expected to serve at least 3 years at a rural location upon graduation at a site mutually agreed upon by the resident and the UMMC. Dr. Ortego plans to practice in Bay St. Louis after completing his residency. “The idea is that you’re happy, that you’re in your hometown,” he said.
According to Dr. Byrd, the 3-year commitment brings job security to rural track residents in their preferred location while meeting the demands of an underserved population. “We are still tweaking this,” he said of the residency track, which includes plans to establish more satellite clinics in other areas of rural Mississippi. “Our department chair does not have 100% control over hiring and office expansion. We are subject to the Mississippi Institutions of Higher Learning, which is a branch of the state government. This has to be addressed at the council of chairs and university chancellor level and even state government. It can be done, but you really must be dedicated.”
Meanwhile, the effect that dermatologists like Dr. Byrd have on citizens of his area of rural Mississippi is palpable. Many refuse to travel outside of Louisville city limits to see a specialist, so when surgery for a suspicious lesion is indicated, they tell him, “You’re going to do it, or it’s not going to get done,” said Dr. Byrd, who continues to serve in the Mississippi Army National Guard as a field surgeon. “I don’t say ‘no’ a whole lot.” He refers patients to Mohs micrographic surgery colleagues in Jackson daily and is transparent with patients who hesitate to elect Mohs surgery. “I’ll say, ‘I can do the job, but there’s a higher risk of positive margins, and a Mohs surgeon could do a much better job.’”
He acknowledged that rural dermatology “isn’t for everyone. It requires a physician that has a good training foundation in medical and surgical dermatology, someone with a ‘can do’ attitude and a healthy level of confidence. I try to do the best for my patients. It’s endearing when they trust you.”
Mary Logue, MD, who practices dermatology in Minot, N.D., finds the structure of UMMC’s rural dermatology track inspiring. Upon completing her dermatology residency at the University of New Mexico, where she remains on the volunteer faculty, she had hoped to return to serve the community of Gallup, N.M., and help bridge the gap in dermatology health care access for residents of rural New Mexico, especially those on Native American reservations. That opportunity never transpired, but Dr. Logue was able to pursue her passion for rural medicine in North Dakota.
“It is my hope that more programs will implement a similar structure to UMMC’s rural dermatology track and get more dermatologists practicing in rural areas,” Dr. Logue told this news organization. “They have developed a very practical and financially sustainable model, which I think every state could benefit from.”
She added that the UMMC “has found a way to bring dermatology to disadvantaged rural communities while also addressing the problem of underrepresented minorities in medicine. Medical students of color and medical students from rural communities are the least represented groups in dermatology, but the most likely to return to their communities to practice. Every day I see patients with adverse dermatologic outcomes as a direct result of lack of access to a dermatologist. This is happening across the country, which is why the efforts of UMMC Dermatology and their department chair, Dr. Brodell, are so important.”
At AAD 22
Synthetic, botanical agents emerging as promising melasma treatments
BOSTON – Though, according to Nada Elbuluk, MD, MSc.
One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”
Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.
One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.
“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”
Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.
“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.
Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.
Botanicals
Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.
The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.
Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.
“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.
Platelet-rich plasma
Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”
A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.
A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.
“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”
Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”
Other emerging topical therapies
Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.
The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.
Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.
BOSTON – Though, according to Nada Elbuluk, MD, MSc.
One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”
Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.
One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.
“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”
Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.
“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.
Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.
Botanicals
Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.
The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.
Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.
“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.
Platelet-rich plasma
Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”
A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.
A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.
“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”
Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”
Other emerging topical therapies
Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.
The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.
Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.
BOSTON – Though, according to Nada Elbuluk, MD, MSc.
One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”
Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.
One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.
“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”
Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.
“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.
Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.
Botanicals
Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.
The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.
Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.
“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.
Platelet-rich plasma
Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”
A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.
A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.
“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”
Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”
Other emerging topical therapies
Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.
The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.
Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.
AT AAD 22
NB-UVB phototherapy plays a key role in psoriasis treatment, expert says
BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.
Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.
“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”
In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.
“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.
Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”
On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).
The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).
It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”
Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.
Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”
For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.
A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.
One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.
“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”
Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”
Dr. Buzney reported having no relevant financial conflicts.
BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.
Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.
“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”
In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.
“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.
Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”
On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).
The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).
It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”
Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.
Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”
For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.
A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.
One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.
“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”
Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”
Dr. Buzney reported having no relevant financial conflicts.
BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.
Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.
“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”
In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.
“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.
Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”
On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).
The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).
It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”
Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.
Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”
For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.
A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.
One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.
“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”
Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”
Dr. Buzney reported having no relevant financial conflicts.
AT AAD 22
Which solid organ transplant recipients face the highest risk of skin cancer?
BOSTON – .
White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.
Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.
The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.
Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.
Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”
To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.
Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.
BOSTON – .
White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.
Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.
The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.
Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.
Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”
To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.
Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.
BOSTON – .
White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.
Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.
The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.
Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.
Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”
To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.
Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.
AT AAD 22
Hair loss: Consider a patient’s supplement use
BOSTON – .
This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.
Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”
In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.
Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?
Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.
Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.
Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.
Dr. Bergfeld noted that biotin, also known as vitamin B7 and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”
To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B12 for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.
While there are not enough data to support a recommendation for supplementation of folic or B12 for alopecia, she said, “vitamin B12 deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”
She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”
Dr. Bergfeld reported having no disclosures related to her presentation.
BOSTON – .
This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.
Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”
In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.
Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?
Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.
Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.
Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.
Dr. Bergfeld noted that biotin, also known as vitamin B7 and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”
To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B12 for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.
While there are not enough data to support a recommendation for supplementation of folic or B12 for alopecia, she said, “vitamin B12 deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”
She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”
Dr. Bergfeld reported having no disclosures related to her presentation.
BOSTON – .
This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.
Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”
In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.
Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?
Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.
Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.
Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.
Dr. Bergfeld noted that biotin, also known as vitamin B7 and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”
To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B12 for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.
While there are not enough data to support a recommendation for supplementation of folic or B12 for alopecia, she said, “vitamin B12 deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”
She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”
Dr. Bergfeld reported having no disclosures related to her presentation.
AT AAD 22
PLA testing brings nuance to the diagnosis of early-stage melanoma
BOSTON – Although
One such test, the Pigmented Lesional Assay (PLA) uses adhesive patches applied to lesions of concern at the bedside to extract RNA from the stratum corneum to help determine the risk for melanoma.
At the annual meeting of the American Academy of Dermatology, Caroline C. Kim, MD, director of melanoma and pigmented lesion clinics at Newton Wellesley Dermatology, Wellesley Hills, Mass., and Tufts Medical Center, Boston, spoke about the PLA, which uses genetic expression profiling to measure the expression level of specific genes that are associated with melanoma: PRAME (preferentially expressed antigen in melanoma) and LINC00518 (LINC). There are four possible results of the test: Aberrant expression of both LINC and PRAME (high risk); aberrant expression of a single gene (moderate risk); aberrant expression of neither gene (low risk); or inconclusive.
Validation data have shown a sensitivity of 91% and a specificity of 69% for the PLA, with a 99% negative predictive value; so a lesion that tested negative by PLA has a less than 1% chance of being melanoma. In addition, a study published in 2020 found that the addition of TERT (telomerase reverse transcriptase) mutation analyses increased the sensitivity of the PLA to 97%.
While the high negative predictive value is helpful to consider in clinical scenarios to rule-out melanoma for borderline lesions, one must consider the positive predictive value as well and how this may impact clinical care, Dr. Kim said. In a study examining outcomes of 381 lesions, 51 were PLA positive (single or double) and were biopsied, of which 19 (37%) revealed a melanoma diagnosis. In a large U.S. registry study of 3,418 lesions, 324 lesions that were PLA double positive were biopsied, with 18.7% revealing a melanoma diagnosis.
“No test is perfect, and this applies to PLA, even if you get a double-positive or double-negative test result,” Dr. Kim said. “You want to make sure that patients are aware of false positives and negatives. However, PLA could be an additional piece of data to inform your decision to proceed with biopsy on select borderline suspicious pigmented lesions. More studies are needed to better understand the approach to single- and double-positive PLA results.”
The PLA kit contains adhesive patches and supplies and a FedEx envelope for return to DermTech, the test’s manufacturer, for processing. The patches can be applied to lesions at least 4 mm in diameter; multiple kits are recommended for those greater than 16 mm in diameter. The test is not validated for lesions located on mucous membranes, palms, soles, nails, or on ulcerated or bleeding lesions, nor for those that have been previously biopsied. It is also not validated for use in pediatric patients or in those with skin types IV or higher. Results are returned in 2-3 days. If insurance does not cover the test, the cost to the patient is approximately $50 per lesion or a maximum of $150, according to Dr. Kim.
