Jeff Craven

Patients with allergic rhinitis receiving oral tree sublingual immunotherapy (SLIT) during pollen season showed improvement in their symptoms, according to recent research released as an abstract for the annual meeting of the American Academy of Allergy, Asthma & Immunology.

Photo courtesy Oak Ridge National Laboratory

Tree pollen season is generally considered to be between February and June, with alder and hazel allergens affecting patients early and oak pollen affecting patients later in the season. Since a major birch allergen, Betula verrucosa 1 (Bet v 1), cross-reacts with alder, hazel, and oak allergens, some patients may experience allergies across the entire tree pollen season from members of this so-called birth homologous group, Hendrik Nolte, MD, senior vice president of research and development at ALK-Abello Americas and International, said in an interview.

According to the U.S. National Health and Nutrition Examination Survey 2005-2006, 16% of 8,086 participants 6 years or older with allergy had a specific immunoglobulin E (IgE) to birch, while 18% had a specific IgE to oak. Patients who reported having hay fever had a specific IgE to birch of 23% and a specific IgE to oak of 26% (J Allergy Clin Immunol. 2011 May;127[5]:1226-1235.e7).

“Patients who are allergic to birch pollen often experience symptoms in response to pollen from other members of the birch homologous group, which prolong the tree season and increase the symptom burden for these patients,” Dr. Nolte said. “Thus, treatment with SLIT-tablet immunotherapy may be an important treatment option for many allergy sufferers.”

Dr. Nolte and colleagues performed a randomized, double-blind, multinational trial of 634 patients before and during tree pollen season in which participants received a daily SLIT tablet or placebo. Patients were between ages 12 and 65 years with allergic rhinitis, and investigators enrolled patients or without conjunctivitis and with or without asthma. The investigations evaluated the patients’ daily symptom score and daily medication score, which was grouped into the total combined score. The patients were also allowed to use their rescue medications during the trial.
 

SLIT demonstrates symptom improvement

“Improvement in allergic rhinoconjunctivitis symptoms and reduction in symptom-relieving medication use with the tree SLIT-tablet during birch, alder/hazel, and oak pollen seasons were significant versus placebo and showed internal consistency across almost 4 months of birch and related tree pollen exposure,” Dr. Nolte said.

Patients showed relative improvements in their total combined score of 39.6% for birch, 29.7% for alder and hazel, 36.0% during oak pollen season, and 35.0% during the entire tree pollen season, compared with placebo (all P ≤ .002). Relative daily symptom scores also improved in the group that received oral SLIT, with 36.8% of patients showing improvement during birch season, 26.0% during alder and hazel season, 31.6% during oak season, and 31.6% across all pollen seasons, compared with those taking placebo (all P ≤ .003). A greater number of patients also achieved a relative improvement in daily medication score during birch season (49.2%), alder and hazel season (43.8%), oak season (45.9%) and during the whole of tree pollen season (45.3%), compared with placebo (P ≤ .002).

“The results support the clinical relevance of cross-reactivity between birch, alder/hazel, and oak pollen homologous allergens,” Dr. Nolte said. “Immunologic cross-reactivity is supported by alder, hazel, and oak specific IgE data and IgG4 in responses to the tree SLIT tablet.”

Dr. Nolte said the next step in his team’s research was to evaluate oral SLIT in a phase 3 trial for children aged 5-17 years.

This study was funded by ALK, and the authors received medical writing and editorial assistance from Scott Medical Communications. Dr. Nolte reported that he is a paid employee of ALK.

SOURCE: Nolte H et al. AAAAI, Abstract 267.

.

Patients with allergic rhinitis receiving oral tree sublingual immunotherapy (SLIT) during pollen season showed improvement in their symptoms, according to recent research released as an abstract for the annual meeting of the American Academy of Allergy, Asthma & Immunology.

Photo courtesy Oak Ridge National Laboratory

Tree pollen season is generally considered to be between February and June, with alder and hazel allergens affecting patients early and oak pollen affecting patients later in the season. Since a major birch allergen, Betula verrucosa 1 (Bet v 1), cross-reacts with alder, hazel, and oak allergens, some patients may experience allergies across the entire tree pollen season from members of this so-called birth homologous group, Hendrik Nolte, MD, senior vice president of research and development at ALK-Abello Americas and International, said in an interview.

According to the U.S. National Health and Nutrition Examination Survey 2005-2006, 16% of 8,086 participants 6 years or older with allergy had a specific immunoglobulin E (IgE) to birch, while 18% had a specific IgE to oak. Patients who reported having hay fever had a specific IgE to birch of 23% and a specific IgE to oak of 26% (J Allergy Clin Immunol. 2011 May;127[5]:1226-1235.e7).

“Patients who are allergic to birch pollen often experience symptoms in response to pollen from other members of the birch homologous group, which prolong the tree season and increase the symptom burden for these patients,” Dr. Nolte said. “Thus, treatment with SLIT-tablet immunotherapy may be an important treatment option for many allergy sufferers.”

Dr. Nolte and colleagues performed a randomized, double-blind, multinational trial of 634 patients before and during tree pollen season in which participants received a daily SLIT tablet or placebo. Patients were between ages 12 and 65 years with allergic rhinitis, and investigators enrolled patients or without conjunctivitis and with or without asthma. The investigations evaluated the patients’ daily symptom score and daily medication score, which was grouped into the total combined score. The patients were also allowed to use their rescue medications during the trial.
 

SLIT demonstrates symptom improvement

“Improvement in allergic rhinoconjunctivitis symptoms and reduction in symptom-relieving medication use with the tree SLIT-tablet during birch, alder/hazel, and oak pollen seasons were significant versus placebo and showed internal consistency across almost 4 months of birch and related tree pollen exposure,” Dr. Nolte said.

Patients showed relative improvements in their total combined score of 39.6% for birch, 29.7% for alder and hazel, 36.0% during oak pollen season, and 35.0% during the entire tree pollen season, compared with placebo (all P ≤ .002). Relative daily symptom scores also improved in the group that received oral SLIT, with 36.8% of patients showing improvement during birch season, 26.0% during alder and hazel season, 31.6% during oak season, and 31.6% across all pollen seasons, compared with those taking placebo (all P ≤ .003). A greater number of patients also achieved a relative improvement in daily medication score during birch season (49.2%), alder and hazel season (43.8%), oak season (45.9%) and during the whole of tree pollen season (45.3%), compared with placebo (P ≤ .002).

“The results support the clinical relevance of cross-reactivity between birch, alder/hazel, and oak pollen homologous allergens,” Dr. Nolte said. “Immunologic cross-reactivity is supported by alder, hazel, and oak specific IgE data and IgG4 in responses to the tree SLIT tablet.”

Dr. Nolte said the next step in his team’s research was to evaluate oral SLIT in a phase 3 trial for children aged 5-17 years.

This study was funded by ALK, and the authors received medical writing and editorial assistance from Scott Medical Communications. Dr. Nolte reported that he is a paid employee of ALK.

SOURCE: Nolte H et al. AAAAI, Abstract 267.

.

Patients with allergic rhinitis receiving oral tree sublingual immunotherapy (SLIT) during pollen season showed improvement in their symptoms, according to recent research released as an abstract for the annual meeting of the American Academy of Allergy, Asthma & Immunology.

Photo courtesy Oak Ridge National Laboratory

Tree pollen season is generally considered to be between February and June, with alder and hazel allergens affecting patients early and oak pollen affecting patients later in the season. Since a major birch allergen, Betula verrucosa 1 (Bet v 1), cross-reacts with alder, hazel, and oak allergens, some patients may experience allergies across the entire tree pollen season from members of this so-called birth homologous group, Hendrik Nolte, MD, senior vice president of research and development at ALK-Abello Americas and International, said in an interview.

According to the U.S. National Health and Nutrition Examination Survey 2005-2006, 16% of 8,086 participants 6 years or older with allergy had a specific immunoglobulin E (IgE) to birch, while 18% had a specific IgE to oak. Patients who reported having hay fever had a specific IgE to birch of 23% and a specific IgE to oak of 26% (J Allergy Clin Immunol. 2011 May;127[5]:1226-1235.e7).

“Patients who are allergic to birch pollen often experience symptoms in response to pollen from other members of the birch homologous group, which prolong the tree season and increase the symptom burden for these patients,” Dr. Nolte said. “Thus, treatment with SLIT-tablet immunotherapy may be an important treatment option for many allergy sufferers.”

Dr. Nolte and colleagues performed a randomized, double-blind, multinational trial of 634 patients before and during tree pollen season in which participants received a daily SLIT tablet or placebo. Patients were between ages 12 and 65 years with allergic rhinitis, and investigators enrolled patients or without conjunctivitis and with or without asthma. The investigations evaluated the patients’ daily symptom score and daily medication score, which was grouped into the total combined score. The patients were also allowed to use their rescue medications during the trial.
 

SLIT demonstrates symptom improvement

“Improvement in allergic rhinoconjunctivitis symptoms and reduction in symptom-relieving medication use with the tree SLIT-tablet during birch, alder/hazel, and oak pollen seasons were significant versus placebo and showed internal consistency across almost 4 months of birch and related tree pollen exposure,” Dr. Nolte said.

Patients showed relative improvements in their total combined score of 39.6% for birch, 29.7% for alder and hazel, 36.0% during oak pollen season, and 35.0% during the entire tree pollen season, compared with placebo (all P ≤ .002). Relative daily symptom scores also improved in the group that received oral SLIT, with 36.8% of patients showing improvement during birch season, 26.0% during alder and hazel season, 31.6% during oak season, and 31.6% across all pollen seasons, compared with those taking placebo (all P ≤ .003). A greater number of patients also achieved a relative improvement in daily medication score during birch season (49.2%), alder and hazel season (43.8%), oak season (45.9%) and during the whole of tree pollen season (45.3%), compared with placebo (P ≤ .002).

