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Use of complimentary and alternative medicine common in diabetes patients

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An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.

Dr. Gregory Rhee

The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.

Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.

Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.

He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.

Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).

Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).

When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).

Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).

Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.

The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.

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An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.

Dr. Gregory Rhee

The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.

Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.

Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.

He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.

Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).

Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).

When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).

Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).

Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.

The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.

An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.

Dr. Gregory Rhee

The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.

Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.

Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.

He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.

Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).

Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).

When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).

Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).

Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.

The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.

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FROM THE EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

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Contact dermatitis content varies among social media sites

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Tue, 03/30/2021 - 15:04

Physicians are active on social media with contact dermatitis content, but they can take more advantage of this opportunity to educate patients, according to a review of posts on YouTube, Facebook, Instagram, Google, Twitter, and Reddit.

Data on social media use suggest that approximately 65% of U.S. adults regularly use social media, and 40% of individuals use it in making medical decisions, Morgan Nguyen, a medical student at Northwestern University, Chicago, said at the annual meeting of the American Contact Dermatitis Society, held virtually this year.

“Dermatologists’ awareness of social media discussions can further their understanding of where patients go for information and what they might encounter,” she said. In particular, “contact dermatitis practitioners can tailor their counseling by knowing what their patients are seeing online.”

To characterize the social media landscape for content related to allergic contact dermatitis (ACD), Ms. Nguyen and colleagues assessed metrics on content and authorship on six different platforms.

For YouTube, the authors reviewed 15 videos related to ACD with views ranging from 24,262 to 232,300. Of these videos, two were produced as medical education, four were produced by patients, and nine were produced by physicians. The content of many videos was poor quality, with an average QUEST score of 7.4/28 overall and 8.7 for physician videos. Video quality was not associated with increased views. Video titles included “What to do if you have a rash on your face,” and “Contact dermatitis on lips!”

Overall, Instagram was more popular than Twitter, particularly among patients. The investigators searched using the hashtags #ContactDermatitis, #AllergicContactDermatitis, and #ContactDerm and reviewed the 100 most recent posts for authorship. The most recent 100 posts occurred over 16 days; physicians, patients, and companies each contributed approximately one-third of the content, but patient content was more focused on symptoms, treatment progress, and advice.

For Instagram, the hashtag search phrase made a notable difference in authorship, Ms. Nguyen said. Physicians were disproportionately more likely to use #AllergicContactDermatitis (43%) compared with patients (22%).

On Twitter, the most recent 100 posts were spread over 152 days, and professional organizations and companies generated approximately two-thirds of the posts. The #ContactDermatitis hashtag was the most common, and accounted for 94% of tweets.



Although patient support groups specific to ACD exist on Facebook, the researchers found none on Reddit. These two venues are designed for creating online communities, rather than simply providing information, and the researchers searched for support groups related to contact dermatitis. One of the main differences between the two is that Facebook allows for the creation of private groups, while Reddit is an open forum.

The largest contact dermatitis Facebook group, the “Eczema, Contact Dermatitis and Patch Testing Alliance,” had 4,665 members at the time of the study, and most groups were private. Although no support groups existed on Reddit, titles of Reddit forums discussing ACD included allergies, askdoctors, fragrance, haircarescience, legaladvice, skincareaddicts, beauty, dermatologyquestions, medical_advice, skincare_addiction, tretinoin, and vulvodynia.

For Google, the researchers used terms similar to “contact dermatitis” as generated by the Google Keyword Planner tool, and used Google Adwords data to estimate monthly searches. The top estimated term was “contact dermatitis,” with 8,322 searches, followed by “contact dermatitis pictures,” with 1,666 searches, and “contact dermatitis treatment” with 595 searches. By contrast, “allergic dermatitis” had an estimated 346 monthly searches, and “allergic contact dermatitis” had 194.

Overall, approximately 9,000 searches each month involve “contact dermatitis,” “allergic contact dermatitis,” or “allergic dermatitis,” said Ms. Nguyen. However, these estimated searches seemed comparatively low, given the high burden of ACD, she said. Although ACD ranks eighth among skin diseases based on health care costs, psoriasis (fourteenth based on health care costs) shows an estimated monthly Google search volume of 600,462, she pointed out.

The study findings were limited by several factors including the potential impact of the COVID-19 pandemic on social media use, and by the lack of specificity associated with the search term “contact dermatitis,” which is not unique to ACD, Ms. Nguyen said.

Although more research on quality assessment is needed, the results suggest that social media is a popular venue for ACD patients to seek and share information, Ms. Nguyen emphasized. There is an opportunity for patch testing physicians to create and disperse educational content for patients using these sites, she concluded.
 

Study highlights education opportunities

“Due to the pandemic, patients have been increasingly interacting with online resources in lieu of coming to a physician’s office,” corresponding author Walter J. Liszewski, MD, of the department of dermatology, Northwestern University, Chicago, said in an interview. “As social media is increasingly used by patients and physicians, it is important to get a sense of its footprint,” he said.

He and Ms. Nguyen were surprised by several of their findings: First, searches for ACD on Google were not particularly common given its relatively high prevalence and economic cost to society. In addition, they found that physicians often used different language than that of patients to describe ACD on Twitter and Instagram. They were also surprised at how often ACD appeared in Reddit posts, which they noted highlights that ACD impacts multiple sections of society.

The greatest challenge in studying social media and medicine is the quality of material available, Dr. Liszewski and Ms. Nguyen observed, emphasizing that while there are numerous videos on ACD on YouTube, the quality is highly variable, and there is a need for more patient-centered, educational materials. However, the results of their study highlight the opportunity for physicians and industry to create medically-accurate educational materials, they added.

Ms. Nguyen and Dr. Liszewski had no financial conflicts to disclose.

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Physicians are active on social media with contact dermatitis content, but they can take more advantage of this opportunity to educate patients, according to a review of posts on YouTube, Facebook, Instagram, Google, Twitter, and Reddit.

Data on social media use suggest that approximately 65% of U.S. adults regularly use social media, and 40% of individuals use it in making medical decisions, Morgan Nguyen, a medical student at Northwestern University, Chicago, said at the annual meeting of the American Contact Dermatitis Society, held virtually this year.

“Dermatologists’ awareness of social media discussions can further their understanding of where patients go for information and what they might encounter,” she said. In particular, “contact dermatitis practitioners can tailor their counseling by knowing what their patients are seeing online.”

To characterize the social media landscape for content related to allergic contact dermatitis (ACD), Ms. Nguyen and colleagues assessed metrics on content and authorship on six different platforms.

For YouTube, the authors reviewed 15 videos related to ACD with views ranging from 24,262 to 232,300. Of these videos, two were produced as medical education, four were produced by patients, and nine were produced by physicians. The content of many videos was poor quality, with an average QUEST score of 7.4/28 overall and 8.7 for physician videos. Video quality was not associated with increased views. Video titles included “What to do if you have a rash on your face,” and “Contact dermatitis on lips!”

Overall, Instagram was more popular than Twitter, particularly among patients. The investigators searched using the hashtags #ContactDermatitis, #AllergicContactDermatitis, and #ContactDerm and reviewed the 100 most recent posts for authorship. The most recent 100 posts occurred over 16 days; physicians, patients, and companies each contributed approximately one-third of the content, but patient content was more focused on symptoms, treatment progress, and advice.

For Instagram, the hashtag search phrase made a notable difference in authorship, Ms. Nguyen said. Physicians were disproportionately more likely to use #AllergicContactDermatitis (43%) compared with patients (22%).

On Twitter, the most recent 100 posts were spread over 152 days, and professional organizations and companies generated approximately two-thirds of the posts. The #ContactDermatitis hashtag was the most common, and accounted for 94% of tweets.



Although patient support groups specific to ACD exist on Facebook, the researchers found none on Reddit. These two venues are designed for creating online communities, rather than simply providing information, and the researchers searched for support groups related to contact dermatitis. One of the main differences between the two is that Facebook allows for the creation of private groups, while Reddit is an open forum.

The largest contact dermatitis Facebook group, the “Eczema, Contact Dermatitis and Patch Testing Alliance,” had 4,665 members at the time of the study, and most groups were private. Although no support groups existed on Reddit, titles of Reddit forums discussing ACD included allergies, askdoctors, fragrance, haircarescience, legaladvice, skincareaddicts, beauty, dermatologyquestions, medical_advice, skincare_addiction, tretinoin, and vulvodynia.