Use in clinical practice
In Dr. Kim’s clinical experience, the PLA can be considered for suspicious pigmented lesions on cosmetically sensitive areas and for suspicious lesions in areas difficult to biopsy or excise. For example, she discussed the case of a 72-year-old woman with a family history of melanoma, who presented to her clinic with a longstanding pigmented lesion on her right upper and lower eyelids that had previously been treated with laser. She had undergone multiple prior biopsies over 12 years, which caused mild to moderate atypical melanocytic proliferation. The PLA result was double negative for PRAME and LINC in her upper and lower eyelid, “which provided reassurance to the patient,” Dr. Kim said. The patient continues to be followed closely for any clinical changes.
Another patient, a 67-year-old woman, was referred to Dr. Kim from out of state for a teledermatology visit early in the COVID-19 pandemic. The patient had a lesion on her right calf that was hard, raised, and pink, did not resemble other lesions on her body, and had been present for a few weeks. “Her husband had recently passed away from brain cancer and she was very concerned about melanoma,” Dr. Kim recalled. “She lived alone, and the adult son was with her during the teledermatology call to assist. The patient asked about the PLA test, and given her difficulty going to a medical office at the time, we agreed to help her with this test.” The patient and her son arranged another teledermatology visit with Dr. Kim after receiving the kit in the mail from DermTech, and Dr. Kim coached them on how to properly administer the test. The results came back as PRAME negative and LINC positive. A biopsy with a local provider was recommended and the pathology results showed an inflamed seborrheic keratosis.
“This case exemplifies a false-positive result. We should be sure to make patients aware of this possibility,” Dr. Kim said.
Incorporating PLA into clinical practice requires certain workflow considerations, with paperwork to fill out in addition to performing the adhesive test, collection of insurance information, mailing the kit via FedEx, retrieving the results, and following up with the patient, said Dr. Kim. “For select borderline pigmented lesions, I discuss the rationale of the test with patients, the possibility of false-positive and false-negative results and the need to return for a biopsy when there is positive result. Clinical follow-up is recommended for negative results. There is also the possibility of charge to the patient if the test is not covered by their insurance.”
Skin biopsy still the gold standard
Despite the availability of the PLA as an assessment tool, Dr. Kim emphasized that skin biopsy remains the gold standard for diagnosing melanoma. “Future prospective randomized clinical trials are needed to examine the role of genetic expression profiling in staging and managing patients,” she said.
In 2019, she and her colleagues surveyed 42 pigmented lesion experts in the United States about why they ordered one of three molecular tests on the market or not and how results affected patient treatment. The proportion of clinicians who ordered the tests ranged from 21% to 29%. The top 2 reasons respondents chose for not ordering the PLA test specifically were: “Feel that further validation studies are necessary” (20%) and “do not feel it would be useful in my practice” (18%).
Results of a larger follow-up survey on usage patterns of PLA of both pigmented lesion experts and general clinicians on this topic are expected to be published shortly.
Dr. Kim reported having no disclosures related to her presentation.
BOSTON – Although
One such test, the Pigmented Lesional Assay (PLA) uses adhesive patches applied to lesions of concern at the bedside to extract RNA from the stratum corneum to help determine the risk for melanoma.
At the annual meeting of the American Academy of Dermatology, Caroline C. Kim, MD, director of melanoma and pigmented lesion clinics at Newton Wellesley Dermatology, Wellesley Hills, Mass., and Tufts Medical Center, Boston, spoke about the PLA, which uses genetic expression profiling to measure the expression level of specific genes that are associated with melanoma: PRAME (preferentially expressed antigen in melanoma) and LINC00518 (LINC). There are four possible results of the test: Aberrant expression of both LINC and PRAME (high risk); aberrant expression of a single gene (moderate risk); aberrant expression of neither gene (low risk); or inconclusive.
Validation data have shown a sensitivity of 91% and a specificity of 69% for the PLA, with a 99% negative predictive value; so a lesion that tested negative by PLA has a less than 1% chance of being melanoma. In addition, a study published in 2020 found that the addition of TERT (telomerase reverse transcriptase) mutation analyses increased the sensitivity of the PLA to 97%.
While the high negative predictive value is helpful to consider in clinical scenarios to rule-out melanoma for borderline lesions, one must consider the positive predictive value as well and how this may impact clinical care, Dr. Kim said. In a study examining outcomes of 381 lesions, 51 were PLA positive (single or double) and were biopsied, of which 19 (37%) revealed a melanoma diagnosis. In a large U.S. registry study of 3,418 lesions, 324 lesions that were PLA double positive were biopsied, with 18.7% revealing a melanoma diagnosis.
“No test is perfect, and this applies to PLA, even if you get a double-positive or double-negative test result,” Dr. Kim said. “You want to make sure that patients are aware of false positives and negatives. However, PLA could be an additional piece of data to inform your decision to proceed with biopsy on select borderline suspicious pigmented lesions. More studies are needed to better understand the approach to single- and double-positive PLA results.”
The PLA kit contains adhesive patches and supplies and a FedEx envelope for return to DermTech, the test’s manufacturer, for processing. The patches can be applied to lesions at least 4 mm in diameter; multiple kits are recommended for those greater than 16 mm in diameter. The test is not validated for lesions located on mucous membranes, palms, soles, nails, or on ulcerated or bleeding lesions, nor for those that have been previously biopsied. It is also not validated for use in pediatric patients or in those with skin types IV or higher. Results are returned in 2-3 days. If insurance does not cover the test, the cost to the patient is approximately $50 per lesion or a maximum of $150, according to Dr. Kim.
Use in clinical practice
In Dr. Kim’s clinical experience, the PLA can be considered for suspicious pigmented lesions on cosmetically sensitive areas and for suspicious lesions in areas difficult to biopsy or excise. For example, she discussed the case of a 72-year-old woman with a family history of melanoma, who presented to her clinic with a longstanding pigmented lesion on her right upper and lower eyelids that had previously been treated with laser. She had undergone multiple prior biopsies over 12 years, which caused mild to moderate atypical melanocytic proliferation. The PLA result was double negative for PRAME and LINC in her upper and lower eyelid, “which provided reassurance to the patient,” Dr. Kim said. The patient continues to be followed closely for any clinical changes.
Another patient, a 67-year-old woman, was referred to Dr. Kim from out of state for a teledermatology visit early in the COVID-19 pandemic. The patient had a lesion on her right calf that was hard, raised, and pink, did not resemble other lesions on her body, and had been present for a few weeks. “Her husband had recently passed away from brain cancer and she was very concerned about melanoma,” Dr. Kim recalled. “She lived alone, and the adult son was with her during the teledermatology call to assist. The patient asked about the PLA test, and given her difficulty going to a medical office at the time, we agreed to help her with this test.” The patient and her son arranged another teledermatology visit with Dr. Kim after receiving the kit in the mail from DermTech, and Dr. Kim coached them on how to properly administer the test. The results came back as PRAME negative and LINC positive. A biopsy with a local provider was recommended and the pathology results showed an inflamed seborrheic keratosis.
“This case exemplifies a false-positive result. We should be sure to make patients aware of this possibility,” Dr. Kim said.
Incorporating PLA into clinical practice requires certain workflow considerations, with paperwork to fill out in addition to performing the adhesive test, collection of insurance information, mailing the kit via FedEx, retrieving the results, and following up with the patient, said Dr. Kim. “For select borderline pigmented lesions, I discuss the rationale of the test with patients, the possibility of false-positive and false-negative results and the need to return for a biopsy when there is positive result. Clinical follow-up is recommended for negative results. There is also the possibility of charge to the patient if the test is not covered by their insurance.”
Skin biopsy still the gold standard
Despite the availability of the PLA as an assessment tool, Dr. Kim emphasized that skin biopsy remains the gold standard for diagnosing melanoma. “Future prospective randomized clinical trials are needed to examine the role of genetic expression profiling in staging and managing patients,” she said.
In 2019, she and her colleagues surveyed 42 pigmented lesion experts in the United States about why they ordered one of three molecular tests on the market or not and how results affected patient treatment. The proportion of clinicians who ordered the tests ranged from 21% to 29%. The top 2 reasons respondents chose for not ordering the PLA test specifically were: “Feel that further validation studies are necessary” (20%) and “do not feel it would be useful in my practice” (18%).
Results of a larger follow-up survey on usage patterns of PLA of both pigmented lesion experts and general clinicians on this topic are expected to be published shortly.
Dr. Kim reported having no disclosures related to her presentation.