“The results support the clinical relevance of cross-reactivity between birch, alder/hazel, and oak pollen homologous allergens,” Dr. Nolte said. “Immunologic cross-reactivity is supported by alder, hazel, and oak specific IgE data and IgG4 in responses to the tree SLIT tablet.”

Dr. Nolte said the next step in his team’s research was to evaluate oral SLIT in a phase 3 trial for children aged 5-17 years.

This study was funded by ALK, and the authors received medical writing and editorial assistance from Scott Medical Communications. Dr. Nolte reported that he is a paid employee of ALK.

SOURCE: Nolte H et al. AAAAI, Abstract 267.

.

Patients with suspected migraine and a normal neurological examination without any atypical features or red flags do not need an MRI or CT, according to recent updated recommendations in a guideline released by the American Headache Society.

Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
 

Assessing the evidence

The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.

The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.

Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
 

Good advice, with caveats

In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.

“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.

However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.

“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”

Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.

“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”

There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.

Patients with suspected migraine and a normal neurological examination without any atypical features or red flags do not need an MRI or CT, according to recent updated recommendations in a guideline released by the American Headache Society.

Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
 

Assessing the evidence

The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.

The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.

Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
 

Good advice, with caveats

In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.

“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.

However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.

“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”

Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.

“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”

There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.

Patients with suspected migraine and a normal neurological examination without any atypical features or red flags do not need an MRI or CT, according to recent updated recommendations in a guideline released by the American Headache Society.

Migraine with atypical features may require neuroimaging, according to the guideline. These include an unusual aura; change in clinical features; a first or worst migraine; a migraine that presents with brainstem aura, confusion, or motor manifestation; migraine accompaniments in later life; headaches that are side-locked or posttraumatic; and aura that presents without headache.
 

Assessing the evidence

The recommendation to avoid MRI or CT in otherwise neurologically normal patients with migraine carried a grade A recommendation from the American Headache Society, while the specific considerations for neuroimaging was based on consensus and carried a grade C recommendation, according to lead author Randolph W. Evans, MD, of the department of neurology at Baylor College of Medicine in Houston, and colleagues.

The recommendations, published in the journal Headache (2020 Feb;60(2):318-36), came from a systematic review of 23 studies of adults at least 18 years old who underwent MRI or CT during outpatient treatment for migraine between 1973 and 2018. Ten studies looked at CT neuroimaging in patients with migraine, nine studies examined MRI neuroimaging alone in patients with migraine, and four studies contained adults with headache or migraine who underwent either MRI or CT. The majority of studies analyzed were retrospective or cross-sectional in nature, while four studies were prospective observational studies.

Dr. Evans and colleagues noted that neuroimaging for patients with suspected migraine is ordered for a variety of reasons, such as excluding conditions that aren’t migraine, diagnostic certainty, cognitive bias, practice workflow, medicolegal concerns, addressing patient and family anxiety, and addressing clinician anxiety. Neuroimaging also can be costly, they said, adding up to an estimated $1 billion annually according to one study, and can lead to additional testing from findings that may not be clinically significant.
 

Good advice, with caveats

In an interview, Alan M. Rapoport, MD, editor-in-chief of Neurology Reviews, said that while he generally does not like broad guideline recommendations, the recommendation made by the American Headache Society to avoid neuroimaging in patients with a normal neurological examination without any atypical features and red flags “takes most of the important factors into consideration and will work almost all the time.” The recommendation made by consensus for specific considerations of neuroimaging was issued by top headache specialists in the United States who reviewed the data, and it is unlikely a patient with a migraine as diagnosed by the International Classification of Headache Disorders with a normal neurological examination would have a significant abnormality that would appear with imaging, Dr. Rapoport said.

“If everyone caring for migraine patients knew these recommendations, and used them unless the patients fit the exclusions mentioned, we would have more efficient clinical practice and save lots of money on unnecessary scanning,” he said.

However, Dr. Rapoport, clinical professor of neurology at the University of California, Los Angeles, founder of the New England Center for Headache, and past president of The International Headache Society, said that not all clinicians will be convinced by the American Headache Society’s recommendations.

“Various third parties often jump on society recommendations or guidelines and prevent smart clinicians from doing what they need to do when they want to disregard the recommendation or guideline,” he explained. “More importantly, if a physician feels the need to think out of the box and image a patient without a clear reason, and the patient cannot pay for the scan when a medical insurance company refuses to authorize it, there can be a bad result if the patient does not get the study.”

Dr. Rapoport noted that the guideline does not address situations where neuroimaging may not pick up conditions that lead to migraine, such as a subarachnoid or subdural hemorrhage, reversible cerebral vasoconstriction syndrome, or early aspects of low cerebrospinal fluid pressure syndrome. Anxiety on the part of the patient or the clinician is another area that can be addressed by future research, he said.

“If the clinician does a good job of explaining the odds of anything significant being found with a typical migraine history and normal examination, and the patient says [they] need an MRI with contrast to be sure, it will be difficult to dissuade them,” said Dr. Rapoport. “If you don’t order one, they will find a way to get one. If it is abnormal, you could be in trouble. Also, if the clinician has no good reason to do a scan but has anxiety about what is being missed, it will probably get done.”

There was no funding source for the guidelines. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, and consultancies for a variety of pharmaceutical companies, agencies, institutions, publishers, and other organizations.

ORLANDO – Biotin is the most popular consumer supplement for alopecia and highly popular online, but should patients be taking it?

Patients may want something “natural” to treat their hair loss, but “natural is not always good,” Amy McMichael, MD, professor and chair of the department of dermatology at Wake Forest Baptist Health, Winston-Salem, N.C., said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dosages of commercially available biotin supplements can vary significantly, with some doses as high as 10,000 mcg, making supraphysiological dosing possible. Dr. McMichael said that, not only is biotin unlikely to help with a patient’s alopecia, but a high intake of biotin can interfere with certain assays that use streptavidin-biotin capture techniques (Clin Chem Lab Med. 2017 May 1;55[6]:817-25). This could present a problem for a patient who experiences an MI or has a thyroid disorder where a high level of biotin could affect lab results, she noted.

Dr. McMichael advises patients that there is a low likelihood that biotin will help their hair loss, and suggests that they stop taking the supplements, noting that all hair supplements contain biotin.

Questioning side effects of 5-alpha reductase inhibitors

Research in the early 2010s associated the 5-alpha reductase inhibitor finasteride with persistent sexual side effects and depression. But a later meta-analysis of the Prostate Cancer Prevention Trial and other trials did not find evidence of persistent sexual side effects or depression in men on finasteride, and the authors said that double-blind, placebo-controlled studies were needed (J Clin Aesthet Dermatol. 2014 Dec;7[12]:51-5).

However, two meta-analyses of 34 clinical trials published in 2015 found that none of the clinical trials evaluating finasteride treatment in patients with androgenic alopecia had accurate safety reporting (JAMA Dermatol. 2015 Jun;151[6]:600-6). Another study published by the same group in 2017 found that 0.8% of men aged 16-42 years to exposed to a 5-alpha reductase inhibitor developed persistent erectile dysfunction after a longer duration of exposure (median, 1,534 days). compared with a shorter duration of exposure (PeerJ. 2017 Mar 9;5:e3020).

The bottom line when considering use of 5-alpha reductase inhibitors in men is to discuss the outlier data on persistent sexual dysfunction in the studies, ask patients whether they have a history of sexual dysfunction and depression, and then only treat appropriate patients with no such history, Dr. McMichael said.

Use of 5-alpha reductase inhibitors also appears to be related to an increased risk of type 2 diabetes in men with benign prostatic hyperplasia, according to more recent data. In a study of patients in the U.K. Clinical Practice Research Datalink and Taiwanese National Health Insurance Research Database who received dutasteride, finasteride, or the alpha blocker tamsulosin, there was a slightly increased risk of type 2 diabetes among those who took the two 5-alpha reductase inhibitors, compared with those on tamsulosin (BMJ. 2019;365:l1204). In light of these results, Dr. McMichael advised clinicians to be aware of these risks and to consider screening patients for type 2 diabetes and ask them about their family history, but the results shouldn’t affect patients at risk for type 2 diabetes or metabolic disorder.
 

JAK inhibitors for alopecia areata

Within the past few years, promising results for Janus kinase (JAK) inhibitors like tofacitinib and ruxolitinib for alopecia areata have been reported, but they are currently not a first-line therapy, Dr. McMichael said. Consider methotrexate first in older adolescents and adults with more than 50% hair loss, followed by a JAK inhibitor if there is no improvement or methotrexate is not tolerated well.

Clinicians can consider enrolling their patients in a clinical trial to give them access to JAK inhibitors as a treatment option, she noted, and if a trial is not available, it may be worth appealing to an insurance company using an article titled “Alopecia areata is a medical disease” coauthored by Dr. McMichael and others (Am Acad Dermatol. 2018 Apr;78[4]:832-4). After two denials by insurance, the manufacturer’s patient assistance program (Xelsource) may be helpful in obtaining tofacitinib (Xeljanz) through a letter and references. There are adolescent data on JAK inhibitors for alopecia, but “absolutely no data” in very young children, so prior to adolescence, she would not recommend this treatment. In a study of 13 adolescents with alopecia areata, totalis, or universalis, those treated with tofacitinib for a mean of 6.5 months, 9 had significant hair regrowth with treatment and adverse events were mild (J Am Acad Dermatol. 2017 Jan;76[1]:29-32).

Dr. McMichael reports being an investigator for Allergan, Intendis, Proctor & Gamble, Samumed, Cassiopia, Concert, Aclaris, and Incyte; and is a consultant for Johnson & Johnson, Proctor & Gamble, Allergan, Bayer, Galderma, Incyte, Samumed, Aclaris, Anacor, Pfizer, Nutrafol, Bioniz, and Almirall.