For Google, the researchers used terms similar to “contact dermatitis” as generated by the Google Keyword Planner tool, and used Google Adwords data to estimate monthly searches. The top estimated term was “contact dermatitis,” with 8,322 searches, followed by “contact dermatitis pictures,” with 1,666 searches, and “contact dermatitis treatment” with 595 searches. By contrast, “allergic dermatitis” had an estimated 346 monthly searches, and “allergic contact dermatitis” had 194.

Overall, approximately 9,000 searches each month involve “contact dermatitis,” “allergic contact dermatitis,” or “allergic dermatitis,” said Ms. Nguyen. However, these estimated searches seemed comparatively low, given the high burden of ACD, she said. Although ACD ranks eighth among skin diseases based on health care costs, psoriasis (fourteenth based on health care costs) shows an estimated monthly Google search volume of 600,462, she pointed out.

The study findings were limited by several factors including the potential impact of the COVID-19 pandemic on social media use, and by the lack of specificity associated with the search term “contact dermatitis,” which is not unique to ACD, Ms. Nguyen said.

Although more research on quality assessment is needed, the results suggest that social media is a popular venue for ACD patients to seek and share information, Ms. Nguyen emphasized. There is an opportunity for patch testing physicians to create and disperse educational content for patients using these sites, she concluded.
 

Study highlights education opportunities

“Due to the pandemic, patients have been increasingly interacting with online resources in lieu of coming to a physician’s office,” corresponding author Walter J. Liszewski, MD, of the department of dermatology, Northwestern University, Chicago, said in an interview. “As social media is increasingly used by patients and physicians, it is important to get a sense of its footprint,” he said.

He and Ms. Nguyen were surprised by several of their findings: First, searches for ACD on Google were not particularly common given its relatively high prevalence and economic cost to society. In addition, they found that physicians often used different language than that of patients to describe ACD on Twitter and Instagram. They were also surprised at how often ACD appeared in Reddit posts, which they noted highlights that ACD impacts multiple sections of society.

The greatest challenge in studying social media and medicine is the quality of material available, Dr. Liszewski and Ms. Nguyen observed, emphasizing that while there are numerous videos on ACD on YouTube, the quality is highly variable, and there is a need for more patient-centered, educational materials. However, the results of their study highlight the opportunity for physicians and industry to create medically-accurate educational materials, they added.

Ms. Nguyen and Dr. Liszewski had no financial conflicts to disclose.

Physicians are active on social media with contact dermatitis content, but they can take more advantage of this opportunity to educate patients, according to a review of posts on YouTube, Facebook, Instagram, Google, Twitter, and Reddit.

Data on social media use suggest that approximately 65% of U.S. adults regularly use social media, and 40% of individuals use it in making medical decisions, Morgan Nguyen, a medical student at Northwestern University, Chicago, said at the annual meeting of the American Contact Dermatitis Society, held virtually this year.

“Dermatologists’ awareness of social media discussions can further their understanding of where patients go for information and what they might encounter,” she said. In particular, “contact dermatitis practitioners can tailor their counseling by knowing what their patients are seeing online.”

To characterize the social media landscape for content related to allergic contact dermatitis (ACD), Ms. Nguyen and colleagues assessed metrics on content and authorship on six different platforms.

For YouTube, the authors reviewed 15 videos related to ACD with views ranging from 24,262 to 232,300. Of these videos, two were produced as medical education, four were produced by patients, and nine were produced by physicians. The content of many videos was poor quality, with an average QUEST score of 7.4/28 overall and 8.7 for physician videos. Video quality was not associated with increased views. Video titles included “What to do if you have a rash on your face,” and “Contact dermatitis on lips!”

Overall, Instagram was more popular than Twitter, particularly among patients. The investigators searched using the hashtags #ContactDermatitis, #AllergicContactDermatitis, and #ContactDerm and reviewed the 100 most recent posts for authorship. The most recent 100 posts occurred over 16 days; physicians, patients, and companies each contributed approximately one-third of the content, but patient content was more focused on symptoms, treatment progress, and advice.

For Instagram, the hashtag search phrase made a notable difference in authorship, Ms. Nguyen said. Physicians were disproportionately more likely to use #AllergicContactDermatitis (43%) compared with patients (22%).

On Twitter, the most recent 100 posts were spread over 152 days, and professional organizations and companies generated approximately two-thirds of the posts. The #ContactDermatitis hashtag was the most common, and accounted for 94% of tweets.



Although patient support groups specific to ACD exist on Facebook, the researchers found none on Reddit. These two venues are designed for creating online communities, rather than simply providing information, and the researchers searched for support groups related to contact dermatitis. One of the main differences between the two is that Facebook allows for the creation of private groups, while Reddit is an open forum.

The largest contact dermatitis Facebook group, the “Eczema, Contact Dermatitis and Patch Testing Alliance,” had 4,665 members at the time of the study, and most groups were private. Although no support groups existed on Reddit, titles of Reddit forums discussing ACD included allergies, askdoctors, fragrance, haircarescience, legaladvice, skincareaddicts, beauty, dermatologyquestions, medical_advice, skincare_addiction, tretinoin, and vulvodynia.

For Google, the researchers used terms similar to “contact dermatitis” as generated by the Google Keyword Planner tool, and used Google Adwords data to estimate monthly searches. The top estimated term was “contact dermatitis,” with 8,322 searches, followed by “contact dermatitis pictures,” with 1,666 searches, and “contact dermatitis treatment” with 595 searches. By contrast, “allergic dermatitis” had an estimated 346 monthly searches, and “allergic contact dermatitis” had 194.

Overall, approximately 9,000 searches each month involve “contact dermatitis,” “allergic contact dermatitis,” or “allergic dermatitis,” said Ms. Nguyen. However, these estimated searches seemed comparatively low, given the high burden of ACD, she said. Although ACD ranks eighth among skin diseases based on health care costs, psoriasis (fourteenth based on health care costs) shows an estimated monthly Google search volume of 600,462, she pointed out.

The study findings were limited by several factors including the potential impact of the COVID-19 pandemic on social media use, and by the lack of specificity associated with the search term “contact dermatitis,” which is not unique to ACD, Ms. Nguyen said.

Although more research on quality assessment is needed, the results suggest that social media is a popular venue for ACD patients to seek and share information, Ms. Nguyen emphasized. There is an opportunity for patch testing physicians to create and disperse educational content for patients using these sites, she concluded.
 

Study highlights education opportunities

“Due to the pandemic, patients have been increasingly interacting with online resources in lieu of coming to a physician’s office,” corresponding author Walter J. Liszewski, MD, of the department of dermatology, Northwestern University, Chicago, said in an interview. “As social media is increasingly used by patients and physicians, it is important to get a sense of its footprint,” he said.

He and Ms. Nguyen were surprised by several of their findings: First, searches for ACD on Google were not particularly common given its relatively high prevalence and economic cost to society. In addition, they found that physicians often used different language than that of patients to describe ACD on Twitter and Instagram. They were also surprised at how often ACD appeared in Reddit posts, which they noted highlights that ACD impacts multiple sections of society.

The greatest challenge in studying social media and medicine is the quality of material available, Dr. Liszewski and Ms. Nguyen observed, emphasizing that while there are numerous videos on ACD on YouTube, the quality is highly variable, and there is a need for more patient-centered, educational materials. However, the results of their study highlight the opportunity for physicians and industry to create medically-accurate educational materials, they added.

Ms. Nguyen and Dr. Liszewski had no financial conflicts to disclose.

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New COVID-19 cases rise again in children

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Thu, 08/26/2021 - 15:49

 

The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

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The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

 

The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Just over 64,000 new cases were reported among children for the week of March 19-25 – up from 57,000 the week before, which, in turn, marked the end of an 8-week decline in new cases. That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.

For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.

There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.

The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.

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Asymptomatic Discolored Lesions on the Groin

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The Diagnosis: Lichen Planus Pigmentosus-Inversus 

Histopathologic examination revealed hyperkeratosis with dense, bandlike, lymphocytic inflammation at the dermoepidermal junction with associated melanin-containing macrophages in the papillary dermis (Figure 1). The physical examination and histopathology were consistent with a diagnosis of lichen planus pigmentosus-inversus (LPPI). Treatment was discussed with the patient, with options including phototherapy, tacrolimus, or a high-dose steroid. Given that the lesions were asymptomatic and not bothersome, the patient denied treatment and agreed to routine follow-up. 

Figure 1. Lichen planus pigmentosus-inversus. A, Hyperkeratosis with lymphocytic inflammation at the dermoepidermal junction with melanin-containing macrophages in the papillary dermis (H&E, original magnification ×40). B, Bandlike lymphocytic infiltrate at the dermoepidermal junction (H&E, original magnification ×20).