BOSTON – Although
One such test, the Pigmented Lesional Assay (PLA) uses adhesive patches applied to lesions of concern at the bedside to extract RNA from the stratum corneum to help determine the risk for melanoma.
At the annual meeting of the American Academy of Dermatology, Caroline C. Kim, MD, director of melanoma and pigmented lesion clinics at Newton Wellesley Dermatology, Wellesley Hills, Mass., and Tufts Medical Center, Boston, spoke about the PLA, which uses genetic expression profiling to measure the expression level of specific genes that are associated with melanoma: PRAME (preferentially expressed antigen in melanoma) and LINC00518 (LINC). There are four possible results of the test: Aberrant expression of both LINC and PRAME (high risk); aberrant expression of a single gene (moderate risk); aberrant expression of neither gene (low risk); or inconclusive.
Validation data have shown a sensitivity of 91% and a specificity of 69% for the PLA, with a 99% negative predictive value; so a lesion that tested negative by PLA has a less than 1% chance of being melanoma. In addition, a study published in 2020 found that the addition of TERT (telomerase reverse transcriptase) mutation analyses increased the sensitivity of the PLA to 97%.
While the high negative predictive value is helpful to consider in clinical scenarios to rule-out melanoma for borderline lesions, one must consider the positive predictive value as well and how this may impact clinical care, Dr. Kim said. In a study examining outcomes of 381 lesions, 51 were PLA positive (single or double) and were biopsied, of which 19 (37%) revealed a melanoma diagnosis. In a large U.S. registry study of 3,418 lesions, 324 lesions that were PLA double positive were biopsied, with 18.7% revealing a melanoma diagnosis.
“No test is perfect, and this applies to PLA, even if you get a double-positive or double-negative test result,” Dr. Kim said. “You want to make sure that patients are aware of false positives and negatives. However, PLA could be an additional piece of data to inform your decision to proceed with biopsy on select borderline suspicious pigmented lesions. More studies are needed to better understand the approach to single- and double-positive PLA results.”
The PLA kit contains adhesive patches and supplies and a FedEx envelope for return to DermTech, the test’s manufacturer, for processing. The patches can be applied to lesions at least 4 mm in diameter; multiple kits are recommended for those greater than 16 mm in diameter. The test is not validated for lesions located on mucous membranes, palms, soles, nails, or on ulcerated or bleeding lesions, nor for those that have been previously biopsied. It is also not validated for use in pediatric patients or in those with skin types IV or higher. Results are returned in 2-3 days. If insurance does not cover the test, the cost to the patient is approximately $50 per lesion or a maximum of $150, according to Dr. Kim.
Use in clinical practice
In Dr. Kim’s clinical experience, the PLA can be considered for suspicious pigmented lesions on cosmetically sensitive areas and for suspicious lesions in areas difficult to biopsy or excise. For example, she discussed the case of a 72-year-old woman with a family history of melanoma, who presented to her clinic with a longstanding pigmented lesion on her right upper and lower eyelids that had previously been treated with laser. She had undergone multiple prior biopsies over 12 years, which caused mild to moderate atypical melanocytic proliferation. The PLA result was double negative for PRAME and LINC in her upper and lower eyelid, “which provided reassurance to the patient,” Dr. Kim said. The patient continues to be followed closely for any clinical changes.
Another patient, a 67-year-old woman, was referred to Dr. Kim from out of state for a teledermatology visit early in the COVID-19 pandemic. The patient had a lesion on her right calf that was hard, raised, and pink, did not resemble other lesions on her body, and had been present for a few weeks. “Her husband had recently passed away from brain cancer and she was very concerned about melanoma,” Dr. Kim recalled. “She lived alone, and the adult son was with her during the teledermatology call to assist. The patient asked about the PLA test, and given her difficulty going to a medical office at the time, we agreed to help her with this test.” The patient and her son arranged another teledermatology visit with Dr. Kim after receiving the kit in the mail from DermTech, and Dr. Kim coached them on how to properly administer the test. The results came back as PRAME negative and LINC positive. A biopsy with a local provider was recommended and the pathology results showed an inflamed seborrheic keratosis.
“This case exemplifies a false-positive result. We should be sure to make patients aware of this possibility,” Dr. Kim said.
Incorporating PLA into clinical practice requires certain workflow considerations, with paperwork to fill out in addition to performing the adhesive test, collection of insurance information, mailing the kit via FedEx, retrieving the results, and following up with the patient, said Dr. Kim. “For select borderline pigmented lesions, I discuss the rationale of the test with patients, the possibility of false-positive and false-negative results and the need to return for a biopsy when there is positive result. Clinical follow-up is recommended for negative results. There is also the possibility of charge to the patient if the test is not covered by their insurance.”
Skin biopsy still the gold standard
Despite the availability of the PLA as an assessment tool, Dr. Kim emphasized that skin biopsy remains the gold standard for diagnosing melanoma. “Future prospective randomized clinical trials are needed to examine the role of genetic expression profiling in staging and managing patients,” she said.
In 2019, she and her colleagues surveyed 42 pigmented lesion experts in the United States about why they ordered one of three molecular tests on the market or not and how results affected patient treatment. The proportion of clinicians who ordered the tests ranged from 21% to 29%. The top 2 reasons respondents chose for not ordering the PLA test specifically were: “Feel that further validation studies are necessary” (20%) and “do not feel it would be useful in my practice” (18%).
Results of a larger follow-up survey on usage patterns of PLA of both pigmented lesion experts and general clinicians on this topic are expected to be published shortly.
Dr. Kim reported having no disclosures related to her presentation.
AT AAD 22
Study finds discrepancies in biopsy decisions, diagnoses based on skin type
BOSTON – compared with White patients, new research shows.
“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.
Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.
“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”
To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.
For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.
Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).
However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).
In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).
Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.
The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.
Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.
And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.
Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.
“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”
Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.
Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.
In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”
The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”
The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – compared with White patients, new research shows.
“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.
Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.
“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”
To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.
For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.
Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).
However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).
In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).
Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.
The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.
Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.
And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.
Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.
“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”
Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.
Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.
In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”
The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”
The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – compared with White patients, new research shows.
“Our findings suggest diagnostic biases based on skin color exist in dermatology practice,” lead author Loren Krueger, MD, assistant professor in the department of dermatology, Emory University School of Medicine, Atlanta, said at the Annual Skin of Color Society Scientific Symposium. “A lower likelihood of biopsy of malignancy in darker skin types could contribute to disparities in cutaneous malignancies,” she added.
Disparities in dermatologic care among Black patients, compared with White patients, have been well documented. Recent evidence includes a 2020 study that showed significant shortcomings among medical students in correctly diagnosing squamous cell carcinoma, urticaria, and atopic dermatitis for patients with skin of color.
“It’s no secret that our images do not accurately or in the right quantity include skin of color,” Dr. Krueger said. “Yet few papers talk about how these biases actually impact our care. Importantly, this study demonstrates that diagnostic bias develops as early as the medical student level.”
To further investigate the role of skin color in the assessment of neoplastic and inflammatory skin conditions and decisions to perform biopsy, Dr. Krueger and her colleagues surveyed 144 dermatology residents and attending dermatologists to evaluate their clinical decisionmaking skills in assessing skin conditions for patients with lighter skin and those with darker skin. Almost 80% (113) provided complete responses and were included in the study.
For the survey, participants were shown photos of 10 neoplastic and 10 inflammatory skin conditions. Each image was matched in lighter (skin types I-II) and darker (skin types IV-VI) skinned patients in random order. Participants were asked to identify the suspected underlying etiology (neoplastic–benign, neoplastic–malignant, papulosquamous, lichenoid, infectious, bullous, or no suspected etiology) and whether they would choose to perform biopsy for the pictured condition.
Overall, their responses showed a slightly higher probability of recommending a biopsy for patients with skin types IV-V (odds ratio, 1.18; P = .054).
However, respondents were more than twice as likely to recommend a biopsy for benign neoplasms for patients with skin of color, compared with those with lighter skin types (OR, 2.57; P < .0001). They were significantly less likely to recommend a biopsy for a malignant neoplasm for patients with skin of color (OR, 0.42; P < .0001).
In addition, the correct etiology was much more commonly missed in diagnosing patients with skin of color, even after adjusting for years in dermatology practice (OR, 0.569; P < .0001).
Conversely, respondents were significantly less likely to recommend a biopsy for benign neoplasms and were more likely to recommend a biopsy for malignant neoplasms among White patients. Etiology was more commonly correct.
The findings underscore that “for skin of color patients, you’re more likely to have a benign neoplasm biopsied, you’re less likely to have a malignant neoplasm biopsied, and more often, your etiology may be missed,” Dr. Krueger said at the meeting.