ORLANDO – Biotin is the most popular consumer supplement for alopecia and highly popular online, but should patients be taking it?

Patients may want something “natural” to treat their hair loss, but “natural is not always good,” Amy McMichael, MD, professor and chair of the department of dermatology at Wake Forest Baptist Health, Winston-Salem, N.C., said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dosages of commercially available biotin supplements can vary significantly, with some doses as high as 10,000 mcg, making supraphysiological dosing possible. Dr. McMichael said that, not only is biotin unlikely to help with a patient’s alopecia, but a high intake of biotin can interfere with certain assays that use streptavidin-biotin capture techniques (Clin Chem Lab Med. 2017 May 1;55[6]:817-25). This could present a problem for a patient who experiences an MI or has a thyroid disorder where a high level of biotin could affect lab results, she noted.

Dr. McMichael advises patients that there is a low likelihood that biotin will help their hair loss, and suggests that they stop taking the supplements, noting that all hair supplements contain biotin.

Questioning side effects of 5-alpha reductase inhibitors

Research in the early 2010s associated the 5-alpha reductase inhibitor finasteride with persistent sexual side effects and depression. But a later meta-analysis of the Prostate Cancer Prevention Trial and other trials did not find evidence of persistent sexual side effects or depression in men on finasteride, and the authors said that double-blind, placebo-controlled studies were needed (J Clin Aesthet Dermatol. 2014 Dec;7[12]:51-5).

However, two meta-analyses of 34 clinical trials published in 2015 found that none of the clinical trials evaluating finasteride treatment in patients with androgenic alopecia had accurate safety reporting (JAMA Dermatol. 2015 Jun;151[6]:600-6). Another study published by the same group in 2017 found that 0.8% of men aged 16-42 years to exposed to a 5-alpha reductase inhibitor developed persistent erectile dysfunction after a longer duration of exposure (median, 1,534 days). compared with a shorter duration of exposure (PeerJ. 2017 Mar 9;5:e3020).

The bottom line when considering use of 5-alpha reductase inhibitors in men is to discuss the outlier data on persistent sexual dysfunction in the studies, ask patients whether they have a history of sexual dysfunction and depression, and then only treat appropriate patients with no such history, Dr. McMichael said.

Use of 5-alpha reductase inhibitors also appears to be related to an increased risk of type 2 diabetes in men with benign prostatic hyperplasia, according to more recent data. In a study of patients in the U.K. Clinical Practice Research Datalink and Taiwanese National Health Insurance Research Database who received dutasteride, finasteride, or the alpha blocker tamsulosin, there was a slightly increased risk of type 2 diabetes among those who took the two 5-alpha reductase inhibitors, compared with those on tamsulosin (BMJ. 2019;365:l1204). In light of these results, Dr. McMichael advised clinicians to be aware of these risks and to consider screening patients for type 2 diabetes and ask them about their family history, but the results shouldn’t affect patients at risk for type 2 diabetes or metabolic disorder.
 

JAK inhibitors for alopecia areata

Within the past few years, promising results for Janus kinase (JAK) inhibitors like tofacitinib and ruxolitinib for alopecia areata have been reported, but they are currently not a first-line therapy, Dr. McMichael said. Consider methotrexate first in older adolescents and adults with more than 50% hair loss, followed by a JAK inhibitor if there is no improvement or methotrexate is not tolerated well.

Clinicians can consider enrolling their patients in a clinical trial to give them access to JAK inhibitors as a treatment option, she noted, and if a trial is not available, it may be worth appealing to an insurance company using an article titled “Alopecia areata is a medical disease” coauthored by Dr. McMichael and others (Am Acad Dermatol. 2018 Apr;78[4]:832-4). After two denials by insurance, the manufacturer’s patient assistance program (Xelsource) may be helpful in obtaining tofacitinib (Xeljanz) through a letter and references. There are adolescent data on JAK inhibitors for alopecia, but “absolutely no data” in very young children, so prior to adolescence, she would not recommend this treatment. In a study of 13 adolescents with alopecia areata, totalis, or universalis, those treated with tofacitinib for a mean of 6.5 months, 9 had significant hair regrowth with treatment and adverse events were mild (J Am Acad Dermatol. 2017 Jan;76[1]:29-32).

Dr. McMichael reports being an investigator for Allergan, Intendis, Proctor & Gamble, Samumed, Cassiopia, Concert, Aclaris, and Incyte; and is a consultant for Johnson & Johnson, Proctor & Gamble, Allergan, Bayer, Galderma, Incyte, Samumed, Aclaris, Anacor, Pfizer, Nutrafol, Bioniz, and Almirall.

ORLANDO – Biotin is the most popular consumer supplement for alopecia and highly popular online, but should patients be taking it?

Patients may want something “natural” to treat their hair loss, but “natural is not always good,” Amy McMichael, MD, professor and chair of the department of dermatology at Wake Forest Baptist Health, Winston-Salem, N.C., said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dosages of commercially available biotin supplements can vary significantly, with some doses as high as 10,000 mcg, making supraphysiological dosing possible. Dr. McMichael said that, not only is biotin unlikely to help with a patient’s alopecia, but a high intake of biotin can interfere with certain assays that use streptavidin-biotin capture techniques (Clin Chem Lab Med. 2017 May 1;55[6]:817-25). This could present a problem for a patient who experiences an MI or has a thyroid disorder where a high level of biotin could affect lab results, she noted.

Dr. McMichael advises patients that there is a low likelihood that biotin will help their hair loss, and suggests that they stop taking the supplements, noting that all hair supplements contain biotin.

Questioning side effects of 5-alpha reductase inhibitors

Research in the early 2010s associated the 5-alpha reductase inhibitor finasteride with persistent sexual side effects and depression. But a later meta-analysis of the Prostate Cancer Prevention Trial and other trials did not find evidence of persistent sexual side effects or depression in men on finasteride, and the authors said that double-blind, placebo-controlled studies were needed (J Clin Aesthet Dermatol. 2014 Dec;7[12]:51-5).

However, two meta-analyses of 34 clinical trials published in 2015 found that none of the clinical trials evaluating finasteride treatment in patients with androgenic alopecia had accurate safety reporting (JAMA Dermatol. 2015 Jun;151[6]:600-6). Another study published by the same group in 2017 found that 0.8% of men aged 16-42 years to exposed to a 5-alpha reductase inhibitor developed persistent erectile dysfunction after a longer duration of exposure (median, 1,534 days). compared with a shorter duration of exposure (PeerJ. 2017 Mar 9;5:e3020).

The bottom line when considering use of 5-alpha reductase inhibitors in men is to discuss the outlier data on persistent sexual dysfunction in the studies, ask patients whether they have a history of sexual dysfunction and depression, and then only treat appropriate patients with no such history, Dr. McMichael said.

Use of 5-alpha reductase inhibitors also appears to be related to an increased risk of type 2 diabetes in men with benign prostatic hyperplasia, according to more recent data. In a study of patients in the U.K. Clinical Practice Research Datalink and Taiwanese National Health Insurance Research Database who received dutasteride, finasteride, or the alpha blocker tamsulosin, there was a slightly increased risk of type 2 diabetes among those who took the two 5-alpha reductase inhibitors, compared with those on tamsulosin (BMJ. 2019;365:l1204). In light of these results, Dr. McMichael advised clinicians to be aware of these risks and to consider screening patients for type 2 diabetes and ask them about their family history, but the results shouldn’t affect patients at risk for type 2 diabetes or metabolic disorder.
 

JAK inhibitors for alopecia areata

Within the past few years, promising results for Janus kinase (JAK) inhibitors like tofacitinib and ruxolitinib for alopecia areata have been reported, but they are currently not a first-line therapy, Dr. McMichael said. Consider methotrexate first in older adolescents and adults with more than 50% hair loss, followed by a JAK inhibitor if there is no improvement or methotrexate is not tolerated well.

Clinicians can consider enrolling their patients in a clinical trial to give them access to JAK inhibitors as a treatment option, she noted, and if a trial is not available, it may be worth appealing to an insurance company using an article titled “Alopecia areata is a medical disease” coauthored by Dr. McMichael and others (Am Acad Dermatol. 2018 Apr;78[4]:832-4). After two denials by insurance, the manufacturer’s patient assistance program (Xelsource) may be helpful in obtaining tofacitinib (Xeljanz) through a letter and references. There are adolescent data on JAK inhibitors for alopecia, but “absolutely no data” in very young children, so prior to adolescence, she would not recommend this treatment. In a study of 13 adolescents with alopecia areata, totalis, or universalis, those treated with tofacitinib for a mean of 6.5 months, 9 had significant hair regrowth with treatment and adverse events were mild (J Am Acad Dermatol. 2017 Jan;76[1]:29-32).

Dr. McMichael reports being an investigator for Allergan, Intendis, Proctor & Gamble, Samumed, Cassiopia, Concert, Aclaris, and Incyte; and is a consultant for Johnson & Johnson, Proctor & Gamble, Allergan, Bayer, Galderma, Incyte, Samumed, Aclaris, Anacor, Pfizer, Nutrafol, Bioniz, and Almirall.

Banning indoor tanning devices outright in the United States, Canada, and Europe could prevent as many as 448,000 melanomas and 9.7 million keratinocyte carcinomas, according to a study published in JAMA Dermatology.

The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.

Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.

The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.

In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.

With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.

The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.

The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
 

Results

The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.

When applying the ban in Europe, the model estimated 203,736 fewer melanomas (­–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (­–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.

Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
 

Implications

In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).

Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”

Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”

Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”

“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”

While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.

“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”

This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.

SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.

Banning indoor tanning devices outright in the United States, Canada, and Europe could prevent as many as 448,000 melanomas and 9.7 million keratinocyte carcinomas, according to a study published in JAMA Dermatology.