The first case of LPPI was reported in 20011; since then, approximately 100 cases have been reported in the literature.2 A rare variant of lichen planus, LPPI predominantly occurs in middle-aged women.2,3 Lichen planus pigmentosus-inversus is characterized by well-circumscribed, brown macules confined to non-sun-exposed intertriginous areas such as the axillae and groin.2 Although the rash remains localized, multiple lesions could arise in the same area, such as the groin as seen in our patient (Figure 2). Unlike in lichen planus, the oral mucosa, nails, and scalp are not affected. Furthermore, pruritus typically is absent in most cases of LPPI.2,4 Histopathologic findings include an atrophic epidermis with lichenoid infiltrates of lymphocytes and histocytes as well as substantial pigmentary incontinence with melanin-containing macrophages in the papillary dermis.4,5 

Figure 2. Lichen planus pigmentosus-inversus. Well-circumscribed, hyperpigmented macules on the lower abdomen and groin.

Given the gender, age, and clinical features of our patient, this case represents a classic scenario of LPPI. It currently is unknown if ethnicity plays a role in the disorder. Lichen planus pigmentosus-inversus initially was thought to be more prevalent in White patients; however, studies have been reported in individuals with darker skin.1,2 

The main differential diagnosis includes erythema dyschromicum perstans, postinflammatory hyperpigmentation, and lichen planus. Although erythema dyschromicum perstans develops in individuals with darker skin, lesions are restricted to the upper torso and limbs.2-4 In both lichen planus and lichen actinicus, skin findings primarily develop in sun-exposed areas, such as the face, neck, and hands.4,6 Given the negative history of trauma, postinflammatory hyperpigmentation was unlikely in our patient. Furthermore, a distinguishing characteristic of LPPI is the deposition of melanin deep within the dermal layer.

Lesions developing in nonexposed intertriginous skin makes LPPI unique and distinguishes it from other more common conditions. The lesions commonly are hyperpigmented and are not as pruritic as other lichen-associated conditions. Lichen planus pigmentosus-inversus often persists for months, and the rash generally is resistant to treatment.2,5 Topical tacrolimus and high-dose steroids may improve symptoms, though results have varied substantially. In addition, some cases have resolved spontaneously.1,4,6,7 Because LPPI is asymptomatic and benign, spontaneous resolution and routine care is a reasonable treatment strategy. Some cases have supported this strategy as safe and high-value care.2 

References
  1. Mohamed M, Korbi M, Hammedi F, et al. Lichen planus pigmentosus inversus: a series of 10 Tunisian patients. Int J Dermatol. 2016;55:1088-1091.
  2. Lichen planus pigmentosus-inversus: a rare variant of lichen planus. J Am Acad Dermatol. 2015;72(suppl 1):AB239. https://doi.org /10.1016/j.jaad.2015.02.959
  3. Chen S, Sun W, Zhou G, et al. Lichen planus pigmentosus-inversus: report of three Chinese cases and review of the published work. J Dermatol. 2015;42:77-80.
  4. Tabanlıoǧlu-Onan D, Íncel-Uysal P, Öktem A, et al. Lichen planus pigmentosus-inversus: a peculiar variant of lichen planus. Dermatologica Sinica. 2017;35:210-212.
  5. Barros HR, Almeida JR, Mattos e Dinato SL, et al. Lichen planus pigmentosus inversus. An Bras Dermatol. 2013;88(6 suppl 1):146-149.
  6. Bennàssar A, Mas A, Julià M, et al. Annular plaques in the skin folds: 4 cases of lichen planus pigmentosus-inversus [in Spanish]. Actas Dermosifiliogr. 2009;100:602-605.
  7. Ghorbel HH, Badri T, Ben Brahim E, et al. Lichen planus pigmentosus inversus. Indian J Dermatol Venereol Leprol. 2014;80:580.
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Drs. Hoang, Downing, Rickstrew, Siscos, and Rajpara are from the Division of Dermatology, University of Kansas Medical Center, Kansas City. Dr. Cook is from the Oklahoma State University Center for Health Sciences, Tulsa.

The authors report no conflict of interest.

Correspondence: Courtney Cook, DO, Oklahoma State University Center for Health Sciences, 1111 W 17th St, Tulsa, OK 74107 ([email protected]). 

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Drs. Hoang, Downing, Rickstrew, Siscos, and Rajpara are from the Division of Dermatology, University of Kansas Medical Center, Kansas City. Dr. Cook is from the Oklahoma State University Center for Health Sciences, Tulsa.

The authors report no conflict of interest.

Correspondence: Courtney Cook, DO, Oklahoma State University Center for Health Sciences, 1111 W 17th St, Tulsa, OK 74107 ([email protected]). 

Author and Disclosure Information

Drs. Hoang, Downing, Rickstrew, Siscos, and Rajpara are from the Division of Dermatology, University of Kansas Medical Center, Kansas City. Dr. Cook is from the Oklahoma State University Center for Health Sciences, Tulsa.

The authors report no conflict of interest.

Correspondence: Courtney Cook, DO, Oklahoma State University Center for Health Sciences, 1111 W 17th St, Tulsa, OK 74107 ([email protected]). 

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The Diagnosis: Lichen Planus Pigmentosus-Inversus 

Histopathologic examination revealed hyperkeratosis with dense, bandlike, lymphocytic inflammation at the dermoepidermal junction with associated melanin-containing macrophages in the papillary dermis (Figure 1). The physical examination and histopathology were consistent with a diagnosis of lichen planus pigmentosus-inversus (LPPI). Treatment was discussed with the patient, with options including phototherapy, tacrolimus, or a high-dose steroid. Given that the lesions were asymptomatic and not bothersome, the patient denied treatment and agreed to routine follow-up. 

Figure 1. Lichen planus pigmentosus-inversus. A, Hyperkeratosis with lymphocytic inflammation at the dermoepidermal junction with melanin-containing macrophages in the papillary dermis (H&E, original magnification ×40). B, Bandlike lymphocytic infiltrate at the dermoepidermal junction (H&E, original magnification ×20).


The first case of LPPI was reported in 20011; since then, approximately 100 cases have been reported in the literature.2 A rare variant of lichen planus, LPPI predominantly occurs in middle-aged women.2,3 Lichen planus pigmentosus-inversus is characterized by well-circumscribed, brown macules confined to non-sun-exposed intertriginous areas such as the axillae and groin.2 Although the rash remains localized, multiple lesions could arise in the same area, such as the groin as seen in our patient (Figure 2). Unlike in lichen planus, the oral mucosa, nails, and scalp are not affected. Furthermore, pruritus typically is absent in most cases of LPPI.2,4 Histopathologic findings include an atrophic epidermis with lichenoid infiltrates of lymphocytes and histocytes as well as substantial pigmentary incontinence with melanin-containing macrophages in the papillary dermis.4,5 

Figure 2. Lichen planus pigmentosus-inversus. Well-circumscribed, hyperpigmented macules on the lower abdomen and groin.

Given the gender, age, and clinical features of our patient, this case represents a classic scenario of LPPI. It currently is unknown if ethnicity plays a role in the disorder. Lichen planus pigmentosus-inversus initially was thought to be more prevalent in White patients; however, studies have been reported in individuals with darker skin.1,2 

The main differential diagnosis includes erythema dyschromicum perstans, postinflammatory hyperpigmentation, and lichen planus. Although erythema dyschromicum perstans develops in individuals with darker skin, lesions are restricted to the upper torso and limbs.2-4 In both lichen planus and lichen actinicus, skin findings primarily develop in sun-exposed areas, such as the face, neck, and hands.4,6 Given the negative history of trauma, postinflammatory hyperpigmentation was unlikely in our patient. Furthermore, a distinguishing characteristic of LPPI is the deposition of melanin deep within the dermal layer.

Lesions developing in nonexposed intertriginous skin makes LPPI unique and distinguishes it from other more common conditions. The lesions commonly are hyperpigmented and are not as pruritic as other lichen-associated conditions. Lichen planus pigmentosus-inversus often persists for months, and the rash generally is resistant to treatment.2,5 Topical tacrolimus and high-dose steroids may improve symptoms, though results have varied substantially. In addition, some cases have resolved spontaneously.1,4,6,7 Because LPPI is asymptomatic and benign, spontaneous resolution and routine care is a reasonable treatment strategy. Some cases have supported this strategy as safe and high-value care.2 

The Diagnosis: Lichen Planus Pigmentosus-Inversus 

Histopathologic examination revealed hyperkeratosis with dense, bandlike, lymphocytic inflammation at the dermoepidermal junction with associated melanin-containing macrophages in the papillary dermis (Figure 1). The physical examination and histopathology were consistent with a diagnosis of lichen planus pigmentosus-inversus (LPPI). Treatment was discussed with the patient, with options including phototherapy, tacrolimus, or a high-dose steroid. Given that the lesions were asymptomatic and not bothersome, the patient denied treatment and agreed to routine follow-up. 

