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New AK treatments: Local reactions are the price for greater clearance rates
, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
This relationship is not new. In a review of treatments for AKs, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, advised that most effective agents trade a higher risk of inflammatory reactions – including erythema, flaking, and scaling – for greater therapeutic gain. In many cases, local skin reactions are an inevitable consequence of their mechanism of action.
Data from the completed phase 3 trials of tirbanibulin 1% ointment (KX01-AK-003 and KX01-AK-004), are illustrative. (Tirbanibulin 1% ointment was approved by the Food and Drug Administration in mid-December, after the Coastal Derm meeting was held.)
In the phase 3 trials, which have not yet been published, tirbanibulin, an inhibitor of Src kinase, which has an antiproliferative action, was four to five times more effective than vehicle by day 57 for overall complete clearance (P < .0001) of AKs and complete clearance of the face (P < .0001), but rates of local skin reactions were generally two to three times higher, according to Dr. Bhatia.
In the KX01-AK-004 trial, for example, 61% of patients had complete clearance of the face, versus 14% of those randomized to vehicle. The difference for overall partial clearance (76% vs. 20%; P < .0001), partial clearance of the face (80% vs. 22%; P < .0001), and partial clearance of the scalp (69% vs. 15%; P < .0001) was even greater. When compared with placebo, tirbanibulin was also associated with greater rates of erythema (90% vs. 31%), crusting (45% vs. 8%), flaking (84% vs. 35%), swelling (38% vs. 2%) and erosions or ulcers (12% vs. 1%).
Although these events might be a challenge with regard to tolerability for some patients, they might best be described as evidence that the drug is working.
“Local skin reactions are anticipated. They are not adverse events. They are not side effects,” Dr. Bhatia said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. “Patients are going to get red, and you need to counsel patients about the 5 days when they can expected to be red. It is a sign of the civil war, if you will, that your skin is taking on with the actinic keratoses.”
Both 3- and 5-day courses of the drug were tested in the clinical trials. (The approved prescribing information recommends treatment on the face or scalp once a day for 5 consecutive days).
Other studies evaluating treatments for AKs have also associated an increased risk of local skin reactions with greater efficacy, Dr. Bhatia noted. As an example, he cited a phase 4 study comparing 0.015% ingenol mebutate gel to diclofenac sodium 3% gel in people with facial and scalp AK lesions.
At the end of the 3-month study, complete clearance was higher among those on ingenol mebutate, which was applied for 3 days, when compared with diclofenac sodium gel, which was applied daily for 3 months (34% vs. 23%; P = .006). However, patients randomized to ingenol mebutate gel had to first weather a higher rate of application-site erythema (19% vs. 12%) before achieving a greater level of clearance.
The correlation between efficacy and local reactions at the site of treatment application emphasizes the importance of educating patients about this relationship and in engaging in shared decision-making, Dr. Bhatia said.
“It is basically a tradeoff between local skin reactions, between frequency [of applications], compliance, and, of course, duration of therapy, even though both drugs served their purposes well,” said Dr. Bhatia, referring to the comparison of the ingenol mebutate and diclofenac gels.
Although not absolute, efficacy and tolerability were also generally inversely related in a recent four-treatment comparison of four commonly used field-directed therapies. In that trial, the primary endpoint was at least a 75% reduction from baseline in the number of AKs to 12 months after treatment ended.
For that outcome, 5% fluorouracil (5-FU) cream (74.7%) was significantly more effective than 5% imiquimod cream (53.9%), methyl aminolevulinate photodynamic therapy (37.7%), and 0.015% ingenol mebutate gel (28.9%). Also, 5-FU treatment was associated with the moderate or severe erythema (81.5%), severe pain (16.%), and a severe burning sensation (21.5%).
Other therapies on the horizon, some of which are already available in Europe or Canada, show a relationship between efficacy and local skin reactions. Of two that Dr. Bhatia cited, 5-FU and salicylic acid combined in a solution and 5-FU and calcipotriene combined in an ointment have demonstrated high rates of efficacy but at the cost of substantial rates of erythema and flaking.
Transient skin reactions can be made acceptable to patients who are informed of the goals of clearing AKs, which includes lowering the risk of cancer, as well as cosmetic improvement. In the phase 4 study comparing ingenol mebutate gel to diclofenac sodium gel, the end-of-study global satisfaction rates were higher (P < .001) for those randomized to the most effective therapy despite the local skin reactions.
Preparing patients for the consequences of therapy for AKs is essential, because optimal therapy involves treating uninvolved skin, according to Hassan Galadari, MD, assistant professor of dermatology, United Arab Emirates University, Dubai. A coauthor of a recent review article on actinic keratoses, Dr. Galadari said in an interview that field treatment means patients might have local skin reactions where they did not previously have lesions.
“Actinic damage may not be visible with the naked eye. That is why field treatment, which is applying medicine in adjacent areas that may appear normal, is indicated,” he said. As a result, “areas that otherwise may have appeared as normal start to react by becoming red, itchy, and even inflamed.”
He agreed with Dr. Bhatia that local skin reactions are typically the price paid for effective control of these precancerous lesions.
This publication and Global Academy for Medical Education are owned by the same parent company.
Dr. Bhatia reports financial relationships with more than 30 pharmaceutical companies with dermatologic products, including Almirall and other companies with products relevant to AK therapies.
, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
This relationship is not new. In a review of treatments for AKs, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, advised that most effective agents trade a higher risk of inflammatory reactions – including erythema, flaking, and scaling – for greater therapeutic gain. In many cases, local skin reactions are an inevitable consequence of their mechanism of action.
Data from the completed phase 3 trials of tirbanibulin 1% ointment (KX01-AK-003 and KX01-AK-004), are illustrative. (Tirbanibulin 1% ointment was approved by the Food and Drug Administration in mid-December, after the Coastal Derm meeting was held.)
In the phase 3 trials, which have not yet been published, tirbanibulin, an inhibitor of Src kinase, which has an antiproliferative action, was four to five times more effective than vehicle by day 57 for overall complete clearance (P < .0001) of AKs and complete clearance of the face (P < .0001), but rates of local skin reactions were generally two to three times higher, according to Dr. Bhatia.
In the KX01-AK-004 trial, for example, 61% of patients had complete clearance of the face, versus 14% of those randomized to vehicle. The difference for overall partial clearance (76% vs. 20%; P < .0001), partial clearance of the face (80% vs. 22%; P < .0001), and partial clearance of the scalp (69% vs. 15%; P < .0001) was even greater. When compared with placebo, tirbanibulin was also associated with greater rates of erythema (90% vs. 31%), crusting (45% vs. 8%), flaking (84% vs. 35%), swelling (38% vs. 2%) and erosions or ulcers (12% vs. 1%).
Although these events might be a challenge with regard to tolerability for some patients, they might best be described as evidence that the drug is working.
“Local skin reactions are anticipated. They are not adverse events. They are not side effects,” Dr. Bhatia said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. “Patients are going to get red, and you need to counsel patients about the 5 days when they can expected to be red. It is a sign of the civil war, if you will, that your skin is taking on with the actinic keratoses.”
Both 3- and 5-day courses of the drug were tested in the clinical trials. (The approved prescribing information recommends treatment on the face or scalp once a day for 5 consecutive days).
Other studies evaluating treatments for AKs have also associated an increased risk of local skin reactions with greater efficacy, Dr. Bhatia noted. As an example, he cited a phase 4 study comparing 0.015% ingenol mebutate gel to diclofenac sodium 3% gel in people with facial and scalp AK lesions.
At the end of the 3-month study, complete clearance was higher among those on ingenol mebutate, which was applied for 3 days, when compared with diclofenac sodium gel, which was applied daily for 3 months (34% vs. 23%; P = .006). However, patients randomized to ingenol mebutate gel had to first weather a higher rate of application-site erythema (19% vs. 12%) before achieving a greater level of clearance.
The correlation between efficacy and local reactions at the site of treatment application emphasizes the importance of educating patients about this relationship and in engaging in shared decision-making, Dr. Bhatia said.
“It is basically a tradeoff between local skin reactions, between frequency [of applications], compliance, and, of course, duration of therapy, even though both drugs served their purposes well,” said Dr. Bhatia, referring to the comparison of the ingenol mebutate and diclofenac gels.
Although not absolute, efficacy and tolerability were also generally inversely related in a recent four-treatment comparison of four commonly used field-directed therapies. In that trial, the primary endpoint was at least a 75% reduction from baseline in the number of AKs to 12 months after treatment ended.
For that outcome, 5% fluorouracil (5-FU) cream (74.7%) was significantly more effective than 5% imiquimod cream (53.9%), methyl aminolevulinate photodynamic therapy (37.7%), and 0.015% ingenol mebutate gel (28.9%). Also, 5-FU treatment was associated with the moderate or severe erythema (81.5%), severe pain (16.%), and a severe burning sensation (21.5%).
Other therapies on the horizon, some of which are already available in Europe or Canada, show a relationship between efficacy and local skin reactions. Of two that Dr. Bhatia cited, 5-FU and salicylic acid combined in a solution and 5-FU and calcipotriene combined in an ointment have demonstrated high rates of efficacy but at the cost of substantial rates of erythema and flaking.
Transient skin reactions can be made acceptable to patients who are informed of the goals of clearing AKs, which includes lowering the risk of cancer, as well as cosmetic improvement. In the phase 4 study comparing ingenol mebutate gel to diclofenac sodium gel, the end-of-study global satisfaction rates were higher (P < .001) for those randomized to the most effective therapy despite the local skin reactions.
Preparing patients for the consequences of therapy for AKs is essential, because optimal therapy involves treating uninvolved skin, according to Hassan Galadari, MD, assistant professor of dermatology, United Arab Emirates University, Dubai. A coauthor of a recent review article on actinic keratoses, Dr. Galadari said in an interview that field treatment means patients might have local skin reactions where they did not previously have lesions.
“Actinic damage may not be visible with the naked eye. That is why field treatment, which is applying medicine in adjacent areas that may appear normal, is indicated,” he said. As a result, “areas that otherwise may have appeared as normal start to react by becoming red, itchy, and even inflamed.”
He agreed with Dr. Bhatia that local skin reactions are typically the price paid for effective control of these precancerous lesions.
This publication and Global Academy for Medical Education are owned by the same parent company.
Dr. Bhatia reports financial relationships with more than 30 pharmaceutical companies with dermatologic products, including Almirall and other companies with products relevant to AK therapies.
, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
This relationship is not new. In a review of treatments for AKs, Neal Bhatia, MD, a dermatologist and researcher at Therapeutics Dermatology, San Diego, advised that most effective agents trade a higher risk of inflammatory reactions – including erythema, flaking, and scaling – for greater therapeutic gain. In many cases, local skin reactions are an inevitable consequence of their mechanism of action.
Data from the completed phase 3 trials of tirbanibulin 1% ointment (KX01-AK-003 and KX01-AK-004), are illustrative. (Tirbanibulin 1% ointment was approved by the Food and Drug Administration in mid-December, after the Coastal Derm meeting was held.)
In the phase 3 trials, which have not yet been published, tirbanibulin, an inhibitor of Src kinase, which has an antiproliferative action, was four to five times more effective than vehicle by day 57 for overall complete clearance (P < .0001) of AKs and complete clearance of the face (P < .0001), but rates of local skin reactions were generally two to three times higher, according to Dr. Bhatia.
In the KX01-AK-004 trial, for example, 61% of patients had complete clearance of the face, versus 14% of those randomized to vehicle. The difference for overall partial clearance (76% vs. 20%; P < .0001), partial clearance of the face (80% vs. 22%; P < .0001), and partial clearance of the scalp (69% vs. 15%; P < .0001) was even greater. When compared with placebo, tirbanibulin was also associated with greater rates of erythema (90% vs. 31%), crusting (45% vs. 8%), flaking (84% vs. 35%), swelling (38% vs. 2%) and erosions or ulcers (12% vs. 1%).
Although these events might be a challenge with regard to tolerability for some patients, they might best be described as evidence that the drug is working.
“Local skin reactions are anticipated. They are not adverse events. They are not side effects,” Dr. Bhatia said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. “Patients are going to get red, and you need to counsel patients about the 5 days when they can expected to be red. It is a sign of the civil war, if you will, that your skin is taking on with the actinic keratoses.”
Both 3- and 5-day courses of the drug were tested in the clinical trials. (The approved prescribing information recommends treatment on the face or scalp once a day for 5 consecutive days).
Other studies evaluating treatments for AKs have also associated an increased risk of local skin reactions with greater efficacy, Dr. Bhatia noted. As an example, he cited a phase 4 study comparing 0.015% ingenol mebutate gel to diclofenac sodium 3% gel in people with facial and scalp AK lesions.
At the end of the 3-month study, complete clearance was higher among those on ingenol mebutate, which was applied for 3 days, when compared with diclofenac sodium gel, which was applied daily for 3 months (34% vs. 23%; P = .006). However, patients randomized to ingenol mebutate gel had to first weather a higher rate of application-site erythema (19% vs. 12%) before achieving a greater level of clearance.
The correlation between efficacy and local reactions at the site of treatment application emphasizes the importance of educating patients about this relationship and in engaging in shared decision-making, Dr. Bhatia said.
“It is basically a tradeoff between local skin reactions, between frequency [of applications], compliance, and, of course, duration of therapy, even though both drugs served their purposes well,” said Dr. Bhatia, referring to the comparison of the ingenol mebutate and diclofenac gels.
Although not absolute, efficacy and tolerability were also generally inversely related in a recent four-treatment comparison of four commonly used field-directed therapies. In that trial, the primary endpoint was at least a 75% reduction from baseline in the number of AKs to 12 months after treatment ended.
For that outcome, 5% fluorouracil (5-FU) cream (74.7%) was significantly more effective than 5% imiquimod cream (53.9%), methyl aminolevulinate photodynamic therapy (37.7%), and 0.015% ingenol mebutate gel (28.9%). Also, 5-FU treatment was associated with the moderate or severe erythema (81.5%), severe pain (16.%), and a severe burning sensation (21.5%).
Other therapies on the horizon, some of which are already available in Europe or Canada, show a relationship between efficacy and local skin reactions. Of two that Dr. Bhatia cited, 5-FU and salicylic acid combined in a solution and 5-FU and calcipotriene combined in an ointment have demonstrated high rates of efficacy but at the cost of substantial rates of erythema and flaking.
Transient skin reactions can be made acceptable to patients who are informed of the goals of clearing AKs, which includes lowering the risk of cancer, as well as cosmetic improvement. In the phase 4 study comparing ingenol mebutate gel to diclofenac sodium gel, the end-of-study global satisfaction rates were higher (P < .001) for those randomized to the most effective therapy despite the local skin reactions.
Preparing patients for the consequences of therapy for AKs is essential, because optimal therapy involves treating uninvolved skin, according to Hassan Galadari, MD, assistant professor of dermatology, United Arab Emirates University, Dubai. A coauthor of a recent review article on actinic keratoses, Dr. Galadari said in an interview that field treatment means patients might have local skin reactions where they did not previously have lesions.
“Actinic damage may not be visible with the naked eye. That is why field treatment, which is applying medicine in adjacent areas that may appear normal, is indicated,” he said. As a result, “areas that otherwise may have appeared as normal start to react by becoming red, itchy, and even inflamed.”
He agreed with Dr. Bhatia that local skin reactions are typically the price paid for effective control of these precancerous lesions.
This publication and Global Academy for Medical Education are owned by the same parent company.
Dr. Bhatia reports financial relationships with more than 30 pharmaceutical companies with dermatologic products, including Almirall and other companies with products relevant to AK therapies.