The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.

Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.

The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.

In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.

With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.

The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.

The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
 

Results

The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.

When applying the ban in Europe, the model estimated 203,736 fewer melanomas (­–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (­–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.

Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
 

Implications

In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).

Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”

Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”

Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”

“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”

While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.

“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”

This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.

SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.

Banning indoor tanning devices outright in the United States, Canada, and Europe could prevent as many as 448,000 melanomas and 9.7 million keratinocyte carcinomas, according to a study published in JAMA Dermatology.

The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.

Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.

The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.

In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.

With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.

The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.

The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
 

Results

The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.

When applying the ban in Europe, the model estimated 203,736 fewer melanomas (­–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (­–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.

Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
 

Implications

In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).

Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”

Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”

Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”

“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”

While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.

“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”

This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.

SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

Over one-third of undisclosed industry payments made to physician-authors of American College of Rheumatology clinical practice guidelines were relevant to guideline recommendations, according to a recent review in Arthritis & Rheumatology.

frankpeters/Getty Images

Since 2014, 56 of 89 total physician-authors across five ACR clinical practice guidelines have been paid a total of $9,728,751 from industry sources. Nineteen of 89 authors received $1,961,362 in industry payments that were directly relevant to a guideline’s recommendations, and $699,561 of these payments (35.7%) were undisclosed, according to Cole Wayant, of the Oklahoma State University Center for Health Sciences, Tulsa, and colleagues.

The ACR’s Policy and Procedure Manual for Clinical Practice Guidelines, last updated in January 2015, allows up to 49% of authors in a clinical practice guideline to have financial conflicts of interest, including intellectual conflicts of interest, and requires them to report those relationships. When the ACR creates a call for letters of interest for a guideline, it includes a list of companies and organizations that could be affected by the guideline topic. To be considered conflict free, an author must not have ties to these companies and organizations for 1 year before the deadline on the letter of interest and 1 year after a guideline is published. This policy extends to members of an ACR guideline development group, literature review team, and voting panel. Under these guidelines, an author who has any relationship with a company is considered conflicted, which counts toward this total.

Mr. Wayant and colleagues performed a cross-sectional study of five ACR guidelines published since August 2014 on axial spondyloarthritis (27 authors), glucocorticoid-induced osteoporosis (21 authors), RA (26 authors), perioperative management of antirheumatic medication (31 authors), and polymyalgia rheumatica (46 authors). Using the Open Payments Database, the researchers searched for any general (speaking fees, consulting fees, education, honoraria, travel, food, or beverage payments) research, associated research, and ownership (stocks or dividends) relationships reported by guideline authors in the 12 months before a guideline was published. The guidelines on axial spondyloarthritis, glucocorticoid-induced osteoporosis, and RA contained specific recommendations for classes of medications or branded drugs, and conflicts from authors in those guidelines were assessed to determine relevancy of those payments.

Of the 56 physician-authors who received at least one payment (62.9%), the median payment was $522. However, 51 authors reported receiving more than $1,000, 42 authors reported more than $10,000, 20 authors reported more than $100,000, and 2 authors reported more than $1 million. Overall, 14 of 56 authors (25.0%) reported having no financial conflicts of interest, but did in fact receive some payment, and $4,189,090 of the $9,728,751 (43.1%) was not reported. The researchers said that the 19 authors with directly relevant payments were members of the voting panel (11 authors), literature review team (6 authors), and core leadership team (3 authors).

Physician-authors of clinical practice guidelines receiving payments from industry is not an issue specific to rheumatology. In an interview, Mr. Wayant said that authors of clinical guidelines across many different medical specialties often work closely with industry and hold “numerous conflicts of interest.”

“If professional societies are meant to be the public face of specialty providers, one would expect the guideline authors to resemble all society members,” Mr. Wayant said. “However, we routinely find that authors of professional society guidelines have large financial conflicts of interest that exceed the national average, indicating that the views and opinions of guideline authors may not reflect the opinion of most providers.”

These financial relationships between industry and physician authors have been shown to affect research results. A Cochrane Review published in 2017 evaluating industry sponsorship and research outcomes found that studies sponsored by industry were more likely to have favorable efficacy results and conclusions, compared with studies not sponsored by industry sources (Cochrane Database Syst Rev. 2017 Feb 16;2:MR000033). As medical societies continue to become more involved with clinical practice guidelines, recommendations from physician-authors with financial ties to industry can present a conflict of interest. Recommendations in clinical practice guidelines often affect reimbursement of a drug from insurance, and an author can vote for a drug recommendation in a guideline that may not match patient values and preferences, noted Mr. Wayant.

“These authors are fundamentally different from the average rheumatologist that stays up to date with the medical literature, in terms of financial ties to industry,” he said. “Removing the influence of for-profit companies from guideline development cannot harm the rigor of the guideline recommendations, since many medical professionals without conflicts are experts in evidence-based medicine and study appraisal.”

Being financially linked to industry does not automatically make one the most qualified candidate for deciding which therapies are best for patients, Mr. Wayant explained, and guidelines should reflect the values of patients and the medical profession, rather than industry.

“Given the importance of guidelines, [we] encourage the ACR and all professional societies to do everything possible to be above reproach and seek out authors who do not have financial conflicts to write the guidelines,” he said.

The authors reported having no funding source for the study. One author reported serving on an advisory board for Janssen involving infliximab and golimumab, for Sanofi Genzyme involving sarilumab, and receiving payment for a survey from Comsort. The other authors reported having no conflicts of interest.

SOURCE: Wayant C et al. Arthritis Rheumatol. 2020 Feb 10. doi: 10.1002/art.41224.

After 12 months of receiving palliative care in an outpatient setting in addition to standard care, patients with Parkinson’s disease and related disorders (PDRD) had improved quality of life (QoL), compared with patients who received standard care alone, according to results from a randomized clinical trial in JAMA Neurology.

The benefits of palliative care even extended to patients’ caregivers, who also appeared to benefit from outpatient palliative care at the 12-month mark, according to lead author Benzi M. Kluger, MD, of the department of neurology, University of Colorado at Denver, Aurora, and colleagues.

Between November 2015 and September 2017, Dr. Kluger and colleagues included 210 patients into the trial from three participating academic tertiary care centers who had “moderate to high palliative care needs” as assessed by the Palliative Care Needs Assessment Tool, which the researchers said are “common reasons for referral” and “reflect a desire to meet patient-centered needs rather than disease-centered markers.” Patients were primarily non-Hispanic white men with a mean age of about 70 years. The researchers also included 175 caregivers in the trial, most of whom were women, spouses to the patients, and in their caregiver role for over 5.5 years.

Patients with PDRD were randomized to receive standard care – usual care through their primary care physician and a neurologist – or “integrated outpatient palliative care,” from a team consisting of a palliative neurologist, nurse, social worker, chaplain, and board-certified palliative medicine physician. The goal of palliative care was addressing “nonmotor symptoms, goals of care, anticipatory guidance, difficult emotions, and caregiver support,” which patients received every 3 months through an in-person outpatient visit or telemedicine.

Quality of life for patients was measured through the Quality of Life in Alzheimer’s Disease (QoL-AD) scale, and caregiver burden was assessed with the Zarit Burden Interview (ZBI-12). The researchers also measured symptom burden and other QoL measures using the Edmonton Symptom Assessment Scale–Revised for Parkinson’s Disease, Parkinson’s Disease Questionnaire, Hospital Anxiety and Depression Scale, Prolonged Grief Disorder questionnaire, and Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being.

Overall, 87 of 105 (82.1%) of patients in the palliative care group went to all their outpatient palliative care visits, and 19 of 106 (17.9%) patients received palliative care through telemedicine. Patients in the palliative care group also attended more neurology visits (4.66 visits) than those in the standard care (3.16 visits) group.

Quality of life significantly improved for patients in the palliative care group, compared with patients receiving standard care only at 6 months (0.66 vs. –0.84; between-group difference, 1.87; 95% confidence interval, 0.47-3.27; P = .009) and at 12 months (0.68 vs. –0.42; between-group difference, 1.36; 95% CI, −0.01 to 2.73; P = .05). These results remained significant at 6 months and 12 months after researchers used multiple imputation to fill in missing data. While there was no significant difference in caregiver burden between groups at 6 months, there was a statistically significant difference at 12 months favoring the palliative care group (between-group difference, −2.60; 95% CI, −4.58 to −0.61; P = .01).

Patients receiving palliative care also had better nonmotor symptom burden, motor symptom severity, and were more likely to complete advance directives, compared with patients receiving standard care alone. “We hypothesize that motor improvements may have reflected an unanticipated benefit of our palliative care team’s general goal of encouraging activities that promoted joy, meaning, and connection,” Dr. Kluger and colleagues said. Researchers also noted that the intervention patients with greater need for palliative care tended to benefit more than patients with patients with lower palliative care needs.

“Because the palliative care intervention is time-intensive and resource-intensive, future studies should optimize triage tools and consider alternative models of care delivery, such as telemedicine or care navigators, to provide key aspects of the intervention at lower cost,” they said.

In a related editorial, Bastiaan R. Bloem, MD, PhD, from the Center of Expertise for Parkinson & Movement Disorders, at Radboud University Medical Center, in the Netherlands, and colleagues acknowledged that the study by Kluger et al. is “timely and practical” because it introduces a system for outpatient palliative care for patients with PDRD at a time when there is “growing awareness that palliative care may also benefit persons with neurodegenerative diseases like Parkinson’s disease.”

The study is also important because it highlights that patients at varying stages of disease, including mild disease, may benefit from an integrated outpatient palliative model, which is not usually considered when determining candidates for palliative care in other scenarios, such as in patients with cancer. Future studies are warranted to assess how palliative care models can be implemented in different disease states and health care settings, they said.