Figure 1. Lichen planus pigmentosus-inversus. A, Hyperkeratosis with lymphocytic inflammation at the dermoepidermal junction with melanin-containing macrophages in the papillary dermis (H&E, original magnification ×40). B, Bandlike lymphocytic infiltrate at the dermoepidermal junction (H&E, original magnification ×20).


The first case of LPPI was reported in 20011; since then, approximately 100 cases have been reported in the literature.2 A rare variant of lichen planus, LPPI predominantly occurs in middle-aged women.2,3 Lichen planus pigmentosus-inversus is characterized by well-circumscribed, brown macules confined to non-sun-exposed intertriginous areas such as the axillae and groin.2 Although the rash remains localized, multiple lesions could arise in the same area, such as the groin as seen in our patient (Figure 2). Unlike in lichen planus, the oral mucosa, nails, and scalp are not affected. Furthermore, pruritus typically is absent in most cases of LPPI.2,4 Histopathologic findings include an atrophic epidermis with lichenoid infiltrates of lymphocytes and histocytes as well as substantial pigmentary incontinence with melanin-containing macrophages in the papillary dermis.4,5 

Figure 2. Lichen planus pigmentosus-inversus. Well-circumscribed, hyperpigmented macules on the lower abdomen and groin.

Given the gender, age, and clinical features of our patient, this case represents a classic scenario of LPPI. It currently is unknown if ethnicity plays a role in the disorder. Lichen planus pigmentosus-inversus initially was thought to be more prevalent in White patients; however, studies have been reported in individuals with darker skin.1,2 

The main differential diagnosis includes erythema dyschromicum perstans, postinflammatory hyperpigmentation, and lichen planus. Although erythema dyschromicum perstans develops in individuals with darker skin, lesions are restricted to the upper torso and limbs.2-4 In both lichen planus and lichen actinicus, skin findings primarily develop in sun-exposed areas, such as the face, neck, and hands.4,6 Given the negative history of trauma, postinflammatory hyperpigmentation was unlikely in our patient. Furthermore, a distinguishing characteristic of LPPI is the deposition of melanin deep within the dermal layer.

Lesions developing in nonexposed intertriginous skin makes LPPI unique and distinguishes it from other more common conditions. The lesions commonly are hyperpigmented and are not as pruritic as other lichen-associated conditions. Lichen planus pigmentosus-inversus often persists for months, and the rash generally is resistant to treatment.2,5 Topical tacrolimus and high-dose steroids may improve symptoms, though results have varied substantially. In addition, some cases have resolved spontaneously.1,4,6,7 Because LPPI is asymptomatic and benign, spontaneous resolution and routine care is a reasonable treatment strategy. Some cases have supported this strategy as safe and high-value care.2 

References
  1. Mohamed M, Korbi M, Hammedi F, et al. Lichen planus pigmentosus inversus: a series of 10 Tunisian patients. Int J Dermatol. 2016;55:1088-1091.
  2. Lichen planus pigmentosus-inversus: a rare variant of lichen planus. J Am Acad Dermatol. 2015;72(suppl 1):AB239. https://doi.org /10.1016/j.jaad.2015.02.959
  3. Chen S, Sun W, Zhou G, et al. Lichen planus pigmentosus-inversus: report of three Chinese cases and review of the published work. J Dermatol. 2015;42:77-80.
  4. Tabanlıoǧlu-Onan D, Íncel-Uysal P, Öktem A, et al. Lichen planus pigmentosus-inversus: a peculiar variant of lichen planus. Dermatologica Sinica. 2017;35:210-212.
  5. Barros HR, Almeida JR, Mattos e Dinato SL, et al. Lichen planus pigmentosus inversus. An Bras Dermatol. 2013;88(6 suppl 1):146-149.
  6. Bennàssar A, Mas A, Julià M, et al. Annular plaques in the skin folds: 4 cases of lichen planus pigmentosus-inversus [in Spanish]. Actas Dermosifiliogr. 2009;100:602-605.
  7. Ghorbel HH, Badri T, Ben Brahim E, et al. Lichen planus pigmentosus inversus. Indian J Dermatol Venereol Leprol. 2014;80:580.
References
  1. Mohamed M, Korbi M, Hammedi F, et al. Lichen planus pigmentosus inversus: a series of 10 Tunisian patients. Int J Dermatol. 2016;55:1088-1091.
  2. Lichen planus pigmentosus-inversus: a rare variant of lichen planus. J Am Acad Dermatol. 2015;72(suppl 1):AB239. https://doi.org /10.1016/j.jaad.2015.02.959
  3. Chen S, Sun W, Zhou G, et al. Lichen planus pigmentosus-inversus: report of three Chinese cases and review of the published work. J Dermatol. 2015;42:77-80.
  4. Tabanlıoǧlu-Onan D, Íncel-Uysal P, Öktem A, et al. Lichen planus pigmentosus-inversus: a peculiar variant of lichen planus. Dermatologica Sinica. 2017;35:210-212.
  5. Barros HR, Almeida JR, Mattos e Dinato SL, et al. Lichen planus pigmentosus inversus. An Bras Dermatol. 2013;88(6 suppl 1):146-149.
  6. Bennàssar A, Mas A, Julià M, et al. Annular plaques in the skin folds: 4 cases of lichen planus pigmentosus-inversus [in Spanish]. Actas Dermosifiliogr. 2009;100:602-605.
  7. Ghorbel HH, Badri T, Ben Brahim E, et al. Lichen planus pigmentosus inversus. Indian J Dermatol Venereol Leprol. 2014;80:580.
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A 45-year-old African American woman presented with an asymptomatic rash that had worsened over the month prior to presentation. It initially began on the upper thighs and then spread to the abdomen, groin, and buttocks. The rash was mildly pruritic and had grown both in size and number of lesions. She had not tried any new over-the-counter medications. Her medical history was notable for late-stage breast cancer diagnosed 4 years prior that was treated with radiation and neoadjuvant NeoPACT—carboplatin, docetaxel, and pembrolizumab. One year prior to presentation, she underwent a lumpectomy that was complicated by gas gangrene of the finger. She has been in remission since the surgery. Physical examination at the current presentation was remarkable for multiple well-circumscribed, hyperpigmented macules on the medial thighs, lower abdomen, and buttocks. Syphilis antibody screening was negative.

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In U.S., lockdowns added 2 pounds per month

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Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.

Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.

“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.

Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.

The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.

Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.

“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”

The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.

Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.

“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”

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

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Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.

Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.

“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.

Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.

The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.

Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.

“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”

The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.

Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.

“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”

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

Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.

Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.

“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.

Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.

The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.

Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.

“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”

The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.

Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.

“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”

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

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Could tamoxifen dose be slashed down to 2.5 mg? 

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Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

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Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

 

Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

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Contact allergen of the year found in foam in shin guards, footwear

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Tue, 03/30/2021 - 14:20

The American Contact Dermatitis Society has selected acetophenone azine, linked to reactions associated with shins pads and footwear, as the “Contact Allergen of the Year” for 2021.

©Jody Dingle/Fotolia.com

The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.

The chemical formula of acetophenone azine is C16H16N2.

Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).

A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.

In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.



In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.

The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.

In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.

“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.

Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.

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The American Contact Dermatitis Society has selected acetophenone azine, linked to reactions associated with shins pads and footwear, as the “Contact Allergen of the Year” for 2021.

©Jody Dingle/Fotolia.com

The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.

The chemical formula of acetophenone azine is C16H16N2.

Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).

A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.

In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.



In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.

The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.

In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.

“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.

Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.

The American Contact Dermatitis Society has selected acetophenone azine, linked to reactions associated with shins pads and footwear, as the “Contact Allergen of the Year” for 2021.

©Jody Dingle/Fotolia.com

The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.

The chemical formula of acetophenone azine is C16H16N2.

Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).

A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.

In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.



In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.

The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.

In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.

“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.

Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.