FROM COASTAL DERM
HPV vaccine appears effective for treating warts, particularly in children
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
The human papillomavirus (HPV) vaccine, recommended by the Centers for Disease Control and Prevention for the prevention of HPV-associated genital warts and neoplasia, appears to be an effective and perhaps underappreciated treatment of existing cutaneous warts, according to expert speaking at the annual Coastal Dermatology symposium, held virtually.
Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston.
“Clearly, if you have someone, particularly a youngster, and you’re having trouble getting rid of their warts and they are age 9 years or above – and they need the vaccine anyhow – that’s a win-win proposition,” Dr. Rosen said.
The current nonavalent HPV vaccine is approved for individuals from age 9 to age 45. Although the CDC recommends routine vaccination at age 11 or 12 years, it allows earlier vaccination within the label.
The recently published and updated evidence of a benefit from treatment comes from a systematic literature review. For the review, 63 articles were drawn from the PubMed and Cochrane databases. The studies yielded 4,439 patients with cutaneous warts at the time they received the HPV vaccine or who specifically received vaccine as a treatment strategy.
As has been suggested previously in the case series and in a limited number of prospective studies, the majority of warts, including cutaneous warts and anogenital warts, resolved following vaccine administration.
“Mostly these were common warts, plantar warts, and flat warts,” Dr. Rosen said, but the paper also reported successful treatment of recurrent respiratory papillomatosis, squamous cell carcinomas, and basal cell carcinomas.
Case reports and small studies associating HPV vaccine with successful resolution of warts are easy to find in the literature. For example, 60% of patients achieved a complete response and 30% a partial response to HPV vaccine in one small prospective study of 26 patients with genital warts. Following vaccination, no recurrences were observed after a median follow-up of more than 8 months.
In the review paper, most of the cases involved patients who received the quadrivalent HPV vaccine, Dr. Rosen noted. Only one received the updated nonavalent vaccine, which, in addition to protection against the 6, 11, 16, and 18 subtypes extends protection to subtypes 31, 33, 45, 52, and 58.
“You would expect the nonavalent vaccine to provide the same protection. It is the same vaccine. It just offers activity against more subtypes,” Dr. Rosen said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He reported that he personally has used the nonavalent vaccine successfully to treat a cutaneous wart.
The nonavalent vaccine can be administered in just two doses for those who receive the first dose before age 15. In others, it is given in three doses at 1- to 2-month intervals, according to Dr. Rosen. He said the efficacy for preventing genital warts and most HPV-related neoplasia exceeds 90%, although it is lower for penile and anal cancer. The protection extends for at least 10 years, but he said that he believes that it is likely to be longer.
“The HPV vaccine is really, really safe,” Dr. Rosen said. Besides injection-site reactions, the most common adverse event is syncope. For this reason, patients are advised to stay seated for 30 minutes after administration.
There is some evidence for cross-immunity for HPV subtypes not covered by the vaccine, particularly among children, Dr. Rosen commented. Citing the review article, he said that, although almost all HPV-associated warts resolve in children when treated with the vaccine, response is somewhat lower in adolescents and further reduced in adults.
In an interview, the senior author of the recent literature review, Natasha A. Mesinkovska, MD, PhD, associate professor of dermatology, University of California, Irvine, agreed with Dr. Rosen about the value of HPV vaccine for patients not responding to conventional therapies for HPV-related cutaneous warts.
“I think HPV vaccine is an excellent option for those patients, even older ones at 45 years of age if cost is not an issue,” she said. She did offer a caveat. In a recent statement from the International Papillomavirus Society (IPVS) on a world shortage of HPV vaccine, it was estimated that supplies might be limited for the next 3-5 years.
Given this shortage, “obtaining them currently may prove to be difficult,” she cautioned.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Expert picks top pediatric dermatology studies of 2020
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Strategies for tracking SARS-CoV-2 could help detect next pandemic
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Moving from subtypes to phenotypes is simplifying management of rosacea
When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.
With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.
“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.
The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.
By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.
Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.
The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.
Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.
Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.
Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.
He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.
“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.
This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.
“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.
“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”
The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.
With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.
“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.
The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.
By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.
Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.
The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.
Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.
Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.
Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.
He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.
“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.
This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.
“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.
“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”
The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
When a new phenotype approach to the diagnosis of rosacea was proposed 2 years ago, this simpler and more accurate method was accompanied by several corollary advantages, including a more rational approach to treatment and better methods of measuring treatment efficacy, according to an expert speaking at the annual Coastal Dermatology Symposium, held virtually.
“By looking at rosacea in a more simple way – but a more accurate way – we are able to track what happens [to key features] over time,” explained Jerry Tan, MD, of the University of Western Ontario, London.
With the previous method of subtyping, many rosacea patients failed to fit neatly into any of the four categories, producing confusion and diverting attention from troublesome symptoms.
“Rosacea patients often present with a range of features that span multiple subtypes or progress between them,” Dr. Tan explained. The risk is not just a delay in diagnosis but a failure to focus on symptoms patients find most bothersome.
The previous diagnostic criteria for rosacea, published in 2002, identified primary and secondary symptoms within its four subtypes. The new diagnostic criteria, endorsed by the National Rosacea Society and published in 2018, rely on phenotypes defined by diagnostic, major, and minor symptoms. Rather than the four previous subtypes, which were erythematotelangiectatic, papulopustular, phymatous, and ocular, the phenotypes facilitate diagnosis in patients with mixed features.