Of note, while 45% of respondents were dermatology residents or fellows, 20.4% had 1-5 years of experience, and about 28% had 10 to more than 25 years of experience.
And while 75% of the dermatology residents, fellows, and attendings were White, there was no difference in the probability of correctly identifying the underlying etiology in dark or light skin types based on the provider’s self-identified race.
Importantly, the patterns in the study of diagnostic discrepancies are reflected in broader dermatologic outcomes. The 5-year melanoma survival rate is 74.1% among Black patients and 92.9% among White patients. Dr. Krueger referred to data showing that only 52.6% of Black patients have stage I melanoma at diagnosis, whereas among White patients, the rate is much higher, at 75.9%.
“We know skin malignancy can be more aggressive and late-stage in skin of color populations, leading to increased morbidity and later stage at initial diagnosis,” Dr. Krueger told this news organization. “We routinely attribute this to limited access to care and lack of awareness on skin malignancy. However, we have no evidence on how we, as dermatologists, may be playing a role.”
Furthermore, the decision to perform biopsy or not can affect the size and stage at diagnosis of a cutaneous malignancy, she noted.
Key changes needed to prevent the disparities – and their implications – should start at the training level, she emphasized. “I would love to see increased photo representation in training materials – this is a great place to start,” Dr. Krueger said.
In addition, “encouraging medical students, residents, and dermatologists to learn from skin of color experts is vital,” she said. “We should also provide hands-on experience and training with diverse patient populations.”
The first step to addressing biases “is to acknowledge they exist,” Dr. Krueger added. “I am hopeful this inspires others to continue to investigate these biases, as well as how we can eliminate them.”
The study was funded by the Rudin Resident Research Award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Photoprotection strategies for melasma are increasing
BOSTON – Untinted chemical sunscreens on the market are not sufficient to protect the skin from the effects of visible light, complicating sun protection efforts for patients with melasma and other conditions aggravated by sun exposure, according to Henry W. Lim, MD.
A , Dr. Lim, former chair of the department of dermatology at Henry Ford Health, Detroit, said at the annual meeting of the American Academy of Dermatology. Tinted sunscreens contain iron oxides; some also contain pigmentary titanium dioxide.
“Black, red, and yellow iron oxide all reflect visible light,” he added, noting that currently, there are no regulations as to how tinted sunscreens are marketed, making it difficult for practicing clinicians to advise patients about what products to choose. However, he said, “unlike ‘SPF’ and ‘broad spectrum’ labeling, there is no specific guidance on tinted sunscreens. “ ‘Universal’ shade is a good start but might not be ideal for users with very fair or deep skin tones,” he noted.
In December 2021, a guide to tinted sunscreens, written by Dr. Lim and colleagues, was published, recommending that consumers choose a product that contains iron oxides, is labeled as broad spectrum, and has an SPF of at least 30.
A comprehensive list of 54 tinted sunscreens with an SPF of 30 or greater that contain iron oxide is also available . The authors of the guide contributed to this resource, which lists sunscreens by average price per ounce.
At the meeting, Dr. Lim highlighted tinted sunscreens that cost about $20 or less per ounce. They include Supergoop 100% Mineral CC Cream (SPF 50); Bare Republic Mineral Tinted Face Sunscreen Lotion (SPF 30); CeraVe Hydrating Sunscreen with Sheer Tint (SPF 30); Tizo Ultra Zinc Body & Face Sunscreen (SPF 40); Vichy Capital Soleil Tinted Face Mineral Sunscreen (SPF 60); EltaMD UV Elements Tinted (SPF 44); La Roche-Posay Anthelios Ultra-Light Tinted Mineral (SPF 50), SkinMedica Essential Defense Mineral Shield (SPF 32), ISDIN Eryfotona Ageless Ultralight Tinted Mineral Sunscreen (SPF 50), and SkinCeuticals Physical Fusion UV Defense (SPF 50).
Sunscreens with antioxidants
Sunscreens with biologically active antioxidants may be another option for patients with melasma. A proof-of-concept study that Dr. Lim and colleagues conducted in 20 patients found that application of a blend of topical antioxidants (2%) was associated with less erythema at the application sites among those with skin phototypes I-III and less pigmentation at the application sites among those with skin phototypes IV-VI after exposure to visible light and UVA-1, compared with controls.
Certain antioxidants have been added to sunscreens currently on the market, including niacinamide (vitamin B3), licochalcone A, carotenoids (beta-carotene), vitamin E, vitamin C, glycyrrhetinic acid, and diethylhexyl syringylidenemalonate.
A recently published paper on the role of antioxidants and free radical quenchers in protecting skin from visible light referred to unpublished data from Dr. Lim (the first author) and colleagues, which demonstrated a significant reduction in visual light–induced hyperpigmentation on skin with sunscreen that contained the antioxidants vitamin E, vitamin C, diethylhexyl syringylidenemalonate, licochalcone A, and a glycyrrhetinic acid, compared with sunscreen that had no antioxidants.
Novel filters
Another emerging option is sunscreen with new filters that cover UVA-1 and visible light. In a randomized, controlled trial of 19 patients, researchers evaluated the addition of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate (MCE) absorber, a new UVA-1 filter known as Mexoryl 400, which has a peak absorption of 385 nm, to a sunscreen formulation.
“Currently, peak absorption in the U.S. is with avobenzone, which peaks at about 357 nm,” but MCE “covers a longer spectrum of UVA-1,” Dr. Lim said. The researchers found that the addition of MCE reduced UVA-1-induced dermal and epidermal alterations at cellular, biochemical, and molecular levels; and decreased UVA-1-induced pigmentation.
Another relatively new filter, phenylene bis-diphenyltriazine (also known as TriAsorB) not only protects against UVA but it extends into the blue light portion of visible light, according to a recently published paper. According to a press release from Pierre Fabre, which has developed the filter, studies have shown that TriAsorB is not toxic for three key species of marine biodiversity: a coral species, a phytoplankton species, and a zooplankton.
This filter and MCE are available in Europe but not in the United States.
Dr. Lim reported that he is an investigator for Incyte, L’Oréal, Pfizer, and the Patient-Centered Outcomes Research Institute.
BOSTON – Untinted chemical sunscreens on the market are not sufficient to protect the skin from the effects of visible light, complicating sun protection efforts for patients with melasma and other conditions aggravated by sun exposure, according to Henry W. Lim, MD.
A , Dr. Lim, former chair of the department of dermatology at Henry Ford Health, Detroit, said at the annual meeting of the American Academy of Dermatology. Tinted sunscreens contain iron oxides; some also contain pigmentary titanium dioxide.
“Black, red, and yellow iron oxide all reflect visible light,” he added, noting that currently, there are no regulations as to how tinted sunscreens are marketed, making it difficult for practicing clinicians to advise patients about what products to choose. However, he said, “unlike ‘SPF’ and ‘broad spectrum’ labeling, there is no specific guidance on tinted sunscreens. “ ‘Universal’ shade is a good start but might not be ideal for users with very fair or deep skin tones,” he noted.
In December 2021, a guide to tinted sunscreens, written by Dr. Lim and colleagues, was published, recommending that consumers choose a product that contains iron oxides, is labeled as broad spectrum, and has an SPF of at least 30.
A comprehensive list of 54 tinted sunscreens with an SPF of 30 or greater that contain iron oxide is also available . The authors of the guide contributed to this resource, which lists sunscreens by average price per ounce.
At the meeting, Dr. Lim highlighted tinted sunscreens that cost about $20 or less per ounce. They include Supergoop 100% Mineral CC Cream (SPF 50); Bare Republic Mineral Tinted Face Sunscreen Lotion (SPF 30); CeraVe Hydrating Sunscreen with Sheer Tint (SPF 30); Tizo Ultra Zinc Body & Face Sunscreen (SPF 40); Vichy Capital Soleil Tinted Face Mineral Sunscreen (SPF 60); EltaMD UV Elements Tinted (SPF 44); La Roche-Posay Anthelios Ultra-Light Tinted Mineral (SPF 50), SkinMedica Essential Defense Mineral Shield (SPF 32), ISDIN Eryfotona Ageless Ultralight Tinted Mineral Sunscreen (SPF 50), and SkinCeuticals Physical Fusion UV Defense (SPF 50).
Sunscreens with antioxidants
Sunscreens with biologically active antioxidants may be another option for patients with melasma. A proof-of-concept study that Dr. Lim and colleagues conducted in 20 patients found that application of a blend of topical antioxidants (2%) was associated with less erythema at the application sites among those with skin phototypes I-III and less pigmentation at the application sites among those with skin phototypes IV-VI after exposure to visible light and UVA-1, compared with controls.