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Obesity pegged as source of marked increased risk of diabetes in PCOS

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Tue, 03/30/2021 - 12:52

The increased risk of type 2 diabetes in women with polycystic ovary syndrome is well established, but a new analysis has shown that obesity is the major mediator and a target for preventing or reversing this comorbidity.

rumruay/Shutterstock

“Most women with PCOS are obese, complicating the effort to understand whether high rates of diabetes in this population are due to PCOS or excess weight, but our study now suggest that obesity isa targetable risk factor,” reported Panagiotis Anagnostis, MD, PhD, a reproductive endocrinologist at the Medical School of Aristotle University, Thessaloniki, Greece.

Obesity is also a known risk factor for type 2 diabetes (T2D), but there is reason to suspect that PCOS, which is associated with abnormal carbohydrate metabolism, has a direct impact on the risk of developing T2D, according to Dr. Anagnostis. It is also reasonable to expect “a synergistic deleterious effect” from PCOS and obesity on adverse changes in glucose metabolism that lead to T2D.

Even though rates of obesity among women with PCOS reach 80% in some studies, Dr. Anagnostis attempted to disentangle the relationship between obesity, PCOS, and risk of T2D using a large set of data drawn from a comprehensive search of published studies.

After screening with predefined criteria, 12 studies provided data on 224,284 women, of whom 45,361 had PCOS and 5,717 had T2D. Not least of the criteria for inclusion in this analysis, all studies stratified women as obese, defined as a body mass index (BMI) greater than 30 kg/m2, or nonobese, he reported at the annual meeting of the Endocrine Society.



Diabetes risk tripled in PCOS

When compared without regard to BMI, the relative risk of having T2D among those with PCOS relative to those without this condition was more than three times greater (RR 3.13; P < .001). When women with PCOS were stratified for BMI, obesity was associated with a more than fourfold increased risk relative to controls without PCOS (RR, 4.06; P < .001).

In women who were nonobese, the risk of T2D was numerically higher for those with PCOS than those without (RR, 2.68), but it was only a trend with a large confidence interval (95% confidence interval, 0.97-7.49).

Among women with PCOS, those who were obese also had a more than fourfold and highly significant increased risk of T2D relative to those who were not obese (RR, 4.20; P < .001).

The message from these data is that obesity is a major and potentially modifiable risk factor for diabetes in women with PCOS, according to Dr. Anagnostis.

He said these data provide the basis for recommending weight loss specifically for managing this common PCOS comorbidity.

Almost the same relative risk of diabetes was derived from an analysis of a women’s health database published 2 years ago in Diabetes Care. In that study with 1,916 person-years of follow-up, the hazard ratio for T2D was also more than three times greater (HR, 3.23; P < .001) for those with PCOS relative to those without the syndrome.

However, normal BMI did not eliminate risk of developing diabetes in this study. Rather, the relative risk of T2D in women with PCOS was higher in those of normal weight, compared with those who were obese (HR, 4.68 vs. 2.36; P < .005). The investigators recommend screening all women with PCOS at least every 3 years with more frequent screening in those with risk factors.



PCOS complexity challenges simple conclusions

The complexity of disturbed metabolic pathways in patients with PCOS and obesity might explain some of the difficulty in unraveling the relationship between these two disease states and diabetes risk. In one recent review, it was suggested that obesity and PCOS share interrelated adverse effects on glucose metabolism. As a result, these associations are “more complex than a simple cause-and-effect process.” the authors of that article concluded.

Furthermore, in their examination of metabolic pathways, genetic susceptibility, and behavioral factors that might link PCOS, weight gain, and T2D, the authors did not ignore the psychological impact of PCOS in causing obesity and, as a byproduct, diabetes. These psychological factors might be relevant to treatment.

For example, depression and stress “might hamper ongoing attempts at lifestyle change and therefore effective weight loss” in at least some women, they cautioned.

However, in encouraging weight loss in overweight women with PCOS, the debate about cause of T2D might be moot in practical terms, according to Michael Dansinger, MD, founding director of the diabetes reversal program at Tufts Medical Center, Boston.

“Reducing excess body fat reduces the risk of type 2 diabetes,” Dr. Dansinger said in an interview. “Since women with obesity and PCOS are clearly at risk for future type 2 diabetes, that’s another reason to lose excess body fat through healthy eating and exercise.”

Dr. Anagnostis and Dr. Dansinger reported no relevant conflicts of interest.

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The increased risk of type 2 diabetes in women with polycystic ovary syndrome is well established, but a new analysis has shown that obesity is the major mediator and a target for preventing or reversing this comorbidity.

rumruay/Shutterstock

“Most women with PCOS are obese, complicating the effort to understand whether high rates of diabetes in this population are due to PCOS or excess weight, but our study now suggest that obesity isa targetable risk factor,” reported Panagiotis Anagnostis, MD, PhD, a reproductive endocrinologist at the Medical School of Aristotle University, Thessaloniki, Greece.

Obesity is also a known risk factor for type 2 diabetes (T2D), but there is reason to suspect that PCOS, which is associated with abnormal carbohydrate metabolism, has a direct impact on the risk of developing T2D, according to Dr. Anagnostis. It is also reasonable to expect “a synergistic deleterious effect” from PCOS and obesity on adverse changes in glucose metabolism that lead to T2D.

Even though rates of obesity among women with PCOS reach 80% in some studies, Dr. Anagnostis attempted to disentangle the relationship between obesity, PCOS, and risk of T2D using a large set of data drawn from a comprehensive search of published studies.

After screening with predefined criteria, 12 studies provided data on 224,284 women, of whom 45,361 had PCOS and 5,717 had T2D. Not least of the criteria for inclusion in this analysis, all studies stratified women as obese, defined as a body mass index (BMI) greater than 30 kg/m2, or nonobese, he reported at the annual meeting of the Endocrine Society.



Diabetes risk tripled in PCOS

When compared without regard to BMI, the relative risk of having T2D among those with PCOS relative to those without this condition was more than three times greater (RR 3.13; P < .001). When women with PCOS were stratified for BMI, obesity was associated with a more than fourfold increased risk relative to controls without PCOS (RR, 4.06; P < .001).

In women who were nonobese, the risk of T2D was numerically higher for those with PCOS than those without (RR, 2.68), but it was only a trend with a large confidence interval (95% confidence interval, 0.97-7.49).

Among women with PCOS, those who were obese also had a more than fourfold and highly significant increased risk of T2D relative to those who were not obese (RR, 4.20; P < .001).

The message from these data is that obesity is a major and potentially modifiable risk factor for diabetes in women with PCOS, according to Dr. Anagnostis.

He said these data provide the basis for recommending weight loss specifically for managing this common PCOS comorbidity.

Almost the same relative risk of diabetes was derived from an analysis of a women’s health database published 2 years ago in Diabetes Care. In that study with 1,916 person-years of follow-up, the hazard ratio for T2D was also more than three times greater (HR, 3.23; P < .001) for those with PCOS relative to those without the syndrome.

However, normal BMI did not eliminate risk of developing diabetes in this study. Rather, the relative risk of T2D in women with PCOS was higher in those of normal weight, compared with those who were obese (HR, 4.68 vs. 2.36; P < .005). The investigators recommend screening all women with PCOS at least every 3 years with more frequent screening in those with risk factors.



PCOS complexity challenges simple conclusions

The complexity of disturbed metabolic pathways in patients with PCOS and obesity might explain some of the difficulty in unraveling the relationship between these two disease states and diabetes risk. In one recent review, it was suggested that obesity and PCOS share interrelated adverse effects on glucose metabolism. As a result, these associations are “more complex than a simple cause-and-effect process.” the authors of that article concluded.

Furthermore, in their examination of metabolic pathways, genetic susceptibility, and behavioral factors that might link PCOS, weight gain, and T2D, the authors did not ignore the psychological impact of PCOS in causing obesity and, as a byproduct, diabetes. These psychological factors might be relevant to treatment.

For example, depression and stress “might hamper ongoing attempts at lifestyle change and therefore effective weight loss” in at least some women, they cautioned.

However, in encouraging weight loss in overweight women with PCOS, the debate about cause of T2D might be moot in practical terms, according to Michael Dansinger, MD, founding director of the diabetes reversal program at Tufts Medical Center, Boston.

“Reducing excess body fat reduces the risk of type 2 diabetes,” Dr. Dansinger said in an interview. “Since women with obesity and PCOS are clearly at risk for future type 2 diabetes, that’s another reason to lose excess body fat through healthy eating and exercise.”

Dr. Anagnostis and Dr. Dansinger reported no relevant conflicts of interest.