“These new studies should continue to highlight the fact that palliative care is not about terminal diseases and dying,” Dr. Bloem and colleagues concluded. “As Kluger and colleagues indicate in their important clinical trial, palliative care is about how to live well.”

Six authors reported receiving a grant from the Patient-Centered Outcomes Research Institute, which was the funding source for the study. Two authors reported receiving grants from the University Hospital Foundation during the study. One author reported receiving grants from Allergan and Merz Pharma and is a consultant for GE Pharmaceuticals and Sunovion Pharmaceuticals; another reported receiving grants from the Archstone Foundation, the California Health Care Foundation, the Cambia Health Foundation, the Gordon and Betty Moore Foundation, the National Institute of Nursing Research, the Stupski Foundation, and the UniHealth Foundation. Dr. Bloem and a colleague reported their institution received a center of excellence grant from the Parkinson’s Foundation.

SOURCE: Kluger B et al. JAMA Neurol. doi: 10.1001/jamaneurol.2019.4992.

After 12 months of receiving palliative care in an outpatient setting in addition to standard care, patients with Parkinson’s disease and related disorders (PDRD) had improved quality of life (QoL), compared with patients who received standard care alone, according to results from a randomized clinical trial in JAMA Neurology.

The benefits of palliative care even extended to patients’ caregivers, who also appeared to benefit from outpatient palliative care at the 12-month mark, according to lead author Benzi M. Kluger, MD, of the department of neurology, University of Colorado at Denver, Aurora, and colleagues.

Between November 2015 and September 2017, Dr. Kluger and colleagues included 210 patients into the trial from three participating academic tertiary care centers who had “moderate to high palliative care needs” as assessed by the Palliative Care Needs Assessment Tool, which the researchers said are “common reasons for referral” and “reflect a desire to meet patient-centered needs rather than disease-centered markers.” Patients were primarily non-Hispanic white men with a mean age of about 70 years. The researchers also included 175 caregivers in the trial, most of whom were women, spouses to the patients, and in their caregiver role for over 5.5 years.

Patients with PDRD were randomized to receive standard care – usual care through their primary care physician and a neurologist – or “integrated outpatient palliative care,” from a team consisting of a palliative neurologist, nurse, social worker, chaplain, and board-certified palliative medicine physician. The goal of palliative care was addressing “nonmotor symptoms, goals of care, anticipatory guidance, difficult emotions, and caregiver support,” which patients received every 3 months through an in-person outpatient visit or telemedicine.

Quality of life for patients was measured through the Quality of Life in Alzheimer’s Disease (QoL-AD) scale, and caregiver burden was assessed with the Zarit Burden Interview (ZBI-12). The researchers also measured symptom burden and other QoL measures using the Edmonton Symptom Assessment Scale–Revised for Parkinson’s Disease, Parkinson’s Disease Questionnaire, Hospital Anxiety and Depression Scale, Prolonged Grief Disorder questionnaire, and Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being.

Overall, 87 of 105 (82.1%) of patients in the palliative care group went to all their outpatient palliative care visits, and 19 of 106 (17.9%) patients received palliative care through telemedicine. Patients in the palliative care group also attended more neurology visits (4.66 visits) than those in the standard care (3.16 visits) group.

Quality of life significantly improved for patients in the palliative care group, compared with patients receiving standard care only at 6 months (0.66 vs. –0.84; between-group difference, 1.87; 95% confidence interval, 0.47-3.27; P = .009) and at 12 months (0.68 vs. –0.42; between-group difference, 1.36; 95% CI, −0.01 to 2.73; P = .05). These results remained significant at 6 months and 12 months after researchers used multiple imputation to fill in missing data. While there was no significant difference in caregiver burden between groups at 6 months, there was a statistically significant difference at 12 months favoring the palliative care group (between-group difference, −2.60; 95% CI, −4.58 to −0.61; P = .01).

Patients receiving palliative care also had better nonmotor symptom burden, motor symptom severity, and were more likely to complete advance directives, compared with patients receiving standard care alone. “We hypothesize that motor improvements may have reflected an unanticipated benefit of our palliative care team’s general goal of encouraging activities that promoted joy, meaning, and connection,” Dr. Kluger and colleagues said. Researchers also noted that the intervention patients with greater need for palliative care tended to benefit more than patients with patients with lower palliative care needs.

“Because the palliative care intervention is time-intensive and resource-intensive, future studies should optimize triage tools and consider alternative models of care delivery, such as telemedicine or care navigators, to provide key aspects of the intervention at lower cost,” they said.

In a related editorial, Bastiaan R. Bloem, MD, PhD, from the Center of Expertise for Parkinson & Movement Disorders, at Radboud University Medical Center, in the Netherlands, and colleagues acknowledged that the study by Kluger et al. is “timely and practical” because it introduces a system for outpatient palliative care for patients with PDRD at a time when there is “growing awareness that palliative care may also benefit persons with neurodegenerative diseases like Parkinson’s disease.”

The study is also important because it highlights that patients at varying stages of disease, including mild disease, may benefit from an integrated outpatient palliative model, which is not usually considered when determining candidates for palliative care in other scenarios, such as in patients with cancer. Future studies are warranted to assess how palliative care models can be implemented in different disease states and health care settings, they said.

“These new studies should continue to highlight the fact that palliative care is not about terminal diseases and dying,” Dr. Bloem and colleagues concluded. “As Kluger and colleagues indicate in their important clinical trial, palliative care is about how to live well.”

Six authors reported receiving a grant from the Patient-Centered Outcomes Research Institute, which was the funding source for the study. Two authors reported receiving grants from the University Hospital Foundation during the study. One author reported receiving grants from Allergan and Merz Pharma and is a consultant for GE Pharmaceuticals and Sunovion Pharmaceuticals; another reported receiving grants from the Archstone Foundation, the California Health Care Foundation, the Cambia Health Foundation, the Gordon and Betty Moore Foundation, the National Institute of Nursing Research, the Stupski Foundation, and the UniHealth Foundation. Dr. Bloem and a colleague reported their institution received a center of excellence grant from the Parkinson’s Foundation.

SOURCE: Kluger B et al. JAMA Neurol. doi: 10.1001/jamaneurol.2019.4992.

After 12 months of receiving palliative care in an outpatient setting in addition to standard care, patients with Parkinson’s disease and related disorders (PDRD) had improved quality of life (QoL), compared with patients who received standard care alone, according to results from a randomized clinical trial in JAMA Neurology.

The benefits of palliative care even extended to patients’ caregivers, who also appeared to benefit from outpatient palliative care at the 12-month mark, according to lead author Benzi M. Kluger, MD, of the department of neurology, University of Colorado at Denver, Aurora, and colleagues.

Between November 2015 and September 2017, Dr. Kluger and colleagues included 210 patients into the trial from three participating academic tertiary care centers who had “moderate to high palliative care needs” as assessed by the Palliative Care Needs Assessment Tool, which the researchers said are “common reasons for referral” and “reflect a desire to meet patient-centered needs rather than disease-centered markers.” Patients were primarily non-Hispanic white men with a mean age of about 70 years. The researchers also included 175 caregivers in the trial, most of whom were women, spouses to the patients, and in their caregiver role for over 5.5 years.

Patients with PDRD were randomized to receive standard care – usual care through their primary care physician and a neurologist – or “integrated outpatient palliative care,” from a team consisting of a palliative neurologist, nurse, social worker, chaplain, and board-certified palliative medicine physician. The goal of palliative care was addressing “nonmotor symptoms, goals of care, anticipatory guidance, difficult emotions, and caregiver support,” which patients received every 3 months through an in-person outpatient visit or telemedicine.

Quality of life for patients was measured through the Quality of Life in Alzheimer’s Disease (QoL-AD) scale, and caregiver burden was assessed with the Zarit Burden Interview (ZBI-12). The researchers also measured symptom burden and other QoL measures using the Edmonton Symptom Assessment Scale–Revised for Parkinson’s Disease, Parkinson’s Disease Questionnaire, Hospital Anxiety and Depression Scale, Prolonged Grief Disorder questionnaire, and Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being.

Overall, 87 of 105 (82.1%) of patients in the palliative care group went to all their outpatient palliative care visits, and 19 of 106 (17.9%) patients received palliative care through telemedicine. Patients in the palliative care group also attended more neurology visits (4.66 visits) than those in the standard care (3.16 visits) group.

Quality of life significantly improved for patients in the palliative care group, compared with patients receiving standard care only at 6 months (0.66 vs. –0.84; between-group difference, 1.87; 95% confidence interval, 0.47-3.27; P = .009) and at 12 months (0.68 vs. –0.42; between-group difference, 1.36; 95% CI, −0.01 to 2.73; P = .05). These results remained significant at 6 months and 12 months after researchers used multiple imputation to fill in missing data. While there was no significant difference in caregiver burden between groups at 6 months, there was a statistically significant difference at 12 months favoring the palliative care group (between-group difference, −2.60; 95% CI, −4.58 to −0.61; P = .01).

Patients receiving palliative care also had better nonmotor symptom burden, motor symptom severity, and were more likely to complete advance directives, compared with patients receiving standard care alone. “We hypothesize that motor improvements may have reflected an unanticipated benefit of our palliative care team’s general goal of encouraging activities that promoted joy, meaning, and connection,” Dr. Kluger and colleagues said. Researchers also noted that the intervention patients with greater need for palliative care tended to benefit more than patients with patients with lower palliative care needs.

“Because the palliative care intervention is time-intensive and resource-intensive, future studies should optimize triage tools and consider alternative models of care delivery, such as telemedicine or care navigators, to provide key aspects of the intervention at lower cost,” they said.