By replacing “the old thought process of subtyping” with a newer focus on phenotypes, the updated criteria were “aimed toward accuracy, simplicity and practicality,” Dr. Tan said.
Moreover, without squeezing patients into subgroups where they do not neatly fit, the new criteria draw attention to the specific symptoms that bring patients to the clinician.
The phenotype approach to treatment strategies was reflected in a systematic review of treatments based on phenotypes that was published in 2019, not long after the new classification system became available. In this review, coauthored by Dr. Tan, the GRADE certainty-of-evidence approach was employed to identify effective therapies, matching specific symptoms with specific therapies such as low-dose isotretinoin for papules or omega-3 fatty acids for dry eyes.
Based on a patient-centric approach that emphasizes control of key symptoms, Dr. Tan also described a method of documenting the severity of major and minor symptoms at each visit. With this method, called a rosacea patient tracker, patients and physicians can determine whether therapies are effective against the signs and symptoms of disease that they find most burdensome, according to Dr. Tan, who was the first author of an article he cited as a reference to this phenotype-based methodology.
Overall, the phenotype approach to rosacea “rationalizes treatment,” he said.
Specifically, the heterogeneity of symptoms in rosacea is mirrored in the heterogeneity of underlying pathophysiology. According to Dr. Tan, the upregulation of cytokines for inflammation, of angiogenic pathways for vascular symptoms, and of matrix metalloproteinases for tissue remodeling are all implicated in rosacea but drive different types of symptoms. While appropriate skin care and efforts to identify and minimize symptom triggers is appropriate for all patients, phenotypes provide a guide to the most appropriate therapies.
He said he hopes that the focus on phenotypes will draw attention to differences in these pathophysiological mechanisms. According to Dr. Tan, evaluating rosacea from the perspective of phenotypes has represented an important paradigm shift that extends beyond diagnosis.
“The move to the phenotype approach is hopefully simpler, more accurate, and more relevant,” Dr. Tan said.
This same approach has been advocated by others, including Esther J. van Zurren, MD, professor of dermatology at Leiden University Medical Centre in the Netherlands, the lead author of the 2018 systematic review article discussed by Dr. Tan. In this review article on the phenotype approach, specific strategies were recommended for specific symptoms on the basis of grading by an international group of experts that included Dr. Tan, a coauthor.
“These strategies should be directed toward achieving improvements in general well-being by targeting those aspects most bothersome to the patient,” the article advises. Like Dr. Tan, she considers this phenotype-based approach to diagnosis and treatment to be a meaningful clinical advance over the guidelines published in 2002.
“Management strategies for people with rosacea should include phenotype-based treatments,” she agreed, adding that specific choices should be made on the basis of these phenotypes “instead of the previous subtype classification.”
The meeting was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
Survey finds Black, Hispanic patients may prefer race-concordant dermatologists, highlighting opportunities for changes in education and practice
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
, according to a patient survey.
In the survey, 42% of self-identified Black patients and 44% of self-identified Hispanic patients assigned some level of importance to the race or ethnicity of their dermatologist. Of patients self-identified as White, the figure was 2%, which was significantly lower (P less than .001).
Responses to the survey indicated that there is concern among non-White patients that White physicians are not fully sensitive to the clinical issues presented by their skin type. For example, 22% of Hispanic patients and 21% of Black patients agreed that a race-concordant physician would be better trained to treat their skin.
The results of the survey were recently published in a Research Letter in the Journal of the American Academy of Dermatology.
When patients were asked to agree or disagree with the statement that non-White patients receive the same quality of care as White patients, about a third disagreed, “but about half said they were unsure, which I interpret basically as a negative answer,” reported the lead author, Adam Friedman, MD, professor and interim chair of the department of dermatology at George Washington University, Washington.
“These data are a call to action. Certainly, we need to diversify our workforce to mirror the overall population, but we can also do more to improve training for dermatologic diseases across skin types,” Dr. Friedman said in an interview.
“Ensuring all skin types are represented in all dermatologic education, from resident book clubs to the national stage is but one step to making dermatology more inclusive and prepared to care for all patients,” he added.
Ninety-two patients receiving dermatology care at Dr. Friedman’s institution completed the survey. Fifty identified themselves as White, nine as Hispanic, and 33 as Black. Allowing patients to self-identify race was an important feature of this survey, according to Dr. Friedman.
“Something I really struggle with is terminology. Are race and ethnicity the appropriate terms when discussing different skin types and tones? It is so easy to misuse even validated tools. The Fitzpatrick Scale, for example, requires patients to relay how easily they burn, but reveals nothing about how patients refer to their skin tone,” Dr. Friedman explained. “We need to reset how we characterize and categorize skin types.”
Among those who assigned at least some importance to having a dermatologist of the same race or ethnicity, the most common reason was that such physicians “are better able to listen and relate to me.” Thirty percent of Black patients and 22% of Hispanic patients agreed with this statement. The perception that such physicians are better trained to treat non-White skin was the next most common reason.
The results of the survey emphasize the importance of ensuring that there is comprehensive training in managing all skin types and that physicians receive rigorous implicit bias and cultural sensitivity training in order to win patient trust, according to Dr. Friedman. He suggested that the perception that White physicians might not provide optimal care to non-White patients by study participants “has some validity. Structural racism in medicine is well-documented, and dermatologists have already begun to combat this on several fronts.”
In fact, the process of conducting and analyzing data from this survey proved to be its own lesson in sociocultural sensitivity, he said.