The increased risk of type 2 diabetes in women with polycystic ovary syndrome is well established, but a new analysis has shown that obesity is the major mediator and a target for preventing or reversing this comorbidity.

rumruay/Shutterstock

“Most women with PCOS are obese, complicating the effort to understand whether high rates of diabetes in this population are due to PCOS or excess weight, but our study now suggest that obesity isa targetable risk factor,” reported Panagiotis Anagnostis, MD, PhD, a reproductive endocrinologist at the Medical School of Aristotle University, Thessaloniki, Greece.

Obesity is also a known risk factor for type 2 diabetes (T2D), but there is reason to suspect that PCOS, which is associated with abnormal carbohydrate metabolism, has a direct impact on the risk of developing T2D, according to Dr. Anagnostis. It is also reasonable to expect “a synergistic deleterious effect” from PCOS and obesity on adverse changes in glucose metabolism that lead to T2D.

Even though rates of obesity among women with PCOS reach 80% in some studies, Dr. Anagnostis attempted to disentangle the relationship between obesity, PCOS, and risk of T2D using a large set of data drawn from a comprehensive search of published studies.

After screening with predefined criteria, 12 studies provided data on 224,284 women, of whom 45,361 had PCOS and 5,717 had T2D. Not least of the criteria for inclusion in this analysis, all studies stratified women as obese, defined as a body mass index (BMI) greater than 30 kg/m2, or nonobese, he reported at the annual meeting of the Endocrine Society.



Diabetes risk tripled in PCOS

When compared without regard to BMI, the relative risk of having T2D among those with PCOS relative to those without this condition was more than three times greater (RR 3.13; P < .001). When women with PCOS were stratified for BMI, obesity was associated with a more than fourfold increased risk relative to controls without PCOS (RR, 4.06; P < .001).

In women who were nonobese, the risk of T2D was numerically higher for those with PCOS than those without (RR, 2.68), but it was only a trend with a large confidence interval (95% confidence interval, 0.97-7.49).

Among women with PCOS, those who were obese also had a more than fourfold and highly significant increased risk of T2D relative to those who were not obese (RR, 4.20; P < .001).

The message from these data is that obesity is a major and potentially modifiable risk factor for diabetes in women with PCOS, according to Dr. Anagnostis.

He said these data provide the basis for recommending weight loss specifically for managing this common PCOS comorbidity.

Almost the same relative risk of diabetes was derived from an analysis of a women’s health database published 2 years ago in Diabetes Care. In that study with 1,916 person-years of follow-up, the hazard ratio for T2D was also more than three times greater (HR, 3.23; P < .001) for those with PCOS relative to those without the syndrome.

However, normal BMI did not eliminate risk of developing diabetes in this study. Rather, the relative risk of T2D in women with PCOS was higher in those of normal weight, compared with those who were obese (HR, 4.68 vs. 2.36; P < .005). The investigators recommend screening all women with PCOS at least every 3 years with more frequent screening in those with risk factors.



PCOS complexity challenges simple conclusions

The complexity of disturbed metabolic pathways in patients with PCOS and obesity might explain some of the difficulty in unraveling the relationship between these two disease states and diabetes risk. In one recent review, it was suggested that obesity and PCOS share interrelated adverse effects on glucose metabolism. As a result, these associations are “more complex than a simple cause-and-effect process.” the authors of that article concluded.

Furthermore, in their examination of metabolic pathways, genetic susceptibility, and behavioral factors that might link PCOS, weight gain, and T2D, the authors did not ignore the psychological impact of PCOS in causing obesity and, as a byproduct, diabetes. These psychological factors might be relevant to treatment.

For example, depression and stress “might hamper ongoing attempts at lifestyle change and therefore effective weight loss” in at least some women, they cautioned.

However, in encouraging weight loss in overweight women with PCOS, the debate about cause of T2D might be moot in practical terms, according to Michael Dansinger, MD, founding director of the diabetes reversal program at Tufts Medical Center, Boston.

“Reducing excess body fat reduces the risk of type 2 diabetes,” Dr. Dansinger said in an interview. “Since women with obesity and PCOS are clearly at risk for future type 2 diabetes, that’s another reason to lose excess body fat through healthy eating and exercise.”

Dr. Anagnostis and Dr. Dansinger reported no relevant conflicts of interest.

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Itch response faster with abrocitinib in trial comparing JAK inhibitor to dupilumab

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Changed
Thu, 03/25/2021 - 09:05

An experimental oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, showed greater itch reduction after 2 weeks of treatment than dupilumab in patients with moderate to severe atopic dermatitis (AD), in a multicenter, randomized trial.

Dr. Jonathan I. Silverberg

In addition, in the study, those on 200-mg and 100-mg daily doses of abrocitinib experienced significantly greater reductions in signs and symptoms of AD at 12 and 16 weeks, than those on placebo, the authors reported.

The findings from the JADE COMPARE trial, published on March 25 in the New England Journal of Medicine, suggest abrocitinib will provide clinicians with another treatment option for patients who don’t get adequate relief from either topical medications or dupilumab. Abrocitinib is associated with a different set of adverse reactions than dupilumab, according to investigators.

In 2017, dupilumab (Dupixent) became the first systemic drug approved by the Food and Drug Administration specifically for AD, though systemic steroids and other immunosuppressant drugs are sometimes prescribed. A monoclonal antibody delivered by subcutaneous injection, dupilumab binds to interleukin-4 receptors to block signaling pathways involved in AD; it is now approved for treatment of patients with moderate to severe AD down to age 6 years.

“It is sort of the bar for efficacy and for safety in those patients, because that’s what we have right now,” said one of the JADE Compare investigators and study author, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview. “For any new therapy coming to market, we really do want to understand how it compares to what’s out there.”

Abrocitinib is a small molecule that inhibits JAK1, which is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin. Two other JAK1 inhibitors, baricitinib and upadacitinib, are also being investigated as systemic treatments for AD.

In JADE COMPARE, people with moderate to severe AD from 18 countries on four continents, entered a 28-day screening period during which they discontinued treatments. They began using emollients twice a day at least 7 days before being randomly assigned to a treatment group, and continued on topical medication once daily. Topical treatments included low- or medium-potency topical glucocorticoids, calcineurin inhibitors, and phosphodiesterase-4 inhibitors.

The researchers randomly assigned 838 to trial groups: 226 received 200 mg of abrocitinib orally once a day, 238 received 100 mg of abrocitinib once a day, 243 received a 300-mg dupilumab injection every other week, and 131 received placebo versions of both medications, for 16 weeks. The mean age of the patients overall was about 38 years; about two-thirds were White.

At 2 weeks, half of the patients on 200 mg of abrocitinib and 31.8% of those on the 100-mg dose had an itch response, defined as at least a 4-point improvement from baseline in the 0-10 Peak Pruritus Numerical Rating Scale. This was compared with 26.4% of those on dupilumab and 13.8% of those on placebo.

And at 12 weeks, more of the patients in the 200-mg abrocitinib group than in the other groups had an Investigator’s Global Assessment (IGA) response (defined as clear or almost clear) and more had an Eczema Area and Severity Index (EASI-75) response (defined as an improvement of at least 75%). (See Table) EASI-75 and IGA responses at week 12 were the primary outcomes of the study.



The differences between both abrocitinib groups and the placebo group were statistically significant by all these measures (P < .001). The difference between the 200-mg abrocitinib and the dupilumab group was only significant for itch at 2 weeks, and the difference in itch response between the 100-mg group and the dupilumab group at 2 weeks was not significant (P < .20).

At 16 weeks, the EASI-75 response (a secondary endpoint) among those on either dose of abrocitinib was not significantly different than among those on dupilumab (71% and 60.3% among those on 200 mg and 100 mg, respectively; and 65.5% among those on dupilumab, compared with 30.6% of those on placebo).

“The patients I have on this medicine [abrocitinib] are very happy,” said one of the study authors, Melinda Gooderham, MsC, MD, an assistant professor at Queen’s University, Kingston, Ont., an investigator in the trial. “It works very quickly for itch,” she said in an interview.

The study didn’t have sufficient statistical power to fully explore the comparison to dupilumab, and future trials will go deeper into the comparison, she added.

Still, in this trial, abrocitinib demonstrated a clear advantage in the speed and depth of efficacy, Dr. Silverberg noted. “The 100-mg dose of abrocitinib was about as effective as, or maybe slightly less effective than, dupilumab, and the 200-mg dose was more effective than dupilumab.”



The overall incidence of adverse events was higher in the 200-mg abrocitinib arm than in the other groups, but the incidence of serious or severe adverse events, and the incidence of adverse events that resulted in discontinuing the medication, were similar across the trial groups.