In a related editorial, Bastiaan R. Bloem, MD, PhD, from the Center of Expertise for Parkinson & Movement Disorders, at Radboud University Medical Center, in the Netherlands, and colleagues acknowledged that the study by Kluger et al. is “timely and practical” because it introduces a system for outpatient palliative care for patients with PDRD at a time when there is “growing awareness that palliative care may also benefit persons with neurodegenerative diseases like Parkinson’s disease.”

The study is also important because it highlights that patients at varying stages of disease, including mild disease, may benefit from an integrated outpatient palliative model, which is not usually considered when determining candidates for palliative care in other scenarios, such as in patients with cancer. Future studies are warranted to assess how palliative care models can be implemented in different disease states and health care settings, they said.

“These new studies should continue to highlight the fact that palliative care is not about terminal diseases and dying,” Dr. Bloem and colleagues concluded. “As Kluger and colleagues indicate in their important clinical trial, palliative care is about how to live well.”

Six authors reported receiving a grant from the Patient-Centered Outcomes Research Institute, which was the funding source for the study. Two authors reported receiving grants from the University Hospital Foundation during the study. One author reported receiving grants from Allergan and Merz Pharma and is a consultant for GE Pharmaceuticals and Sunovion Pharmaceuticals; another reported receiving grants from the Archstone Foundation, the California Health Care Foundation, the Cambia Health Foundation, the Gordon and Betty Moore Foundation, the National Institute of Nursing Research, the Stupski Foundation, and the UniHealth Foundation. Dr. Bloem and a colleague reported their institution received a center of excellence grant from the Parkinson’s Foundation.

SOURCE: Kluger B et al. JAMA Neurol. doi: 10.1001/jamaneurol.2019.4992.

ORLANDO – Do you have pediatric patients with atopic dermatitis (AD) flares despite complying with treatment, or those who have a new rash in an unusual area? Consider patch testing to assess whether they have allergic contact dermatitis.

Jeff Craven/MDedge News

“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.

Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.

“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.

He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.

When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).

But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.

Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.

Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).

All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.

One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.

“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.

In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.

SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.

SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.

Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.

Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”

Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).

Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.

For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.

Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.

ORLANDO – Do you have pediatric patients with atopic dermatitis (AD) flares despite complying with treatment, or those who have a new rash in an unusual area? Consider patch testing to assess whether they have allergic contact dermatitis.

Jeff Craven/MDedge News

“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.

Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.

“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.

He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.

When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).

But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.

Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.

Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).

All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.

One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.

“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.

In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.

SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.

SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.

Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.

Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”

Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).

Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.

For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.

Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.

ORLANDO – Do you have pediatric patients with atopic dermatitis (AD) flares despite complying with treatment, or those who have a new rash in an unusual area? Consider patch testing to assess whether they have allergic contact dermatitis.

Jeff Craven/MDedge News

“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.

Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.

“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.

He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.

When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).

But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.

Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.

Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).

All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.

One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.

“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.

In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.

SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.

SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.

Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.

Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”

Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).

Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.

For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.

Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

ORLANDO – Dermatologists may have to contend with some of mankind’s oldest diseases – from group A streptococcus to measles – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.

While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1_UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.

“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”

Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”

2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.

“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.

In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.

“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”

One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.

“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”

Dr. Finch reported no relevant conflicts of interest.

ORLANDO – Because Food and Drug Administration–approved treatment options for children and adolescents with severe dermatologic diseases are limited, systemic therapies for these patients often require the use of off-label medications. However, this scenario is changing, A. Yasmine Kirkorian, MD, said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Jeff Craven/MDedge News

“I really would like to emphasize that children with severe disease need to be treated,” added Dr. Kirkorian, a pediatric dermatologist at George Washington University, Washington, and Children’s National Health System, where she is interim chief of the division of dermatology.

Current on-label systemic therapies for pediatric skin disease include etanercept for psoriasis (4 years and older), ustekinumab for psoriasis (12 years and older), adalimumab for hidradenitis suppurativa (12 years and older), and omalizumab for chronic idiopathic urticaria (12 years and older). A new addition to the list is dupilumab, which was approved for children and adolescents with atopic dermatitis (AD) aged 12 years and older in 2019, she noted.

Dupilumab is currently being studied in children aged 6 months to 12 years, and other clinical trials are evaluating more options for pediatric patients with AD, alopecia areata, and psoriasis. They include a clinical trial of the oral Janus kinase 3 (JAK3) inhibitor PF-06651600 in patients aged 12 years and older with alopecia areata. Six biologic therapies are being evaluated for psoriasis in patients beginning at 6 years: ixekizumab, secukinumab, ustekinumab, guselkumab, brodalumab, and apremilast.

Some systemic therapies are off-label “but used all the time” for dermatologic diseases in pediatrics, Dr. Kirkorian noted. One example is methotrexate, which is approved by the FDA for acute lymphoblastic leukemia, meningeal leukemia, and juvenile idiopathic arthritis down to infancy. Having existing efficacy and safety data for a medication in a pediatric population, even for a different disease, can be helpful when counseling parents of children with severe dermatologic disease. “If you have something, even in an older population of children, it can be reassuring, or you can use evidence from other diseases,” she said.

While methotrexate is a cheap option and approved by the FDA for other pediatric indications down to infancy, the cons of using it to treat AD in pediatric patients are numerous. Treatment requires a number of blood draws for lab testing, which can be discouraging for younger patients, and the reported adverse effect profile may be concerning to some parents, while “in practice doesn’t really occur,” she said. Methotrexate is a teratogen so is not appropriate for teenagers who are sexually active and not using contraception.

The “biggest problem,” though, is the issue of whether methotrexate is effective, since it doesn’t always work for AD, Dr. Kirkorian said. “Even at the highest doses, I often feel that we fail the atopic children,” as opposed to using it to treat psoriasis, “where you know I’m going to get you on something that works.”

In contrast, cyclosporine is FDA approved down to infancy, and works quickly as a bridge to other therapy, and is not expensive, Dr. Kirkorian said. Cons include the need for blood draws, blood pressure checks, drug interactions, and adverse effects, she noted, adding that she tries to use cyclosporine as a bridge to on-label and off-label dupilumab.

Even with FDA approval for dupilumab down to age 12 years, she said it can be difficult to get insurance approval for the on-label treatment for patients in this age group with AD, before they first fail other therapies (even with off-label systemic drugs). For patients under age 12 years, getting approval is even more challenging and requires rigorous documentation of what therapies the child has failed, and how it has affected their quality of life, she said.

“If you send in a letter to the insurance company without an IGA [Investigator Global Assessment] or SCORAD, you’re going to get rejected,” Dr. Kirkorian said. In addition to those two measures, she provides “everything else,” including the impact of the disease on quality of life of patients, and school, she said, adding, “Did they miss school, did they get hospitalized for infections? And do they have comorbid diseases that might help you get approval?”

In pediatric patients with psoriasis, common issues are more likely to be about how insurance dictates step therapy. She has often found that young children may stop responding to etanercept after a few years, which can justify a switch to ustekinumab or a new treatment in a clinical trial, she said. Adolescents with psoriasis can receive ustekinumab, which is approved for psoriasis in patients aged 12-17 years, she said, noting that the infrequent ustekinumab dosing schedule is often beneficial in this population.

When all other approved options fail for young patients with psoriasis, justifying off-label use isn’t always easy. “You just have to make a justification based on the literature, even though it’s off label,” citing available safety information for other diseases, and “demonstrate over and over the impact on quality of life,” which works “most of the time,” Dr. Kirkorian said.

She reported having no conflicts of interest.

ORLANDO – Because Food and Drug Administration–approved treatment options for children and adolescents with severe dermatologic diseases are limited, systemic therapies for these patients often require the use of off-label medications. However, this scenario is changing, A. Yasmine Kirkorian, MD, said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Jeff Craven/MDedge News

“I really would like to emphasize that children with severe disease need to be treated,” added Dr. Kirkorian, a pediatric dermatologist at George Washington University, Washington, and Children’s National Health System, where she is interim chief of the division of dermatology.

Current on-label systemic therapies for pediatric skin disease include etanercept for psoriasis (4 years and older), ustekinumab for psoriasis (12 years and older), adalimumab for hidradenitis suppurativa (12 years and older), and omalizumab for chronic idiopathic urticaria (12 years and older). A new addition to the list is dupilumab, which was approved for children and adolescents with atopic dermatitis (AD) aged 12 years and older in 2019, she noted.

Dupilumab is currently being studied in children aged 6 months to 12 years, and other clinical trials are evaluating more options for pediatric patients with AD, alopecia areata, and psoriasis. They include a clinical trial of the oral Janus kinase 3 (JAK3) inhibitor PF-06651600 in patients aged 12 years and older with alopecia areata. Six biologic therapies are being evaluated for psoriasis in patients beginning at 6 years: ixekizumab, secukinumab, ustekinumab, guselkumab, brodalumab, and apremilast.

Some systemic therapies are off-label “but used all the time” for dermatologic diseases in pediatrics, Dr. Kirkorian noted. One example is methotrexate, which is approved by the FDA for acute lymphoblastic leukemia, meningeal leukemia, and juvenile idiopathic arthritis down to infancy. Having existing efficacy and safety data for a medication in a pediatric population, even for a different disease, can be helpful when counseling parents of children with severe dermatologic disease. “If you have something, even in an older population of children, it can be reassuring, or you can use evidence from other diseases,” she said.

While methotrexate is a cheap option and approved by the FDA for other pediatric indications down to infancy, the cons of using it to treat AD in pediatric patients are numerous. Treatment requires a number of blood draws for lab testing, which can be discouraging for younger patients, and the reported adverse effect profile may be concerning to some parents, while “in practice doesn’t really occur,” she said. Methotrexate is a teratogen so is not appropriate for teenagers who are sexually active and not using contraception.