After a draft completed peer review and was accepted for publication, Dr. Friedman was confronted with numerous criticisms of the language that was used. In particular, one of his former residents, Misty Eleryan, MD, who is now a Mohs Fellow at the University of California, Los Angeles, was instrumental in pointing out problems. Ultimately, he withdrew the paper to rephrase the findings.
“It was not until then that I also learned that there is a JAAD Sensitivity Workgroup, which was very helpful in identifying issues we had overlooked,” Dr. Friedman said. For example, he had used the term “minorities” for non-White populations, which is not only inaccurate in many situations but has a pejorative undertone.
“It is important to recognize that the impact is more important than the intention,” said Dr. Friedman, who reported that he learned a lot in this process.
It is the need for this type of augmented sensitivity that the survey underscores, he added. He called for cultural sensitivity to be part of medical training to undo unrecognized bias, and said, “We need to understand how our patients perceive us.”
SOURCE: Friedman A et al. J Am Acad Dermatol. 2020 Sep 16;S0190-9622(20)32620-7. doi: 10.1016/j.jaad.2020.09.032.
Stenotic lesion outcomes better if fractional flow reserve guides PCI
Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.
For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.
“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”
The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.
“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.
In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.
The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.
Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.
In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.
In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.
It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.
“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.
Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.
“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.
“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.
Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.
For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.
“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”
The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.
“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.
In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.
The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.
Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.
In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.
In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.
It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.
“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.
Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.
“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.
“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.
Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.
For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.
“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”
The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.
“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.
In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.
The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.
Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.
In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.
In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.
It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.
“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.
Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.
“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.
“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.
FROM AHA 2020
‘Soak-and-smear’ AD protocol backed by evidence
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
For acne in darker skin, judicious use of peeling agents can speed resolution
according to an expert, who cited both published data and empirical experience at the virtual Skin of Color Update 2020.
Because of the risk of exacerbating hyperpigmentation, superficial peels must be used judiciously, but “peels do add some benefit in terms of resolving the hyperpigmentation more rapidly,” Andrew Alexis, MD, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said at the meeting.
Addressing hyperpigmentation in skin of color is a critical goal. For many patients, the postinflammatory hyperpigmentation (PIH) that accompanies acne in Fitzpatrick skin types IV or higher imposes a greater burden than the acne itself.
“PIH is one of the driving forces among patients with darker skin coming to a dermatologist,” said Dr. Alexis, who is also professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York. “Patients often describe these hyperpigmented macules as scars, and they are concerned that they are not reversible.”
In darker skin, the combination of treatments used for acne should address the pathogenic factors that contribute to acne and PIH at the same time, according to Dr. Alexis. He advised describing the goals and the timeline of acne and PIH resolution at the very first visit.
Of these two goals, resolution of PIH is often the more challenging. First-line topical retinoids have anti-inflammatory effects, but Dr. Alexis suggested that additional agents, such as topical antibiotics, topical dapsone, and benzoyl peroxide, are commonly needed to fully control inflammation.
“Topical retinoids serve as the foundation of acne treatment, especially in skin of color due to their dual action on acne and PIH,” he said. However, he added that this needs support with a “well-rounded combination therapy to address as many pathogenic factors as possible.”
One of these factors is subclinical inflammation. Citing studies first initiated at Howard University, Washington, Dr. Alexis said there are now compelling data showing T lymphocyte infiltration and increased expression of proinflammatory cytokines even in clinically uninvolved skin in acne patients with darker skin.
In patients with significant PIH, he considers oral antibiotics for their systemic anti-inflammatory effects, singling out sarecycline as a narrow-spectrum agent with a potent effect on Cutibacterium acnes. This tetracycline, a relatively recent addition to acne treatment options, has specifically been shown to be “superior to placebo across a diverse patient population” that includes those with darker skin tones.
“Another addition that can be leveraged for anti-inflammatory effects is topical minocycline foam. This has also been studied in diverse patient populations and shown to be superior to vehicle,” Dr. Alexis said.
For acne, the response to most of these therapies is relatively rapid, but control of PIH takes longer. After resolution of acne, he considers superficial chemical peels to speed the healing of PIH.
In a small randomized trial he cited, superficial glycolic acid peel added to a modified Kligman formula (hydroquinone 2%, tretinoin 0.05%, and hydrocortisone 1%) provided significantly lower scores in the mean Hyperpigmentation Area and Severity Index at 12 weeks (P = .004) and 21 weeks (P < .001 relative to the Kligman formula alone). Dr. Alexis said he has had the same clinical experience with chemical peels
For many acne patients with darker skin, good results are achieved after four weeks on a multidrug combination with a topical retinoid backbone. One week after stopping the combination, the superficial chemical peel can be started at a very low dose on an every-other-night schedule. If tolerated, the dose can be slowly increased.
Slow up-titration of all topical agents in skin of color, not just superficial chemical peels, is prudent, according to Dr. Alexis. For patients new to retinoids, he also recommended every-other-night dosing to avoid the irritation that might exacerbate PIH. He said the risks of adverse reactions come early. “We need to hold the hands of our patients through the first 2 weeks. Warn of dryness and pealing. Recommend moisturizers and keep the doses low.”
The benefits and risks of acne treatment are different in dark relative to light skin, Dr. Alexis emphasized. He added that a measured approach that includes specific strategies for PIH delivers results.