Certain antioxidants have been added to sunscreens currently on the market, including niacinamide (vitamin B3), licochalcone A, carotenoids (beta-carotene), vitamin E, vitamin C, glycyrrhetinic acid, and diethylhexyl syringylidenemalonate.
A recently published paper on the role of antioxidants and free radical quenchers in protecting skin from visible light referred to unpublished data from Dr. Lim (the first author) and colleagues, which demonstrated a significant reduction in visual light–induced hyperpigmentation on skin with sunscreen that contained the antioxidants vitamin E, vitamin C, diethylhexyl syringylidenemalonate, licochalcone A, and a glycyrrhetinic acid, compared with sunscreen that had no antioxidants.
Novel filters
Another emerging option is sunscreen with new filters that cover UVA-1 and visible light. In a randomized, controlled trial of 19 patients, researchers evaluated the addition of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate (MCE) absorber, a new UVA-1 filter known as Mexoryl 400, which has a peak absorption of 385 nm, to a sunscreen formulation.
“Currently, peak absorption in the U.S. is with avobenzone, which peaks at about 357 nm,” but MCE “covers a longer spectrum of UVA-1,” Dr. Lim said. The researchers found that the addition of MCE reduced UVA-1-induced dermal and epidermal alterations at cellular, biochemical, and molecular levels; and decreased UVA-1-induced pigmentation.
Another relatively new filter, phenylene bis-diphenyltriazine (also known as TriAsorB) not only protects against UVA but it extends into the blue light portion of visible light, according to a recently published paper. According to a press release from Pierre Fabre, which has developed the filter, studies have shown that TriAsorB is not toxic for three key species of marine biodiversity: a coral species, a phytoplankton species, and a zooplankton.
This filter and MCE are available in Europe but not in the United States.
Dr. Lim reported that he is an investigator for Incyte, L’Oréal, Pfizer, and the Patient-Centered Outcomes Research Institute.
BOSTON – Untinted chemical sunscreens on the market are not sufficient to protect the skin from the effects of visible light, complicating sun protection efforts for patients with melasma and other conditions aggravated by sun exposure, according to Henry W. Lim, MD.
A , Dr. Lim, former chair of the department of dermatology at Henry Ford Health, Detroit, said at the annual meeting of the American Academy of Dermatology. Tinted sunscreens contain iron oxides; some also contain pigmentary titanium dioxide.
“Black, red, and yellow iron oxide all reflect visible light,” he added, noting that currently, there are no regulations as to how tinted sunscreens are marketed, making it difficult for practicing clinicians to advise patients about what products to choose. However, he said, “unlike ‘SPF’ and ‘broad spectrum’ labeling, there is no specific guidance on tinted sunscreens. “ ‘Universal’ shade is a good start but might not be ideal for users with very fair or deep skin tones,” he noted.
In December 2021, a guide to tinted sunscreens, written by Dr. Lim and colleagues, was published, recommending that consumers choose a product that contains iron oxides, is labeled as broad spectrum, and has an SPF of at least 30.
A comprehensive list of 54 tinted sunscreens with an SPF of 30 or greater that contain iron oxide is also available . The authors of the guide contributed to this resource, which lists sunscreens by average price per ounce.
At the meeting, Dr. Lim highlighted tinted sunscreens that cost about $20 or less per ounce. They include Supergoop 100% Mineral CC Cream (SPF 50); Bare Republic Mineral Tinted Face Sunscreen Lotion (SPF 30); CeraVe Hydrating Sunscreen with Sheer Tint (SPF 30); Tizo Ultra Zinc Body & Face Sunscreen (SPF 40); Vichy Capital Soleil Tinted Face Mineral Sunscreen (SPF 60); EltaMD UV Elements Tinted (SPF 44); La Roche-Posay Anthelios Ultra-Light Tinted Mineral (SPF 50), SkinMedica Essential Defense Mineral Shield (SPF 32), ISDIN Eryfotona Ageless Ultralight Tinted Mineral Sunscreen (SPF 50), and SkinCeuticals Physical Fusion UV Defense (SPF 50).
Sunscreens with antioxidants
Sunscreens with biologically active antioxidants may be another option for patients with melasma. A proof-of-concept study that Dr. Lim and colleagues conducted in 20 patients found that application of a blend of topical antioxidants (2%) was associated with less erythema at the application sites among those with skin phototypes I-III and less pigmentation at the application sites among those with skin phototypes IV-VI after exposure to visible light and UVA-1, compared with controls.
Certain antioxidants have been added to sunscreens currently on the market, including niacinamide (vitamin B3), licochalcone A, carotenoids (beta-carotene), vitamin E, vitamin C, glycyrrhetinic acid, and diethylhexyl syringylidenemalonate.
A recently published paper on the role of antioxidants and free radical quenchers in protecting skin from visible light referred to unpublished data from Dr. Lim (the first author) and colleagues, which demonstrated a significant reduction in visual light–induced hyperpigmentation on skin with sunscreen that contained the antioxidants vitamin E, vitamin C, diethylhexyl syringylidenemalonate, licochalcone A, and a glycyrrhetinic acid, compared with sunscreen that had no antioxidants.
Novel filters
Another emerging option is sunscreen with new filters that cover UVA-1 and visible light. In a randomized, controlled trial of 19 patients, researchers evaluated the addition of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate (MCE) absorber, a new UVA-1 filter known as Mexoryl 400, which has a peak absorption of 385 nm, to a sunscreen formulation.
“Currently, peak absorption in the U.S. is with avobenzone, which peaks at about 357 nm,” but MCE “covers a longer spectrum of UVA-1,” Dr. Lim said. The researchers found that the addition of MCE reduced UVA-1-induced dermal and epidermal alterations at cellular, biochemical, and molecular levels; and decreased UVA-1-induced pigmentation.
Another relatively new filter, phenylene bis-diphenyltriazine (also known as TriAsorB) not only protects against UVA but it extends into the blue light portion of visible light, according to a recently published paper. According to a press release from Pierre Fabre, which has developed the filter, studies have shown that TriAsorB is not toxic for three key species of marine biodiversity: a coral species, a phytoplankton species, and a zooplankton.
This filter and MCE are available in Europe but not in the United States.
Dr. Lim reported that he is an investigator for Incyte, L’Oréal, Pfizer, and the Patient-Centered Outcomes Research Institute.
AT AAD 22
For pemphigus, rituximab is first line, expert says
BOSTON – . This drug is more rapidly effective, more likely to provide sustained remission, better tolerated, and lowers health care costs, according to an expert summary at the annual meeting of the American Academy of Dermatology.
With rituximab “we are not only able to offer better efficacy, earlier and longer remissions, less side effects, less risk of relapse after a response, but it is actually cheaper,” reported Erin X. Wei, MD, director of the Bullous Diseases Clinic at Brigham and Women’s Hospital, Boston.
There are many treatments that reduce the inflammatory component of pemphigus. Corticosteroids, doxycycline, mycophenolate mofetil, azathioprine, and methotrexate are among those options commonly considered in the early control of this rare and potentially fatal autoimmune blistering disease of the skin, mouth, and other tissues.
Not all of these options have been compared directly in controlled trials, but Dr. Wei indicated that the preponderance of evidence is now on the side of rituximab as a first-line choice. For example, in the multicenter Ritux 3 trial, which compared a tapered regimen of prednisone alone to rituximab combined with a shorter and lower-dose prednisone taper in patients with pemphigus, complete response rates off therapy at 2 years were 89% in the rituximab group versus 34% in the group that received prednisone alone.
“This was quite a remarkable difference,” said Dr. Wei, who noted that remissions overall occurred faster in the rituximab group and were more durable once achieved.
No other treatment option has demonstrated this degree of relative benefit over corticosteroids, according to Dr. Wei. She said there is evidence that mycophenolate mofetil acts more rapidly, but it has not been shown to be superior for sustained complete response. Nor has azathioprine provided a clear advantage over steroids. There are no well-conducted comparisons of methotrexate and prednisone, according to Dr. Wei, assistant professor at Harvard Medical School, Boston.
Corticosteroids, doxycycline, and immunomodulators have been characterized as mainstays of early treatment in pemphigus, but Dr. Wei argued that the evidence supports starting with the most effective therapy first. There are many advantages to suppressing disease activity “as soon as possible” after diagnosis.
Early control “is associated with a more sustained remission, lower overall steroid use, and better quality of life,” said Dr. Wei, listing the hazards of starting with less effective therapy, and explaining why she has moved to rituximab as a first-line choice. According to her, there are data to support these advantages.