The “biggest problem,” though, is the issue of whether methotrexate is effective, since it doesn’t always work for AD, Dr. Kirkorian said. “Even at the highest doses, I often feel that we fail the atopic children,” as opposed to using it to treat psoriasis, “where you know I’m going to get you on something that works.”

In contrast, cyclosporine is FDA approved down to infancy, and works quickly as a bridge to other therapy, and is not expensive, Dr. Kirkorian said. Cons include the need for blood draws, blood pressure checks, drug interactions, and adverse effects, she noted, adding that she tries to use cyclosporine as a bridge to on-label and off-label dupilumab.

Even with FDA approval for dupilumab down to age 12 years, she said it can be difficult to get insurance approval for the on-label treatment for patients in this age group with AD, before they first fail other therapies (even with off-label systemic drugs). For patients under age 12 years, getting approval is even more challenging and requires rigorous documentation of what therapies the child has failed, and how it has affected their quality of life, she said.

“If you send in a letter to the insurance company without an IGA [Investigator Global Assessment] or SCORAD, you’re going to get rejected,” Dr. Kirkorian said. In addition to those two measures, she provides “everything else,” including the impact of the disease on quality of life of patients, and school, she said, adding, “Did they miss school, did they get hospitalized for infections? And do they have comorbid diseases that might help you get approval?”

In pediatric patients with psoriasis, common issues are more likely to be about how insurance dictates step therapy. She has often found that young children may stop responding to etanercept after a few years, which can justify a switch to ustekinumab or a new treatment in a clinical trial, she said. Adolescents with psoriasis can receive ustekinumab, which is approved for psoriasis in patients aged 12-17 years, she said, noting that the infrequent ustekinumab dosing schedule is often beneficial in this population.

When all other approved options fail for young patients with psoriasis, justifying off-label use isn’t always easy. “You just have to make a justification based on the literature, even though it’s off label,” citing available safety information for other diseases, and “demonstrate over and over the impact on quality of life,” which works “most of the time,” Dr. Kirkorian said.

She reported having no conflicts of interest.

ORLANDO – Because Food and Drug Administration–approved treatment options for children and adolescents with severe dermatologic diseases are limited, systemic therapies for these patients often require the use of off-label medications. However, this scenario is changing, A. Yasmine Kirkorian, MD, said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Jeff Craven/MDedge News

“I really would like to emphasize that children with severe disease need to be treated,” added Dr. Kirkorian, a pediatric dermatologist at George Washington University, Washington, and Children’s National Health System, where she is interim chief of the division of dermatology.

Current on-label systemic therapies for pediatric skin disease include etanercept for psoriasis (4 years and older), ustekinumab for psoriasis (12 years and older), adalimumab for hidradenitis suppurativa (12 years and older), and omalizumab for chronic idiopathic urticaria (12 years and older). A new addition to the list is dupilumab, which was approved for children and adolescents with atopic dermatitis (AD) aged 12 years and older in 2019, she noted.

Dupilumab is currently being studied in children aged 6 months to 12 years, and other clinical trials are evaluating more options for pediatric patients with AD, alopecia areata, and psoriasis. They include a clinical trial of the oral Janus kinase 3 (JAK3) inhibitor PF-06651600 in patients aged 12 years and older with alopecia areata. Six biologic therapies are being evaluated for psoriasis in patients beginning at 6 years: ixekizumab, secukinumab, ustekinumab, guselkumab, brodalumab, and apremilast.

Some systemic therapies are off-label “but used all the time” for dermatologic diseases in pediatrics, Dr. Kirkorian noted. One example is methotrexate, which is approved by the FDA for acute lymphoblastic leukemia, meningeal leukemia, and juvenile idiopathic arthritis down to infancy. Having existing efficacy and safety data for a medication in a pediatric population, even for a different disease, can be helpful when counseling parents of children with severe dermatologic disease. “If you have something, even in an older population of children, it can be reassuring, or you can use evidence from other diseases,” she said.

While methotrexate is a cheap option and approved by the FDA for other pediatric indications down to infancy, the cons of using it to treat AD in pediatric patients are numerous. Treatment requires a number of blood draws for lab testing, which can be discouraging for younger patients, and the reported adverse effect profile may be concerning to some parents, while “in practice doesn’t really occur,” she said. Methotrexate is a teratogen so is not appropriate for teenagers who are sexually active and not using contraception.

The “biggest problem,” though, is the issue of whether methotrexate is effective, since it doesn’t always work for AD, Dr. Kirkorian said. “Even at the highest doses, I often feel that we fail the atopic children,” as opposed to using it to treat psoriasis, “where you know I’m going to get you on something that works.”

In contrast, cyclosporine is FDA approved down to infancy, and works quickly as a bridge to other therapy, and is not expensive, Dr. Kirkorian said. Cons include the need for blood draws, blood pressure checks, drug interactions, and adverse effects, she noted, adding that she tries to use cyclosporine as a bridge to on-label and off-label dupilumab.

Even with FDA approval for dupilumab down to age 12 years, she said it can be difficult to get insurance approval for the on-label treatment for patients in this age group with AD, before they first fail other therapies (even with off-label systemic drugs). For patients under age 12 years, getting approval is even more challenging and requires rigorous documentation of what therapies the child has failed, and how it has affected their quality of life, she said.

“If you send in a letter to the insurance company without an IGA [Investigator Global Assessment] or SCORAD, you’re going to get rejected,” Dr. Kirkorian said. In addition to those two measures, she provides “everything else,” including the impact of the disease on quality of life of patients, and school, she said, adding, “Did they miss school, did they get hospitalized for infections? And do they have comorbid diseases that might help you get approval?”

In pediatric patients with psoriasis, common issues are more likely to be about how insurance dictates step therapy. She has often found that young children may stop responding to etanercept after a few years, which can justify a switch to ustekinumab or a new treatment in a clinical trial, she said. Adolescents with psoriasis can receive ustekinumab, which is approved for psoriasis in patients aged 12-17 years, she said, noting that the infrequent ustekinumab dosing schedule is often beneficial in this population.

When all other approved options fail for young patients with psoriasis, justifying off-label use isn’t always easy. “You just have to make a justification based on the literature, even though it’s off label,” citing available safety information for other diseases, and “demonstrate over and over the impact on quality of life,” which works “most of the time,” Dr. Kirkorian said.

She reported having no conflicts of interest.

ORLANDO – Dermatologists should be well versed in addressing common concerns that patients, family members, and the media have about photoprotection, Adam Friedman, MD, advised at the ODAC Dermatology, Aesthetic, & Surgical Conference.

“Know the controversies. Be armed and ready when these patients come to your office with questions,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview at the meeting, where he presented on issues related to photoprotection.

Which SPF to choose and the impact of sunscreen on vitamin D are among the issues patients may be asking about.

Sunscreen SPFs above 50 don’t technically provide a “meaningful” increase in ultraviolet protection, given that this value relates to filtering about 98% of UVB, but they still can provide some benefit, which has to do with real-world human error, Dr. Friedman said.

“Most people don’t use sunscreens the right way,” meaning they don’t apply enough to achieve the SPF listed, he added in the interview. “A higher SPF is meaningful, because if they apply less [sunscreen], they actually still are in that safety window,” with the higher SPF sunscreen. (The American Academy of Dermatology recommends an SPF of 30 or higher.) Several studies have shown that a SPF of 70 or 100 is superior to 50, likely because of this “dilutional” effect.

Patients may have concerns about the effects of sunscreen on vitamin D production, the environment, and hair loss, and whether they have endocrine disrupting effects, added Dr. Friedman, who is also the medical director of the meeting.

Inhibition of cutaneous vitamin D synthesis after using sunscreen can vary, based on whether a person has properly applied sunscreen, the season, latitude, and an individual’s age and obesity level. Patients with low vitamin D levels can use a vitamin D supplement to achieve sufficient levels, and patients concerned about the impact of sunscreen and vitamin D can be advised to take 600 IU of vitamin D3 a day, according to Dr. Friedman. Some studies have suggested that UVB exposure and risk of certain cancers are inversely correlated, implicating cutaneous vitamin D synthesis (J Clin Transl Endocrinol. 2014 Oct 5;1[4]:179-86). But correlation does not equal causation, he pointed out.

Other concerns stem from the potential for oxybenzone, a UVA/UVB filter in more than 70% of sunscreens, to act as an endocrine disruptor in people and whether it is potentially damaging the environment. The data driving these concerns “stem from the bench, not the real world,” Dr. Friedman said. While topical application of oxybenzone can result in systemic absorption, and even though it’s been detected in waters that are heavily populated or where people go on vacation, there is no evidence demonstrating toxicity to humans or the coral reefs. “At least the information we have to date says they don’t,” he added.

In a randomized clinical trial recently published in JAMA, Food and Drug Administration investigators found that systemic skin absorption with geometric mean plasma concentrations greater than 0.5 ng/mL with six active ingredients in sunscreen that were tested, including oxybenzone (JAMA. 2020;323[3]:256-7). The study was part of an FDA proposed rule requesting additional information on sunscreen ingredients; the plasma concentrations exceeded the level at which further safety studies could potentially be waived.

The study, Dr. Friedman said, “only demonstrated the ability to detect these UV filters at very small concentrations in the blood. They have yet to show any meaningful biologic correlation to these findings.”

For those patients who prefer not to use chemical filters, Dr. Friedman suggests recommending mineral-based sunscreens, of which he said micro- and nanoparticulate formulations offer the best cosmesis by sitting more evenly on the skin, being more amenable to thinner and less-lipophilic vehicles, and limiting visible light scattering (thereby limiting the unsightly white appearance) – while maintaining UV scattering efficacy. However, controversy has emerged as there are past studies that posit the theoretical danger of nanoparticles in sunscreens, given their potential to penetrate the skin and enter cells.