Providing treatment with a strategy that addresses both acne and PIH, he said, “we can have excellent outcomes time and time again for acne in patients with darker skin types.”
There is an evidence basis for making effective treatment of PIH a specific goal in the treatment of acne. In a study that evaluated the psychosocial impact of PIH in 50 patients with acne, 54% responded that PIH was a source of embarrassment. The study was one of the first to evaluate the impact of PIH as a separate source of impaired quality of life in acne patients.
“To improve the patient’s quality of life, the dermatologist should treat acne and postinflammatory hyperpigmentation at the same time,” said Katlein Franca, MD, PhD, assistant professor of dermatology, University of Miami.
In particular, Dr. Franca, who led the PIH study, suggested that PIH, like acne, is a source of low self-esteem. In regard to PIH, “most patients feel embarrassed about the spots,” she said in an interview.
“Strategies to hide the hyperpigmented spots include the use of makeup and even different hairstyles to cover the affected areas,” she added, indicating that treatments provided to clear PIH as well as acne can remove a source of stress and threat to a sense of well-being.
Dr. Alexis reports financial relationships with many pharmaceutical companies, including those that make acne drugs.
according to an expert, who cited both published data and empirical experience at the virtual Skin of Color Update 2020.
Because of the risk of exacerbating hyperpigmentation, superficial peels must be used judiciously, but “peels do add some benefit in terms of resolving the hyperpigmentation more rapidly,” Andrew Alexis, MD, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said at the meeting.
Addressing hyperpigmentation in skin of color is a critical goal. For many patients, the postinflammatory hyperpigmentation (PIH) that accompanies acne in Fitzpatrick skin types IV or higher imposes a greater burden than the acne itself.
“PIH is one of the driving forces among patients with darker skin coming to a dermatologist,” said Dr. Alexis, who is also professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York. “Patients often describe these hyperpigmented macules as scars, and they are concerned that they are not reversible.”
In darker skin, the combination of treatments used for acne should address the pathogenic factors that contribute to acne and PIH at the same time, according to Dr. Alexis. He advised describing the goals and the timeline of acne and PIH resolution at the very first visit.
Of these two goals, resolution of PIH is often the more challenging. First-line topical retinoids have anti-inflammatory effects, but Dr. Alexis suggested that additional agents, such as topical antibiotics, topical dapsone, and benzoyl peroxide, are commonly needed to fully control inflammation.
“Topical retinoids serve as the foundation of acne treatment, especially in skin of color due to their dual action on acne and PIH,” he said. However, he added that this needs support with a “well-rounded combination therapy to address as many pathogenic factors as possible.”
One of these factors is subclinical inflammation. Citing studies first initiated at Howard University, Washington, Dr. Alexis said there are now compelling data showing T lymphocyte infiltration and increased expression of proinflammatory cytokines even in clinically uninvolved skin in acne patients with darker skin.
In patients with significant PIH, he considers oral antibiotics for their systemic anti-inflammatory effects, singling out sarecycline as a narrow-spectrum agent with a potent effect on Cutibacterium acnes. This tetracycline, a relatively recent addition to acne treatment options, has specifically been shown to be “superior to placebo across a diverse patient population” that includes those with darker skin tones.
“Another addition that can be leveraged for anti-inflammatory effects is topical minocycline foam. This has also been studied in diverse patient populations and shown to be superior to vehicle,” Dr. Alexis said.
For acne, the response to most of these therapies is relatively rapid, but control of PIH takes longer. After resolution of acne, he considers superficial chemical peels to speed the healing of PIH.
In a small randomized trial he cited, superficial glycolic acid peel added to a modified Kligman formula (hydroquinone 2%, tretinoin 0.05%, and hydrocortisone 1%) provided significantly lower scores in the mean Hyperpigmentation Area and Severity Index at 12 weeks (P = .004) and 21 weeks (P < .001 relative to the Kligman formula alone). Dr. Alexis said he has had the same clinical experience with chemical peels
For many acne patients with darker skin, good results are achieved after four weeks on a multidrug combination with a topical retinoid backbone. One week after stopping the combination, the superficial chemical peel can be started at a very low dose on an every-other-night schedule. If tolerated, the dose can be slowly increased.
Slow up-titration of all topical agents in skin of color, not just superficial chemical peels, is prudent, according to Dr. Alexis. For patients new to retinoids, he also recommended every-other-night dosing to avoid the irritation that might exacerbate PIH. He said the risks of adverse reactions come early. “We need to hold the hands of our patients through the first 2 weeks. Warn of dryness and pealing. Recommend moisturizers and keep the doses low.”
The benefits and risks of acne treatment are different in dark relative to light skin, Dr. Alexis emphasized. He added that a measured approach that includes specific strategies for PIH delivers results.
Providing treatment with a strategy that addresses both acne and PIH, he said, “we can have excellent outcomes time and time again for acne in patients with darker skin types.”
There is an evidence basis for making effective treatment of PIH a specific goal in the treatment of acne. In a study that evaluated the psychosocial impact of PIH in 50 patients with acne, 54% responded that PIH was a source of embarrassment. The study was one of the first to evaluate the impact of PIH as a separate source of impaired quality of life in acne patients.
“To improve the patient’s quality of life, the dermatologist should treat acne and postinflammatory hyperpigmentation at the same time,” said Katlein Franca, MD, PhD, assistant professor of dermatology, University of Miami.