“Several studies have observed that rituximab, within the first 6 months of disease onset, is associated with a higher rate of complete response and a longer duration of complete response,” Dr. Wei said.
Intravenous immunoglobulin (IVIG) therapy is effective in many patients but less reliable, and it has other disadvantages relative to rituximab as a first-line therapy.
“IVIG in pemphigus works quickly when it works, but it is more expensive and it is more of an ongoing therapy relative to rituximab,” said Dr. Wei, referring to the lower likelihood of IVIG to provide sustained remissions.
The price of rituximab is high relative to prednisone or other immunomodulators, but management costs are ultimately reduced because of better disease control, according to Dr. Wei. She cited a Canadian study published several years ago in which health care costs in the 6 months prior to rituximab were compared to costs over 6 months after it was initiated.
In this cohort of 89 patients with pemphigus or pemphigoid, the average cost per patient for 6 months of care prior to starting rituximab was $42,231 in Canadian dollars. After treatment was started, the cost fell to $29,423, a 30% reduction, over the next 6 months.
“It takes rituximab up to 3 months or sometimes even longer to achieve its greatest benefit, making these results even more impressive,” Dr. Wei said.
The activity of rituximab to suppress autoreactive B-cells can be monitored with antidesmoglein autoantibody levels and by measuring CD20-positive cell percentages. Unlike severity of disease at baseline, which Dr. Wei said is not a reliable predictor of relapse risk, these can guide steroid tapering.
“If the patient is not making new autoantibodies, then tapering steroids can be considered safe,” Dr. Wei said.
One small case series cited by Dr. Wei has suggested that rituximab might be effectively employed as a maintenance therapy for pemphigus. The maintenance treatment, which initially consisted of 1 g of rituximab every 6 months, was evaluated in 11 patients with a history of severe and frequent relapses.
In this group, rituximab was first employed to achieve a complete response. The maintenance was initiated when patients were in remission. In some patients, the maintenance dose interval was extended to once every 12 months over time. During a mean follow-up of 4 years, all 11 patients remained in complete remission.
“This was a remarkable result,” said Dr. Wei, who noted that there were no serious adverse events associated with rituximab maintenance over this period. This cannot be considered a routine strategy without a large patient experience, according to Dr. Wei, but it does provide another piece of evidence that rituximab is effective and well tolerated.
There are no guidelines from a major organization that establish an evidence-based treatment algorithm for pemphigus, but Dr. Wei is not alone in considering early initiation of the most effective therapy as the best approach to sustained control.
“I agree that rituximab is a good first-line option for pemphigus patients,” said Kara Heelan, MBBCh, MD, a consultant dermatologist at the Royal Marsden and Lister Hospital, London. She was the first author of the cost-effectiveness study that Dr. Wei cited. The study was published when she was an associate in the division of dermatology at the University of Toronto.
By calling rituximab “a good” option rather than a potential standard, Dr. Heelan appeared to be more circumspect than Dr. Wei about its central role in the care of pemphigus, but she did agree in an interview that this agent “has been shown to be cost-effective.” In her study, this was an advantage attributed to relative efficacy and safety that reduced use of health care resources.
A version of this article first appeared on Medscape.com.
BOSTON – . This drug is more rapidly effective, more likely to provide sustained remission, better tolerated, and lowers health care costs, according to an expert summary at the annual meeting of the American Academy of Dermatology.
With rituximab “we are not only able to offer better efficacy, earlier and longer remissions, less side effects, less risk of relapse after a response, but it is actually cheaper,” reported Erin X. Wei, MD, director of the Bullous Diseases Clinic at Brigham and Women’s Hospital, Boston.
There are many treatments that reduce the inflammatory component of pemphigus. Corticosteroids, doxycycline, mycophenolate mofetil, azathioprine, and methotrexate are among those options commonly considered in the early control of this rare and potentially fatal autoimmune blistering disease of the skin, mouth, and other tissues.
Not all of these options have been compared directly in controlled trials, but Dr. Wei indicated that the preponderance of evidence is now on the side of rituximab as a first-line choice. For example, in the multicenter Ritux 3 trial, which compared a tapered regimen of prednisone alone to rituximab combined with a shorter and lower-dose prednisone taper in patients with pemphigus, complete response rates off therapy at 2 years were 89% in the rituximab group versus 34% in the group that received prednisone alone.
“This was quite a remarkable difference,” said Dr. Wei, who noted that remissions overall occurred faster in the rituximab group and were more durable once achieved.
No other treatment option has demonstrated this degree of relative benefit over corticosteroids, according to Dr. Wei. She said there is evidence that mycophenolate mofetil acts more rapidly, but it has not been shown to be superior for sustained complete response. Nor has azathioprine provided a clear advantage over steroids. There are no well-conducted comparisons of methotrexate and prednisone, according to Dr. Wei, assistant professor at Harvard Medical School, Boston.
Corticosteroids, doxycycline, and immunomodulators have been characterized as mainstays of early treatment in pemphigus, but Dr. Wei argued that the evidence supports starting with the most effective therapy first. There are many advantages to suppressing disease activity “as soon as possible” after diagnosis.
Early control “is associated with a more sustained remission, lower overall steroid use, and better quality of life,” said Dr. Wei, listing the hazards of starting with less effective therapy, and explaining why she has moved to rituximab as a first-line choice. According to her, there are data to support these advantages.
“Several studies have observed that rituximab, within the first 6 months of disease onset, is associated with a higher rate of complete response and a longer duration of complete response,” Dr. Wei said.
Intravenous immunoglobulin (IVIG) therapy is effective in many patients but less reliable, and it has other disadvantages relative to rituximab as a first-line therapy.
“IVIG in pemphigus works quickly when it works, but it is more expensive and it is more of an ongoing therapy relative to rituximab,” said Dr. Wei, referring to the lower likelihood of IVIG to provide sustained remissions.
The price of rituximab is high relative to prednisone or other immunomodulators, but management costs are ultimately reduced because of better disease control, according to Dr. Wei. She cited a Canadian study published several years ago in which health care costs in the 6 months prior to rituximab were compared to costs over 6 months after it was initiated.
In this cohort of 89 patients with pemphigus or pemphigoid, the average cost per patient for 6 months of care prior to starting rituximab was $42,231 in Canadian dollars. After treatment was started, the cost fell to $29,423, a 30% reduction, over the next 6 months.
“It takes rituximab up to 3 months or sometimes even longer to achieve its greatest benefit, making these results even more impressive,” Dr. Wei said.
The activity of rituximab to suppress autoreactive B-cells can be monitored with antidesmoglein autoantibody levels and by measuring CD20-positive cell percentages. Unlike severity of disease at baseline, which Dr. Wei said is not a reliable predictor of relapse risk, these can guide steroid tapering.
“If the patient is not making new autoantibodies, then tapering steroids can be considered safe,” Dr. Wei said.
One small case series cited by Dr. Wei has suggested that rituximab might be effectively employed as a maintenance therapy for pemphigus. The maintenance treatment, which initially consisted of 1 g of rituximab every 6 months, was evaluated in 11 patients with a history of severe and frequent relapses.
In this group, rituximab was first employed to achieve a complete response. The maintenance was initiated when patients were in remission. In some patients, the maintenance dose interval was extended to once every 12 months over time. During a mean follow-up of 4 years, all 11 patients remained in complete remission.
“This was a remarkable result,” said Dr. Wei, who noted that there were no serious adverse events associated with rituximab maintenance over this period. This cannot be considered a routine strategy without a large patient experience, according to Dr. Wei, but it does provide another piece of evidence that rituximab is effective and well tolerated.
There are no guidelines from a major organization that establish an evidence-based treatment algorithm for pemphigus, but Dr. Wei is not alone in considering early initiation of the most effective therapy as the best approach to sustained control.
“I agree that rituximab is a good first-line option for pemphigus patients,” said Kara Heelan, MBBCh, MD, a consultant dermatologist at the Royal Marsden and Lister Hospital, London. She was the first author of the cost-effectiveness study that Dr. Wei cited. The study was published when she was an associate in the division of dermatology at the University of Toronto.
By calling rituximab “a good” option rather than a potential standard, Dr. Heelan appeared to be more circumspect than Dr. Wei about its central role in the care of pemphigus, but she did agree in an interview that this agent “has been shown to be cost-effective.” In her study, this was an advantage attributed to relative efficacy and safety that reduced use of health care resources.
A version of this article first appeared on Medscape.com.
BOSTON – . This drug is more rapidly effective, more likely to provide sustained remission, better tolerated, and lowers health care costs, according to an expert summary at the annual meeting of the American Academy of Dermatology.