However, nausea affected 11.1% of the patients in the 200-mg abrocitinib group and 4.2% of those in the 100-mg abrocitinib group. Acne was also reported in these groups (6.6% and 2.9%, among those on 200 mg and 100 mg, respectively, compared with 1.2% of those on dupilumab and none of those on placebo). In a few of those on abrocitinib, herpes zoster flared up. And median platelet counts decreased among the patients taking abrocitinib, although none dropped below 75,000/mm3. Serious infections were reported in two patients on abrocitinib, but resolved.

By contrast, only 2.9% of the patients on dupilumab had nausea. But 6.2% in the dupilumab group had conjunctivitis, compared with 1.3% of patients in the 200-mg abrocitinib group and 0.8 in the 100-mg abrocitinib group.

As an oral medication, abrocitinib will appeal to patients who want to avoid injections, and dosing will be easier to adjust, Dr. Silverberg said. On the other hand, he added, dupilumab will have an advantage for patients who don’t want to take a daily medication, or who are concerned about the adverse events associated with abrocitinib, particularly those with blood-clotting disorders.

On the basis of two previous JADE phase 3 trials, Pfizer has submitted a new drug application for abrocitinib for treating moderate to severe AD in patients aged 12 and older to the FDA; a decision is expected in April, according to the company. The company has also applied to market the drug in Europe and the United Kingdom.

The study was funded by Pfizer. Dr. Silverberg’s disclosures included serving as a consultant to companies including AbbVie, Pfizer, and Regeneron. Several authors are Pfizer employees; other authors had disclosures related to Pfizer and other pharmaceutical companies.

 

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An experimental oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, showed greater itch reduction after 2 weeks of treatment than dupilumab in patients with moderate to severe atopic dermatitis (AD), in a multicenter, randomized trial.

Dr. Jonathan I. Silverberg

In addition, in the study, those on 200-mg and 100-mg daily doses of abrocitinib experienced significantly greater reductions in signs and symptoms of AD at 12 and 16 weeks, than those on placebo, the authors reported.

The findings from the JADE COMPARE trial, published on March 25 in the New England Journal of Medicine, suggest abrocitinib will provide clinicians with another treatment option for patients who don’t get adequate relief from either topical medications or dupilumab. Abrocitinib is associated with a different set of adverse reactions than dupilumab, according to investigators.

In 2017, dupilumab (Dupixent) became the first systemic drug approved by the Food and Drug Administration specifically for AD, though systemic steroids and other immunosuppressant drugs are sometimes prescribed. A monoclonal antibody delivered by subcutaneous injection, dupilumab binds to interleukin-4 receptors to block signaling pathways involved in AD; it is now approved for treatment of patients with moderate to severe AD down to age 6 years.

“It is sort of the bar for efficacy and for safety in those patients, because that’s what we have right now,” said one of the JADE Compare investigators and study author, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview. “For any new therapy coming to market, we really do want to understand how it compares to what’s out there.”

Abrocitinib is a small molecule that inhibits JAK1, which is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin. Two other JAK1 inhibitors, baricitinib and upadacitinib, are also being investigated as systemic treatments for AD.

In JADE COMPARE, people with moderate to severe AD from 18 countries on four continents, entered a 28-day screening period during which they discontinued treatments. They began using emollients twice a day at least 7 days before being randomly assigned to a treatment group, and continued on topical medication once daily. Topical treatments included low- or medium-potency topical glucocorticoids, calcineurin inhibitors, and phosphodiesterase-4 inhibitors.

The researchers randomly assigned 838 to trial groups: 226 received 200 mg of abrocitinib orally once a day, 238 received 100 mg of abrocitinib once a day, 243 received a 300-mg dupilumab injection every other week, and 131 received placebo versions of both medications, for 16 weeks. The mean age of the patients overall was about 38 years; about two-thirds were White.

At 2 weeks, half of the patients on 200 mg of abrocitinib and 31.8% of those on the 100-mg dose had an itch response, defined as at least a 4-point improvement from baseline in the 0-10 Peak Pruritus Numerical Rating Scale. This was compared with 26.4% of those on dupilumab and 13.8% of those on placebo.

And at 12 weeks, more of the patients in the 200-mg abrocitinib group than in the other groups had an Investigator’s Global Assessment (IGA) response (defined as clear or almost clear) and more had an Eczema Area and Severity Index (EASI-75) response (defined as an improvement of at least 75%). (See Table) EASI-75 and IGA responses at week 12 were the primary outcomes of the study.



The differences between both abrocitinib groups and the placebo group were statistically significant by all these measures (P < .001). The difference between the 200-mg abrocitinib and the dupilumab group was only significant for itch at 2 weeks, and the difference in itch response between the 100-mg group and the dupilumab group at 2 weeks was not significant (P < .20).

At 16 weeks, the EASI-75 response (a secondary endpoint) among those on either dose of abrocitinib was not significantly different than among those on dupilumab (71% and 60.3% among those on 200 mg and 100 mg, respectively; and 65.5% among those on dupilumab, compared with 30.6% of those on placebo).

“The patients I have on this medicine [abrocitinib] are very happy,” said one of the study authors, Melinda Gooderham, MsC, MD, an assistant professor at Queen’s University, Kingston, Ont., an investigator in the trial. “It works very quickly for itch,” she said in an interview.

The study didn’t have sufficient statistical power to fully explore the comparison to dupilumab, and future trials will go deeper into the comparison, she added.

Still, in this trial, abrocitinib demonstrated a clear advantage in the speed and depth of efficacy, Dr. Silverberg noted. “The 100-mg dose of abrocitinib was about as effective as, or maybe slightly less effective than, dupilumab, and the 200-mg dose was more effective than dupilumab.”



The overall incidence of adverse events was higher in the 200-mg abrocitinib arm than in the other groups, but the incidence of serious or severe adverse events, and the incidence of adverse events that resulted in discontinuing the medication, were similar across the trial groups.

However, nausea affected 11.1% of the patients in the 200-mg abrocitinib group and 4.2% of those in the 100-mg abrocitinib group. Acne was also reported in these groups (6.6% and 2.9%, among those on 200 mg and 100 mg, respectively, compared with 1.2% of those on dupilumab and none of those on placebo). In a few of those on abrocitinib, herpes zoster flared up. And median platelet counts decreased among the patients taking abrocitinib, although none dropped below 75,000/mm3. Serious infections were reported in two patients on abrocitinib, but resolved.

By contrast, only 2.9% of the patients on dupilumab had nausea. But 6.2% in the dupilumab group had conjunctivitis, compared with 1.3% of patients in the 200-mg abrocitinib group and 0.8 in the 100-mg abrocitinib group.

As an oral medication, abrocitinib will appeal to patients who want to avoid injections, and dosing will be easier to adjust, Dr. Silverberg said. On the other hand, he added, dupilumab will have an advantage for patients who don’t want to take a daily medication, or who are concerned about the adverse events associated with abrocitinib, particularly those with blood-clotting disorders.

On the basis of two previous JADE phase 3 trials, Pfizer has submitted a new drug application for abrocitinib for treating moderate to severe AD in patients aged 12 and older to the FDA; a decision is expected in April, according to the company. The company has also applied to market the drug in Europe and the United Kingdom.

The study was funded by Pfizer. Dr. Silverberg’s disclosures included serving as a consultant to companies including AbbVie, Pfizer, and Regeneron. Several authors are Pfizer employees; other authors had disclosures related to Pfizer and other pharmaceutical companies.

 

An experimental oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, showed greater itch reduction after 2 weeks of treatment than dupilumab in patients with moderate to severe atopic dermatitis (AD), in a multicenter, randomized trial.

Dr. Jonathan I. Silverberg

In addition, in the study, those on 200-mg and 100-mg daily doses of abrocitinib experienced significantly greater reductions in signs and symptoms of AD at 12 and 16 weeks, than those on placebo, the authors reported.

The findings from the JADE COMPARE trial, published on March 25 in the New England Journal of Medicine, suggest abrocitinib will provide clinicians with another treatment option for patients who don’t get adequate relief from either topical medications or dupilumab. Abrocitinib is associated with a different set of adverse reactions than dupilumab, according to investigators.

In 2017, dupilumab (Dupixent) became the first systemic drug approved by the Food and Drug Administration specifically for AD, though systemic steroids and other immunosuppressant drugs are sometimes prescribed. A monoclonal antibody delivered by subcutaneous injection, dupilumab binds to interleukin-4 receptors to block signaling pathways involved in AD; it is now approved for treatment of patients with moderate to severe AD down to age 6 years.