In particular, Dr. Franca, who led the PIH study, suggested that PIH, like acne, is a source of low self-esteem. In regard to PIH, “most patients feel embarrassed about the spots,” she said in an interview.
“Strategies to hide the hyperpigmented spots include the use of makeup and even different hairstyles to cover the affected areas,” she added, indicating that treatments provided to clear PIH as well as acne can remove a source of stress and threat to a sense of well-being.
Dr. Alexis reports financial relationships with many pharmaceutical companies, including those that make acne drugs.
according to an expert, who cited both published data and empirical experience at the virtual Skin of Color Update 2020.
Because of the risk of exacerbating hyperpigmentation, superficial peels must be used judiciously, but “peels do add some benefit in terms of resolving the hyperpigmentation more rapidly,” Andrew Alexis, MD, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said at the meeting.
Addressing hyperpigmentation in skin of color is a critical goal. For many patients, the postinflammatory hyperpigmentation (PIH) that accompanies acne in Fitzpatrick skin types IV or higher imposes a greater burden than the acne itself.
“PIH is one of the driving forces among patients with darker skin coming to a dermatologist,” said Dr. Alexis, who is also professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York. “Patients often describe these hyperpigmented macules as scars, and they are concerned that they are not reversible.”
In darker skin, the combination of treatments used for acne should address the pathogenic factors that contribute to acne and PIH at the same time, according to Dr. Alexis. He advised describing the goals and the timeline of acne and PIH resolution at the very first visit.
Of these two goals, resolution of PIH is often the more challenging. First-line topical retinoids have anti-inflammatory effects, but Dr. Alexis suggested that additional agents, such as topical antibiotics, topical dapsone, and benzoyl peroxide, are commonly needed to fully control inflammation.
“Topical retinoids serve as the foundation of acne treatment, especially in skin of color due to their dual action on acne and PIH,” he said. However, he added that this needs support with a “well-rounded combination therapy to address as many pathogenic factors as possible.”
One of these factors is subclinical inflammation. Citing studies first initiated at Howard University, Washington, Dr. Alexis said there are now compelling data showing T lymphocyte infiltration and increased expression of proinflammatory cytokines even in clinically uninvolved skin in acne patients with darker skin.
In patients with significant PIH, he considers oral antibiotics for their systemic anti-inflammatory effects, singling out sarecycline as a narrow-spectrum agent with a potent effect on Cutibacterium acnes. This tetracycline, a relatively recent addition to acne treatment options, has specifically been shown to be “superior to placebo across a diverse patient population” that includes those with darker skin tones.
“Another addition that can be leveraged for anti-inflammatory effects is topical minocycline foam. This has also been studied in diverse patient populations and shown to be superior to vehicle,” Dr. Alexis said.
For acne, the response to most of these therapies is relatively rapid, but control of PIH takes longer. After resolution of acne, he considers superficial chemical peels to speed the healing of PIH.
In a small randomized trial he cited, superficial glycolic acid peel added to a modified Kligman formula (hydroquinone 2%, tretinoin 0.05%, and hydrocortisone 1%) provided significantly lower scores in the mean Hyperpigmentation Area and Severity Index at 12 weeks (P = .004) and 21 weeks (P < .001 relative to the Kligman formula alone). Dr. Alexis said he has had the same clinical experience with chemical peels
For many acne patients with darker skin, good results are achieved after four weeks on a multidrug combination with a topical retinoid backbone. One week after stopping the combination, the superficial chemical peel can be started at a very low dose on an every-other-night schedule. If tolerated, the dose can be slowly increased.
Slow up-titration of all topical agents in skin of color, not just superficial chemical peels, is prudent, according to Dr. Alexis. For patients new to retinoids, he also recommended every-other-night dosing to avoid the irritation that might exacerbate PIH. He said the risks of adverse reactions come early. “We need to hold the hands of our patients through the first 2 weeks. Warn of dryness and pealing. Recommend moisturizers and keep the doses low.”
The benefits and risks of acne treatment are different in dark relative to light skin, Dr. Alexis emphasized. He added that a measured approach that includes specific strategies for PIH delivers results.
Providing treatment with a strategy that addresses both acne and PIH, he said, “we can have excellent outcomes time and time again for acne in patients with darker skin types.”
There is an evidence basis for making effective treatment of PIH a specific goal in the treatment of acne. In a study that evaluated the psychosocial impact of PIH in 50 patients with acne, 54% responded that PIH was a source of embarrassment. The study was one of the first to evaluate the impact of PIH as a separate source of impaired quality of life in acne patients.
“To improve the patient’s quality of life, the dermatologist should treat acne and postinflammatory hyperpigmentation at the same time,” said Katlein Franca, MD, PhD, assistant professor of dermatology, University of Miami.
In particular, Dr. Franca, who led the PIH study, suggested that PIH, like acne, is a source of low self-esteem. In regard to PIH, “most patients feel embarrassed about the spots,” she said in an interview.
“Strategies to hide the hyperpigmented spots include the use of makeup and even different hairstyles to cover the affected areas,” she added, indicating that treatments provided to clear PIH as well as acne can remove a source of stress and threat to a sense of well-being.
Dr. Alexis reports financial relationships with many pharmaceutical companies, including those that make acne drugs.
FROM SOC 2020
When recommending photoprotection in dark skin, consider cosmesis
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
FROM SOC 2020