With rituximab “we are not only able to offer better efficacy, earlier and longer remissions, less side effects, less risk of relapse after a response, but it is actually cheaper,” reported Erin X. Wei, MD, director of the Bullous Diseases Clinic at Brigham and Women’s Hospital, Boston.
There are many treatments that reduce the inflammatory component of pemphigus. Corticosteroids, doxycycline, mycophenolate mofetil, azathioprine, and methotrexate are among those options commonly considered in the early control of this rare and potentially fatal autoimmune blistering disease of the skin, mouth, and other tissues.
Not all of these options have been compared directly in controlled trials, but Dr. Wei indicated that the preponderance of evidence is now on the side of rituximab as a first-line choice. For example, in the multicenter Ritux 3 trial, which compared a tapered regimen of prednisone alone to rituximab combined with a shorter and lower-dose prednisone taper in patients with pemphigus, complete response rates off therapy at 2 years were 89% in the rituximab group versus 34% in the group that received prednisone alone.
“This was quite a remarkable difference,” said Dr. Wei, who noted that remissions overall occurred faster in the rituximab group and were more durable once achieved.
No other treatment option has demonstrated this degree of relative benefit over corticosteroids, according to Dr. Wei. She said there is evidence that mycophenolate mofetil acts more rapidly, but it has not been shown to be superior for sustained complete response. Nor has azathioprine provided a clear advantage over steroids. There are no well-conducted comparisons of methotrexate and prednisone, according to Dr. Wei, assistant professor at Harvard Medical School, Boston.
Corticosteroids, doxycycline, and immunomodulators have been characterized as mainstays of early treatment in pemphigus, but Dr. Wei argued that the evidence supports starting with the most effective therapy first. There are many advantages to suppressing disease activity “as soon as possible” after diagnosis.
Early control “is associated with a more sustained remission, lower overall steroid use, and better quality of life,” said Dr. Wei, listing the hazards of starting with less effective therapy, and explaining why she has moved to rituximab as a first-line choice. According to her, there are data to support these advantages.
“Several studies have observed that rituximab, within the first 6 months of disease onset, is associated with a higher rate of complete response and a longer duration of complete response,” Dr. Wei said.
Intravenous immunoglobulin (IVIG) therapy is effective in many patients but less reliable, and it has other disadvantages relative to rituximab as a first-line therapy.
“IVIG in pemphigus works quickly when it works, but it is more expensive and it is more of an ongoing therapy relative to rituximab,” said Dr. Wei, referring to the lower likelihood of IVIG to provide sustained remissions.
The price of rituximab is high relative to prednisone or other immunomodulators, but management costs are ultimately reduced because of better disease control, according to Dr. Wei. She cited a Canadian study published several years ago in which health care costs in the 6 months prior to rituximab were compared to costs over 6 months after it was initiated.
In this cohort of 89 patients with pemphigus or pemphigoid, the average cost per patient for 6 months of care prior to starting rituximab was $42,231 in Canadian dollars. After treatment was started, the cost fell to $29,423, a 30% reduction, over the next 6 months.
“It takes rituximab up to 3 months or sometimes even longer to achieve its greatest benefit, making these results even more impressive,” Dr. Wei said.
The activity of rituximab to suppress autoreactive B-cells can be monitored with antidesmoglein autoantibody levels and by measuring CD20-positive cell percentages. Unlike severity of disease at baseline, which Dr. Wei said is not a reliable predictor of relapse risk, these can guide steroid tapering.
“If the patient is not making new autoantibodies, then tapering steroids can be considered safe,” Dr. Wei said.
One small case series cited by Dr. Wei has suggested that rituximab might be effectively employed as a maintenance therapy for pemphigus. The maintenance treatment, which initially consisted of 1 g of rituximab every 6 months, was evaluated in 11 patients with a history of severe and frequent relapses.
In this group, rituximab was first employed to achieve a complete response. The maintenance was initiated when patients were in remission. In some patients, the maintenance dose interval was extended to once every 12 months over time. During a mean follow-up of 4 years, all 11 patients remained in complete remission.
“This was a remarkable result,” said Dr. Wei, who noted that there were no serious adverse events associated with rituximab maintenance over this period. This cannot be considered a routine strategy without a large patient experience, according to Dr. Wei, but it does provide another piece of evidence that rituximab is effective and well tolerated.
There are no guidelines from a major organization that establish an evidence-based treatment algorithm for pemphigus, but Dr. Wei is not alone in considering early initiation of the most effective therapy as the best approach to sustained control.
“I agree that rituximab is a good first-line option for pemphigus patients,” said Kara Heelan, MBBCh, MD, a consultant dermatologist at the Royal Marsden and Lister Hospital, London. She was the first author of the cost-effectiveness study that Dr. Wei cited. The study was published when she was an associate in the division of dermatology at the University of Toronto.
By calling rituximab “a good” option rather than a potential standard, Dr. Heelan appeared to be more circumspect than Dr. Wei about its central role in the care of pemphigus, but she did agree in an interview that this agent “has been shown to be cost-effective.” In her study, this was an advantage attributed to relative efficacy and safety that reduced use of health care resources.
A version of this article first appeared on Medscape.com.
AT AAD 2022
Dupilumab treats itch and clears lesions in prurigo nodularis patients
BOSTON – of treatment, in a phase 3 trial presented at the American Academy of Dermatology 2022 Annual Meeting.
There are currently no Food and Drug Administration–approved systemic therapies for PN. Although several treatments for the disease are used off label for the condition, such as ultraviolet light therapy and immunosuppressive agents, moderate to severe PN is usually difficult to control, noted Gil Yosipovitch, MD, director of the Miami Itch Center at the University of Miami Miller School of Medicine, Florida. He led the research and presented the findings at the conference.
“Many dermatologists feel very uncomfortable dealing with these patients because they suffer from chronicity, they are miserable, and previously, the drugs didn’t work well,” Dr. Yosipovitch told this news organization. The results from this trial “are very promising,” he said. “It opens a new field of treatment for itchy conditions.”
The trial, named LIBERTY-PN PRIME2, enrolled patients aged 18-80 who had been living with PN for at least 3 months. Patients had at least 20 lesions at baseline as well as severe itch, defined as a score of 7 or greater on the Worst Itch Numerical Rating Scale (WI-NRS). The scale ranges from 0 (no itch) to 10 (worst itch imaginable). Participants also had a history of treatment failure with medium to super-potent topical corticosteroids (TCSs), or treatment with TCSs was not medically advisable for them.
The randomized, double-blinded study enrolled 160 adults with PN. Of those, 78 were assigned to the treatment arm and received a 600-mg loading dose of dupilumab, administered subcutaneously, followed by 300-mg doses every 2 weeks for 24 weeks; 82 patients were allocated to receive placebo.
During the study, 25 patients in the placebo arm discontinued treatment. In the treatment arm, one patient was not treated and two discontinued treatment due to lack of efficacy.
The primary endpoint of the study was a reduction of at least 4 points on the WI-NRS at 12 weeks. Secondary endpoints included at least a 4-point WI-NRS reduction at 24 weeks and clear to nearly clear skin, defined as having a score of 0 or 1 on the Investigator’s Global Assessment PN-Stage (IGN PN-S). The scale ranges from 0 (clear) to 4 (severe).
At 12 weeks, 37.2% of patients given dupilumab reported a reduction of at least 4 points in WI-NRS, compared with 22.0% of patients given placebo (P = .0216). By 24 weeks, 57.7% of adults who received dupilumab achieved a greater than or equal to 4-point reduction in WI-NRS, compared with 19.5% of those who received placebo (P < .0001). Additionally, 44.9% of participants in the treatment arm achieved a score of 0 or 1 on the IGA PN-S, compared with 15.9% of those in the placebo arm (P < .0001).
Forty-four participants who received dupilumab (57.1%) and 42 participants who received placebo (51.2%) reported at least one treatment-emergent adverse event (TEAE) during the study, though none of these events were serious. The most common TEAE in the study was headache, occurring in five patients taking placebo and four patients receiving dupilumab. In the dupilumab group, there were five cases of herpes virus infection, four non-herpes skin infections, and three cases of conjunctivitis. In the placebo group, seven non-herpes skin infections were reported.
Sanofi and Regeneron, who jointly developed dupilumab, plan to file for regulatory approval for dupilumab for PN “around the world” in the first half of this year, according to a press release.
“It’s great news and a step in the right direction,” Sarina Elmariah, MD, PhD, a dermatologist at Massachusetts General Hospital and instructor of dermatology at Harvard Medical School, both in Boston, told this news organization. She was not involved with the research.