“It is sort of the bar for efficacy and for safety in those patients, because that’s what we have right now,” said one of the JADE Compare investigators and study author, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview. “For any new therapy coming to market, we really do want to understand how it compares to what’s out there.”

Abrocitinib is a small molecule that inhibits JAK1, which is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin. Two other JAK1 inhibitors, baricitinib and upadacitinib, are also being investigated as systemic treatments for AD.

In JADE COMPARE, people with moderate to severe AD from 18 countries on four continents, entered a 28-day screening period during which they discontinued treatments. They began using emollients twice a day at least 7 days before being randomly assigned to a treatment group, and continued on topical medication once daily. Topical treatments included low- or medium-potency topical glucocorticoids, calcineurin inhibitors, and phosphodiesterase-4 inhibitors.

The researchers randomly assigned 838 to trial groups: 226 received 200 mg of abrocitinib orally once a day, 238 received 100 mg of abrocitinib once a day, 243 received a 300-mg dupilumab injection every other week, and 131 received placebo versions of both medications, for 16 weeks. The mean age of the patients overall was about 38 years; about two-thirds were White.

At 2 weeks, half of the patients on 200 mg of abrocitinib and 31.8% of those on the 100-mg dose had an itch response, defined as at least a 4-point improvement from baseline in the 0-10 Peak Pruritus Numerical Rating Scale. This was compared with 26.4% of those on dupilumab and 13.8% of those on placebo.

And at 12 weeks, more of the patients in the 200-mg abrocitinib group than in the other groups had an Investigator’s Global Assessment (IGA) response (defined as clear or almost clear) and more had an Eczema Area and Severity Index (EASI-75) response (defined as an improvement of at least 75%). (See Table) EASI-75 and IGA responses at week 12 were the primary outcomes of the study.



The differences between both abrocitinib groups and the placebo group were statistically significant by all these measures (P < .001). The difference between the 200-mg abrocitinib and the dupilumab group was only significant for itch at 2 weeks, and the difference in itch response between the 100-mg group and the dupilumab group at 2 weeks was not significant (P < .20).

At 16 weeks, the EASI-75 response (a secondary endpoint) among those on either dose of abrocitinib was not significantly different than among those on dupilumab (71% and 60.3% among those on 200 mg and 100 mg, respectively; and 65.5% among those on dupilumab, compared with 30.6% of those on placebo).

“The patients I have on this medicine [abrocitinib] are very happy,” said one of the study authors, Melinda Gooderham, MsC, MD, an assistant professor at Queen’s University, Kingston, Ont., an investigator in the trial. “It works very quickly for itch,” she said in an interview.

The study didn’t have sufficient statistical power to fully explore the comparison to dupilumab, and future trials will go deeper into the comparison, she added.

Still, in this trial, abrocitinib demonstrated a clear advantage in the speed and depth of efficacy, Dr. Silverberg noted. “The 100-mg dose of abrocitinib was about as effective as, or maybe slightly less effective than, dupilumab, and the 200-mg dose was more effective than dupilumab.”



The overall incidence of adverse events was higher in the 200-mg abrocitinib arm than in the other groups, but the incidence of serious or severe adverse events, and the incidence of adverse events that resulted in discontinuing the medication, were similar across the trial groups.

However, nausea affected 11.1% of the patients in the 200-mg abrocitinib group and 4.2% of those in the 100-mg abrocitinib group. Acne was also reported in these groups (6.6% and 2.9%, among those on 200 mg and 100 mg, respectively, compared with 1.2% of those on dupilumab and none of those on placebo). In a few of those on abrocitinib, herpes zoster flared up. And median platelet counts decreased among the patients taking abrocitinib, although none dropped below 75,000/mm3. Serious infections were reported in two patients on abrocitinib, but resolved.

By contrast, only 2.9% of the patients on dupilumab had nausea. But 6.2% in the dupilumab group had conjunctivitis, compared with 1.3% of patients in the 200-mg abrocitinib group and 0.8 in the 100-mg abrocitinib group.

As an oral medication, abrocitinib will appeal to patients who want to avoid injections, and dosing will be easier to adjust, Dr. Silverberg said. On the other hand, he added, dupilumab will have an advantage for patients who don’t want to take a daily medication, or who are concerned about the adverse events associated with abrocitinib, particularly those with blood-clotting disorders.

On the basis of two previous JADE phase 3 trials, Pfizer has submitted a new drug application for abrocitinib for treating moderate to severe AD in patients aged 12 and older to the FDA; a decision is expected in April, according to the company. The company has also applied to market the drug in Europe and the United Kingdom.

The study was funded by Pfizer. Dr. Silverberg’s disclosures included serving as a consultant to companies including AbbVie, Pfizer, and Regeneron. Several authors are Pfizer employees; other authors had disclosures related to Pfizer and other pharmaceutical companies.

 

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Here we go again? Rate of COVID-19 in children takes a turn for the worse

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Thu, 08/26/2021 - 15:49

 

After declining for 8 consecutive weeks, new cases of COVID-19 rose among children in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A total of 57,078 new cases were reported in children during the week of March 12-18, compared with 52,695 for the previous week, ending a streak of declines going back to mid-January, the AAP and CHA said in their weekly COVID-19 report.

Also up for the week was the proportion of all cases occurring in children. The 57,000-plus cases represented 18.7% of the total (304,610) for all ages, and that is the largest share of the new-case burden for the entire pandemic. The previous high, 18.0%, came just 2 weeks earlier, based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



Speaking of the entire pandemic, the total number of COVID-19 cases in children is over 3.34 million, and that represents 13.3% of cases among all ages in the United States. The cumulative rate of infection as of March 18 was 4,440 cases per 100,000 children, up from 4,364 per 100,000 a week earlier, the AAP and CHA said.

At the state level, Vermont has now passed the 20% mark (20.1%, to be exact) for children’s proportion of cases and is higher in that measure than any other state. The highest rate of infection (8,763 cases per 100,000) can be found in North Dakota, the AAP/CHA data show.

There were only two new coronavirus-related deaths during the week of March 12-18 after Kansas revised its mortality data, bringing the total to 268 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting deaths by age, the AAP and CHA said.

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After declining for 8 consecutive weeks, new cases of COVID-19 rose among children in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A total of 57,078 new cases were reported in children during the week of March 12-18, compared with 52,695 for the previous week, ending a streak of declines going back to mid-January, the AAP and CHA said in their weekly COVID-19 report.

Also up for the week was the proportion of all cases occurring in children. The 57,000-plus cases represented 18.7% of the total (304,610) for all ages, and that is the largest share of the new-case burden for the entire pandemic. The previous high, 18.0%, came just 2 weeks earlier, based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



Speaking of the entire pandemic, the total number of COVID-19 cases in children is over 3.34 million, and that represents 13.3% of cases among all ages in the United States. The cumulative rate of infection as of March 18 was 4,440 cases per 100,000 children, up from 4,364 per 100,000 a week earlier, the AAP and CHA said.

At the state level, Vermont has now passed the 20% mark (20.1%, to be exact) for children’s proportion of cases and is higher in that measure than any other state. The highest rate of infection (8,763 cases per 100,000) can be found in North Dakota, the AAP/CHA data show.

There were only two new coronavirus-related deaths during the week of March 12-18 after Kansas revised its mortality data, bringing the total to 268 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting deaths by age, the AAP and CHA said.

 

After declining for 8 consecutive weeks, new cases of COVID-19 rose among children in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A total of 57,078 new cases were reported in children during the week of March 12-18, compared with 52,695 for the previous week, ending a streak of declines going back to mid-January, the AAP and CHA said in their weekly COVID-19 report.

Also up for the week was the proportion of all cases occurring in children. The 57,000-plus cases represented 18.7% of the total (304,610) for all ages, and that is the largest share of the new-case burden for the entire pandemic. The previous high, 18.0%, came just 2 weeks earlier, based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.



Speaking of the entire pandemic, the total number of COVID-19 cases in children is over 3.34 million, and that represents 13.3% of cases among all ages in the United States. The cumulative rate of infection as of March 18 was 4,440 cases per 100,000 children, up from 4,364 per 100,000 a week earlier, the AAP and CHA said.

At the state level, Vermont has now passed the 20% mark (20.1%, to be exact) for children’s proportion of cases and is higher in that measure than any other state. The highest rate of infection (8,763 cases per 100,000) can be found in North Dakota, the AAP/CHA data show.

There were only two new coronavirus-related deaths during the week of March 12-18 after Kansas revised its mortality data, bringing the total to 268 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting deaths by age, the AAP and CHA said.

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