But continually emerging evidence has shown that commercially available nanosunscreens are safe, with no toxicity even at the cellular level when applied to the skin in sunscreen or in cosmetics. “All evidence to date suggests they do not do this,” Dr. Friedman said, noting that, in Europe, the European Commission’s Scientific Committee on Consumer Safety has stated that nanoparticles below a concentration of 25% in sunscreens is safe, “just don’t put them in aerosolized forms.”

Lastly, while some recent studies have detected titanium dioxide on the hair shafts of patients with and without frontal fibrosing alopecia, Dr. Friedman noted more evidence is needed before recommending that these patients avoid using sunscreen (Br J Dermatol. 2019 Jul;181[1]:216-7). “Correlation does not mean causation, and the current dogma is that there’s no connection between these two,” he commented.

Dr. Friedman reported consulting and advisory board relationships with numerous companies; he also reported speaking for Regeneron, Abbvie, and Dermira, and receiving grants with Pfizer and DF Pharma.

ORLANDO – Dermatologists should be well versed in addressing common concerns that patients, family members, and the media have about photoprotection, Adam Friedman, MD, advised at the ODAC Dermatology, Aesthetic, & Surgical Conference.

“Know the controversies. Be armed and ready when these patients come to your office with questions,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview at the meeting, where he presented on issues related to photoprotection.

Which SPF to choose and the impact of sunscreen on vitamin D are among the issues patients may be asking about.

Sunscreen SPFs above 50 don’t technically provide a “meaningful” increase in ultraviolet protection, given that this value relates to filtering about 98% of UVB, but they still can provide some benefit, which has to do with real-world human error, Dr. Friedman said.

“Most people don’t use sunscreens the right way,” meaning they don’t apply enough to achieve the SPF listed, he added in the interview. “A higher SPF is meaningful, because if they apply less [sunscreen], they actually still are in that safety window,” with the higher SPF sunscreen. (The American Academy of Dermatology recommends an SPF of 30 or higher.) Several studies have shown that a SPF of 70 or 100 is superior to 50, likely because of this “dilutional” effect.

Patients may have concerns about the effects of sunscreen on vitamin D production, the environment, and hair loss, and whether they have endocrine disrupting effects, added Dr. Friedman, who is also the medical director of the meeting.

Inhibition of cutaneous vitamin D synthesis after using sunscreen can vary, based on whether a person has properly applied sunscreen, the season, latitude, and an individual’s age and obesity level. Patients with low vitamin D levels can use a vitamin D supplement to achieve sufficient levels, and patients concerned about the impact of sunscreen and vitamin D can be advised to take 600 IU of vitamin D3 a day, according to Dr. Friedman. Some studies have suggested that UVB exposure and risk of certain cancers are inversely correlated, implicating cutaneous vitamin D synthesis (J Clin Transl Endocrinol. 2014 Oct 5;1[4]:179-86). But correlation does not equal causation, he pointed out.

Other concerns stem from the potential for oxybenzone, a UVA/UVB filter in more than 70% of sunscreens, to act as an endocrine disruptor in people and whether it is potentially damaging the environment. The data driving these concerns “stem from the bench, not the real world,” Dr. Friedman said. While topical application of oxybenzone can result in systemic absorption, and even though it’s been detected in waters that are heavily populated or where people go on vacation, there is no evidence demonstrating toxicity to humans or the coral reefs. “At least the information we have to date says they don’t,” he added.

In a randomized clinical trial recently published in JAMA, Food and Drug Administration investigators found that systemic skin absorption with geometric mean plasma concentrations greater than 0.5 ng/mL with six active ingredients in sunscreen that were tested, including oxybenzone (JAMA. 2020;323[3]:256-7). The study was part of an FDA proposed rule requesting additional information on sunscreen ingredients; the plasma concentrations exceeded the level at which further safety studies could potentially be waived.

The study, Dr. Friedman said, “only demonstrated the ability to detect these UV filters at very small concentrations in the blood. They have yet to show any meaningful biologic correlation to these findings.”

For those patients who prefer not to use chemical filters, Dr. Friedman suggests recommending mineral-based sunscreens, of which he said micro- and nanoparticulate formulations offer the best cosmesis by sitting more evenly on the skin, being more amenable to thinner and less-lipophilic vehicles, and limiting visible light scattering (thereby limiting the unsightly white appearance) – while maintaining UV scattering efficacy. However, controversy has emerged as there are past studies that posit the theoretical danger of nanoparticles in sunscreens, given their potential to penetrate the skin and enter cells.

But continually emerging evidence has shown that commercially available nanosunscreens are safe, with no toxicity even at the cellular level when applied to the skin in sunscreen or in cosmetics. “All evidence to date suggests they do not do this,” Dr. Friedman said, noting that, in Europe, the European Commission’s Scientific Committee on Consumer Safety has stated that nanoparticles below a concentration of 25% in sunscreens is safe, “just don’t put them in aerosolized forms.”

Lastly, while some recent studies have detected titanium dioxide on the hair shafts of patients with and without frontal fibrosing alopecia, Dr. Friedman noted more evidence is needed before recommending that these patients avoid using sunscreen (Br J Dermatol. 2019 Jul;181[1]:216-7). “Correlation does not mean causation, and the current dogma is that there’s no connection between these two,” he commented.

Dr. Friedman reported consulting and advisory board relationships with numerous companies; he also reported speaking for Regeneron, Abbvie, and Dermira, and receiving grants with Pfizer and DF Pharma.

ORLANDO – Dermatologists should be well versed in addressing common concerns that patients, family members, and the media have about photoprotection, Adam Friedman, MD, advised at the ODAC Dermatology, Aesthetic, & Surgical Conference.

“Know the controversies. Be armed and ready when these patients come to your office with questions,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview at the meeting, where he presented on issues related to photoprotection.

Which SPF to choose and the impact of sunscreen on vitamin D are among the issues patients may be asking about.

Sunscreen SPFs above 50 don’t technically provide a “meaningful” increase in ultraviolet protection, given that this value relates to filtering about 98% of UVB, but they still can provide some benefit, which has to do with real-world human error, Dr. Friedman said.

“Most people don’t use sunscreens the right way,” meaning they don’t apply enough to achieve the SPF listed, he added in the interview. “A higher SPF is meaningful, because if they apply less [sunscreen], they actually still are in that safety window,” with the higher SPF sunscreen. (The American Academy of Dermatology recommends an SPF of 30 or higher.) Several studies have shown that a SPF of 70 or 100 is superior to 50, likely because of this “dilutional” effect.

Patients may have concerns about the effects of sunscreen on vitamin D production, the environment, and hair loss, and whether they have endocrine disrupting effects, added Dr. Friedman, who is also the medical director of the meeting.

Inhibition of cutaneous vitamin D synthesis after using sunscreen can vary, based on whether a person has properly applied sunscreen, the season, latitude, and an individual’s age and obesity level. Patients with low vitamin D levels can use a vitamin D supplement to achieve sufficient levels, and patients concerned about the impact of sunscreen and vitamin D can be advised to take 600 IU of vitamin D3 a day, according to Dr. Friedman. Some studies have suggested that UVB exposure and risk of certain cancers are inversely correlated, implicating cutaneous vitamin D synthesis (J Clin Transl Endocrinol. 2014 Oct 5;1[4]:179-86). But correlation does not equal causation, he pointed out.

Other concerns stem from the potential for oxybenzone, a UVA/UVB filter in more than 70% of sunscreens, to act as an endocrine disruptor in people and whether it is potentially damaging the environment. The data driving these concerns “stem from the bench, not the real world,” Dr. Friedman said. While topical application of oxybenzone can result in systemic absorption, and even though it’s been detected in waters that are heavily populated or where people go on vacation, there is no evidence demonstrating toxicity to humans or the coral reefs. “At least the information we have to date says they don’t,” he added.

In a randomized clinical trial recently published in JAMA, Food and Drug Administration investigators found that systemic skin absorption with geometric mean plasma concentrations greater than 0.5 ng/mL with six active ingredients in sunscreen that were tested, including oxybenzone (JAMA. 2020;323[3]:256-7). The study was part of an FDA proposed rule requesting additional information on sunscreen ingredients; the plasma concentrations exceeded the level at which further safety studies could potentially be waived.

The study, Dr. Friedman said, “only demonstrated the ability to detect these UV filters at very small concentrations in the blood. They have yet to show any meaningful biologic correlation to these findings.”

For those patients who prefer not to use chemical filters, Dr. Friedman suggests recommending mineral-based sunscreens, of which he said micro- and nanoparticulate formulations offer the best cosmesis by sitting more evenly on the skin, being more amenable to thinner and less-lipophilic vehicles, and limiting visible light scattering (thereby limiting the unsightly white appearance) – while maintaining UV scattering efficacy. However, controversy has emerged as there are past studies that posit the theoretical danger of nanoparticles in sunscreens, given their potential to penetrate the skin and enter cells.

But continually emerging evidence has shown that commercially available nanosunscreens are safe, with no toxicity even at the cellular level when applied to the skin in sunscreen or in cosmetics. “All evidence to date suggests they do not do this,” Dr. Friedman said, noting that, in Europe, the European Commission’s Scientific Committee on Consumer Safety has stated that nanoparticles below a concentration of 25% in sunscreens is safe, “just don’t put them in aerosolized forms.”

Lastly, while some recent studies have detected titanium dioxide on the hair shafts of patients with and without frontal fibrosing alopecia, Dr. Friedman noted more evidence is needed before recommending that these patients avoid using sunscreen (Br J Dermatol. 2019 Jul;181[1]:216-7). “Correlation does not mean causation, and the current dogma is that there’s no connection between these two,” he commented.

Dr. Friedman reported consulting and advisory board relationships with numerous companies; he also reported speaking for Regeneron, Abbvie, and Dermira, and receiving grants with Pfizer and DF Pharma.