“We’re finally starting to shed light on this condition and its pathogenesis,” she said. She noted that other potential therapeutics for PN are also in development. “It’s reflective of the fact that we are making strides in this area.”
Sanofi and Regeneron Pharmaceuticals sponsored the LIBERTY-PN PRIME2 trial. Dr. Yosipovitch has reported financial relationships with Bellus Health, Eli Lilly, Galderma, GSK, Kiniksa Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and Trevi Therapeutics. Dr. Elmariah is on the advisory boards of Sanofi, Galderma, and Trevi Therapeutics.
A version of this article first appeared on Medscape.com.
BOSTON – of treatment, in a phase 3 trial presented at the American Academy of Dermatology 2022 Annual Meeting.
There are currently no Food and Drug Administration–approved systemic therapies for PN. Although several treatments for the disease are used off label for the condition, such as ultraviolet light therapy and immunosuppressive agents, moderate to severe PN is usually difficult to control, noted Gil Yosipovitch, MD, director of the Miami Itch Center at the University of Miami Miller School of Medicine, Florida. He led the research and presented the findings at the conference.
“Many dermatologists feel very uncomfortable dealing with these patients because they suffer from chronicity, they are miserable, and previously, the drugs didn’t work well,” Dr. Yosipovitch told this news organization. The results from this trial “are very promising,” he said. “It opens a new field of treatment for itchy conditions.”
The trial, named LIBERTY-PN PRIME2, enrolled patients aged 18-80 who had been living with PN for at least 3 months. Patients had at least 20 lesions at baseline as well as severe itch, defined as a score of 7 or greater on the Worst Itch Numerical Rating Scale (WI-NRS). The scale ranges from 0 (no itch) to 10 (worst itch imaginable). Participants also had a history of treatment failure with medium to super-potent topical corticosteroids (TCSs), or treatment with TCSs was not medically advisable for them.
The randomized, double-blinded study enrolled 160 adults with PN. Of those, 78 were assigned to the treatment arm and received a 600-mg loading dose of dupilumab, administered subcutaneously, followed by 300-mg doses every 2 weeks for 24 weeks; 82 patients were allocated to receive placebo.
During the study, 25 patients in the placebo arm discontinued treatment. In the treatment arm, one patient was not treated and two discontinued treatment due to lack of efficacy.
The primary endpoint of the study was a reduction of at least 4 points on the WI-NRS at 12 weeks. Secondary endpoints included at least a 4-point WI-NRS reduction at 24 weeks and clear to nearly clear skin, defined as having a score of 0 or 1 on the Investigator’s Global Assessment PN-Stage (IGN PN-S). The scale ranges from 0 (clear) to 4 (severe).
At 12 weeks, 37.2% of patients given dupilumab reported a reduction of at least 4 points in WI-NRS, compared with 22.0% of patients given placebo (P = .0216). By 24 weeks, 57.7% of adults who received dupilumab achieved a greater than or equal to 4-point reduction in WI-NRS, compared with 19.5% of those who received placebo (P < .0001). Additionally, 44.9% of participants in the treatment arm achieved a score of 0 or 1 on the IGA PN-S, compared with 15.9% of those in the placebo arm (P < .0001).
Forty-four participants who received dupilumab (57.1%) and 42 participants who received placebo (51.2%) reported at least one treatment-emergent adverse event (TEAE) during the study, though none of these events were serious. The most common TEAE in the study was headache, occurring in five patients taking placebo and four patients receiving dupilumab. In the dupilumab group, there were five cases of herpes virus infection, four non-herpes skin infections, and three cases of conjunctivitis. In the placebo group, seven non-herpes skin infections were reported.
Sanofi and Regeneron, who jointly developed dupilumab, plan to file for regulatory approval for dupilumab for PN “around the world” in the first half of this year, according to a press release.
“It’s great news and a step in the right direction,” Sarina Elmariah, MD, PhD, a dermatologist at Massachusetts General Hospital and instructor of dermatology at Harvard Medical School, both in Boston, told this news organization. She was not involved with the research.
“We’re finally starting to shed light on this condition and its pathogenesis,” she said. She noted that other potential therapeutics for PN are also in development. “It’s reflective of the fact that we are making strides in this area.”
Sanofi and Regeneron Pharmaceuticals sponsored the LIBERTY-PN PRIME2 trial. Dr. Yosipovitch has reported financial relationships with Bellus Health, Eli Lilly, Galderma, GSK, Kiniksa Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and Trevi Therapeutics. Dr. Elmariah is on the advisory boards of Sanofi, Galderma, and Trevi Therapeutics.
A version of this article first appeared on Medscape.com.
BOSTON – of treatment, in a phase 3 trial presented at the American Academy of Dermatology 2022 Annual Meeting.
There are currently no Food and Drug Administration–approved systemic therapies for PN. Although several treatments for the disease are used off label for the condition, such as ultraviolet light therapy and immunosuppressive agents, moderate to severe PN is usually difficult to control, noted Gil Yosipovitch, MD, director of the Miami Itch Center at the University of Miami Miller School of Medicine, Florida. He led the research and presented the findings at the conference.
“Many dermatologists feel very uncomfortable dealing with these patients because they suffer from chronicity, they are miserable, and previously, the drugs didn’t work well,” Dr. Yosipovitch told this news organization. The results from this trial “are very promising,” he said. “It opens a new field of treatment for itchy conditions.”
The trial, named LIBERTY-PN PRIME2, enrolled patients aged 18-80 who had been living with PN for at least 3 months. Patients had at least 20 lesions at baseline as well as severe itch, defined as a score of 7 or greater on the Worst Itch Numerical Rating Scale (WI-NRS). The scale ranges from 0 (no itch) to 10 (worst itch imaginable). Participants also had a history of treatment failure with medium to super-potent topical corticosteroids (TCSs), or treatment with TCSs was not medically advisable for them.
The randomized, double-blinded study enrolled 160 adults with PN. Of those, 78 were assigned to the treatment arm and received a 600-mg loading dose of dupilumab, administered subcutaneously, followed by 300-mg doses every 2 weeks for 24 weeks; 82 patients were allocated to receive placebo.
During the study, 25 patients in the placebo arm discontinued treatment. In the treatment arm, one patient was not treated and two discontinued treatment due to lack of efficacy.
The primary endpoint of the study was a reduction of at least 4 points on the WI-NRS at 12 weeks. Secondary endpoints included at least a 4-point WI-NRS reduction at 24 weeks and clear to nearly clear skin, defined as having a score of 0 or 1 on the Investigator’s Global Assessment PN-Stage (IGN PN-S). The scale ranges from 0 (clear) to 4 (severe).
At 12 weeks, 37.2% of patients given dupilumab reported a reduction of at least 4 points in WI-NRS, compared with 22.0% of patients given placebo (P = .0216). By 24 weeks, 57.7% of adults who received dupilumab achieved a greater than or equal to 4-point reduction in WI-NRS, compared with 19.5% of those who received placebo (P < .0001). Additionally, 44.9% of participants in the treatment arm achieved a score of 0 or 1 on the IGA PN-S, compared with 15.9% of those in the placebo arm (P < .0001).
Forty-four participants who received dupilumab (57.1%) and 42 participants who received placebo (51.2%) reported at least one treatment-emergent adverse event (TEAE) during the study, though none of these events were serious. The most common TEAE in the study was headache, occurring in five patients taking placebo and four patients receiving dupilumab. In the dupilumab group, there were five cases of herpes virus infection, four non-herpes skin infections, and three cases of conjunctivitis. In the placebo group, seven non-herpes skin infections were reported.
Sanofi and Regeneron, who jointly developed dupilumab, plan to file for regulatory approval for dupilumab for PN “around the world” in the first half of this year, according to a press release.
“It’s great news and a step in the right direction,” Sarina Elmariah, MD, PhD, a dermatologist at Massachusetts General Hospital and instructor of dermatology at Harvard Medical School, both in Boston, told this news organization. She was not involved with the research.
“We’re finally starting to shed light on this condition and its pathogenesis,” she said. She noted that other potential therapeutics for PN are also in development. “It’s reflective of the fact that we are making strides in this area.”
Sanofi and Regeneron Pharmaceuticals sponsored the LIBERTY-PN PRIME2 trial. Dr. Yosipovitch has reported financial relationships with Bellus Health, Eli Lilly, Galderma, GSK, Kiniksa Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and Trevi Therapeutics. Dr. Elmariah is on the advisory boards of Sanofi, Galderma, and Trevi Therapeutics.
A version of this article first appeared on Medscape.com.
AT AAD 2022